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CODE OF STATE REGULATIONS 1JOHN R. ASHCROFT (3/31/19)Secretary of State

Rules ofDepartment of Health and

Senior ServicesDivision 30—Division of Regulation and Licensure

Chapter 1—Controlled Substances

Title Page

19 CSR 30-1.002 Schedules of Controlled Substances .........................................................3

19 CSR 30-1.004 List of Excepted Substances.................................................................13

19 CSR 30-1.006 List of Exempt Anabolic Steroid Products................................................13

19 CSR 30-1.008 List of Excluded Veterinary Anabolic Steroid Implant Products......................14

19 CSR 30-1.010 Schedules of Controlled Substances (Rescinded November 30, 2000)...............14

19 CSR 30-1.011 Definitions......................................................................................15

19 CSR 30-1.013 Miscellaneous Fees ...........................................................................16

19 CSR 30-1.015 Registrations and Fees........................................................................16

19 CSR 30-1.017 Registration Process ..........................................................................16

19 CSR 30-1.019 Registration Location.........................................................................19

19 CSR 30-1.020 List of Excepted Substances (Rescinded November 30, 2000) ........................19

19 CSR 30-1.023 Registration Changes .........................................................................19

19 CSR 30-1.025 List of Exempt Anabolic Steroid Products (Rescinded November 30, 2000).......20

19 CSR 30-1.026 Separate Registrations ........................................................................20

19 CSR 30-1.027 Investigative and Administrative Procedures .............................................21

19 CSR 30-1.030 Requirements for Controlled Substances Registration(Rescinded November 30, 2000) ..........................................................21

19 CSR 30-1.031 Physical Security Requirements.............................................................21

19 CSR 30-1.032 Security for Nonpractitioners ...............................................................21

19 CSR 30-1.033 Hearing Procedures on Controlled Substances Registration(Rescinded November 30, 2000) ..........................................................22

2 CODE OF STATE REGULATIONS (3/31/19) JOHN R. ASHCROFT

Secretary of State

19 CSR 30-1.034 Security for Practitioners ....................................................................22

19 CSR 30-1.035 Requirements for Prescribing, Dispensing and Administering Controlled Substances (Rescinded November 30, 2000) ...............................23

19 CSR 30-1.036 Disposing of Unwanted Controlled Substances(Rescinded November 30, 2000) ..........................................................23

19 CSR 30-1.040 Dispensing and Distribution of Controlled Substances in Certain Situations(Rescinded July 30, 2003) ..................................................................23

19 CSR 30-1.041 Records Requirements........................................................................23

19 CSR 30-1.042 Inventory Requirements ......................................................................23

19 CSR 30-1.044 Continuing Records General Requirements...............................................25

19 CSR 30-1.046 Records for Manufacturers, Distributors, Importers and Exporters ..................25

19 CSR 30-1.048 Records for Practitioners and Researchers................................................26

19 CSR 30-1.050 Records for Chemical Analysts .............................................................27

19 CSR 30-1.052 Records for Long-Term Care Facilities (LTCF)..........................................27

19 CSR 30-1.060 Determining Lawful Prescribing, Dispensing and Administeringof Controlled Substances....................................................................28

19 CSR 30-1.062 Transmission of Prescriptions ...............................................................28

19 CSR 30-1.064 Partial Filling of Controlled Substance Prescriptions ...................................28

19 CSR 30-1.066 Dispensing by Individual Practitioners ....................................................29

19 CSR 30-1.068 Administering In Emergency Rooms.......................................................29

19 CSR 30-1.070 Emergency Dispensing of Schedule II Substances.......................................29

19 CSR 30-1.072 Dispensing of Schedule V Substances .....................................................30

19 CSR 30-1.074 Dispensing Without a Prescription .........................................................30

19 CSR 30-1.076 Emergency Distribution by a Pharmacy ...................................................32

19 CSR 30-1.078 Disposing of Unwanted Controlled Substances ..........................................32

Title 19—DEPARTMENT OFHEALTH AND SENIOR SERVICES

Division 30—Division ofRegulation and Licensure

Chapter 1—Controlled Substances

19 CSR 30-1.002 Schedules of ControlledSubstances

PURPOSE: The Department of Health andSenior Services has prepared a list of all drugsfalling within the purview of controlled sub-stances.

(1) Schedules of Controlled Substances.(A) Schedule I shall consist of the drugs

and other substances, by whatever officialname, common or usual name, chemicalname or brand name designated, listed in thissection. Each drug or substance has beenassigned the Drug Enforcement Administra-tion (DEA) Controlled Substances CodeNumber set forth opposite it.

1. Opiates. Unless specifically exceptedor unless listed in another schedule, any ofthe following opiates, including their isomers,esters, ethers, salts, and salts of isomers,esters and ethers, whenever the existence ofsuch isomers, esters, ethers, and salts is pos-sible within the specific chemical designa-tion:

A. Acetyl-alpha-methylfentanyl (N-(1-(1-methyl-2-phenethyl)-4-piperidinyl)-N-phenylacetamide) 9815

B. Acetylmethadol 9601C. Acetyl fentanyl (N-(1-

phenethylpiperidin-4-yl)-N-phenylacetamide) 9821

D. N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: acryl fentanyl, acryloylfentanyl) 9811

E. AH-7921(3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl] benzamide) 9551

F. Allylprodine 9602G. Alphacetylmethadol (except

levoalphacetylmethadol also known as levo-alpha-acetylmethadol levothadyl acetate or LAAM) 9603

H. Alphameprodine 9604I. Alphamethadol 9605J. Alpha-methylfentanyl

(N-1-(alphamethyl-beta-phenyl) ethyl-4-piperidyl) propionanilide; 1-(1-methyl-2-phenylethyl)-4 ((N-propanilido) piperidine) 9814

K. Alpha-methylthiofentanyl (N-(1-methyl-2-(2-thienyl) ethyl-4-piperidinyl)-N-phenylpropanamide) 9832

L. Benzethidine 9606M. Betacetylmethadol 9607N. Beta-hydroxyfentanyl

(N-(1-(2-hydroxy-2-phenethyl)-4-piperidinyl)-N-phenylpropanamide) 9830

O. Beta-hydroxy-3-methylfentanyl (other name:N-(1-(2-hydroxy-2-phenethyl)-3-methyl-4-piperidinyl)-N-phenylpropanamide) 9831

P. Betameprodine 9608Q. Betamethadol 9609R. Betaprodine 9611S. Clonitazene 9612T. Dextromoramide 9613U. Diampromide 9615V. Diethylthiambutene 9616W. Difenoxin 9168X. Dimenoxadol 9617Y. Dimepheptanol 9618Z. Dimethylthiambutene 9619AA. Dioxaphetyl butyrate 9621BB. Dipipanone 9622CC. Ethylmethylthiambutene 9623DD. Etonitazene 9624EE. Etoxeridine 9625FF. N-(4-fluorophenyl)-N-

(1-phenethylpiperidin-4-yl)isobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: 4-fluoroisobutyryl fentanyl, para-fluoroisobutyryl fentanyl) 9824

GG. N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide (Other names: furanyl fentanyl) 9834

HH. Furethidine 9626II. Hydroxypethidine 9627JJ. Ketobemidone 9628KK. Levomoramide 9629LL. Levophenacylmorphan 9631MM. 3-Methylfentanyl (N-(3-

methyl-1-(2-phenylethyl)-4-piperidyl)-N-phenylproanamide), itsoptical and geometric isomers, salts, and salts of isomers 9813

NN. 3-Methylthiofentanyl (N-((3-methyl-1-(2-thienyl)ethyl-4-piperidinyl)-Nphenylpropanamide) 9833

OO. Morpheridine 9632PP. MPPP (1-methyl-4-phenyl-

4-propionoxypiperidine) 9661QQ. MT–45 (1-cyclohexyl-

4-(1,2-diphenylethyl)piperazine) (9560)

RR. Noracymethadol 9633SS. Norlevorphanol 9634TT. Normethadone 9635UU. Norpipanone 9636VV. N-(2-fluorophenyl)-2-

methoxy-N-(1-phenethylpiperidin-4-yl)acetamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: ocfentanil) 9838

WW. Para-fluorofentanyl(N-(4-fluorophenyl)-N-(1-(2-phenethyl)-4-piperidinyl) propanamide 9812

XX. PEPAP (1-(-2-phenethyl)-4-phenyl-4-acetoxypiperidine) 9663

YY. Phenadoxone 9637ZZ. Phenampromide 9638AAA. Phenomorphan 9647BBB. Phenoperidine 9641CCC. Piritramide 9642DDD. Proheptazine 9643EEE. Properidine 9644FFF. Propiram 9649GGG. Racemoramide 9645HHH. N-(1-phenethylpiperidin-

4-yl)-N-phenyltetrahydrofuran-2-carboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: tetrahydrofuranyl fentanyl) 9843

III. Thiofentany (N-phenyl-N-(1-(2-thienyl)ethyl-4-piperidinyl)-propanamide 9835

JJJ. Tilidine 9750KKK. Trimeperidine 9646

2. Opium derivatives. Unless specifical-ly excepted or unless listed in another sched-ule, any of the following opium derivatives,its salts, isomers, and salts of isomers when-ever the existence of such salts, isomers, andsalts of isomers is possible within the specif-ic chemical designation:

A. Acetorphine 9319B. Acetyldihydrocodeine 9051C. Benzylmorphine 9052D. Codeine methylbromide 9070E. Codeine-N-Oxide 9053F. Cyprenorphine 9054G. Desomorphine 9055H. Dihydromorphine 9145I. Drotebanol 9335J. Etorphine (except

hydrochloride salt) 9056K. Heroin 9200L. Hydromorphinol 9301


Chapter 1—Controlled Substances 19 CSR 30-1

M. Methyldesorphine 9302N. Methyldihydromorphine 9304O. Morphine methylbromide 9305P. Morphine methylsulfonate 9306Q. Morphine-N-Oxide 9307R. Myrophine 9308S. Nicocodeine 9309T. Nicomorphine 9312U. Normorphine 9313V. Pholcodine 9314W. Thebacon 9315

3. Opiate Similar Synthetic Substances.Substances scheduled by the United StatesDrug Enforcement Administration as sub-stances that share a pharmacological profilesimilar to fentanyl, morphine, and other syn-thetic opioids, unless specifically excepted orunless listed in another schedule. These sub-stances are:

A. Butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide) 9822

B. U–47700 (3,4-Dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide) 9547

4. Hallucinogenic substances. Unlessspecifically excepted or unless listed inanother schedule, any material, compound,mixture or preparation, which contains anyquantity of the following hallucinogenic sub-stances or which contains any of its salts, iso-mers, and salts of isomers whenever the exis-tence of such salts, isomers, and salts ofisomers is possible within the specific chem-ical designation (For purposes of paragraph(1)(A)4. of this rule only, the term isomerincludes the optical, position, and geometricisomers.):

A. Alpha-ethyltryptamine 7249Some trade or other names: etryptamine;Monase; alpha-ethyl-1H-indole-3-ethenamine;3-(2-aminobutyl)indole; alpha-ET; and AET;

B. 4-bromo-2,5-dimethoxyamphetamine 7391

Some trade or other names: 4-bromo-2, 5-dimethoxy-a-methylphenethylamine; 4-bromo-2, 5-DMA;

C. 4-bromo-2,5-dimethoxyphenethylamine 7392

D. 2,5-dimethoxyamphetamine 7396Some trade or other names: 2,5-dimethoxy-amethylphenethylamine; 2,5-DMA;

E. 2,5-dimethoxy-4-ethylamphetamine 7399

Some trade or other names: DOETF. 2,5-dimethoxy-4-(n)-

propylthiophenethylamine (other name: 2C-T-7) 7348

G. 2-(2,5-Dimethoxy-4-(n)-propylphenyl) ethanamine

(2C-P) 7524H. 2-(2,5-Dimethoxy-4-

ethylphenyl) ethanamine

(2C-E ) 7509I. 2-(2,5-Dimethoxy-4-

methylphenyl) ethanamine (2C-D) 7508

J. 2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine (2C-N) 7521

K. 2-(2,5-Dimethoxyphenyl) ethanamine (2C-H) 7517

L. 2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C-C) 7519

M. 2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C-T-2) 7385

N. 2-(4-Iodo-2,5-dimethoxyphenyl) ethanamine (2C-I) 7518

O. 2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C-T-4) 7532

P. 4-methoxyamphetamine 7411Some trade or other names: 4-methoxy-amethylphenethylamine; paramethoxyam-phetamine; PMA;

Q. 5-methoxy-3,4-methylenedioxyamphetamine 7401

R. 4-methyl-2,5-dimethoxyamphetamine 7395

Some trade and other names: 4-methyl-2, 5-dimethoxy-a-methylphenethylamine; DOM;and STP;

S. 3,4-methylenedioxyamphetamine 7400

T. 3,4-methylenedioxymetham-phetamine(MDMA) 7405

U. 3,4-methylenedioxy-N-ethylamphetamine (also known as N-ethylalpha-methyl-3,4 (methylenedioxy)phenethylamine, N-ethylMDA,MDE and MDEA) 7404

V. N-hydroxy-3,4-methylenedioxyamphetamine (also known as N-hydroxy-alpha-methyl-3,4(methylenedioxy) phenethylamine and N-hydroxy MDA) 7402

W. 3,4,5-trimethoxyamphetamine 7390

X. 5-MeO-DMT or 5-methoxy-N,N-dimethyltryptamine 7431

Y. Alpha-methyltryptamine 7432Z. Bufotenine 7433

Some trade and other names: 3-(b-Dimethy-laminoethyl)-5-hydroxyindole; 3-(2-dimethy-laminoethyl)-5-indolol; N, N-dimethylsero-tonin; 5-hydroxy-N,N-dimethyltryptamine;mappine;

AA. Diethyltryptamine 7434Some trade and other names: N, N-Diethyl-tryptamine; DET;

BB. Dimethyltryptamine Some trade or other names: DMT; 7435

CC. 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-DIPT) 7439

DD. Ibogaine 7260Some trade and other names: 7-Ethyl-6,6β,7,8,9,10,12,13-octahydro-2-methoxy-6,9-methano-5H-pyrido [1’,2’:1,2] azepino[5,4-b] indole; Tabernanthe iboga;

EE. Lysergic acid diethylamide 7315FF. Marihuana 7360

Some trade or other names: marijuana;GG. Mescaline 7381HH. Parahexyl 7374

Some trade or other names: 3-Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran; Synhexyl;

II. Peyote 7415Meaning all parts of the plant presently clas-sified botanically as Lophophora williamsiiLemaire, whether growing or not; the seedsthereof; any extract from any part of suchplant; and every compound, manufacture,salt, derivative, mixture or preparation ofsuch plant, its seeds or extracts;

JJ. N-ethyl-3-piperidyl benzilate 7482

KK. N-methyl-3-piperidyl benzilate 7484

LL. Psilocybin 7437MM. Psilocyn 7438NN. Tetrahydrocannabinols naturally

contained in a plant of the genus Cannabis(cannabis 7370 plant), as well as syntheticequivalents of the substances contained in thecannabis plant or in the resinous extractivesof such plant, and/or synthetic substances,derivatives and their isomers, or both, withsimilar chemical structure and pharmacolog-ical activity to those substances contained inthe plant, such as the following:

(I) 1 cis or trans tetrahydrocannabi-nol and their optical isomers;

(II) 6 cis or trans tetrahydro-cannabinol and their optical isomers;

(III) 3,4 cis or trans tetrahydro-cannabinol and its optical isomers; and

(IV) Since nomenclature of thesesubstances is not internationally standard-ized, compounds of these structures, regard-less of numerical designation of atomic posi-tions are covered.

OO. Ethylamine analog of phencyclidine 7455

Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1-phenylcyclohexyl)ethylamine, N-(1-phenylcyclohexyl)-ethy-lamine, cyclohexamine, PCE;

PP. Pyrrolidine analog of phencyclidine 7458

Some trade or other names: 1-(1-phenylcy-clohexyl)-pyrrolidine PCPy, PHP;

QQ. Thiophene analog of phencyclidine 7470


Secretary of State

19 CSR 30-1—DEPARTMENT OF HEALTHAND SENIOR SERVICES Division 30—Division of Regulation and Licensure

Some trade or other names: 1-(1-(2-thienyl)-cyclohexyl)-piperidine, 2-thienyl analog ofphencyclidine, TPCP, TCP;

RR. 1-(1-(2-thienyl)cyclohexyl)pyrrolidine 7473

Some other names: TCPy.SS. Salvia divinorumTT. Salvinorin AUU. Synthetic cannabinoids: Unless

specifically exempted or unless listed inanother schedule, any material, compound,mixture, or preparation which contains anyquantity of the following substances, orwhich contains their salts, isomers, and saltsof isomers whenever the existence of suchsalts, isomers, and salts of isomers is possiblewithin the specific chemical designation:

(I) Any compound structurallyderived from 3-(1-naphthoyl)indole or 1H-indol-3-yl-(1-naphthyl)methane by substitu-tion at the nitrogen atom of the indole ring byalkyl, haloalkyl, alkenyl, cycloalkylmethyl,cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethylgroup, whether or not further substituted inthe indole ring to any extent, whether or notsubstituted in the naphthyl ring to any extent.Including, but not limited to:

(a) AM2201, or 1-(5-fluoropentyl)-3-(1-naphthoyl)indole 7201

(b) JWH-007, or 1-pentyl-2-methyl-3-(1-naphthoyl)indole

(c) JWH-015, or 1-propyl-2-methyl-3-(1-naphthoyl)indole

(d) JWH-018, or 1-pentyl-3-(1-naphthoyl)indole 7118

(e) JWH-019, or 1-hexyl-3-(1-naphthoyl)indole 7019

(f) JWH-073, or 1-butyl-3-(1-naphthoyl)indole 7173

(g) JWH-081, or 1-pentyl-3-(4-methoxy-1-naphthoyl)indole 7081

(h) JWH-098, or 1-pentyl-2-methyl-3-(4-methoxy-1-naphthoyl)indole

(i) JWH-122, or 1-pentyl-3-(4-methyl-1-

naphthoyl)indole 7122(j) JWH-164, or 1-pentyl-

3-(7-methoxy-1-naphthoyl)indole

(k) JWH-200, or 1-(2-(4-(morpholinyl)ethyl))-3-(1-naphthoyl)indole 7200

(l) JWH-210, or 1-pentyl-3-(4-ethyl-1-naphthoyl)indole

(m) JWH-398, or 1-pentyl-3-(4-chloro-1-

naphthoyl)indole 7398(II) Any compound structurally

derived from 3-(1-naphthoyl)pyrrole by sub-stitution at the nitrogen atom of the pyrrolering by alkyl, haloalkyl, alkenyl, cycloalkyl-methyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethylgroup, whether or not further substituted inthe pyrrole ring to any extent, whether or notsubstituted in the naphthyl ring to any extent;

(III) Any compound structurallyderived from 1-(1-naphthylmethyl)indene bysubstitution at the 3-position of the indenering by alkyl, haloalkyl, alkenyl, cycloalkyl-methyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethylgroup, whether or not further substituted inthe indene ring to any extent, whether or notsubstituted in the naphthyl ring to any extent;

(IV) Any compound structurallyderived from 3-phenylacetylindole by substi-tution at the nitrogen atom of the indole ringwith alkyl, haloalkyl, alkenyl, cycloalkyl-methyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethylgroup, whether or not further substituted inthe indole ring to any extent, whether or notsubstituted in the phenyl ring to any extent.Including, but not limited to:

(a) JWH-201, or 1-pentyl-3-(4-methoxyphenylacetyl)indole

(b) JWH-203, or 1-pentyl-3-(2-chlorophenylacetyl)indole

7203(c) JWH-250, or 1-pentyl-

3-(2-methoxyphenylacetyl)indole

6250(d) JWH-251, or 1-pentyl-

3-(2-methylphenylacetyl)indole

(e) RCS-8, or 1-(2-cyclohexylethyl)-3-(2-methoxyphenylacetyl)indole

7008(V) Any compound structurally

derived from 2-(3-hydroxycyclohexyl)phenolby substitution at the 5-position of the pheno-lic ring by alkyl, haloalkyl, alkenyl,cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or 2-(4-mor-pholinyl)ethyl group, whether or not substi-tuted in the cyclohexyl ring to any extent.Including, but not limited to:

(a) CP 47,497 & homologues, or2-[(1R,3S)-3- hydroxycyclohexyl]-5-(2-methy-loctan-2-yl)phenol), where side chain n=5,and homologues where side chain n-4,6, or 7;7297, 7298

(VI) Any compound containing a 3-(benzoyl)indole structure with substitution atthe nitrogen atom of the indole ring by alkyl,haloalkyl, alkenyl, cycloalkylmethyl,cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethylgroup, whether or not further substituted inthe indole ring to any extent and whether ornot substituted in the phenyl ring to anyextent. Including, but not limited to:

(a) AM-694, or 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole 7694

(b) RCS-4, or 1-pentyl-3-(4-methoxybenzoyl)indole

(SR-19 and RCS-4) 7104(VII) CP 50,556-1, or

[(6S,6aR,9R,10aR)-9-hydroxy-6-methyl-3-[ ( 2 R ) - 5 - p h e n y l p e n t a n - 2 - y l ] o x y -5,6,6a,7,8,9,10,10a-octahydrophenanthridin-1-yl] acetate

(VIII) HU-210, or (6aR,10aR)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methy-l o c t a n - 2 - y l ) - 6 a , 7 , 1 0 , 1 0 a -tetrahydrobenzo[c]chromen-1-ol

(IX) HU-211, orDexanabinol,(6aS,10aS)-9-(hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol

(X) Dimethylheptylpyran, orDMHP

5. Depressants. Unless specificallyexcepted or unless listed in another schedule,any material compound, mixture or prepara-tion which contains any quantity of the fol-lowing substances having a depressant effecton the central nervous system, including itssalts, isomers, and salts of isomers wheneverthe existence of such salts, isomers, and saltsof isomers is possible within the specificchemical designation:

A. Gamma-hydroxybutyric acid andother names GHB; gamma-hydroxybutyrate;4-hydroxybutyrate; 4-hydroxybutonic acid;sodium oxybate; sodium oxybutryrate; 2010

B. Mecloqualone 2572C. Methaqualone 2565

6. Stimulants. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture, or prepa-ration which contains any quantity of the fol-lowing substances having a stimulant effecton the central nervous system, including itssalts, isomers, and salts of isomers:

A. Aminorex 1585Some trade or other names: aminoxaphen; 2-amino-5-phenyl-2-oxazoline; 4,5-dihydro-5-phenyl-2-oxazolamine;

B. N-benzylpiperazine (some other names: BZP, 1-benzylpiperzaine) 7493

C. Cathinone (Some trade or other names: 2-amino-1-phenyl-1-propanone,



alphaaminopropiophenone, 2-aminopropiophenone andnorephedrone) 1235

D. Fenethylline 1503E. 3-Fluoromethcathinone 1233F. 4-Fluoromethcathinone 1238G. Mephedrone, or 4-

methylmethcathinone 1248H. Methcathinone 1237

Some trade or other names: 2-(methylamino)-propiophenone; alpha-(methylamino) propio-phenone; 2-(methylamino)-1-phenylpropan-1-one; alpha-N-methylaminopropiophenone;monomethylpropion; ephedrone; N-methyl-cathinone; methylcathinine; AL-464; AL-422;AL-463 and URI 432;

I. 4-methoxymethcathinoneJ. cis-4-methylaminorex

(cis-4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine) 1590

K. Methylenedioxypyrovalerone,MDPV, or (1-(1,3-Benzodioxol-5-yl)-2-(1-pyrrolidinyl)-1-pentanone 7535

L. Methylone, or 3,4-Methylenedioxymethcathinone

7540M. 4-Methyl-alpha-

pyrrolidinobutiophenone, or MPBP

N. N-ethylamphetamine 1475O. N,N-dimethylamphetamine 1480

(some other names: N,N-alpha-trimethylben-zeneethanamine; N,N-alpha-trimethylphenethylamine)

P. Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC) 7222

Q. Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22) 7225

R. N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide(AB-FUBINACA) 7012

S. N-(1-amino-3, 3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) 7035

7. A temporary listing of substancessubject to emergency scheduling under feder-al law shall include any material, compound,mixture or preparation which contains anyquantity of the following substances:

A. (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone, its optical, positional, and geometric isomers, salts, and salts of isomers (Other names: UR-

144, 1-pentyl-3-(2,2,3,3-tetramethylcyclopropoyl)indole)

7144B. [1-(5-fluoro-pentyl)-1H-

indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone, its optical,positional, and geometric isomers, salts, and salts of isomers (Other names: 5- fluoro-UR-144, 5-F-UR-144, XLR11, 1-(5-fluoro-pentyl)-3-(2,2,3,3-tetramethylcyclopropoyl)indole)

7011C. N-(1-adamantyl)-1-pentyl-1H-

indazole-3-carboxamide, its optical, positional, and geometric isomers, salts, and salts of isomer (Other names: APINACA, AKB48) 7048

D. 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine, its optical, positional, andgeometric isomers, salts, and salts of isomers (Other names: 25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) 7538

E. 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine, its optical, positional, and

geometric isomers, salts, and salts of isomers (Other names: 25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 7537

F. 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine, its optical, positional, andgeometric isomers, salts, and salts of isomers (Other names: 25B-NBOMe; 2C-B-NBOMe;25B; Cimbi-36) 7536

G. 4-methyl-N-ethylcathinone,its optical, positional, andgeometric isomers, salts, and salts of isomers (Other names:4-MEC; 2-(ethylamino)-1-(4-methylphenyl)propan-1-one) 1249

H. 4-methyl-alpha-pyrrolidinopropiophenone, its optical, positional, and geometric isomers, salts, andsalts of isomers (Other names: 4-MePPP; MePPP; 4-methyl-α-pyrrolidinopropiophenone; 1-(4-methylphenyl)-2-(pyrrolidin-1-yl)-propan-1-one) 7498

I. alpha-pyrrolidinopentiophenone, its optical, positional, and geometric isomers, salts, and

salts of isomers (Other names:α-PVP; α-pyrrolidinovalerophenone; 1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one) 7545

J. Butylone, its optical, positional, and geometric isomers, salts, and salts of isomers (Other names: bk-MBDB; 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one) 7541

K. Pentedrone, its optical, positional, and geometric isomers, salts, and salts of isomers (Other names: α-methylaminovalerophenone; 2-(methylamino)-1-phenylpentan-1-one) 1246

L. Pentylone, its optical, positional, and geometric isomers, salts, and salts of isomers (Other names: bk-MBDP; 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one) 7542

M. Naphyrone, its optical, positional, and geometric isomers, salts, and salts of isomers (Other names: naphthylpyrovalerone; 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one) 1258

N. alpha-pyrrolidinobutiophenone,its optical, positional, and geometric isomers, salts, and salts of isomers (Other names: α-PBP; 1-phenyl-2-(pyrrolidin-1-yl)butan-1-one) 7546

O. N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts, and salts of isomers (Other names: AB-CHMINACA) 7031

P. N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide, its optical, positional, andgeometric isomers, salts, and salts of isomers (Other names: AB-PINACA) 7023

Q. [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone, its optical, positional, and geometric isomers, salts, and salts of isomers (Other names: THJ-2201) 7024


Secretary of State


R. N-[1-[2-hydroxy-2-(thiophen-2-yl) ethyl]piperidin-4-yl]-N-phenylpropionamide, its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers (Other names: beta-hydroxythiofentanyl) 9836

S. N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, itsoptical, positional, and geometric isomers, salts, and salts of isomers (Other names: acetyl fentanyl) 9821

T. N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts, and salts of isomers (Other names: MAB-CHMINACA; ADB-CHMINACA) 7032

U. methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical,positional, and geometric isomers, salts and salts of isomers (Other names: 5F–ADB; 5F–MDMB–PINACA) (7034)

V. methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F–AMB) (7033)

W. N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide, its optical, positional, and geometricisomers, salts and salts of isomers (Other names: 5F–APINACA, 5F–AKB48) (7049)

X. N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: ADB–FUBINACA) (7010)

Y. methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate, its optical,positional, and geometric isomers, salts and salts ofisomers (Other names: MDMB–CHMICA, MMB–CHMINACA) (7042)

Z. methyl 2-(1-(4-

fluorobenzyl)- 1Hindazole-3-carboxamido)-3,3- dimethylbutanoate, its optical,positional, and geometric isomers, salts and salts ofisomers (Other names: MDMB–FUBINACA) (7020)

AA. N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: ortho-fluorofentanyl, 2-fluorofentanyl) (9816)

BB. 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its isomers, esters, ethers, salts and salts of isomers, estersand ethers (Other name: methoxyacetyl fentanyl) (9825)

CC. methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate, its optical, positional, and geometric isomers, salts and salts ofisomers (Other names: FUB–AMB, MMB–FUBINACA, AMB–FUBINACA) (7021)

DD. N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide,its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: cyclopropyl fentanyl) (9845)

EE. N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: valeryl fentanyl) (9804)

FF. N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl) butyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para-fluorobutyryl fentanyl) (9823)

GG. N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)butyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para-methoxybutyryl fentanyl) (9837)

HH. N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide, its

isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para-chloroisobutyryl fentanyl) (9826)

II. N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: isobutyryl fentanyl) (9827)

JJ. N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: cyclopentyl fentanyl) (9847)

KK. Fentanyl-related substances, their isomers, esters, ethers, salts and salts of isomers, esters and ethers. 9850

(I) Fentanyl-related substancemeans any substance not otherwise listedunder another Administration ControlledSubstance Code Number, and for which noexemption or approval is in effect under sec-tion 505 of the Federal Food, Drug, and Cos-metic Act 21 U.S.C. 355, that is structurallyrelated to fentanyl by one (1) or more of thefollowing modifications:

(a) Replacement of the phenylportion of the phenethyl group by any mono-cycle, whether or not further substituted in oron the monocycle;

(b) Substitution in or on thephenethyl group with alkyl, alkenyl, alkoxyl,hydroxyl, halo, haloalkyl, amino or nitrogroups;

(c) Substitution in or on thepiperidine ring with alkyl, alkenyl, alkoxyl,ester, ether, hydroxyl, halo, haloalkyl, aminoor nitro groups;

(d) Replacement of the anilinering with any aromatic monocycle whether ornot further substituted in or on the aromaticmonocycle; and/or

(e) Replacement of the N-propi-onyl group by another acyl group.

LL. Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: NM2201; CBL2201) (7221)

MM. N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers



(Other names: 5F-AB-PINACA) (7025)

NN. 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Othernames: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYLBINACA;CUMYL-4CN-BINACA; SGT-78) (7089)

OO. methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Othernames: MMB-CHMICA,

AMB-CHMICA) (7044)PP. 1-(5-fluoropentyl)-N-(2-

phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-CUMYL-P7AICA) (7085)

QQ. N-Ethylpentylone, its optical, positional, and geometric isomers, salts andsalts of isomers (Other names: ephylone, 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-pentan-1-one) (7543)

8. Khat, to include all parts of the plantpresently classified botanically as cathaedulis, whether growing or not; the seedsthereof; any extract from any part of suchplant; and every compound, manufacture,salt, derivative, mixture, or preparation of theplant, its seed or extracts. 7032

(B) Schedule II shall consist of the drugsand other substances, by whatever officialname, common or usual name, chemicalname, or brand name designated, listed inthis section. Each drug or substance has beenassigned the Controlled Substances CodeNumber set forth opposite it.

1. Substances, vegetable origin, orchemical synthesis. Unless specificallyexcepted or unless listed in another schedule,Schedule II shall include any of the followingsubstances whether produced directly or indi-rectly by extraction from substances of veg-etable origin or independently by means ofchemical synthesis or by a combination ofextraction and chemical synthesis:

A. Opium and opiate; and any salt,compound, derivative, or preparation of

opium or opiate, excluding apomorphine,thebaine-derived butorphanol, dextrorphan,nalbuphine, nalmefene, naloxegol, naloxone,and naltrexone and their respective salts, butincluding the following:

(I) Raw opium 9600(II) Opium extracts 9610(III) Opium fluid 9620(IV) Powdered opium 9639(V) Granulated opium 9640(VI) Tincture of opium 9630(VII) Codeine 9050(VIII) Dihydroetorphine 9334(IX) Ethylmorphine 9190(X) Etorphine hydrochloride 9059(XI) Hydrocodone 9193(XII) Hydromorphone 9150(XIII) Metopon 9260(XIV) Morphine 9300(XV) Oripavine 9330(XVI) Oxycodone 9143(XVII) Oxymorphone 9652(XVIII) Thebaine 9333

B. Any salt, compound, derivative, orpreparation thereof which is chemicallyequivalent or identical with any of the sub-stances referred to in subparagraph(1)(B)1.A. of this rule shall be included inSchedule II, except that these substances shallnot include the isoquinoline alkaloids ofopium;

C. Opium poppy and poppy straw 9650

D. Coca leaves (9040) and any salt,compound, derivative, or preparation of cocaleaves (including cocaine (9041) and ecgo-nine (9180) and their salts, isomers, deriva-tives, and salts of isomers and derivatives),and any salt, compound, derivative, or prepa-ration thereof which is chemically equivalentor identical with any of these substances,except that the substances shall not include:

(I) Decocainized coca leaves orextraction of coca leaves, which extractionsdo not contain cocaine or ecgonine; or

(II) Ioflupane;E. Concentrate of poppy straw (the

crude extract of poppy straw in either liq-uid, solid, or powder form which containsthe phenanthrene alkaloids of the opiumpoppy) 9670

2. Opiates. Unless specifically exceptedor unless in another schedule any of the fol-lowing opiates, including its isomers, esters,ethers, salts, and salts of isomers, esters, andethers whenever the existence of such iso-mers, esters, ethers, and salts is possiblewithin the specific chemical designation, dex-trorphan, and levopropoxyphene excepted:

A. Alfentanil 9737B. Alphaprodine 9010C. Anileridine 9020D. Bezitramide 9800E. Bulk Dextropropoxyphene

(Non-dosage Forms) 9273F. Carfentanil 9743G. Dihydrocodeine 9120H. Diphenoxylate 9170I. Fentanyl 9801J. Isomethadone 9226K. Levo-alphacetylmethadol 9220

Some other names: levo-alphaacetyl-methadol, levomethadyl acetate, LAAM 9648

L. Levomethorphan 9210M. Levorphanol 9220N. Metazocine 9240O. Methadone 9250P. Methadone-Intermediate,

4-cyano-2-dimethylamino-4,4-diphenyl butane 9254

Q. Moramide-Intermediate, 2-methyl-3-morpholino-1,1-diphenylpropane-carboxylic acid 9802

R. Pethidine (Meperidine) 9230S. Pethidine-Intermediate-A, 4-

cyano-1-methyl-4-phenylpiperidine 9232

T. Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate 9233

U. Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid 9234

V. Phenazocine 9715W. Piminodine 9730X. Racemethorphan 9732Y. Racemorphan 9733Z. Remifentanil 9739AA. Sufentanil 9740BB. Tapentadol 9780CC. Thiafentanil 9729

3. Stimulants. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture, or prepa-ration which contains any quantity of the fol-lowing substances having a stimulant effecton the central nervous system:

A. Amphetamine, its salts, optical isomers, and salts of its optical isomers 1100

B. Lisdexamfetamine, its salts, isomers, and salts of itsisomers 1205

C. Methamphetamine, its salts, isomers, and salts of itsisomers 1105

D. Phenmetrazine and its salts 1631E. Methylphenidate 1724

4. Depressants. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture, or prepa-ration which contains any quantity of the fol-lowing substances having a depressant effecton the central nervous system, including itssalts, isomers, and salts of isomers wheneverthe existence of such salts, isomers, and salts


Secretary of State


of isomers is possible within the specificchemical designation:

A. Amobarbital 2125B. Glutethimide 2550C. Pentobarbital 2270D. Phencyclidine 7471E. Secobarbital 2315

5. Hallucinogenic substances:A. Nabilone 7379

Another name for nabilone: (±)trans-3-(1, 1-dimethylheptyl)-6, 6a,7,8,10,10a-hexahydro-1-hydroxy-6, 6-dimethyl-9H-dibenzo(b,d)pyran-9-one.

B. Dronabinol [(-)-delta-9-transtetrahydrocannabinol] in an oral solution in adrug product approved for marketing by theUnited States Food and Drug Administra-tion. (7365)

6. Immediate precursors. Unless specif-ically excepted or unless listed in anotherschedule, any material, compound, mixture,or preparation which contains any quantity ofthe following substances:

A. Immediate precursor toamphetamine and methamphetamine:

(I) Phenylacetone 8501Some trade or other names: phenyl-2-propanone; P2P; benzyl methyl ketone;methyl benzyl ketone;

B. Immediate precursors to phencycli-dine (PCP):

(I) 1-phenylcyclohexylamine 7460(II) 1-piperidinocyclo-

hexanecarbonitrile (PCC) 8603

C. Immediate precursor to fentanyl:(I) 4-anilino-N-phenethyl-4-

piperidine (ANPP) 83337. Any material, compound, mixture, or

preparation which contains any quantity ofthe following alkyl nitrites:

A. Amyl nitrite; B. Butyl nitrite.

(C) Schedule III shall consist of the drugsand other substances, by whatever officialname, common or usual name, chemicalname, or brand name designated, listed inthis section. Each drug or substance has beenassigned the DEA Controlled SubstancesCode Number set forth opposite it.

1. Stimulants. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture, or prepa-ration which contains any quantity of the fol-lowing substances having a stimulant effecton the central nervous system, including itssalts, isomers (whether optical, position, orgeometric), and salts of such isomers when-ever the existence of such salts, isomers, andsalts of isomers is possible within the specif-ic chemical designation:

A. Those compounds, mixtures, orpreparations in dosage unit form containingany stimulant substances listed in Schedule II

which compounds, mixtures, or preparationswere listed on August 25, 1971, as exceptedcompounds under section 308.32 and anyother drug of the quantitive compositionshown in that list for those drugs or which isthe same except that it contains a lesser quan-tity of controlled substances 1405

B. Benzphetamine 1228C. Chlorphentermine 1645D. Clortermine 1647E. Phendimetrazine 1615

2. Depressants. Unless specificallyexcepted or unless listed in another schedule,any material compound, mixture, or prepara-tion which contains any quantity of the fol-lowing substances having a depressant effecton the central nervous system:

A. Any compound, mixture, or prepa-ration containing:

(I) Amobarbital 2126(II) Secobarbital 2316(III) Pentobarbital 2271

or any salt thereof and one (1) or more otheractive medicinal ingredients which are notlisted in any schedule;

B. Any suppository dosage form con-taining:

(I) Amobarbital 2126(II) Secobarbital 2316(III) Pentobarbital 2271

or any salt of any of these drugs and approvedby the Food and Drug Administration formarketing only as a suppository;

C. Any substance which contains anyquantity of a derivative of barbituric acid orany salt thereof 2100

D. Chlorhexadol 2510E. Embutramide 2020F. Any drug product containing

gamma hydroxybutyric acid, including itssalts, isomers, and salts of isomer, for whichan application is approved under section 505of the Federal Food, Drug, and CosmeticAct; 2012

G. Ketamine, its salts, isomer,and salts of isomers (some other names for ketamine: (±)-2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone) 7285

H. Lysergic acid 7300I. Lysergic acid amide 7310J. Methyprylon 2575K. Perampanel, and its salts,

isomers, and salts of isomers 2261

L. Sulfondiethylmethane 2600M. Sulfonethylmethane 2605N. Sulfonmethane 2610O. Tiletamine and zolazepam

or any salt thereof 7295Some trade or other names for a tiletamine-zolazepam combination product: Telazol.Some trade or other names for tiletamine: 2-

(ethylamino)-2-(2-thienyl)-cyclohexanone. Some trade or other names for zolazepam: 4-(2 - f luoropheny l ) -6 -8-d ihydro-1,3,8-trimethylpyrazolo-(3,4-e) (1,4)-diazepin-7(1H)-one, flupyrazapon.

3. Nalorphine 94004. Narcotics drugs. Unless specifically

excepted or unless listed in another schedule,any material, compound, mixture, or prepa-ration containing limited quantities of any ofthe following narcotic drugs or any saltsthereof:

A. Not more than 1.8 grams ofcodeine per one hundred milliliters (100mL) or not more than ninety milligrams (90mg) per dosage unit, with an equal orgreater quantity of an isoquinoline alkaloidof opium 9803

B. Not more than 1.8 grams ofcodeine per one hundred milliliters (100 mL)or not more than ninety milligrams (90 mg)per dosage unit, with one (1) or more active,nonnarcotic ingredients in recognized thera-peutic amounts 9804

C. Not more than 1.8 grams of dihy-drocodeine per one hundred milliliters (100mL) or not more than ninety milligrams (90mg) per dosage unit, with one (1) or moreactive, nonnarcotic ingredients in recognizedtherapeutic amounts 9807

D. Not more than three hundredmilligrams (300 mg) of ethylmorphine perone hundred milliliters (100 mL) or notmore than fifteen milligrams (15 mg) perdosage unit, with one (1) or more active,nonnarcotic ingredients in recognized ther-apeutic amounts 9808

E. Not more than five hundred mil-ligrams (500 mg) of opium per one hundredmilliliters (100 mL) or per one hundredgrams (100 g) or not more than twenty-fivemilligrams (25 mg) per dosage unit, with one(1) or more active nonnarcotic ingredients inrecognized therapeutic amounts 9809

F. Not more than fifty milligrams (50mg) of morphine per one hundred milliliters(100 mL) or per one hundred grams (100 g),with one (1) or more active, nonnarcoticingredients in recognized therapeuticamounts 9810

5. Any material, compound, mixture, orpreparation containing any of the followingnarcotic drugs or their salts, as set forthbelow:

A. Buprenorphine 90646. Anabolic steroids. Unless specially

excepted or unless listed in another schedule,any material, compound, mixture, or prepa-ration containing any quantity of the follow-ing substances, including its salts, isomers,and salts of isomers whenever the existenceof such salts of isomers is possible within thespecific chemical designation. DEA hasassigned code 4000 for all anabolic steroids.



Anabolic steroids. Any drug or hormonalsubstance, chemically and pharmacologicallyrelated to testosterone (other than estrogens,progestins, corticosteroids, and dehy-droepiandrosterone) that promotes musclegrowth, except an anabolic steroid which isexpressly intended for administration throughimplants to cattle or other nonhuman speciesand which has been approved by the Secre-tary of Health and Human Services for thatadministration. If any person prescribes, dis-penses, or distributes such steroid for humanuse, such person shall be considered to haveprescribed, dispensed, or distributed ananabolic steroid within the meaning of thissubdivision. Unless specifically excepted orunless listed in another schedule, any materi-al, compound, mixture, or preparation con-taining any quantity of the following sub-stances, including its salts, esters, and ethers:

A. 3β,17β-dihydroxy-5α-androstane B. 3α,17β-dihydroxy-5α-androstane C. 5α-androstan-3,17-dione D. 1-androstenediol (3β,17β-dihy-

droxy-5α-androst-1-ene) E. 1-androstenediol (3α,17β-dihy-

droxy-5α-androst-1-ene) F. 4-androstenediol (3β,17β-dihy-

droxy-androst-4-ene) G. 5-androstenediol (3β,17β-dihy-

droxy-androst-5-ene)H. 1-androstenedione ([5α]-androst-

1-en-3,17-dione) I. 4-androstenedione (androst-4-en-

3,17-dione) J. 5-androstenedione (androst-5-en-

3,17-dione) K. Bolasterone (7α,17α-dimethyl-

17β-hydroxyandrost-4-en-3-one) L. Boldenone (17β-hydroxyandrost-

1,4,-diene-3-one)M. Boldione (androstra-1,4-diene-

3,17-dione)N. Calusterone (7β,17α-dimethyl-17

β-hydroxyandrost-4-en-3-one)O. Clostebol (4-chloro-17β-hydrox-

yandrost-4-en-3-one) P. Dehydrochloromethyltestosterone

(4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one)

Q. Desoxymethyltestosterone (17α-methyl-5α-androst-2-en-17β-ol) (a.k.a.madol)

R. Dihydrotestosterone (4-Dihy-drotestosterone) (s) 4-dihydrotestosterone(17β-hydroxy-androstan-3-one)

S. Drostanolone(17β-hydroxy-2α-methyl-5α-androstan-3-one)

T. Ethylestrenol(17α-ethyl-17β-hydroxyestr-4-ene)

U. Fluoxymesterone(9-fluoro-17α-methyl-11 β,17β-dihydroxyandrost-4-en-3-one)

V. Formebulone (Formebolone) (2-

formyl-17α-methyl-11α,17β-dihydroxyan-drost-1,4-dien-3-one)

W. Furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]-furazan)

X. 13β-ethyl-17β-hydroxygon-4-en-3-one

Y. 4-hydroxytestosterone (4,17β-dihy-droxy-androst-4-en-3-one)

Z. 4-hydroxy-19-nortestosterone(4,17β-dihydroxy-estr-4-en-3-one)

AA. Mestanolone (17α-methyl-17β-hydroxy-5α-androstan-3-one)

BB. Mesterolone(1α-methyl-17β-hydroxy-[5α]-androstan-3-one)

CC. Methandienone(17α-methyl-17β-hydroxyandrost-1,4-dien-3-one)

DD. Methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene)

EE. Methasterone (2α,17α-dimethyl-5α-androstan-17β-ol-3-one)

FF. Methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one)

GG. 17α-methyl-3 β,17β-dihydroxy-5α-androstane

HH. 17α-methyl-3α,17β-dihydroxy-5α-androstane

II. 17α-methyl-3β,17β-dihydroxyan-drost-4-ene

JJ. 17α-methyl-4-hydroxynandrolone(17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one)

KK. Methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one)

LL. Methyltrienolone (17α-methyl-17β-hydroxyestra-4,9,11-trien-3-one)

MM. Methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one)

NN. Mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one)

OO. 17α-methyl-Δ1-dihydrotestos-terone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. 17-α-methyl-1-testos-terone)

PP. Nandrolone (17β-hydroxyestr-4-ene-3-one)

QQ. 19 -no r - 4 - and ro s t en ed i o l(3β,17β-dihydroxyestr-4-ene)

RR . 19 - no r - 4 - a nd ro s t e n ed i o l(3α,17β-dihydroxyestr-4-ene)

SS. 19-nor-4,9(10)-androstadiene-dione (estra-4,9(10)-diene-3,17-dione)

TT. 19-nor-5-androstenediol (3β,17β-dihydroxyestr-5-ene)

UU. 19 -no r - 5 - and ro s t ened i o l(3α,17β-dihydroxyestr-5-ene)

VV. 19-nor-4-androstenedione (estr-4-en-3,17-dione)

WW. 19-nor-5-androstenedione (estr-5-en-3,17-dione)

XX. Norbolethone (13β,17α-diethyl-17β-hydroxygon-4-en-3-one)

YY. Norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one)

ZZ. Norethandrolone (17α-ethyl-17β-

hydroxyestr-4-en-3-one) AAA. Normethandrolone (17α-

methyl-17β-hydroxyestr-4-en-3-one) BBB. Oxandrolone (17α-methyl-17β-

hydroxy-2-oxa-[5α]-androstan-3-one) CCC. Oxymesterone (17α-methyl-

4,17β-dihydroxyandrost-4-en-3-one) DDD. Oxymetholone (17α-methyl-2-

hydroxymethylene-17β -hydroxy-[5α ] -androstan-3-one)

EEE. Prostanozol (17β-hydroxy-5α-androstano[3,2-c]pyrazole)

FFF. Stanolone (Δ1-dihydrotestos-terone (a.k.a. 1-testosterone)(17β-hydroxy-5α-androst-1-en-3-one))

GGG. Stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole)

HHH. Stenbolone (17β-hydroxy-2-methyl-[5α]-androst-1-en-3-one)

III. Testolactone(13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lac-tone)

JJJ. Testosterone(17β-hydroxyan-drost-4-en-3-one);

K K K . Te t r a hyd r o g e s t r i n o n e(13β,17α-diethyl-17β-hydroxygon-4,9, 11-trien-3-one)

LLL. Trenbolone (17β-hydroxyestr-4,9,11-trien-3-one)

MMM. Any salt, ester, or isomer of adrug or substance described or listed in thissubparagraph, if that salt, ester, or isomerpromotes muscle growth except an anabolicsteroid which is expressly intended foradministration through implants to cattle orother nonhuman species and which has beenapproved by the secretary of Health andHuman Services for that administration.

7. Dronabinol (synthetic) in sesame oiland encapsulated in a soft gelatin capsule in aUnited States Food and Drug Administrationapproved drug product 7369(Some other names for dronabinol:(6aRtrans)- 6a,7,8,10a-tetrahydro-6.6.9-trimethyl-3-pentyl-6H-dibenzo (b,d) pyran-1-ol, or (-) -delta-9-(trans)-tetrahydrocannabi-nol.)

(D) Schedule IV shall consist of the drugsand other substances, by whatever officialname, common or usual name, chemicalname, or brand name designated, listed inthis section. Each drug or substance has beenassigned the DEA Controlled SubstancesCode Number set forth opposite it.

1. Narcotic drugs. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture, or prepa-ration containing limited quantities of any ofthe following narcotic drugs or any saltsthereof:

A. Not more than one milligram (1mg) of difenoxin (DEA Drug Code No.9168) and not less than twenty-five micro-grams (25 mcg) of atropine sulfate per dosage


Secretary of State


unit 9167B. Dextropropoxyphene (alpha-(+)-

4-dimethylamino-1,2-diphenyl-3-methyl-2-propionoxybutane) 9278

C. 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, its salts, opti-cal and geometric isomers, and salts of theseisomers (including tramadol) 9752

D. Narcotic drugs containing nonnar-cotic active medicinal ingredients. Any com-pound, mixture, or preparation containingany of the following limited quantities of nar-cotic drugs or salts thereof, which shallinclude one (1) or more nonnarcotic activemedicinal ingredients in sufficient proportionto confer upon the compound, mixture, orpreparation valuable medicinal qualities otherthan those possessed by the narcotic drugalone:

(I) Not more than two hundred mil-ligrams (200 mg) of codeine per one hundredmilliliters (100 mL) or per one hundredgrams (100 g);

(II) Not more than one hundredmilligrams (100 mg) of dihydrocodeine perone hundred milliliters (100 mL) or per onehundred grams (100 g); or

(III) Not more than one hundredmilligrams (100 mg) of ethylmorphine perone hundred milliliters (100 mL) or per onehundred grams (100 g).

2. Depressants. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture, or prepa-ration which contains any quantity of the fol-lowing substances, including its salts, iso-mers, and salts of isomers whenever theexistence of such salts, isomers, and salts ofisomers is possible within the specific chem-ical designation:

A. Alfaxalone 2731B. Alprazolam 2882C. Barbital 2145D. Bromazepam 2748E. Camazepam 2749F. Carisoprodol 8192G. Chloral betaine 2460H. Chloral hydrate 2465I. Chlordiazepoxide 2744J. Clobazam 2751K. Clonazepam 2737L. Clorazepate 2768M. Clotiazepam 2752N. Cloxazolam 2753O. Delorazepam 2754P. Diazepam 2765Q. Dichloralphenazone 2467R. Estazolam 2756S. Ethchlorvynol 2540T. Ethinamate 2545U. Ethyl loflazepate 2758V. Fludiazepam 2759W. Flunitrazepam 2763X. Flurazepam 2767

Y. Fospropofol 2138Z. Halazepam 2762AA. Haloxazolam 2771BB. Ketazolam 2772CC. Loprazolam 2773DD. Lorazepam 2885EE. Lormetazepam 2774FF. Mebutamate 2800GG. Medazepam 2836HH. Meprobamate 2820II. Methohexital 2264JJ. Methylphenobarbital

(Mephobarbital) 2250KK. Midazolam 2884LL. Nimetazepam 2837MM. Nitrazepam 2834NN. Nordiazepam 2838OO. Oxazepam 2835PP. Oxazolam 2839QQ. Paraldehyde 2585RR. Petrichloral 2591SS. Phenobarbital 2285TT. Pinazepam 2883UU. Prazepam 2764VV. Quazepam 2881WW. Suvorexant 2223XX. Temazepam 2925YY. Tetrazepam 2886ZZ. Triazolam 2887AAA. Zaleplon 2781BBB. Zolpidem 2783CCC. Zopiclone 2784

3. Fenfluramine. Any material, com-pound, mixture, or preparation which containsany quantity of the following substances,including its salts, isomers (whether optical,position, or geometric), and salts of such iso-mers, whenever the existence of such salts,isomers, and salts of isomers is possible:

A. Fenfluramine 16704. Lorcaserin. Any material, compound,

mixture, or preparation which contains anyquantity of the following substances, includ-ing its salts, isomers, and salts of isomers,whenever the existence of such salts, isomers,and salts of isomers is possible:

A. Lorcaserin 16255. Stimulants. Unless specifically

excepted or unless listed in another schedule,any material, compound, mixture, or prepa-ration which contains any quantity of the fol-lowing substances having a stimulant effecton the central nervous system, including itssalts, isomers, and salts of isomers:

A. Cathine ((+)-norpseudoephedrine) 1230

B. Diethylpropion 1610C. Fencamfamin 1760D. Fenproporex 1575E. Mazindol 1605F. Mefenorex 1580G. Modafinil 1680H. Pemoline (including

organometallic complexesand chelates thereof) 1530

I. Phentermine 1640

J. Pipradrol 1750K. Sibutramine 1675L. SPA (-)-1-dimethylamino-

1,2-diphenylethane 16356. Other substances. Unless specifically

excepted or unless listed in another schedule,any material, compound, mixture, or prepa-ration which contains any quantity of the fol-lowing substances, including its salts:

A. Pentazocine 9709B. Butorphanol (including its

optical isomers) 9720C. Eluxadoline (5-[[[(2S)-2-

amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl] [(1S)-1-(4-phenyl-1 H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid) (including its optical isomers)and its salts, isomers, and salts of isomers 9725

7. Ephedrine. Any material, compound,mixture, or preparation which contains anyquantity of the following substances having astimulant effect on the central nervous systemincluding their salts, isomers, and salts of iso-mers:

A. Ephedrine or its salts, optical iso-mers, or salts of optical isomers as the onlyactive medicinal ingredient or containsephedrine or its salts, optical isomers, or saltsof optical isomers and therapeutically insignif-icant quantities of another active medicinalingredient.

(E) Schedule V shall consist of the drugsand other substances, by whatever officialname, common or usual name, chemicalname, or brand name designated, listed inthis subsection.

1. Narcotic drugs containing nonnarcot-ic active medicinal ingredients. Any com-pound, mixture, or preparation containingany of the following narcotic drugs, or theirsalts calculated as the free anhydrous base oralkaloid, in limited quantities as follows,which shall include one (1) or more nonnar-cotic active medicinal ingredients in suffi-cient proportion to confer upon the com-pound, mixture, or preparation valuablemedicinal qualities other than those pos-sessed by the narcotic drug alone:

A. Not more than two hundred mil-ligrams (200 mg) of codeine per one hundredmilliliters (100 mL) or per one hundredgrams (100 g);

B. Not more than one hundred mil-ligrams (100 mg) of dihydrocodeine per onehundred milliliters (100 mL) or per one hun-dred grams (100 g);

C. Not more than one hundred mil-ligrams (100 mg) of ethylmorphine per onehundred milliliters (100 mL) or per one hun-dred grams (100 g);



D. Not more than two and five-tenthsmilligrams (2.5 mg) of diphenoxylate and notless than twenty-five micrograms (25 mcg) ofatropine sulfate per dosage unit;

E. Not more than one hundred mil-ligrams (100 mg) of opium per one hundredmilliliters (100 mL) or per one hundredgrams (100 g); and

F. Not more than five-tenths mil-ligram (0.5 mg) of difenoxin (DEA DrugCode No. 9168) and not less than twenty-fivemicrograms (25 mcg) of atropine sulfate perdosage unit.

2. Stimulants. Unless specificallyexempted or excluded or unless listed inanother schedule, any material, compound,mixture, or preparation which contains anyquantity of the following substances having astimulant effect on the central nervous systemincluding its salts, isomers, and salts of iso-mers:

A. Pyrovalerone 14853. Any compound, mixture, or prepara-

tion containing any detectable quantity ofpseudoephedrine or its salts or optical iso-mers, or salts of optical isomers or any com-pound, mixture, or preparation containingany detectable quantity of ephedrine or itssalts or optical isomers, or salts of opticalisomers if the drug preparations are starch-based solid dose forms, if such preparationsare sold over the counter without a prescrip-tion. The following drug preparations con-taining ephedrine and pseudoephedrine arenot scheduled controlled substances:

A. Drug preparations in liquid form;B. Drug preparations that require a

prescription in order to be dispensed.4. Unless specifically exempted or

excluded or unless listed in another schedule,any material, compound, mixture, or prepa-ration which contains any quantity of the fol-lowing substances having a depressant effecton the central nervous system, including itssalts:

A. Ezogabine [N-[2-amino-4(4- fluorobenzylamino)-phenyl]-carbamic acid ethyl ester] 2779

B. Lacosamide [(R)-2-acetoamido-N-benzyl-3-methoxy-propionamide] 2746

C. Pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid] 2782

D. Brivaracetam ((25)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanamide) (also referredto as BRV; UCB-34714; Briviact) 2710

5. Approved cannabidiol drugs.A. A drug product in finished dosage

formulation that has been approved by theU.S. Food and Drug Administration that con-tains cannabidiol (2-[1R-3-methyl-6R-(1-

methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis andno more than one tenth percent (0.1%) (w/w)residual tetrahydro cannabinols 7367

(2) Excluded Nonnarcotic Substances. Thefollowing nonnarcotic substances which,under the Federal Food, Drug, and CosmeticAct (21 U.S.C. 301) and section 201(g)(1) ofthe federal Controlled Substances Act (21U.S.C. 811(g)(1)), may be lawfully sold overthe counter without a prescription, areexcluded from all schedules pursuant to sec-tion 195.015(5), RSMo.


Secretary of State


AUTHORITY: sections 195.015 and 195.195,RSMo Supp. 2017.* Material found in thisrule previously filed as 19 CSR 30-1.010.Original rule filed April 14, 2000, effectiveNov. 30, 2000. Amended: Filed Jan. 31, 2003,effective July 30, 2003. Amended: Filed Sept.30, 2016, effective May 30, 2017. Emergencyamendment filed Oct. 25, 2018, effective Nov.4, 2018, expired May 2, 2019. Amended: FiledOct. 25, 2018, effective April 30, 2019.

*Original authority: 195.015, RSMo 1971, amended 1989,2014, 2017 and 195.195, RSMo 1957, amended 1971,1989, 1993, 2014, 2017.

19 CSR 30-1.004 List of Excepted Sub-stances

PURPOSE: The Department of Health isauthorized to except by rule any compound,mixture or preparation containing any stimu-lant or depressant substance if one or moreactive medicinal ingredients not having a stim-ulant or depressant effect on the central ner-vous system is included to negate the potentialfor abuse. The compounds, mixtures andpreparations excluded are listed in this rule.

PUBLISHER’S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorporat-ed by reference as a portion of this rule wouldbe unduly cumbersome or expensive. There-fore, the material which is so incorporated ison file with the agency who filed this rule, andwith the Office of the Secretary of State. Anyinterested person may view this material ateither agency’s headquarters or the same willbe made available at the Office of the Secre-tary of State at a cost not to exceed actual cost

of copy reproduction. The entire text of therule is printed here. This note refers only tothe incorporated by reference material.

(1) Excepted Stimulant or Depressant Com-pounds—Exempt Prescription Products. Thelisted drugs in dosage unit form and any otherdrug of the quantitative composition shown inPart 1300 to end of Title 21, the Code of Fed-eral Regulations, April 1998 or which is thesame except that it contains a lesser quantity of controlled substances or other substanceswhich do not have a stimulant, depressant orhallucinogenic effect and which are restricted by law to dispensing or prescription, areexcepted from the provisions of sections195.030, 195.040, 195.050 and 195.100,RSMo as provided for in section195.017.6(5) and .8(3), RSMo. The rules ofthe Drug Enforcement Administration, 21CFR Part 1300 to the end of Title 21, arehereby incorporated by reference and made apart of this rule.

(2) Excepted Chemical Preparations—Exempt Chemical Preparations. The listedpreparations in unit form and any otherpreparation of the quantitative compositionshown in Part 1300 to end of Title 21, theCode of Federal Regulations, April 1998which is the same except that it contains alesser quantity of controlled substances orother substances which do not have a stimu-lant, depressant or hallucinogenic effect areexcepted from the provisions of sections195.030, 195.040, 195.050 and 195.110,RSMo as provided for in section195.017.6(5) and .8(3), RSMo. The rules ofthe Drug Enforcement Administration, 21

CFR Part 1300 to the end of Title 21, arehereby incorporated by reference and made apart of this rule.

AUTHORITY: section 195.195, RSMo 1994.*Material found in this rule previously filed as19 CSR 30-1.020. Original rule filed April14, 2000, effective Nov. 30, 2000.

*Original authority: 195.195, RSMo 1957, amended1971, 1989, 1993.

19 CSR 30-1.006 List of Exempt AnabolicSteroid Products

PURPOSE: This rule maintains a list ofanabolic steroid products excluded from 19CSR 30-1.002(1)(C)5. in conformance withfederal law.

(1) Persons who in the course of legitimatebusiness handle products listed in the Table ofExempt Anabolic Steroid Products in thissection shall be exempt from the registration,records, reports, prescriptions, physical secu-rity and import and export requirements asso-ciated with Schedule III substances.

(A) Trade Name Company NDC or DIN No.1. Androgyn L.A. Forest Pharmaceuticals, 0456-1005

St. Louis, MO2. Andro-Estro Rugby Laboratories, 0536-1605

90-4 Rockville Center, NY3. depANDROGYN Forest Pharmaceuticals, 0456-1020

St. Louis, MO4. DEPO-T.E. Quality Research Pharma- 52765-257

ceuticals, Camel, IN5. depTESTROGEN Martica Pharmaceuticals, 51698-257

Phoenix, AZ6. Duomone Wintec Pharmaceutical, 52047-360

Pacific, MO



Excluded Nonnarcotic Productsmg or

Company Trade Name NDC Code Form Controlled Substance mg/mL

Bioline Laboratories Theophed 00719-1945 TB Phenobarbital 8.00Aphena Pharma Nasal decongestant/ Levometamfetamine 50.00Solutions—New York, LLC inhaler/vapor (l-desoxyephedrine)

Goldline Laboratories Guiaphed Elixir 00182-1377 EL Phenobarbital 4.00Goldline Laboratories Tedrigen Tablets 00182-0134 TB Phenobarbital 8.00Hawthorne Products, Inc. Choate’s Leg Freeze LQ Chloral hydrate 246.67Parke-Davis & Co. Tedral 00071-0230 TB Phenobarbital 8.00Parke-Davis & Co. Tedral Elixir 00071-0242 EX Phenobarbital 40.00Parke-Davis & Co. Tedral S.A. 00071-0231 TB Phenobarbital 8.00Parke-Davis & Co. Tedral Suspension 00071-0237 SU Phenobarbital 80.00Parmed Pharmacy Asma-Ese 00349-2018 TB Phenobarbital 8.10Rondex Labs Azma-Aids 00367-3153 TB Phenobarbital 8.00Smith Kline Consumer Benzedrex 49692-0928 IN Propylhexedrine 250.00Sterling Drug, Inc. Bronkolixir 00057-1004 EL Phenobarbital 0.80Sterling Drug, Inc. Bronkotabs 00057-1005 TB Phenobarbital 8.00Vicks Chemical Co. Vicks Inhaler 23900-0010 IN I-Desoxyephedrine 113.00White Hall Labs Primatene 00573-2940 TB Phenobarbital 8.00

(P-tablets)

Trade Name Company NDC or DIN No.7. DURATESTRIN W.E. Hauck, Alpharetta, 43797-016

GA8. DUO-SPAN II Primedics Laboratories, 0684-0102

Gardena, CA9. Estratest Solvay Pharmaceuticals, 0032-1026

Marietta, GA 10. Estratest HS Solvay Pharmaceuticals, 0032-1023

Marietta, GA 11. Menogen Sage Pharmaceuticals, 59243-570

Shreveport, LA 12. Menogen HS Sage Pharmaceuticals, 59243-560

Shreveport, LA13. PAN ESTRA Pan American Labs, 0525-0175

TEST Covington, LA14. Premarin with Ayerst Labs., Inc. 0046-0879

Methyltestos- New York, NYterone

15. Premarin with Ayerst Labs., Inc., 0046-0878 Methyltestos- New York, NYterone

16. Synovex H Syntex Animal Health, Pellets in Palo Alto, CAprocess

17. Synovex H Syntex Animal Health,Pellets in Palo Alto, CAprocess granulation

18. Synovex Plus Fort Dodge Animalin-process Health,granulation Fort Dodge, IA

19. Synovex Plus Fort Dodge Animalin-process Health,bulk pellets Fort Dodge, IA

20. Testagen Clint Pharmaceuticals, 55553-257Nashville, TN

21. TEST-ESTRO Rugby Laboratories, 0536-9470 Cypionates Rockville Centre, NY

22. Testoderm Alza Corp., 17314-46084 mg/d Palo Alto, CA

23. Testoderm Alza Corp., 17314-46096 mg/d Palo Alto, CA

24. Testoderm Alza Corp., 17314-2836with Adhesive Palo Alto, CA6 mg/d

25. Testoderm Alza Corp., in-process film Palo Alto, CA

26. Testoderm Alza Corp.,with Adhesive Palo Alto, CAin-process film

27. Testosterone I.D.E.-Interstate, 0814-7737 Cyp 50 Estradiol Amityville, NYCyp 2

28. Testosterone Best Generics, No. 54274-530 Cypionate- Miami Beach, FL Estradiol CypionateInjection

29. Testosterone Schein Pharmaceuticals, 0364-6611 Cypionate- Port Washington, NYEstradiol CypionateInjection

30. Testosterone Steris Labs., Inc., 0402-0257 Cypionate-Estra- Phoenix, AZ diol CypionateInjection

31. Testosterone Goldline Labs, 0182-3069Cypionate-Estra- Ft. Lauderdale, FLdiol CypionateInjection

32. Testosterone The Upjohn Co., 0009-0253Cypionate-Estra- Kalamazoo, MIdiol CypionateInjection

33. Testosterone Goldline Labs., 0182-3073Enanthate-Estra- Ft. Lauderdale, FLdiol ValerateInjection

34. Testosterone Schein Pharmaceuticals, 0364-6618 Enanthate-Estra- Port Washington, NYdiol Valerate Injection

35. Testosterone Steris Labs., Inc., 0402-0360Enanthate-Estra- Phoenix, AZdiol ValerateInjection

Trade Name Company NDC or DIN No.36. Tilapia Sex Rangen, Inc.,

Reversal Feed Buhl, ID(Investigational)

37. Tilapia Sex Ziegler Brothers, Inc.Reversal Feed Gardners, PA(Investigational)

AUTHORITY: section 195.195, RSMo 1994.*Material found in this rule previouly filed as19 CSR 30-1.025. Original rule filed April14, 2000, effective Nov. 30, 2000.


19 CSR 30-1.008 List of Excluded Veteri-nary Anabolic Steroid Implant Products

PURPOSE: This rule maintains a list of vet-erinary anabolic steroid products excludedfrom 19 CSR 30-1.002(1)(C)5. in confor-mance with federal law.

(1) The following products containing ananabolic steroid that are expressly intendedfor administration through implants to cattleor other nonhuman species and which havebeen approved by the Secretary of Health andHuman Services for such administration andare excluded from all schedules pursuant tosection 195.017.5, RSMo.

Trade Name Company NDC or DIN No.(A) Component E-H Vetlife, Inc., 021641-002

Norcross, GA(B) Component E-H Elanco, 01968327

Scarborough, ON(C) Component TE-S Vetlife, Inc., 021641-004

Norcross, GA(D) Component T-H Vetlife, Inc., 021641-006

Norcross, GA(E) Component T-S Vetlife, Inc., 021641-005

Norcross, GA(F) F-TO Animal Health, 00093351

Upjohn International,Kalamazoo, MI

(G) Finaplix-H Hoechst RousselVet, 12799-807-10Somerville, NJ

(H) Finaplix-S Hoechst RousselVet, 12799-807-07Somerville, NJ

(I) Heifer-oid Anchor Division,Boehringer Ingelheim,St. Joseph, MO

(J) Heifer-oid Bio-Ceutic Division,Boehringer Ingelheim, St. Joseph, MO

(K) Heifer-oid Ivy Laboratories, Inc.,Overland Park, KS

(L) Implus-H The Upjohn Co., 0009-0434-01Kalamazoo, MI

(M) Implus-H Upjohn Co., Animal 06-0434-01Health Division, 01968327Orangeville, ON

(N) Revalor-G Hoechst Roussel Vet, 12799-811Somerville, NJ

(O) Revalor-H Hoechst Roussel Vet, 12799-810Somerville, NJ

(P) Revalor-S Hoechst Roussel Vet, 12799-809Somerville, NJ

(Q) Synovex H Fort Dodge Labs, 0856-3901Fort Dodge, IA

(R) Synovex H Syntex Laboratories,Palo Alto, CA

(S) Synovex Plus Fort Dodge Labs, 0856-3904Fort Dodge, IA

AUTHORITY: section 195.195, RSMo 1994and 195.017, RSMo Supp. 1999.* Originalrule filed April 14, 2000, effective Nov. 30,2000.

*Original authority: 195.017, RSMo 1971, amended 1987,1989, 1994, 1996, 1997, 1998 and 195.195, RSMo 1957,amended 1971, 1989, 1993.

19 CSR 30-1.010 Schedules of ControlledSubstances(Rescinded November 30, 2000)

AUTHORITY: section 195.195, RSMo Supp.1993. This rule was previously filed as 13CSR 50-130.010 and 19 CSR 10-130.010.Original rule filed Jan. 31, 1972, effectiveApril 1, 1972. Amended: Filed Oct. 4, 1972,effective Oct. 14, 1972. Amended: Filed April4, 1973, effective April 14, 1973. Amended:Filed Sept. 28, 1973, effective Nov. 4, 1973.Amended: Filed Jan. 3, 1974, effective Jan.13, 1974. Amended: Filed Oct. 9, 1974,effective Oct. 19, 1974. Amended: Filed July17, 1975, effective July 27, 1975. Amended:Filed Oct. 8, 1975, effective Oct. 18, 1975.Refiled: March 24, 1976. Amended: FiledOct. 12, 1976, effective Jan. 13, 1977.Amended: Filed March 15, 1977, effectiveMarch 24, 1977. Amended: Filed Nov. 14,1977, effective Nov. 6, 1977. Amended: FiledSept. 28, 1977, effective Jan. 13, 1978.Amended: Filed March 9, 1978, effective Feb.24, 1978. Amended: Filed Oct. 2, 1978,effective Sept. 27, 1978. Amended: FiledNov. 14, 1978, effective June 16, 1978.Amended: Filed Nov. 14, 1978, effective Oct.25, 1978. Amended: Filed Feb. 13, 1979,effective Feb. 9, 1979. Amended: Filed Feb.19, 1980, effective Feb. 11, 1980. Amended:Filed Oct. 14, 1980, effective July 24, 1980.Amended: Filed Oct. 14, 1980, effective Aug.21, 1980. Amended: Filed Oct. 14, 1981,effective Oct. 30, 1980. Amended: Filed Oct.14, 1981, effective May 8, 1981. Amended:Filed Oct. 14, 1981, effective Aug. 20, 1981.Amended: Filed Nov. 1, 1982, effective Dec.11, 1982. Amended: Filed Jan. 12, 1983,effective Feb. 11, 1983. Amended: FiledMarch 11, 1983, effective April 1, 1983.Amended: Filed Sept. 2, 1983, effective Dec.11, 1983. Amended: Filed Nov. 7, 1983,effective Dec. 11, 1983. Amended: Filed July12, 1984, effective Aug. 11, 1984. Amended:Filed Sept. 20, 1984, effective Nov. 11, 1984.Amended: Filed Jan. 15, 1985, effective Feb.11, 1985. Amended: Filed May 29, 1985,effective June 27, 1985. Amended: Filed July


Secretary of State




24, 1985, effective Aug. 26, 1985. Amended:Filed Sept. 12, 1985, effective Oct. 11, 1985.Changed to 19 CSR 10-130.010, effective Oct.11, 1985. Amended: Filed Jan. 3, 1986,effective Jan. 16, 1986. Changed to 19 CSR30-1.010, effective Aug. 11, 1986. Amended:Filed April 17, 1987, effective May 14, 1987.Amended: Filed July 3, 1987, effective Aug.27, 1987. Amended: Filed May 3, 1988,effective May 26, 1988. Amended: Filed Sept.25, 1989, effective Oct. 27, 1989. Emergen-cy amendment filed April 3, 1991, effectiveApril 13, 1991, expired Aug. 10, 1991. Emer-gency amendment filed May 1, 1991, effectiveMay 11, 1991, expired Sept. 7, 1991. Emer-gency amendment filed July 23, 1991, effec-tive Aug. 2, 1991, expired Nov. 28, 1991.Amended: Filed April 3, 1991, effective Sept.30, 1991. Amended: Filed May 1, 1991,effective Sept. 30, 1991. Amended: FiledMarch 2, 1992, effective Aug. 6, 1992.Amended: Filed July 6, 1993, effective Dec.9, 1993. Emergency amendment filed Jan. 5,1994, effective Jan. 15, 1994, expired May14, 1994. Amended: Filed Jan. 5, 1994,effective July 30, 1994. Rescinded: FiledApril 14, 2000, effective Nov. 30, 2000.

State v. Miller, 588 SW2d 237 (Mo. App.1979). Evidence of the presence ofamphetamine is sufficient to support a con-trolled substances conviction; no quantitativeanalysis is necessary. Those rules refiledbetween January 1 and March 31, 1976 werenot required to be published under section536.021, RSMo. Also, courts must take judi-cial notice of the contents of the Code ofState Regulations.

Selvey v. State, 578 SW2d 64 (Mo. App.1979). Phenmetrazine, originally establishedstatutorily as a Schedule III controlled sub-stance, was rescheduled by the Division ofHealth to Schedule II. Such a rescheduling iswithin the statutory power granted the Divi-sion of Health and does not usurp the leg-islative power of the general assembly.

State v. Davis, 450 SW2d 168 (Mo. App.1970). Statutes which direct the Division ofHealth to prepare a list of drugs classified asbarbiturates and stimulants, the sale of whichare made unlawful by statute, does not violatethe Missouri Constitution prohibition in Arti-cle I, section 31 against delegation of author-ity to an agency to make a rule fixing a fineor imprisonment as punishment for its viola-tion.

19 CSR 30-1.011 Definitions

PURPOSE: This rule contains definitions

which establish the intended meaning of cer-tain terms used throughout this chapter.

(1) As used in this chapter, the followingterms shall have the meanings specified:

(A) Commercial container means any bot-tle, jar, tube, ampule or other receptacle inwhich a substance is held for distribution ordispensing to an ultimate user and, in addi-tion, any box or package in which the recep-tacle is held for distribution or dispensing toan ultimate user. The term commercial con-tainer does not include any package liner,package insert of other material kept with orwithin a commercial container, nor any car-ton, crate, drug or other package in whichcommercial containers are stored or are usedfor shipment of controlled substances;

(B) Controlled substances administrationrecord means the form used to record infor-mation when administering individual drugdoses to patients;

(C) Dispenser means an individual practi-tioner, institutional practitioner, pharmacy orpharmacist who dispenses a controlled sub-stance;

(D) Hospice means a public agency or pri-vate organization or subdivision of either ofthese that is primarily engaged in providingcare to dying persons and their families andmeets the standards specified in 19 CSR 30-35;

(E) Hospital employee means a nurse,physician, pharmacist or other responsiblepatient-care employee;

(F) Individual practitioner means a physi-cian, dentist, veterinarian, optometrist orother individual licensed, registered or other-wise permitted by the United States or Mis-souri to dispense a controlled substance in thecourse of professional practice, but does notinclude a pharmacist, a pharmacy or an insti-tutional practitioner;

(G) Institutional practitioner means a hos-pital or other person (other than an individu-al) licensed, registered or otherwise permit-ted by the United States or Missouri todispense a controlled substance in the courseof professional practice, but does not includea pharmacy;

(H) Long-term care facility means a nurs-ing home, retirement care, mental care, orother facility or institution which providesextended health care to resident patients;

(I) Name means the official name, com-mon or usual name, chemical name or brandname of a substance;

(J) Nurse means a registered or licensedpractical nurse licensed under Chapter 335,RSMo;

(K) Patient care areas means any area of ahospital where medical attention is rendered

to a patient;(L) Pre-hospital emergency medical ser-

vice means an emergency medical servicessystem as defined in Chapter 190, RSMo pro-viding services to persons prior to admissionto a hospital;

(M) Prescription means an order for med-ication which is dispensed to or for an ulti-mate user but does not include an order formedication which is dispensed for immediateadministration to the ultimate user. (Forexample, an order to dispense a drug to a bedpatient for immediate administration in a hos-pital is not a prescription.);

(N) Readily retrievable means that certainrecords are kept by automatic data processingsystems or other electronic or mechanizedrecord keeping systems in a manner that theycan be separated out from all other records;and/or records are kept on which certainitems are asterisked, redlined, highlighted orin some other manner visually identifiableapart from other items appearing on therecords; and records are provided withinthree working days of a request;

(O) Registration means a Missouri con-trolled substances registration;

(P) Reregistration means a registrationissued to a person who was previously regis-tered and whose application for reregistrationwas received by the Department of Healthprior to the expiration of the previous regis-tration;

(Q) Temporary location registration meansa registration issued to an individual practi-tioner who:

1. Has a current Missouri professionallicense to practice and is registered with theDepartment of Health at the address listed onhis/her professional license;

2. Has a federal Drug EnforcementAdministration registration that is valid inMissouri;

3. Anticipates practicing in Missouriwithin the next 12 months;

4. Does not practice for more than 90consecutive calendar days at any location;

5. Maintains a record of the date(s) andlocation(s) of all practice activity in Missouriand makes the record available to the Bureauof Narcotics and Dangerous Drugs. Thisrecord shall be retained for two years;

6. Maintains all required controlled sub-stance records at each location;

7. Does not receive or stock controlledsubstances at any location;

(2) Any term not defined in this rule shallhave the definition set forth in Chapter 195,RSMo.

AUTHORITY: section 195.195, RSMo 2000.*


Secretary of State


Original rule filed April 14, 2000, effectiveNov. 30, 2000. Amended: Filed Jan. 31,2003, effective July 30, 2003.


19 CSR 30-1.013 Miscellaneous Fees

PURPOSE: This rule establishes and fixescertain fees and charges statutorily autho-rized to be made by the Department of Healthin provisions codified in Chapters 195 and610, RSMo.

(1) Fees for copies of public records or otherdocuments:

(A) Copy, per page $ 0.25(B) Research fee, per hour $15.00

(2) Payment of fee may be required inadvance.

(3) Fees are nonrefundable.

AUTHORITY: section 195.030, RSMo Supp.1999 and 195.195, RSMo 1994.* Originalrule filed April 14, 2000, effective Nov. 30,2000.


19 CSR 30-1.015 Registrations and Fees

PURPOSE: This rule establishes fees for var-ious types of registration, a late registrationfee, manner of payment, and exemption fromthe registration fee.

(1) For each registration or re-registrationto—

(A) Manufacture controlled substances, theregistrant shall pay a fee of sixty-six dollars($66);

(B) Distribute controlled substances, theregistrant shall pay a fee of sixty-six dollars($66);

(C) Dispense controlled substances listedin Schedules II–V including dispensing ofcontrolled substances by individual practi-tioners in training programs or to conductresearch or instructional activities with thosesubstances, the registrant shall pay a fee ofthirty dollars ($30);

(D) Conduct research or instructionalactivities with a controlled substance listed inSchedule I, the registrant shall pay a fee ofthirty dollars ($30);

(E) Conduct chemical analysis with con-trolled substances listed in any schedule, the

registrant shall pay a fee of thirty dollars($30); and

(F) Import or export controlled substanceslisted in any schedule, the registrant shall paya fee of sixty-six dollars ($66).

(2) Lapsed Registration Fee. A late charge often dollars ($10) must be submitted with theoriginal registration fee if an application issubmitted more than fifteen (15) days after aprevious registration has expired.

(3) Time and Method of Payment andRefunds. Registration and re-registration feesshall be paid at the time when the applicationfor registration or re-registration is submittedfor filing. This is a nonrefundable processingfee. Payment should be made in the form of apersonal, certified, or cashier’s check ormoney order made payable to Department ofHealth and Senior Services. Payments madein the form of stamps, foreign currency, orthird-party endorsed checks will not beaccepted. Applications and fees submittedelectronically online shall use a credit cardand use the online payment system providedon the department’s website.

(4) Persons Exempt From Fee. The Depart-ment of Health and Senior Services shallexempt the following persons from paymentof a fee for registration or re-registration:

(A) Any official or agency of the UnitedStates Army, Navy, Marine Corps, Air Force,Coast Guard, Veterans Administration, orPublic Health Service who is authorized toprocure or purchase controlled substances forofficial use;

(B) Any official, employee or other civilofficer, or agency of the United States or stateor any political subdivision or agency who isauthorized to purchase controlled substances,to obtain these substances from officialstocks, to dispense or administer these sub-stances, to conduct research, instructionalactivities, or chemical analysis with thesesubstances, or any combination of them, inthe course of his/her official duties oremployment;

(C) In order to claim exemption from pay-ment of a registration or re-registration fee,the registrant shall apply for exemption bycompleting appropriate sections of the appli-cation;

(D) Exemption from payment of a registra-tion or re-registration fee does not relieve theregistrant of any other requirements or dutiesprescribed by law; and

(E) Any registration that is exempt frompayment pursuant to this section shall be validonly when authorized persons are conductingactivities in the course of their official duties

or employment at their government practicelocation. If the person conducts controlledsubstance activities away from his or her gov-ernment practice location, the person shallapply and submit the required fee for a non-exempt registration.

AUTHORITY: sections 195.030 and 195.195,RSMo 2000.* Original rule filed April 14,2000, effective Nov. 30, 2000. Amended:Filed Jan. 31, 2003, effective July 30, 2003.Amended: Filed April 29, 2011, effective Nov.30, 2011.


19 CSR 30-1.017 Registration Process

PURPOSE: This rule establishes the periodand expiration of registration, the process ofapplying for registration, and informationrequired to complete an application for regis-tration.

(1) Database and Survey Process. (A) Applicants may apply for and receive a

registration that is effective for up to twelve(12) months.

(B) Applicants may apply with either apaper application or through the department’selectronic online system.

(C) Simultaneously with completing anapplication for a controlled substances regis-tration, practitioners may also complete anannual voluntary census to assist the depart-ment in determining practitioner shortagesand underserved regions of the state.Required questions and fields for controlledsubstance registrations are marked with anasterisk (*) in the electronic online systemand on paper applications.

(2) Period of Registration.(A) Any registration shall be current and

effective for twelve (12) months from the dateissued or until the expiration date assigned atthe time the registration is issued. No personwho is required to be registered shall conductany activity for which registration is requiredwithout a current registration. No controlledsubstance activities shall take place after aregistration expires until a new registrationhas been issued.

(B) At the time any registration is issued,the registration shall be assigned to one oftwelve (12) groups which shall correspond tothe months of the year. The expiration date ofall registrations within any group shall be thelast day of the month designated for thatgroup.



(C) Registrations for manufacturers anddistributors may be assigned to a singlegroup, and the expiration date may be lessthan twelve (12) months from the date theregistration was issued.

(D) Training program registrations may beassigned to a single group, and the expirationdate may be less than twelve (12) monthsfrom the date the registration was issued.

(E) A certificate of registration shall bemade available online and printable to theregistrant which shall include the name andaddress of the registrant, the expiration dateof the registration, and a registration numberfor the convenience of identifying a registra-tion or a registrant. The same registrationnumber may be used for a new registrationfor the same person.

(3) Requirements for All Applicants.(A) Any person who is required to be reg-

istered and who is not so registered mayapply for registration at any time. No personrequired to be registered shall engage in anyactivity for which registration is requireduntil the application for registration is pro-cessed and the registration is issued. Allapplications are for new registrations.

(B) Applications for registration shall bemade on forms designated by the Departmentof Health and Senior Services. Applicationforms may be requested from the MissouriDepartment of Health and Senior Services,PO Box 570, Jefferson City, MO 65102-0570or may be completed online and submittedelectronically via the Missouri Department ofHealth and Senior Services’ website atwww.health.mo.gov along with the requiredfee.

(C) A written application in paper formshall contain the signature of the applicantand shall be provided to the Department ofHealth and Senior Services with any requiredfee. This is a nonrefundable processing fee.

(D) An application which does not containor is not accompanied by the required infor-mation or fee may be denied sixty (60) daysafter notifying the applicant of the deficiency.

(E) An application may be withdrawn bymaking a written request to the Departmentof Health and Senior Services.

(F) A person who is registered may con-duct activities with controlled substances inSchedules II, III, IV, and V, as authorized bystatute, unless a registration is restricted as toschedules or activities because of a settlementagreement, probation, or other disciplinaryaction taken by the Department of Health andSenior Services, the Drug EnforcementAdministration, or a professional licensingboard. Authority to conduct activities withcontrolled substances in Schedule I requires a

separate application and registration.

(4) All applicants shall make full, true, andcomplete answers on the application. TheDepartment of Health and Senior Servicesmay require an applicant to submit docu-ments or written statements of fact relevant tothe application as considered necessary todetermine whether the application should begranted. The failure of the applicant to pro-vide these documents or statements withinsixty (60) days after being requested to do soshall be considered to be a waiver by theapplicant of an opportunity to present thesedocuments or facts for consideration in grant-ing or denying the application.

(5) Applications for Individual PractitionerRegistrations. Applications by physicians, vet-erinarians, optometrists, podiatrists, andresearchers for Missouri Controlled SubstanceRegistrations shall include:

(A) The applicant’s full legal name (firstname, middle name, and last name), includ-ing any suffixes such as junior, senior, or III,gender, race, and ethnicity;

(B) A listing of all addresses and practicelocations where controlled substance activi-ties will be taking place. The applicant’sstreet addresses, cities, zip codes, counties,and state. The number of hours worked perweek for each location shall be provided forperforming direct patient care (non-hospital),administration, research, teaching, in-patienthospital care, and other. The applicant shallalso identify his or her primary, principlepractice location, where he or she spends themost time. This will be the principle practiceaddress that appears on the controlled sub-stances registration. A physical street addressis required and post office box addresses shallnot be accepted;

(C) Whether the application is for a physi-cian, veterinarian, optometrist, podiatrist, orresearcher;

(D) His or her anticipated drug activitiessuch as administering, prescribing, or dis-pensing;

(E) The required fee and fee information.If claiming an exemption from a fee, theapplicant shall identify the name of the gov-ernment agency that employs him or her;

(F) His or her business telephone number,fax number, email address, federal controlledsubstances registration number, if applicable;professional degree, if applicable; and pro-fessional license number, if applicable. If theapplicant has an application pending for afederal controlled substances registrationnumber, the applicant shall indicate the appli-cation is pending;

(G) Whether the applicant, or any officer

of a corporate applicant, or individualemployed by any applicant having access tocontrolled substances, has ever entered a pleaof guilty, no contest, nolo contendere, or oth-erwise been convicted of any violation of anystate or federal law related to the possession,manufacture, distribution, dispensing, or pre-scribing of controlled substances. If theanswer is yes, the applicant shall provide anexplanation;

(H) If the applicant is an individual or aregistrant that holds a professional license,whether he or she is currently licensed andregistered to practice his or her professionunder the laws of this state;

(I) If the applicant is not an individual orregistrant that holds a professional license,the applicant shall answer yes or no towhether the applicant is currently authorizedto conduct business under the laws of thisstate;

(J) Previous Discipline. If the applicant cur-rently holds or has previously held a state orfederal controlled substance registration orstate professional license or registration, theapplicant shall answer yes or no to whether theapplicant’s license, registration, or applicationor renewal thereof has ever been surrendered,revoked, suspended, denied, restricted, orplaced on probation and if any such action ispending. If the answer is yes, the applicantshall provide an explanation;

(K) Whether the applicant is abusing or hasabused or been treated for or diagnosed withaddiction regarding controlled substances dur-ing the past year. For purposes of this subsec-tion, “abusing” or “abused” means using orhaving used a controlled substance in a man-ner not authorized under Chapter 195,RSMo;

(L) Copies and attachments of any guiltypleas, convictions, or disciplinary actionsidentified in subsections (G) and (J) of thissection, if the department does not alreadyhave them on file;

(M) The original signature of the individu-al applicant, if the application is submitted onpaper;

(N) His or her Social Security number anddate of birth (MM/DD/YYYY);

(O) The date the application is signed;(P) What drug schedules the applicant is

requesting authority in; and(Q) A listing of mid-level practitioners by

name and license number with whom appli-cant has agreements pursuant to Chapter 334,RSMo.

(6) Applications for Pharmacies and Busi-nesses. Applications for retail pharmaciesand ambulance services, ambulatory surgerycenters, analytical laboratories, correctional

centers, distributors, exporters, hospices,hospitals, importers, manufacturers, narcotictreatment programs, long-term care facilityE-kits, teaching institutions, researchers, orother applicants not listed in sections (5)–(8),shall include:

(A) The applicant’s full legal name, and ifapplicable, d/b/a name;

(B) The applicant’s tax ID number, ifapplicable;

(C) The applicant’s facility license num-ber, if applicable, and federal controlled sub-stances registration number. If the applicanthas an application pending for a federal con-trolled substances registration number, theapplicant shall indicate an application ispending;

(D) The applicant’s email address;(E) The applicant’s principle Missouri

business street address, city, state, county,and zip code as it will appear on the con-trolled substances registration certificate.Post office box numbers shall not be accept-ed. A separate mailing address may also beprovided;

(F) The applicant’s business telephonenumber and fax number;

(G) The applicant’s type of business activ-ity, licensure type, licensure agency, andlicense number;

(H) What controlled substance schedulesthe applicant is requesting authority in;

(I) The applicant’s criminal history infor-mation as it pertains to controlled substancelaws. The applicant shall answer yes or no asto whether the owner, CEO or administrator,corporate officer, medical director, pharma-cist in charge, or any employee with access tocontrolled drugs has ever pled guilty, no con-test, nolo contendere, or ever been convictedof any violation of state or federal law relat-ing to controlled substances;

(J) Whether there are any previous orpending disciplinary actions regarding theapplicant’s professional license or any con-trolled substance registration, whether theapplicant’s privileges or authority have beenrevoked, surrendered, suspended, restricted,or placed on probation, or if any applicationfor a state license or any drug registration hasever been denied;

(K) The application shall be submittedwith the required fee and fee information. Ifclaiming an exemption from a fee, the appli-cant must identify the name of the govern-ment agency;

(L) Copies and attachments of any guiltypleas, convictions, or disciplinary actionsidentified in subsections (I) and (J) of thissection, if the department does not alreadyhave them on file;

(M) If the applicant is a retail business, the

applicant shall provide a letter from the Mis-souri Department of Revenue that documentsthat no Missouri taxes are due and the appli-cant is in good standing; and

(N) The applicant shall sign and date anapplication submitted on paper and may usethe electronic process if applying online. Anapplication may be signed by the owner, chiefexecutive officer or administrator, corporateofficer, medical director, or pharmacist incharge.

(7) Applications for Dentists. Applicationsfor dentists with the degrees of D.D.S. orD.M.D. shall include:

(A) The applicant’s full legal name (firstname, middle name, and last name), includ-ing any suffixes such as junior, senior, or III;

(B) His or her Social Security number anddate of birth (MM/DD/YYYY);

(C) The applicant’s federal controlled sub-stances registration number. If the applicanthas an application pending for a federal con-trolled substances registration number, theapplicant shall indicate the application ispending;

(D) The applicant’s gender, race, and eth-nicity;

(E) The applicant’s email address;(F) The applicant’s primary specialty and

any board certification;(G) Whether the applicant is licensed to

practice and conduct activities and the appli-cant’s licensure type, license number, andname of licensing agency;

(H) What drug schedules the applicant isrequesting to conduct activities in;

(I) The applicant’s anticipated drug activi-ties such as administering, prescribing, ordispensing;

(J) The applicant’s street addresses, city,zip code, county, and state of their primary,principle practice location, where they spendthe most time. This will be the address thatappears on the controlled substances registra-tion. Post office box numbers shall not beaccepted. Applicants shall also provide anysecondary practice locations and the numberof chair-side work hours per week at eachlocation. The number of hours worked perweek for each location shall be provided forperforming direct patient care (non-hospital),administration, research, teaching, in-patienthospital care, and other;

(K) The applicant’s business phone num-ber and fax number;

(L) The applicant’s criminal history infor-mation as it pertains to controlled substancelaws. The applicant shall answer yes or no asto whether the applicant or any employeeswith access to controlled drugs have ever pledguilty, no contest, nolo contendere, or ever

been convicted of any violation of state orfederal law relating to controlled substances;

(M) Information regarding any previous orpending disciplinary actions regarding theapplicant’s professional license or any con-trolled substance registration, as to whetherthe applicant’s privileges or authority havebeen revoked, surrendered, suspended,restricted, or placed on probation, or if anyapplication for a state license or any drugregistration has ever been denied;

(N) Whether the applicant is abusing or hasabused or been treated for or diagnosed withaddiction regarding controlled substances dur-ing the past year. For purposes of this subsec-tion, “abusing” or “abused” means using orhaving used a controlled substance in a man-ner not authorized under Chapter 195,RSMo;

(O) The application shall be submittedwith the required fee and fee information. Ifclaiming an exemption from a fee, the appli-cant shall identify the name of the govern-ment agency that employs him or her;

(P) The applicant shall provide copies andattachments of any guilty pleas, convictions,or disciplinary actions identified in subsec-tions (L) and (M) of this section, if thedepartment does not already have them onfile; and

(Q) The applicant shall sign and date anapplication submitted on paper and may usethe electronic process if applying online.

(8) Applications for Mid-Level Practitioners.Applications for mid-level practitioners asdefined by 21 CFR 1300.01(b)(28) such asadvanced practice nurses and physician assis-tants shall include:

(A) The applicant’s full legal name (firstname, middle name, and last name), includ-ing any suffixes such as junior, senior, or III;

(B) The applicant’s social security numberand date of birth (MM/DD/YYYY);

(C) The applicant’s federal controlled sub-stances registration number. If the applicanthas an application pending for a federal con-trolled substances registration number, theapplicant shall indicate the application ispending;

(D) The applicant’s gender, race, and eth-nicity;

(E) The applicant’s email address;(F) Whether the applicant is licensed to

practice and conduct activities and the appli-cant’s licensure type, license number, andname of licensing agency;

(G) What controlled substance schedules(III, IV, or V) the applicant is requesting toconduct activities in;

(H) Which physicians the applicant hascollaborative or supervision agreements with;


Secretary of State


(I) A copy of the applicant’s collaborativeor supervision agreements with physicians,and a list of controlled substances from eachphysician that the mid-level practitioner isauthorized to conduct activities with, in thatagreement;

(J) The applicant’s street address, city, zipcode, county, and state of the applicant’s pri-mary, principle practice location. This will bethe principle address that appears on the con-trolled substances registration. Post officeboxes shall not be accepted. Applicants shallalso provide any secondary practice locationaddresses and the number of hours workedper week for each location for performingdirect patient care (non-hospital), administra-tion, research, teaching, in-patient hospitalcare, and other;

(K) The applicant’s business phone num-ber and fax number;

(L) The applicant’s criminal history infor-mation as it pertains to controlled substancelaws. The applicant shall answer yes or no asto whether the applicant or any employeewith access to controlled drugs has ever pledguilty, no contest, nolo contendere, or everbeen convicted of any violation of state orfederal law relating to controlled substances;

(M) Information regarding any previous orpending disciplinary actions regarding theapplicant’s professional license or any con-trolled substance registration, as to whetherthe applicant’s privileges or authority havebeen revoked, surrendered, suspended,restricted, or placed on probation, or if anyapplication for a state license or any drugregistration has ever been denied;

(N) Whether the applicant has abused orbeen treated for or diagnosed with addictionregarding controlled substances during thepast year. For purposes of this subsection,“abusing” or “abused” means using or havingused a controlled substance in a manner notauthorized under Chapter 195, RSMo;

(O) The application shall be submittedwith the required fee and fee information. Ifclaiming an exemption from a fee, the appli-cant shall identify the name of the govern-ment agency that employs the applicant;

(P) The applicant shall provide copies andattachments of any guilty pleas, convictions,or disciplinary actions identified in subsec-tions (L) and (M) of this section, if thedepartment does not already have them onfile; and

(Q) The applicant shall sign and date anapplication submitted on paper and may usethe electronic process if applying online.

AUTHORITY: section 195.195, RSMo 2000.*Original rule filed April 14, 2000, effectiveNov. 30, 2000. Amended: Filed Jan. 31,

2003, effective July 30, 2003. Amended:Filed April 29, 2011, effective Nov. 30, 2011.


19 CSR 30-1.019 Registration Location

PURPOSE: This rule establishes require-ments for the physical location of a registra-tion.

(1) A controlled substance registration shallbe issued at a U.S. Postal Service streetaddress.

(2) A controlled substance registration shallbe issued to an individual practitioner at aMissouri practice location where controlledsubstance and other patient care activitiesoccur.

AUTHORITY: section 195.195, RSMo 2000.*Original rule filed April 14, 2000, effectiveNov. 30, 2000. Amended: Filed Jan. 31,2003, effective July 30, 2003. Amended:Filed April 29, 2011, effective Nov. 30, 2011.


19 CSR 30-1.020 List of Excepted Sub-stances(Rescinded November 30, 2000)

AUTHORITY: section 195.195, RSMo Supp.1989. This rule was previously filed as 13CSR 50-130.020. Original rule filed Sept. 28,1977, effective Jan. 13, 1978. Amended:Filed Nov. 14, 1978, effective Dec. 11, 1978.Amended: Filed Oct. 12, 1979, effective Nov.11, 1979. Amended: Filed Oct. 14, 1981,effective Nov. 2, 1981. Amended: Filed Nov.1, 1982, effective Dec. 11, 1982. Amended:Filed Nov. 7, 1983, effective Dec. 11, 1983.Amended: Filed Oct. 2, 1991, effective Feb.6, 1992. Rescinded: Filed April 14, 2000,effective Nov. 30, 2000.

19 CSR 30-1.023 Registration Changes

PURPOSE: This rule establishes proceduresfor modifying an existing registration,describes the conditions under which a regis-tration automatically terminates, and pro-hibits the transfer of a registration.

(1) Modification of Registration.(A) Any registrant may apply to modify

his/her registration to authorize the handlingof controlled substances in additional sched-ules by submitting a request in writing to the

department. No fee shall be required to bepaid for the modification. The application formodification shall be handled in the samemanner as an application for registration.

(B) Any registrant may request to modifyhis or her name or address as shown on theregistration provided that such a modificationdoes not constitute a change of ownership orlocation. The request shall be made in writ-ing and no fee shall be required to be paid forthe modification. The request for changesmay be submitted electronically using thedepartment’s online database system.Requests submitted in paper form shall con-tain the registrant’s signature.

(C) When the registrant’s name or addressas shown on the registration changes, the reg-istrant shall notify the Department of Healthand Senior Services in writing, including theregistrant’s signature, prior to or within thir-ty (30) days subsequent to the effective dateof the change. No fee shall be required to bepaid for the modification.

(D) Collector of Unwanted ControlledSubstances. A current registrant with thedepartment may request to have their regis-tration modified to authorize the collection ofunwanted controlled substances. Requestsshall be submitted in writing to the Bureau ofNarcotics and Dangerous Drugs, PO Box570, Jefferson City, MO, 65102-0570.Requests shall provide the requesting regis-trant’s name, address, and current MissouriControlled Substances Registration number.Requests shall identify the method of collec-tion such as either a collection receptacle boxor mail-back return system, or both, and shallidentify the exact physical address of thereceptacle. Collection receptacles located inlong term care facilities shall be maintainedby a retail pharmacy or a hospital/clinic withan on-site pharmacy. The bureau will respondto the registrant’s request in writing. Regis-trants authorized by the department to collectunwanted controlled substances shall complywith all requirements for record keeping andsecurity in accordance with federal regula-tions. The privilege of being a collector maybe terminated if the registrant’s authority tocollect is terminated by the United StatesDrug Enforcement Administration, a judicialorder, an act by a state licensing board oragency, or if the collector’s registration isrestricted as a matter of public discipline bythe department. An authorized collector whowishes to cease being a collector shall notifythe bureau in writing of the date that collec-tions will cease.

(2) Termination of Registration.(A) The registration of any person shall

terminate—1. On the expiration date assigned to the

registration at the time the registration was



issued;2. If and when the person dies;3. If and when the person ceases legal

existence;4. If and when a business changes own-

ership, except—A. The registration shall not termi-

nate for thirty (30) days from the effectivedate of the change if the new owner appliesfor a registration within the thirty- (30-) dayperiod and the corresponding Drug Enforce-ment Administration registration remainseffective as provided for by the DrugEnforcement Administration;

5. If and when the person discontinuesbusiness or changes business location,except—

A. The registration shall not termi-nate for thirty (30) days from the effectivedate of the change if the person applies for anew registration or modification within thethirty- (30-) day period; or

6. Upon the written request of the regis-trant.

(B) A mid-level practitioner’s registrationshall be contingent upon the physician withwhom he or she has entered into an agree-ment pursuant to Chapter 334, RSMo, havinga current and valid registration. When suchphysician’s registration expires, closes, or isno longer valid, any mid-level practitioner(s)with whom he or she has entered into anagreement shall no longer have controlledsubstance authority. The mid-level practition-er(s) shall cease controlled drug activitiesuntil the physician has obtained a new regis-tration or the mid-level practitioner(s)obtain(s) another agreement with anotherphysician pursuant to Chapter 334, RSMo.Mid-level practitioners and any physicianwith whom he or she has entered into anagreement pursuant to Chapter 334, RSMo,shall notify the Department of Health andSenior Services of the termination of anysuch agreement.

(C) Any registrant who ceases legal exis-tence or discontinues business or profession-al practice shall notify the Department ofHealth and Senior Services of the effectivedate of this action and promptly returnhis/her registration certificate to the Depart-ment of Health and Senior Services.

(3) Transfer of Registration. No registrationor any authority conferred by registrationshall be assigned or otherwise transferred.

AUTHORITY: section 195.195, RSMo Supp.2018.* Original rule filed April 14, 2000,effective Nov. 30, 2000. Amended: Filed Jan.31, 2003, effective July 30, 2003. Amended:Filed April 29, 2011, effective Nov. 30, 2011.Emergency amendment filed Sept. 17, 2018,effective Sept. 27, 2018, expired March 25,

2019. Amended: Filed Sept. 17, 2018, effec-tive March 30, 2019.

*Original authority: 195.195, RSMo 1957, amended1971, 1989, 1993, 2014.

19 CSR 30-1.025 List of Exempt AnabolicSteroid Products (Rescinded November 30, 2000)

AUTHORITY: section 195.015.4, RSMoSupp. 1989. Original rule filed July 6, 1993,effective Dec. 9, 1993. Rescinded: FiledApril 14, 2000, effective Nov. 30, 2000.

19 CSR 30-1.026 Separate Registrations

PURPOSE: This rule defines the require-ments for controlled substance registrationsfor separate activities and for separate sites,and defines when a separate registration isnot required.

(1) Independent Activities. The followingeight groups of activities are deemed to beindependent of each other and require sepa-rate registration:

(A) Manufacturing controlled substances; (B) Distributing controlled substances,

except:1. A dispenser distributing less than

5% of the total combined dosage units of con-trolled substances distributed and dispensedin a calendar year shall be exempt fromobtaining a separate registration for distribut-ing;

2. A dispenser distributing more than5% of the total combined dosage units of con-trolled substances distributed and dispensedin a calendar year must obtain a separate reg-istration as a distributor but shall be exemptfrom maintaining separate inventories under19 CSR 30-1.042;

(C) Dispensing controlled substances listedin Schedules II–V;

(D) Conducting research and instructionalactivities with controlled substances listed inSchedule I;

(E) Conducting research with controlledsubstances listed in Schedules II–V;

(F) Conducting a narcotic treatment pro-gram with narcotic controlled substances list-ed in Schedules II–V;

(G) Conducting instructional activitieswith controlled substances listed in SchedulesII–V;

(H) Importing controlled substances; (I) Exporting controlled substances;(J) Conducting chemical analysis with con-

trolled substances listed in any schedule.

(2) No activity shall be conducted with anycontrolled substance in any schedule notrequested for and shown on the current regis-tration.

(3) Separate Locations. A separate registra-tion is required for each principal place ofbusiness or professional practice at one gen-eral physical location where controlled sub-stances are manufactured, distributed or dis-pensed by a person.

(A) For purposes of registration only, thefollowing locations shall be deemed not to beplaces where controlled substances are man-ufactured, distributed or dispensed:

1. A warehouse where controlled sub-stances are stored by or on behalf of a reg-istered person, unless these substances aredistributed directly from the warehouse toregistrants other than the registered person orto persons not required to register;

2. An office used by agents of a regis-trant where sales of controlled substances aresolicited, made or supervised but which nei-ther contains these substances (other thansubstances for display purposes or lawful dis-tribution as samples only) nor serves as a dis-tribution point for filling sales orders;

3. An office used by a practitioner (whois registered at another location) where con-trolled substances are prescribed but neitheradministered nor otherwise dispensed as aregular part of the professional practice of thepractitioner at the office and where no sup-plies of controlled substances are maintained;

4. A location on the immediate or con-tiguous property of a hospital, provided thatthe location is owned and operated by thehospital and controlled substances are notdispensed for use away from the location;

5. A separate location from a registeredpre-hospital emergency medical service loca-tion where an emergency vehicle is housedthat does not have a permanent location ofoperation and which rotates between loca-tions at least every 30 days for operationalreasons other than controlled substance regis-tration;

6. A pre-hospital emergency medicalservice located outside the state of Missourithat renders assistance to a pre-hospital emer-gency medical service located in the state ofMissouri under a mutual aid contract in thecase of an emergency, major catastrophe orother unforeseen event that jeopardizes theability of the local Missouri pre-hospitalemergency medical service to promptlyrespond.

(B) A separate registration is not requiredfor each separate practice location for anindividual practitioner who has a temporarylocation registration.


Secretary of State


AUTHORITY: section 195.195, RSMo 1994.*Original rule filed April 14, 2000, effectiveNov. 30, 2000.


19 CSR 30-1.027 Investigative and Admin-istrative Procedures

PURPOSE: This rule establishes proceduresfor the handling and disposition of informa-tion indicating violations of Chapter 195,RSMo by the Department of Health, pursuantto the mandates of section 195.040.

(1) The Department of Health may allow offi-cers of state and federal administrative agen-cies to attend and participate in informal con-ferences conducted with Missouri controlledsubstances registrants, Missouri regulatedchemical registrants or applicants in order toassist the Department of Health in its delib-erations.



19 CSR 30-1.030 Requirements for Con-trolled Substances Registration(Rescinded November 30, 2000)

AUTHORITY: section 195.195, RSMo 1994.This rule was previously filed as 13 CSR 50-131.010. Original rule filed Jan. 31, 1972,effective April 1, 1972. Amended: Filed April12, 1983, effective July 11, 1983. Amended:Filed May 31, 1989, effective Oct. 1, 1989.Amended: Filed Nov. 26, 1991, effective April9, 1992. Amended: Filed Aug. 26, 1992,effective April 8, 1993. Amended: Filed Nov.1, 1994, effective June 30, 1995. Rescinded:Filed April 14, 2000, effective Nov. 30, 2000.

19 CSR 30-1.031 Physical Security Re-quirements

PURPOSE: This rule requires applicants andregistrants to maintain security controls andprocedures to prevent theft and diversion ofcontrolled substances.

(1) All applicants and registrants shall pro-vide effective controls and procedures toguard against theft and diversion of con-trolled substances. In order to determinewhether a registrant has provided effectivecontrols against diversion, the Department of

Health shall use the security requirement setforth in 19 CSR 30-1.032–19 CSR 30-1.034as standards for the physical security controlsand operating procedures necessary to pre-vent diversion. Substantial compliance withthese standards may be deemed sufficient bythe Department of Health after evaluation ofthe overall security system and needs of theapplicant or registrant.

(2) Physical security controls shall be com-mensurate with the schedules and quantity ofcontrolled substances in the possession of theregistrant in normal business operations. If acontrolled substance is transferred to a dif-ferent schedule, or a noncontrolled substanceis listed on any schedule, or the quantity ofcontrolled substances in the possession of theregistrant in normal business operations sig-nificantly increases, physical security con-trols shall be expanded and extended accord-ingly.

(3) All registrants who receive or transfersubstantial quantities of controlled substancesin normal business operations shall employsecurity procedures to guard against in-tran-sit losses.



19 CSR 30-1.032 Security for Nonpracti-tioners

PURPOSE: This rule describes specificactions required of nonpractitioner regis-trants to maintain effective security.

PUBLISHER’S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorpo-rated by reference as a portion of this rulewould be unduly cumbersome or expensive.This material as incorporated by reference inthis rule shall be maintained by the agency atits headquarters and shall be made availableto the public for inspection and copying at nomore than the actual cost of reproduction.This note applies only to the reference mate-rial. The entire text of the rule is printedhere.

(1) Before distributing a controlled substanceto any person who the registrant does notknow to be registered to possess the con-trolled substance, the registrant shall make agood faith inquiry either with the federal

Drug Enforcement Administration (DEA) orwith the Department of Health and SeniorServices to determine that the person is reg-istered to possess the controlled substance.

(2) The registrant shall design and operate asystem to disclose to the registrant suspiciousorders of controlled substances. The regis-trant shall inform the Department of Healthand Senior Services of suspicious orderswhen discovered by the registrant. Suspiciousorders include orders of unusual size, ordersdeviating substantially from a normal patternand orders of unusual frequency.

(3) The registrant shall notify the Departmentof Health and Senior Services of any theft orsignificant loss of any controlled substancesupon discovery of this theft or loss.

(A) The registrant shall complete and sub-mit a Report of Loss, Theft or Diversion ofControlled Substances or Regulated Chemi-cals to the Department of Health and SeniorServices no later than seven (7) business daysafter the discovery of such a loss. If the extentof the loss cannot be fully determined in thattime frame, the registrant shall contact theDepartment of Health and Senior Services torequest permission to submit an interimreport and arrange for a complete report to becompleted and submitted. The registrant mayattach a copy of a completed Drug Enforce-ment Administration Loss Form in lieu ofcompleting the back or second page of aReport of Loss, Theft or Diversion of Con-trolled Substances or Regulated Chemicalsform. In the event of theft, diversion or sus-pected theft or diversion, the report submit-ted to the Department of Health and SeniorServices shall be accompanied by or followedby a summary of the internal investigationperformed, the outcome of the investigation,and a copy of any law enforcement agencyreport completed if applicable.

(B) If an insignificant amount of a con-trolled substance is lost during lawful activi-ties authorized under Chapter 195, RSMo,the reason for the loss or a description ofwhat occurred, the name of the drug and theamount lost shall be documented in writing,signed by the registrant and attached or filedwith the last completed annual inventory.

(4) The registrant shall not distribute anycontrolled substance as a complimentarysample to any potential or current customerwithout the prior written request of the cus-tomer, to be used only for satisfying the legit-imate medical needs of patients of the cus-tomer and only in reasonable quantities. Therequest must contain the name, address andregistration number of the customer and the




Secretary of State


name of the specific controlled substancedesired. The request shall be preserved by theregistrant with other records of distribution ofcontrolled substances. In addition, therequirements for order forms shall be com-plied with for any distribution of a controlledsubstance listed in Schedule I or II.

(5) Entities registered with the Department ofHealth and Senior Services as distributorsshall be deemed to have met security require-ments for storage of Schedule V controlledsubstance drug products containing ephedrineor pseudoephedrine if those products arestored in compliance and consistent with theregulated chemicals requirements set forth bythe United States Drug Enforcement Admin-istration and 21 CFR 1309.71 which is here-by incorporated by reference in this rule, aspublished on April 1, 2005 by the U.S. Gov-ernment Printing Office, U.S. Superinten-dent of Documents, Washington, DC 20402-001; www.gpoaccess.gov/cfr/retrieve.html.This rule does not incorporate any subse-quent amendments or additions. Distributorswill be required to conduct backgroundchecks on employees with access to thesesubstances and to report losses of controlledsubstances as required in 19 CSR 30-1.034.

AUTHORITY: sections 195.017, RSMo Supp.2005 and 195.195, RSMo 2000.* Originalrule filed April 14, 2000, effective Nov. 30,2000. Emergency amendment filed Aug. 18,2005, effective Aug. 28, 2005, expired Feb.23, 2006. Amended: Filed Sept. 1, 2005,effective Feb. 28, 2006.

*Original authority: 195.017, RSMo 1971, amended 1987,1989, 1994, 1996, 1997, 1998, 2001, 2005 and 195.195,RSMo 1957, amended 1971, 1989, 1993.

19 CSR 30-1.033 Hearing Procedures onControlled Substances Registration (Rescinded November 30, 2000)

AUTHORITY: sections 195.040.11 and195.195, RSMo Supp. 1989. Original rulefiled Aug. 26, 1992, effective April 8, 1993.Rescinded: Filed April 14, 2000, effectiveNov. 30, 2000.

19 CSR 30-1.034 Security for Practitioners

PURPOSE: This rule describes specificactions required of practitioner registrants tomaintain effective security. This rule also cre-ates and defines the form which must be usedby a registrant to report any theft or loss ofcontrolled substances to the Department ofHealth.

(1) Physical Security.(A) Controlled substances listed in Sched-

ules I and II shall be stored in a securelylocked, substantially constructed cabinet.

(B) Controlled substances listed in Sched-ules III, IV and V shall be stored in a secure-ly locked, substantially constructed cabinet.However, pharmacies may disperse these sub-stances throughout the stock of noncontrolledsubstances in such a manner as to obstructthe theft or diversion of the controlled sub-stances.

(C) This rule also shall apply to nonpracti-tioners authorized to conduct research orchemical analysis under another registration.

(2) Other Security. (A) The registrant shall not employ as an

agent or employee who has access to con-trolled substances any person who has beenfound guilty or entered a plea of guilty ornolo contendere in a criminal prosecutionunder the laws of any state or of the UnitedStates for any offense related to controlledsubstances or who has had an application fora state or federal controlled substance regis-tration denied or has had his/her registrationrevoked or surrendered for cause at any time.For purposes of this subsection, the term forcause means a surrender in place of or as aconsequence of any federal or state adminis-trative, civil or criminal action resulting froman investigation of the individual’s handlingof controlled substances.

1. A registrant may apply in writing tothe Department of Health and Senior Ser-vices for a waiver of subsection (2)(A) of thisrule for a specific employee.

2. The Department of Health and SeniorServices may issue a written waiver to anyregistrant upon determination that a waiverwould be consistent with the public healthand safety. In making this determination, theDepartment of Health and Senior Servicesshall consider—the duties of the employee,the circumstances surrounding the convic-tion, the length of time since the convictionwas entered, whether a waiver has beengranted by the federal Drug EnforcementAdministration (DEA) pursuant to 21 CFR1301.76, the security measures taken by theemployer to prevent the theft and diversion ofcontrolled substances, and any other factorsconsistent with public health and safety.

(B) A registrant shall notify the Depart-ment of Health and Senior Services of thetheft, diversion or significant loss of any con-trolled substances or regulated chemicalsupon discovery.

1. The registrant shall complete andsubmit a report of the loss or diversion ofcontrolled substances to the Department of

Health and Senior Services no later thanseven (7) business days after the discovery ofsuch a loss. The loss report form shall con-tain the following information: name andaddress of registrant, business phone num-ber; Missouri Controlled Substance Registra-tion Number; federal Drug EnforcementAdministration Registration number; date oftheft or loss; date of discovery of theft orloss; county of location; principal type ofregistration such as M.D., D.O., D.P.M.,O.D., D.V.M., D.D.S., D.M.D., A.N.P.,emergency medical service, pharmacy, hospi-tal, manufacturer, nursing home kit, narcotictreatment program, teaching institution, dis-tributor, importer, exporter, or other speci-fied business; whether or not the loss or theftwas reported to law enforcement; the nameand phone number of the law enforcementagency reported to; the number of losses orthefts the registrant has experienced in thepast twenty-four (24) months; the type of lossor diversion such as, break in/burglary, rob-bery, employee theft, forged or falsifiedrecords, lost in transit, or other explainedtype of loss; if lost in transit, the name of thecommon carrier and name of consignee; thename(s) of the individual diverting controlledsubstances who was responsible for the theftor loss; copy of registrant’s internal inves-tigative report involving the loss or theft; thefull name, date of birth and Social Securitynumber of the individual(s) responsible forthe theft or diversion, if known; a copy of thepolice report if law enforcement was notified;if the loss or diversion was in transit, identi-fy the origin of the delivery, the name of thecarrier(s) used and the name of the con-signee; a list of all controlled substances lost,stolen or diverted by their generic name,trade name, the dosage strength, dosage formand quantity; the signature of the personcompleting the loss report and their title andthe date of their signature. If the extent of theloss cannot be fully determined in that timeframe, the registrant shall contact the Depart-ment of Health and Senior Services to requestpermission to submit an interim report andarrange for a complete report to be complet-ed and submitted. The registrant may attach acopy of a completed Drug EnforcementAdministration Loss Form in lieu of complet-ing the back or second page of a loss reportform provided by the Department of Healthand Senior Services. In the event of theft,diversion or suspected theft or diversion, thereport submitted to the Department of Healthand Senior Services shall be accompanied byor followed by a summary of the internalinvestigation performed, the outcome of theinvestigation, and a copy of any law enforce-ment agency report completed if applicable.

2. If an insignificant amount of a con-trolled substance is lost during lawful activi-ties authorized under Chapter 195, RSMo,the reason for the loss or a description ofwhat occurred, the name of the drug and theamount lost shall be documented in writing,signed by the registrant and attached or filedwith the last completed annual inventory.

AUTHORITY: section 195.195, RSMo 2000.*Original rule filed April 14, 2000, effectiveNov. 30, 2000. Amended: Filed Jan. 31,2003, effective July 30, 2003.


19 CSR 30-1.035 Requirements for Pre-scribing, Dispensing and AdministeringControlled Substances(Rescinded November 30, 2000)

AUTHORITY: sections 195.040.3(2),195.050.6 and 195.195, RSMo 1994. Origi-nal rule filed Nov. 14, 1988, effective Feb.24, 1989. Amended: Filed Aug. 26, 1992,effective April 8, 1993. Amended: Filed Nov.1, 1994, effective June 30, 1995. Rescinded:Filed April 14, 2000, effective Nov. 30, 2000.

19 CSR 30-1.036 Disposing of UnwantedControlled Substances (Rescinded November 30, 2000)

AUTHORITY: section 195.050.6, RSMo1986. Original rule filed Jan. 18, 1989,effective April 27, 1989. Rescinded: FiledApril 14, 2000, effective Nov. 30, 2000.

19 CSR 30-1.040 Dispensing and Distribu-tion of Controlled Substances in CertainSituations(Rescinded July 30, 2003)

AUTHORITY: section 195.195, RSMo 1986.This rule was previously filed as 13 CSR 50-132.010. Original rule filed Jan. 31, 1972,effective April 1, 1972. Rescinded: Filed Jan.31, 2003, effective July 30, 2003.

19 CSR 30-1.041 Records Requirements

PURPOSE: This rule defines the record keep-ing and inventory requirements for variousclasses of registrants.

(1) Persons Required to Keep Records. (A) Each registrant shall maintain the

records and inventory required by 19 CSR30-1.041–19 CSR 30-1.052, except as

exempted by 19 CSR 30-1.041–19 CSR 30-1.052.

(B) Registered individual practitioners andinstitutional practitioners are required to keeprecords with respect to controlled substanceswhich are prescribed, administered or dis-pensed.

(C) A registered person using any con-trolled substance in research conducted inconformity with an exemption granted undersection 505(i) or 512(j) of the federal Food,Drug and Cosmetic Act (21 U.S.C. 355(i) or360(j)) at a registered establishment whichmaintains records in accordance with eitherof those sections is not required to keeprecords if s/he notifies the Department ofHealth of the name, address and registrationnumber of the establishment maintainingthese records.

(D) A registered person using any con-trolled substance in preclinical research or inteaching at a registered establishment whichmaintains records with respect to these sub-stances is not required to keep records if s/henotifies the Department of Health of thename, address and registration number of theestablishment maintaining the records.

(E) Notice required by subsection (1)(D) ofthis rule shall be given at the time the personapplies for registration or re-registration andshall be made in the form of an attachment tothe application, which shall be filed with theapplication.

(2) Maintenance of Records and Inventories.Every inventory and other record required tobe kept under 19 CSR 30-1.041–19 CSR 30-1.052, shall be kept by the registrant and beavailable, for at least two years from the dateof the inventory or record, for inspecting andcopying by authorized employees of theDepartment of Health, except that financialand shipping records (such as invoices andpacking slips, but not executed order forms)may be kept at a central location rather thanat the registered location if the registrantobtains from the Department of Healthapproval of his/her central record keepingsystem and a permit to keep central records.The permit to keep central records shall besubject to the following conditions:

(A) The permit shall specify the nature ofthe records to be kept centrally and the exactlocation where the records will be kept;

(B) The registrant agrees to deliver all orany part of these records to the registeredlocation within three working days of receiptof a written request from the Department ofHealth for these records and if the Depart-ment of Health chooses to do so in lieu ofrequiring delivery of records to the registeredlocation, to allow authorized employees ofthe Department of Health to inspect therecords at the central location upon request

by the employees without a warrant of anykind;

(C) The failure of the registrant to performhis/her agreements under the permit shallrevoke, without further action, the permit andall other such permits held by the registrantunder other registrations. In the event of arevocation of other permits under subsection(2)(C) of this rule, the registrant, within 30days after the revocation, shall comply withthe requirement that all records be kept at theregistered location.

(3) Each registered individual practitioner,institutional practitioner, manufacturer, dis-tributor, importer and exporter shall maintaininventories and records of controlled sub-stances as follows:

(A) Inventories and records of controlledsubstances listed in Schedules I and II shallbe maintained separately from all of therecords of the registrant;

(B) Inventories and records of controlledsubstances listed in Schedules III, IV and Vshall be maintained either separately from allother records of the registrant or in a formthat the information required is readilyretrievable from the ordinary businessrecords of the registrant.

(4) Each registered pharmacy shall maintainthe inventories and records of controlled sub-stances as follows:

(A) Inventories and records of all con-trolled substances listed in Schedules I and IIshall be maintained separately from all otherrecords of the pharmacy and prescriptions forthese substances shall be maintained in a sep-arate prescription file;

(B) Inventories and records of controlledsubstances listed in Schedules III, IV and Vshall be maintained either separately from allother records of the pharmacy or in a formthat the information required is readilyretrievable from ordinary business records ofthe pharmacy and prescriptions for those sub-stances shall be maintained in a separate pre-scription file.

AUTHORITY: sections 195.050 and 195.195,RSMo 1994 and 195.030, RSMo Supp.1999.* Original rule filed April 14, 2000,effective Nov. 30, 2000.

*Original authority: 195.030, RSMo 1939, amended 1971,1989, 1993, 1997, 1999; 195.050, RSMo 1939, amended1971, 1989; and 195.195, RSMo 1957, amended 1971,1989, 1993.

19 CSR 30-1.042 Inventory Requirements

PURPOSE: This rule defines requirementsfor the form and maintenance of controlledsubstance inventories.



(1) General Requirements.(A) Each inventory shall contain a com-

plete and accurate record of all controlledsubstances on hand on the date the inventorywas taken. Controlled substances shall bedeemed to be on hand if they are in the pos-session of or under the control of the regis-trant, including substances returned by a cus-tomer, substances ordered by a customer butnot yet invoiced, substances stored in a ware-house on behalf of the registrant and sub-stances in the possession of employees of theregistrant and intended for distribution ascomplimentary samples.

(B) A separate inventory shall be made bya registrant for each registered location. Inthe event controlled substances are in the pos-session or under the control of the registrantat a location for which s/he is not registered,the substances shall be included in the inven-tory of the registered location to which theyare subject to control or to which the personpossessing the substance is responsible. Eachinventory for a registered location shall bekept at the registered location.

(C) A separate inventory shall be made bya registrant for each independent activity forwhich s/he is registered.

(D) A registrant may take an inventoryeither as of the opening of business or as ofthe close of business on the inventory date.The registrant shall indicate on the inventoryrecords whether the inventory is taken as ofthe opening or as of the close of business andthe date the inventory is taken.

(E) An inventory must be maintained in apermanent written, typewritten or printedform. An inventory taken by use of an oralrecording device must be transcribed prompt-ly.

(2) Initial Inventory Date. (A) Every person required to keep records

who is registered with the Department ofHealth after May 1, 1971 and who was notregistered previously shall take an inventoryof all stocks of controlled substances on handon the date s/he first engages in the manufac-ture, distribution or dispensing of controlledsubstances.

(B) Compliance with federal initial inven-tory date requirements is deemed satisfactory.Duplicate inventories are not required.

(3) Annual Inventory Date. After the initialinventory is taken, the registrant shall take anew inventory of all stocks of controlled sub-stances on hand at least once a year. Theannual inventory may be taken on any datethat is within one year of the previous annu-al inventory date.

(4) Inventory Date for Newly ControlledSubstances. On the effective date of a rule bythe Department of Health adding a substanceto any schedule of controlled substances,which substance was not listed immediatelyprior to that date in any such schedule, everyregistrant required to keep records who ismanufacturing, distributing or dispensing thatsubstance shall take inventory of all stocks ofthe substance on hand. After that, this sub-stance shall be included in each inventorymade by the registrant.

(5) Inventories of Manufacturers. Each regis-tered manufacturer shall include the follow-ing information in his/her inventory:

(A) For each controlled substance in bulkform to be used in (or capable of use in) themanufacture of the same or other controlledor noncontrolled substances in finished form,the name of the substance and the total quan-tity of the substance to the nearest metric unitweight consistent with unit size (except thatfor inventories made in 1971, avoirdupoisweights may be utilized where metric weightsare not readily available);

(B) For each controlled substance in theprocess of manufacture on the inventory datethe name of the substance, the quantity of thesubstance in each batch, stage of manufac-ture, or both, identified by the batch numberor other appropriate identifying number andthe physical form which the substance is totake upon completion of the manufacturingprocess (for example, granulations, tablets,capsules or solutions), identified by the batchnumber or other appropriate identifying num-ber and if possible the finished form of thesubstance (for example, ten milligram (10mg) tablet or ten milligram (10 mg) concen-tration per fluid ounce or milliliter) and thenumber or volume;

(C) For each controlled substance in fin-ished form, the name of the substance; eachfinished form of the substance (for example,ten milligram (10 mg) tablet or ten milligram(10 mg) concentration per fluid ounce ormilliliter); the number of units or volume ofeach finished form in each commercial con-tainer (for example, four 100 tablet bottles orthree milliliter (3 ml) vials); the number ofcommercial containers of each finished form(for example, four 100 tablet bottles or sixthree milliliter (3 ml) vials);

(D) For each controlled substance notincluded in subsections (5)(A)–(C) of thisrule (for example, damaged, defective orimpure substances awaiting disposal, sub-stances held for quality control purposes orsubstances maintained for extemporaneouscompoundings), the name of the substance;the total quantity of the substance to the near-

est metric unit weight or the total number ofunits of finished form; the reason for the sub-stance being maintained by the registrant andwhether the substance is capable of use in themanufacture of any controlled substance infinished form.

(6) Inventories of Distributors. Each regis-tered distributor shall include in his/herinventory the same information required ofmanufacturers in subsections (5)(C) and (D)of this rule.

(7) Inventories of Dispensers andResearchers. Each person registered to dis-pense or conduct research with controlledsubstances and required to keep records shallinclude in his/her inventory the same infor-mation required of manufacturers in subsec-tions (5)(C) and (D) of this rule. In deter-mining the number of units of each finishedform of a controlled substance in a commer-cial container which has been opened, thedispenser shall do as follows:

(A) If the substance is listed in Schedule Ior II, s/he shall make an exact count or mea-sure of the contents;

(B) If the substance is listed in ScheduleIII, IV or V, s/he shall make an estimatedcount or measure of the contents, unless thecontainer holds more than 1,000 tablets orcapsules in which case s/he must make anexact count of the contents.

(8) Inventories of Importers and Exporters.Each registered importer or exporter shallinclude in his/her inventory the same infor-mation required of manufacturers in subsec-tions (5)(A), (C) and (D) of this rule. Eachregistered importer and exporter who also isregistered as a manufacturer or as a distribu-tor shall include in his/her inventory as animporter or exporter only those stocks ofcontrolled substances that actually are sepa-rated from his/her stocks as a manufactureror as a distributor (for example, in-transit orin storage for shipment).

(9) Inventories for Chemical Analysts. Eachanalytical laboratory registered to conductchemical analysis with controlled substancesshall include in its inventory the same infor-mation required of manufacturers in subsec-tions (5)(A), (C) and (D) of this rule as tosubstances which have been manufactured,imported or received by the laboratory con-ducting the inventory. If less than one kilo-gram (1 kg) of any controlled substance(other than a hallucinogenic controlled sub-stance listed in Schedule I) or less than twen-ty grams (20 g) of a hallucinogenic substancelisted in Schedule I (other than lysergic aciddiethylamide) or less than point five gram


Secretary of State


(0.5 g) of lysergic acid diethylamide, is onhand at the time of inventory, those sub-stances need not be included in the inventory.Laboratories of the division may process upto one hundred fifty grams (150 g) of any hal-lucinogenic substance in Schedule I withoutregard to a need for an inventory of thosesubstances.

AUTHORITY: sections 195.030, RSMo Supp.1999 and 195.195, RSMo 1994.* Originalrule filed April 14, 2000, effective Nov. 30,2000.


19 CSR 30-1.044 Continuing Records Gen-eral Requirements

PURPOSE: This rule sets requirements forthe maintenance of ongoing controlled sub-stance records.

(1) Every registrant required to keep recordsshall maintain on a current basis a completeand accurate record of each such substancemanufactured, imported, received, sold,delivered, exported or otherwise disposed ofby him/her.

(2) Separate records shall be maintained by aregistrant for each registered location exceptas provided in 19 CSR 30-1.041(2). In theevent controlled substances are in the posses-sion or under the control of a registrant at alocation for which s/he is not registered, thesubstance shall be included in the records ofthe registered location to which they are sub-ject to control or to which the person pos-sessing the substance is responsible.

(3) Separate records shall be maintained by aregistrant for each independent activity forwhich s/he is registered.

(4) In recording dates of receipt, importation,distribution, exportation or other transfers,the date on which the controlled substancesare actually received, imported, distributed,exported or otherwise transferred shall beused as the date of receipt or distribution ofany documents of transfer (for example,invoices or packing slips).

(5) Records must be provided to the Depart-ment of Health within three working daysupon request.

AUTHORITY: sections 195.050 and 195.195,RSMo 1994.* Original rule filed April 14,2000, effective Nov. 30, 2000.

*Original authority: 195.050, RSMo 1939, amended 1971,1989 and 195.195, RSMo 1957, amended 1971, 1989,1993.

19 CSR 30-1.046 Records for Manufac-turers, Distributors, Importers andExporters

PURPOSE: This rule sets requirements forrecord keeping by manufacturers, distribu-tors, importers and exporters of controlledsubstances.

(1) Records for Manufacturers. Each regis-tered manufacturer shall maintain recordswith the following information:

(A) For each controlled substance in bulkform to be used in or capable of use in orbeing used in the manufacture of the same orother controlled or noncontrolled substancesin finished form—

1. The name of the substance; 2. The quantity manufactured in bulk

form by the registrant, including the date,quantity and batch or other identifying num-ber of each batch manufactured;

3. The quantity received from other per-sons including the date and quantity of eachreceipt and the name, address and registrationnumber of the other person from whom thesubstance was received;

4. The quantity imported directly by theregistrant (under a registration as animporter) for use in manufacture by him/her,including the date, quantity and import per-mit or declaration number for each importa-tion;

5. The quantity used to manufacture thesame substance in finished form including thedate and batch or other identifying number ofeach manufacture; the quantity used in themanufacture; the finished form (for example,ten milligram (10 mg) tablets or ten mil-ligram (10 mg) concentration per fluid ounceor milliliter); the number of units of finishedform manufactured; the quantity used in qual-ity control; the quantity lost during manufac-turing and the causes for the loss, if known;the total quantity of the substance containedin the finished form; the theoretical and actu-al yields and other information as is neces-sary to account for all controlled substancesused in the manufacturing process;

6. The quantity used to manufactureother controlled and noncontrolled sub-stances, including the name of each substancemanufactured and the information required inparagraph (1)(A)5. of this rule;

7. The quantity distributed in bulk formto other persons, including the date and quan-tity of each distribution and the name,

address and registration number of each per-son to whom a distribution was made;

8. The quantity exported directly by theregistrant, including the date, quantity andexport permit or declaration number of eachexportation;

9. The quantity distributed or disposedof in any other manner by the registrant (forexample, distribution of complimentary sam-ples or by destruction) including the date andmanner of distribution or disposal, the name,address and registration number of the personto whom distributed and the quantity dis-tributed or disposed;

(B) For each controlled substance in fin-ished form—

1. The name of the substance; 2. Each finished form (for example, ten

milligram (10 mg) tablet or ten milligram (10mg) concentration per fluid ounce ormilliliter) and the number of units or volumeof finished form in each commercial contain-er (for example, 100 tablet bottle or threemilliliter (3 ml) vial);

3. The number of containers of eachsuch commercial finished form manufacturedfrom bulk form by the registrant, includingthe information required in paragraph(1)(A)5. of this rule;

4. The number of units of finishedforms, commercial containers, or both,received from other persons, including thedate of and number of units, commercial con-tainers, or both, in each receipt and thename, address and registration number of theperson from whom the units were received;

5. The number of units of finished form,commercial containers, or both, importeddirectly by the registrant, including the dateof and the number of units, commercial con-tainers, or both, in each importation;

6. The number of units, commercialcontainers, or both, manufactured by the reg-istrant from units in finished form receivedfrom others or imported including: the dateand batch or other identifying number of eachmanufacture; the operation performed (forexample, repackaging or relabeling); thenumber of units of finished form used in themanufacture, the number manufactured andthe number lost during the manufacture, withthe causes for these losses, if known, andother information as is necessary to accountfor all controlled substances used in the man-ufacturing process;

7. The number of commercial contain-ers distributed to other persons including thedate of and number of containers in each dis-tribution and the name, address and registra-tion number of the person to whom the con-tainers were distributed;




Secretary of State


8. The number of commercial contain-ers exported directly by the registrant, includ-ing the date, number of containers and exportpermit or declaration number for each expor-tation;

9. The number of units of finished forms,commercial containers, or both, distributed ordisposed of in any other manner by the regis-trant (for example, by distribution of compli-mentary samples or by destruction), includingthe date and manner of distribution or dispos-al, the name, address and registration numberof the person to whom distributed and thequantity in finished form distributed or dis-posed.

(2) Records for Distributors. Each registereddistributor shall maintain records with thefollowing information for each controlledsubstance:

(A) The name of the substance; (B) Each finished form (for example, ten

milligram (10 mg) tablet or ten milligram (10mg) concentration per fluid ounce ormilliliter) and the number of units or volumeof finished form in each commercial contain-er (for example, 100 tablet bottle or threemilliliter (3 ml) vial);

(C) The number of commercial containersof each such finished form received fromother persons, including the date of and num-ber of containers in each receipt and thename, address and registration number of theperson from whom the containers werereceived;

(D) The number of commercial containersof each finished form imported directly bythe registrant including the date of and thenumber of containers in each importation;

(E) The number of commercial containersof each finished form distributed to other per-sons, including the date of and number ofcontainers in each distribution and the name,address and registration number of the personto whom the containers were distributed;

(F) The number of commercial containersof the finished form exported directly by theregistrant, including the date of and the num-ber of containers in each exportation;

(G) The number of units or volume of fin-ished forms, commercial containers, or both,distributed or disposed of in any other man-ner by the registrant (for example, by distri-bution as complimentary samples) includingthe date and manner of distribution or dis-posal, the name, address and registrationnumber of the person to whom distributedand the quantity of the substance in finishedform distributed or disposed.

(3) Records for Importers. Each registeredimporter shall maintain records with the fol-lowing information for each controlled sub-stance:

(A) The name of the substance;

(B) The quantity (or number of units orvolume in finished form) imported, includingthe date, quantity (or number of units or vol-ume) and import permit or declaration num-ber for each importation;

(C) The quantity (or number of units orvolume in finished form) distributed to otherpersons, including the date, quantity (or num-ber of units or volume) of each distributionand the name, address and registration num-ber of each person to whom a distributionwas made;

(D) The quantity disposed of in any othermanner by the registrant except quantitiesused in manufacturing by an importer undera registration as a manufacture, which quan-tities are to be recorded, including the dateand manner of disposal and the quantity dis-posed.

(4) Records for Exporters. Each registeredexporter shall maintain records with the fol-lowing information for each controlled sub-stance:

(A) The name of the substance; (B) The quantity (or number of units or

volume in finished form) received from otherpersons, including the date and quantity (ornumber of units or volume) of each receiptand the name, address and registration num-ber of each person from whom the substancewas received;

(C) The quantity (or number of units orvolume in finished form) exported, includingthe date, quantity (or number of units or vol-ume) and the export permit or declarationnumber for each exportation, but excludingall quantities (and numbers of units and vol-umes) manufactured by an exporter under aregistration as a manufacture, which quanti-ties (and numbers of units and volumes) areto be recorded;

(D) The quantity disposed of in any othermanner by the registrant including the dateand manner of disposal and the quantity dis-posed.



19 CSR 30-1.048 Records for Practitionersand Researchers

PURPOSE: This rule sets requirements forrecord keeping for practitioners andresearchers. It also sets requirements for theuse of facsimile and electronic prescriptions.

PUBLISHER’S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorporat-

ed by reference as a portion of this rule wouldbe unduly cumbersome or expensive. Thismaterial as incorporated by reference in thisrule shall be maintained by the agency at itsheadquarters and shall be made available tothe public for inspection and copying at nomore than the actual cost of reproduction.This note applies only to the reference materi-al. The entire text of the rule is printed here.

(1) Each individual practitioner, institutionalpractitioner, and pharmacy shall maintainrecords with the following information foreach controlled substance received, main-tained, dispensed, or disposed:

(A) The name of the substance; (B) Each finished form (for example, ten

milligram (10 mg) tablet or ten milligram (10mg) concentration per fluid ounce ormilliliter) and the number of units or volumeof finished form in each commercial contain-er (for example, one hundred (100) tablet bot-tle or three milliliter (3 ml) vial);

(C) The number of commercial containersof each finished form received from otherpersons, including the date of and number ofcontainers in each receipt and the name,address and registration number of the personfrom whom the containers were received;

(D) The number of units or volume of thefinished form dispensed including the nameand address of the person to whom it was dis-pensed, the date of dispensing, the number ofunits or volume dispensed, and the written ortypewritten name or initials of the individualwho dispensed or administered the substance;and

(E) The number of units or volume of thefinished forms, commercial containers, orboth, disposed of in any other manner by theregistrant, including the date and manner ofdisposal and the quantity of the substance infinished form disposed.

(2) Each individual practitioner shall main-tain a record of the date, full name andaddress of the patient, the drug name,strength, dosage form, and quantity for allcontrolled substances prescribed or adminis-tered. This record may be maintained in thepatient’s medical record. When the controlledsubstance record is maintained in thepatient’s medical record and the practitioneris not the custodian of the medical record, thepractitioner shall make the controlled sub-stance record available as required in 19 CSR30-1.041 and 19 CSR 30-1.044.

(3) Individual practitioners shall maintain therecords listed in subsections (1)(A)–(E) ofthis rule separately from patient medicalrecords.

(4) A registrant who transfers a controlledsubstance to or receives a controlled sub-stance from another registrant shall maintain

a written record of the transfer which con-tains the following information: the date oftransfer, drug name, strength, dosage form,quantity, name, address and registration num-ber of the transferring registrant, and thename, address and registration number of thereceiving registrant.

(5) Drug Enforcement Administration officialorder forms shall be used for transfers ofSchedule II controlled substances.

(6) A prescription may not be issued for anindividual practitioner to obtain controlledsubstances for dispensing or administering topatients.

(7) Prescriptions which are transmitted byfacsimile to a pharmacy for dispensing shallinclude the telephone number of the facsimi-le machine or computer from which it is sentand the date and time of transmission. Imme-diately after a Schedule III, IV or V pre-scription or a Schedule II prescription for along-term care facility patient or hospicepatient or for a Schedule II narcotic substanceto be compounded for the direct administra-tion to a patient by parenteral, intravenous,intramuscular, subcutaneous, or intraspinalinfusion is transmitted to a pharmacy by fac-simile equipment, the practitioner or thepractitioner’s agent shall sign and date theface of the prescription. The prescriptionsshall be maintained in chronological orderseparately from patient medical records in amanner so each prescription is readilyretrievable for inspection at the transmittingpractitioner’s office. In the event the facsimi-le is transmitted from a long-term care facil-ity or hospital, the prescription shall be main-tained at the long-term care facility orhospital in chronological order separatelyfrom the patient medical records in a mannerso each prescription is readily retrievable, ormaintained in the patient medical records.

(8) Any pharmacy receiving a controlled sub-stance prescription transmitted by facsimileequipment shall maintain the facsimile copyof the prescription along with the date andtime of transmission and the telephone num-ber of the facsimile machine from which itoriginated, as a part of its original prescrip-tion records.

(9) The creation, signature, transmission, andprocessing of controlled substance prescrip-tions electronically and record keeping forelectronic controlled substance prescriptionsshall meet the requirements of 21 CFR Parts1300 to end, which are hereby incorporatedby reference in this rule as published April 1,2014, by the Office of Federal Register,National Archives and Records Administra-tion, and are made available to the public bythe U.S. Government Printing Office, 732 N.

Capitol Street NW, Washington, D.C. 20401,or at www.gpoaccess.gov/cfr/. This rule doesnot incorporate any subsequent amendmentsor additions.

AUTHORITY: section 195.050, RSMo 2000,and section 195.195, RSMo Supp. 2014.*Original rule filed April 14, 2000, effectiveNov. 30, 2000. Amended: Filed Jan. 29,2015, effective July 30, 2015.


19 CSR 30-1.050 Records for ChemicalAnalysts

PURPOSE: This rule sets requirements forrecord keeping for chemical analyst regis-trants.

(1) Each person registered to conduct chemi-cal analysis with controlled substances shallmaintain records with the following informa-tion (to the extent known and reasonablyascertainable by him/her) for each controlledsubstance:

(A) The name of the substance; (B) The form(s) in which the substance is

received, imported or manufactured by theregistrant (for example, powder, granulation,tablet, capsule or solution) and the concen-tration of the substance in that form (forexample, Chemically Pure (CP), UnitedStates Pharmacopeia (USP), National Formu-lary (NF), ten milligram (10 mg) tablet or tenmilligram (10 mg) concentration permilliliter);

(C) The total number of the formsreceived, imported or manufactured (forexample 100 tablets, 30 one milliliter (1 ml)vials or ten grams (10 g) powder), includingthe date and quantity of each receipt, impor-tation or manufacture and the name, addressand registration number, if any, of the personfrom whom the substance was received; and

(D) The quantity distributed, exported ordestroyed in any manner by the registrant(except quantities used in chemical analysisor other laboratory work), including the dateand manner of distribution, exportation ordestruction and the name, address and regis-tration number, if any, of each person towhom the substance was distributed orexported.

(2) Order forms, import and export permits,import invoices and export declarations relat-ing to controlled substances shall be main-tained separately from all other records of theregistrant.

(3) Records of controlled substances used inchemical analysis or other laboratory workare not required.

(4) Records relating to known or suspectedcontrolled substances received as samples foranalysis are not required under section (1) ofthis rule.



19 CSR 30-1.052 Records for Long-TermCare Facilities (LTCF)

PURPOSE: This rule sets requirements forrecord keeping by long-term care facility reg-istrants.

(1) Long-term care facilities (LTCFs) andtheir suppliers shall maintain written recordsof transfers of controlled substances from thesupplier to the LTCF emergency kit.

(2) The records shall include the date oftransfer; the name of each controlled sub-stance, the strength, dosage form and quanti-ty; the name, address and controlled sub-stance registration number of the supplier andthe name, address and controlled substanceregistration number of the LTCF. FederalDrug Enforcement Administration (DEA)official order forms shall not be used torecord transfers of controlled substances toLTCF emergency kits.

(3) No physician’s order or prescription shallbe used for initial stocking or replacement ofcontrolled substances in the emergency kit.Controlled substances contained in the kitshall be obtained from a pharmacy, hospitalor practitioner who holds a controlled sub-stances registration.

(4) The administration and medical staff ofthe LTCF, in conjunction with the primarysupplier, shall designate in written protocolsand procedures who may have access to theemergency kit, who may administer con-trolled substances from the emergency kit andunder what circumstances and a list of thecontrolled substances it intends to maintain inthe emergency kit. These protocols and pro-cedures shall be subject to review andapproval by the Department of Health. Onlythose individuals designated in the LTCF’swritten policies and procedures shall have



access to or administer controlled substancesfrom the emergency kit.

(5) Each administration of controlled sub-stances from the emergency kit shall be basedupon a practitioner’s order and shall berecorded in an administration record separatefrom the patient’s medical record. Thisadministration record shall include: the date,patient’s name, drug name, drug strength,dosage, ordering practitioner’s name andname of the person administering the con-trolled substance.



19 CSR 30-1.060 Determining Lawful Pre-scribing, Dispensing and Administering ofControlled Substances

PURPOSE: This rule defines the statutoryand regulatory basis for determining what islawful prescribing, dispensing and adminis-tering of controlled substances.

When determining if controlled substancesare being lawfully prescribed, dispensed andadministered by practitioners, the Depart-ment of Health shall enforce Chapter 195,RSMo, the Department of Health rules in 19CSR 30 pertaining to controlled substances,and the federal Controlled Substances Act 21U.S.C. 801–966, and its regulations, 21 CFR1300–1399. In determining lawful prescrib-ing, dispensing and administering of con-trolled substances, the Department of Healthalso shall consider the provisions of Chapters330, 332, 334, 335, 336, 338 and 340,RSMo, the rules in 4 CSR 110, 4 CSR 150,4 CSR 200, 4 CSR 210, 4 CSR 220, 4 CSR230 and 4 CSR 270, and protocols relating tothe respective practitioners established and onfile at the respective licensing boards.

AUTHORITY: sections 195.030, RSMo Supp.1999 and 195.195, RSMo 1994.* Originalrule filed April 14, 2000, effective Nov 30,2000.

*Original authority: 195.030, RSMo 1939, amended 1971,1989, 1993, 1995, 1999 and 195.195, RSMo 1957,amended 1971, 1989, 1993.

19 CSR 30-1.062 Transmission of Prescrip-tions

PURPOSE: This rule sets requirements gov-erning the transmission of prescription infor-mation.

PUBLISHER’S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorporat-ed by reference as a portion of this rule wouldbe unduly cumbersome or expensive. Thismaterial as incorporated by reference in thisrule shall be maintained by the agency at itsheadquarters and shall be made available tothe public for inspection and copying at nomore than the actual cost of reproduction.This note applies only to the reference materi-al. The entire text of the rule is printed here.

(1) Prescriptions in Schedule II. A pharma-cist may dispense a controlled substance inSchedule II only under a written prescriptionsigned by the practitioner, except as providedin section 195.060.3, RSMo. A prescriptionfor a Schedule II controlled substance may betransmitted from the prescribing practitionerto a pharmacy by facsimile equipment, pro-vided the original written, signed prescrip-tion is presented to the pharmacist for reviewprior to the actual dispensing of the con-trolled substance, except that—

(A) A prescription written for a ScheduleII narcotic substance to be compounded forthe direct administration to a patient by par-enteral, intravenous, intramuscular, subcuta-neous, or intraspinal infusion may be trans-mitted by the practitioner or the practitioner’sagent to the pharmacy by facsimile. The fac-simile which has been reduced to writingshall serve as, and shall be maintained in thesame manner, as an original written prescrip-tion.

(B) A prescription written for a Schedule IIsubstance for a resident of a long-term carefacility may be transmitted by the practition-er or the practitioner’s agent to the pharmacyby facsimile. The facsimile which has beenreduced to writing shall serve as, and shall bemaintained in the same manner, as an origi-nal written prescription.

(C) A prescription written for a ScheduleII substance for a patient of a hospice may betransmitted by the practitioner or the practi-tioner’s agent to the pharmacy by facsimile.The practitioner or the practitioner’s agentshall note on the prescription that the patientis a hospice patient. The facsimile which hasbeen reduced to writing shall serve as, andshall be maintained in the same manner, as anoriginal written prescription.

(2) Prescriptions in Schedule III, IV, or V. Apharmacist may dispense directly a controlledsubstance in Schedule III, IV, or V only undera written prescription signed by a practitioneror a facsimile of a written, signed prescriptiontransmitted by the practitioner or his/herauthorized agent or under an oral prescription

made by an individual practitioner whethercommunicated by the practitioner or his/herauthorized agent by the authorizing practition-er or the practitioner’s agent to the pharmacy.All oral prescriptions shall be promptlyreduced to writing by the pharmacist contain-ing all information required in section195.060, RSMo, except for the signature ofthe practitioner.

(3) Written Prescriptions. All written con-trolled substance prescriptions shall be signedby the prescribing practitioner on the dateprescribed. No controlled substance prescrip-tion shall be signed prior to the actual date itis issued.

(4) Prescriptions Transmitted by ElectronicComputer Transmission. A pharmacist maydispense a controlled substance in Schedule II,III, IV, or V under a prescription transmittedfrom the prescribing practitioner to a pharma-cy by electronic computer transmission pro-vided that the prescription and its transmissioncomplies with federal law regarding electronicprescriptions as found in the Code of FederalRegulations, Title 21 Part 1300 to end. Thefederal rules regarding electronic prescrip-tions are hereby incorporated by reference inthis rule as published April 1, 2014, by theOffice of Federal Register, National Archivesand Records Administration, and are madeavailable to the public by the U.S. Govern-ment Printing Office, 732 N. Capitol StreetNW, Washington, D.C. 20401, or atwww.gpoaccess.gov/cfr/. This rule does notincorporate any subsequent amendments oradditions.

AUTHORITY: section 195.195, RSMo Supp.2014.* Original rule filed April 14, 2000,effective Nov. 30, 2000. Amended: Filed Jan.29, 2015, effective July 30, 2015.


19 CSR 30-1.064 Partial Filling of Con-trolled Substance Prescriptions

PURPOSE: This rule sets requirements forthe partial filling of Schedule II prescriptions.

(1) The partial filling of a prescription for acontrolled substance listed in Schedule II ispermissible, if the pharmacist is unable to sup-ply the full quantity called for in a written oremergency oral prescription, and s/he makes anotation of the quantity supplied on the face ofthe written prescription (or written record ofthe emergency oral prescription), or in theelectronic record. The remaining portion ofthe prescription may be filled within seventy-two (72) hours of the first partial filling; how-ever, if the remaining portion is not or cannot


Secretary of State


be filled within the seventy-two- (72-) hourperiod, the pharmacist shall so notify the pre-scribing individual practitioner. No furtherquantity may be supplied beyond seventy-two(72) hours without a new prescription.

(2) The partial filling of a prescription forcontrolled substances listed in Schedules II,III, IV, or V is permissible, provided that:

(A) Partial filling may occur at the requestof a patient or it may be directed by the pre-scriber, unless the prescription is written fora patient in a long-term care facility (LTCF)or for a patient with a medical diagnosis doc-umenting a terminal illness, in which case thepharmacist must record on the prescriptionwhether the patient is “terminally ill” or“LTCF patient.”;

(B) Each partial dispensing is recorded inthe same manner as a refilling would be;

(C) With each partial dispensing, the phar-macy must document the date and quantitydispensed on the original prescription recordor their electronic computer applications,provided that the electronic system meets allof the federal requirements for handling ofelectronic prescriptions for controlled sub-stances, including the ability to retrieve theinformation pertaining to partially filled con-trolled substances;

(D) The total quantity dispensed in all par-tial fillings cannot exceed the total quantityprescribed;

(E) No dispensing occurs:1. For controlled substances listed in

Schedule II, after thirty (30) days after thedate on which the original prescription wasissued;

2. For controlled substances listed inSchedules III, IV, and V after six (6) monthsafter the date on which the original prescrip-tion was issued.

(F) A partial dispensing is not considereda “refill” if the patient does not receive thefull authorized amount at one time; and

(G) The prescription was written and filledin accordance with all other applicable lawsand regulations.

AUTHORITY: sections 195.080 and 195.195,RSMo Supp. 2018.* Original rule filed April14, 2000, effective Nov. 30, 2000. Amended:Filed Jan. 29, 2015, effective July 30, 2015.Emergency amendment filed Sept. 17, 2018,effective Sept. 27, 2018, expired March 25,2019. Amended: Filed Sept. 17, 2018, effec-tive March 30, 2019.

*Original authority: 195.080, RSMo 1939, 1965, 1971,1987, 1989, 1997, 2005, 2010, 2012, 2014, 2018 and195.195, RSMo 1957, amended 1971, 1989, 1993, 2014.

19 CSR 30-1.066 Dispensing by IndividualPractitioners

PURPOSE: This rule sets requirements forindividual practitioners who dispense con-trolled substances.

(1) An individual practitioner who dispensescontrolled substances shall—

(A) Provide direct supervision to employ-ees or agents who assist in the administeringor dispensing of controlled substances. Con-trolled substances shall not be dispensed froman individual practitioner’s inventory unless apractitioner is physically in the registeredlocation except pursuant to the provisions ofsection (2) of this rule;

(B) Package all controlled substances dis-pensed from an individual practitioner’sinventory in compliance with the Poison Pre-vention Packaging Act of 1970, 15 U.S.C.1471–1476;

(C) Permanently affix a label to the exteri-or of the drug container which includes: thedate, the name and address of the dispensingpractitioner, the name of the patient, direc-tions for use, and the exact name and strengthof the drug dispensed for all controlled sub-stances dispensed;

(D) Dispense only to individuals withwhom the practitioner has established anddocumented a practitioner/patient relation-ship. An individual practitioner shall not dis-pense under the order of another practitionernot practicing at that location.

(2) Mid-level practitioners shall not indepen-dently purchase, stock, administer, and dis-pense controlled substances. Controlled sub-stances may be administered or dispensedfrom an individual practitioner’s inventory bya mid-level practitioner with whom he or shehas entered into an agreement pursuant toChapter 334, RSMo, when the practitioner isnot present at the registered location.

AUTHORITY: section 195.195, RSMo 2000.*Original rule filed April 14, 2000, effectiveNov. 30, 2000. Amended: Filed April 29,2011, effective Nov. 30, 2011.


19 CSR 30-1.068 Administering In Emer-gency Rooms

PURPOSE: This rule sets requirements foradministering controlled substances in hospi-tal emergency rooms.

(1) Controlled substances may be adminis-tered to a hospital emergency room patientunder a verbal order of a registered practi-tioner who is not physically present if—

(A) The order is for a legitimate medicalpurpose and the practitioner who orders theadministration of a controlled substance isacting in the usual course of his/her medicalpractice, after sufficient examination andestablishment of a practitioner/patient rela-tionship;

(B) The practitioner who orders the admin-istration of a controlled substance is a medi-cal staff member of the hospital;

(C) The administration of a controlled sub-stance is documented in a formal medicalrecord for the patient;

(D) The patient is assessed in the hospitalby a practitioner, when available, or a regis-tered nurse. If the patient is not assessed by apractitioner in the hospital, a registered nurseshall assess the patient and confirm and doc-ument in the patient’s medical record theexistence of a preestablished pract-itioner/patient relationship with the practi-tioner who ordered administration of a con-trolled substance;

(E) The order is written in the patient’smedical record and is authenticated by theordering practitioner within a time frame andmanner as defined by the medical staff incooperation with nursing and administration.This policy shall be included in the hospital’swritten policies and procedures.



19 CSR 30-1.070 Emergency Dispensing ofSchedule II Substances

PURPOSE: This rule provides for the pre-scribing and dispensing of Schedule II drugsin an emergency situation.

(1) In the case of a bona fide emergency sit-uation, as defined by the Department ofHealth, a pharmacist may dispense a Sched-ule II controlled substance upon receivingoral authorization of a prescribing practition-er; provided, that—

(A) The quantity prescribed and dispensedis limited to the amount adequate to treat thepatient during the emergency period. Pre-scribing or dispensing beyond the emergencyperiod must be pursuant to a written pre-scription;

(B) The prescription immediately shall bereduced to writing by the pharmacist andshall contain all information, except for theprescribing practitioner’s signature;

(C) If the prescribing practitioner is notknown to the pharmacist, s/he must makereasonable effort to determine that the oral



authorization came from a practitioner, byverifying his/her phone number against thatlisted in the directory and other good faithefforts to insure his/her identity;

(D) Within seven days after authorizing anemergency oral prescription, the prescribingpractitioner must cause a written prescriptionfor the emergency quantity prescribed to bedelivered to the dispensing pharmacist. Theprescription shall have written on its faceauthorization for emergency dispensing. Thewritten prescription may be delivered to thepharmacist in person or by mail, but if deliv-ered by mail it must be postmarked within theseven-day period. Upon receipt, the dispens-ing pharmacist shall attach this prescriptionto the oral emergency prescription which hadearlier been reduced to writing. The pharma-cist shall notify the Department of Health ifthe prescribing practitioner fails to deliver awritten prescription to him/her; failure of thepharmacist to do so shall void the authorityconferred by this section to dispense withouta written prescription of a prescribing practi-tioner.

(2) Definition of Emergency Situation. Forthe purpose of authorizing an oral prescrip-tion of a controlled substance listed in Sched-ule II of the controlled substances law (sec-tions 195.010–195.320, RSMo), the termemergency situation means those situations inwhich the prescribing practitioner determinesthat—

(A) Immediate administration of a con-trolled substance is necessary for propertreatment of the intended ultimate user;

(B) No appropriate alternative treatment isavailable, including administration of a drugwhich is not a controlled substance underSchedule II;

(C) It is not reasonably possible for theprescribing practitioner to provide a writtenprescription to be presented to the person dis-pensing the substance prior to the dispensing.



19 CSR 30-1.072 Dispensing of Schedule VSubstances

PURPOSE: This rule provides for the pre-scribing, administering and dispensing ofSchedule V drugs.

(1) A pharmacist may dispense directly acontrolled substance listed in Schedule Vpursuant to a prescription. A prescription fora controlled substance listed in Schedule V

may be refilled only as expressly authorizedby the prescribing individual practitioner. Ifthis authorization is not given, the prescrip-tion may not be refilled. A pharmacist dis-pensing those substances pursuant to a pre-scription shall label the substance and file theprescription.

(2) An individual practitioner may administeror dispense directly a controlled substancelisted in Schedule V in the course of his/herprofessional practice without a prescription.

(3) An institutional practitioner may adminis-ter or dispense directly (but not prescribe) acontrolled substance listed in Schedule Vonly pursuant to a written prescription signedby the prescribing individual practitioner orpursuant to an oral prescription made by aprescribing individual practitioner andpromptly reduced to writing by the pharma-cist (containing all information requiredexcept for the signature of the prescribingindividual practitioner) or pursuant to anorder for medication made by an individualpractitioner which is dispensed for immediateadministration to the ultimate user.



19 CSR 30-1.074 Dispensing Without aPrescription

PURPOSE: This rule provides for dispensingSchedule V controlled substances without aprescription in certain situations.

(1) Definitions. For the purposes of this rule,the following terms shall apply:

(A) “Dispenser” means a pharmacist,intern pharmacist, or registered pharmacytechnician who sells, dispenses, or otherwiseprovides methamphetamine precursor prod-ucts to purchasers.

(B)“Methamphetamine precursor prod-ucts” means both Schedule V pseu-doephedrine products and any other drugproduct containing any detectable amount ofephedrine, pseudoephedrine, or phenyl-propanolamine, including the salts or opticalisomers or salts of optical isomers orephedrine, its salts or optical isomers, or saltsof optical isomers of ephedrine, pseu-doephedrine, or phenylpropanolamine.

(C) “Valid photo identification” means aphoto identification that is issued by a state orthe federal government or a document that,with respect to identification, is consideredacceptable and showing the date of birth of

the person, including forms of identificationacceptable under federal regulations 8 CFR274a.2(b)(1)(v)(A) and (B).

(2) Dispensing Without a Prescription. Acontrolled substance listed in Schedule Vwhich is not a prescription drug under thefederal Food, Drug and Cosmetic Act, and isnot a methamphetamine precursor product,may be dispensed by a pharmacist without aprescription to a purchaser at retail; provid-ed, that—

(A) Dispensing is made only by a pharma-cist and not by a non-pharmacist employeeeven if under the supervision of a pharmacist(although after the pharmacist has fulfilledhis/her professional and legal responsibili-ties, the actual cash transaction, credit trans-action, or delivery may be completed by anon-pharmacist); and

(B) Dispensing, sale, distribution, or oth-erwise providing is limited to not more thantwo hundred forty cubic centimeters (240 cc)or eight ounces (8 oz.) of any controlled sub-stance containing opium, nor more than onehundred twenty cubic centimeters (120 cc) orfour ounces (4 oz.) of any other controlledsubstance, nor more than forty-eight (48)dosage units of any controlled substance con-taining opium, nor more than twenty-four(24) dosage units of any other controlled sub-stance may be dispensed at retail to the samepurchaser in any given forty-eight (48)-hourperiod.

(3) Methamphetamine precursor productsmay be sold, dispensed, distributed, or oth-erwise provided only as follows:

(A) Products that are designated ScheduleV controlled substances which contain anydetectable amount of pseudoephedrine,ephedrine, phenylpropanolamine, their saltsor optical isomers, or salts of their opticalisomers may be sold, distributed, or other-wise provided only by a pharmacist or phar-macy ancillary personnel as authorized by theMissouri State Board of Pharmacy;

(B) Dispensers of methamphetamine pre-cursor products shall exercise reasonable carein assuring that the purchaser has not exceed-ed the three and six-tenths (3.6)-gram limitper day or the nine (9)-gram limit per thirty(30)-day period;

(C) Dispensers shall utilize the real-timeelectronic pseudoephedrine tracking systemestablished and maintained by the MissouriDepartment of Health and Senior Services(DHSS);

(D) Methamphetamine precursor productsregulated by Missouri law as controlled sub-stances shall only be sold to customers eigh-teen (18) years of age or older who present avalid photo identification;


Secretary of State




(E) Any dispenser who sells, dispenses, orotherwise provides any methamphetamineprecursor product shall submit the followinginformation to the DHSS electronic databaseat the time of purchase:

1. Date and time of transaction;2. Pharmacy identification information,

including:A. National Council for Prescription

Drug Programs identification number; orB. National Association of Boards of

Pharmacy identification number; orC. Vendor assigned site and/or phar-

macy identifier;3. Purchaser information, including the

following fields:A. Purchaser’s given or first name;B. Purchaser’s middle name (if any);C. Purchaser’s surname or last name;D. The purchaser’s full name shall be

entered into the database without the use ofinitials or nicknames;

E. Purchaser’s date of birth; andF. Purchaser’s address, including

number, street, city, state, and zip code;4. Identification of the form of valid

photo identification presented by the purchas-er; including issuing agency of the photoidentification and identification numberappearing on the photo identification;

5. Purchaser’s signature;6. Dispenser identification, including:

A. The name of the individual per-forming the transaction; or

B. The initials of the individual per-forming the transaction;

7. Transaction number, assigned by thedatabase provider/vendor;

8. Purchase transaction information,including the following:

A. Product Universal Product Code(UPC);

B. Product National Drug Code(NDC) (optional);

C. Unique product description; andD. Purchase quantity, in grams as—

(I) Product grams per box andnumber of boxes in transaction;

(II) Product grams per dosage formsuch as tablet, capsule, or milliliter, andnumber of dosages per transaction; or

(III) Other mechanism identified bythe database provider/vendor; and

9. Form of pseudoephedrine in a mannerdefined by the database provider/vendor,including but not limited to:

A. Tablet;B. Capsule;C. Liquid-filled gelcap; or D. Liquid;

(F) Purchaser information provided andentered into the DHSS electronic database

shall be the same as that on the presentedidentification. Full names shall be used andnot merely initials or a nickname;

(G) If the DHSS electronic database is notavailable at the time of the sale of themethamphetamine precursor product, theinformation to be provided in subsection(3)(E) above shall be recorded manually andentered into the DHSS electronic database assoon as practicable after the system is backonline, as specified in subsection (3)(I). Sig-natures shall be captured on paper and thenmay be scanned to the database;

(H) Every dispenser who sells, dispensesor otherwise provides any methamphetamineprecursor product shall maintain a bound log-book in addition to the electronic databasesystem. The logbook shall be used for docu-menting a clear audit trail of any alterations,changes, or deletions to the original transac-tion record, and sales that occurred duringsystem failures, including date and time ofentry into the database, justification, andresultant contacts with law enforcementbecause the override button was used;

(I) In the event that the DHSS electronicdatabase is unavailable for five (5) minutes ormore due to a failure on the DHSS networkor because of a failure attributable to systemsother than the DHSS, the dispenser may con-tinue with the transaction until the system isavailable. All information required to be cap-tured with each transaction shall be retainedand documented. The information may beentered into the database where it may beheld pending until the system comes back online, or all of the required information fortransactions occurring during the time theDHSS electronic database is unavailable mustbe recorded manually and entered into theDHSS electronic database by the registrant assoon as is practicable, but within no morethan forty-eight (48) hours following theresumption of operability. Documentationshall also identify the reason for the late entryinto the DHSS electronic database;

(J) At least once each month, the pharma-cist-in-charge shall review the logbook ofchanges and the changes captured by thedatabase to see what changes and alterationspharmacy employees have entered regardingsales of methamphetamine precursors. Thedate and time that the pharmacist-in-chargeconducts this monthly review shall be docu-mented in the bound logbook maintained bythe pharmacy in addition to the electronicsystem;

(K) Documentation in the bound logbookshall be maintained in a readily retrievablemanner for two (2) years from the date of thetransaction and available for inspection andcopying by authorized DHSS employees and

law enforcement; (L) Denials of Sales and Dispensings.

1. Except as provided in subsection (D)of this section, if an individual attempts topurchase a methamphetamine precursor prod-uct in violation of the three and six-tenths(3.6) gram per day or nine (9) gram permonth quantity restrictions or age restrictionestablished by sections 195.017 and 195.417,RSMo, the dispenser shall refuse to make thesale. The purchaser must be at least eighteen(18) years of age.

2. Sales of methamphetamine precursorproducts shall be denied to purchasers whoare not able to produce a valid governmentissued identification card with the requiredinformation displayed on it.

3. In the event that the dispenser per-ceives that refusal of the purchase may placehim or her in imminent physical harm, thenthe dispenser may use the database safetyoverride function to proceed with the transac-tion, provided that—

A. When jeopardy is no longer per-ceived, the dispenser shall immediately con-tact local law enforcement to report the pur-chase; and

B. The dispenser shall document intheir manual log, the circumstance, the indi-vidual contacted at the local law enforcementagency, and the date and time of that contact;

(M) Pharmacy Employees. Employees in apharmacy shall be assigned individual per-sonal passwords to identify their own trans-actions in the database.

1. Pharmacy employees shall only usetheir own passwords for their own transac-tions and shall not dispense or make a saleunder the password of another person.

2. The database computer shall not beleft on and unattended so that another personcan use the previous user’s password. Usersshall close out their personal access whentheir activities are completed.

3. The pharmacist-in-charge shall beresponsible for insuring pharmacy employeeshave adequate password privileges. The phar-macist-in-charge shall insure that newemployees have their own personal passwordsand also insure that ex-employees have theirpasswords removed from the system;

(N) Access to Database by Law Enforce-ment and Regulatory Agencies.

1. Access to the database and controlledsubstance records shall be made available tothose agencies with authority under Chapter195 and Chapter 338, RSMo.

2. Law enforcement agencies and regu-latory agencies shall only have the ability toread and review and shall not be able to enterdata or change records.

3. It shall be the responsibility of eachagency’s administrator, chief, sheriff, orother chief executive officer to insure—

A. Only authorized employees haveaccess to the database;

B. Employees only use their ownpasswords and passwords are not shared;

C. Each employee adheres to all stateand federal laws regarding confidentiality;and

D. As employees change, that newpasswords are assigned to new employees andpasswords of ex-employees or transferredemployees are removed. The chief, sheriff,or chief executive officer of the law enforce-ment or regulatory agency shall notify theDHSS in writing when an employee’s accessis to be added or removed; and

(O) Method for Enforcement Agencies toGain or Alter Access to the Database.

1. Requests submitted to the DHSS toadd or remove an employee from access tothe database shall—

A. Be submitted in writing on theagency’s letterhead;

B. State whether this is a request foran employee to be granted access to thedatabase or a request to remove an employ-ee’s access;

C. Provide the employee’s full nameand title;

D. Provide the employee’s MissouriPOST certification number if the employee isa sworn law enforcement officer; and

E. Be signed by the chief, sheriff, orchief executive officer of the requesting agen-cy.

2. Multiple requests for multipleemployees and actions may be submitted onone (1) letter.

3. The DHSS shall notify the provider ofthe database in writing of persons who aregiven access or have access removed.

4. The DHSS may restrict access to thedatabase to a limited number of people ineach agency, depending on the size of theagency, their locations, and number of swornofficers engaged in the actual enforcement ofcontrolled substance laws.

AUTHORITY: sections 195.017 and 195.417,RSMo Supp. 2010 and sections 195.030,195.050, and 195.195, RSMo 2000.* Origi-nal rule filed April 14, 2000, effective Nov.30, 2000. Emergency amendment filed Aug.18, 2005, effective Aug. 28, 2005, expiredFeb. 23, 2006. Amended: Filed Sept. 1, 2005,effective Feb. 28, 2006. Emergency amend-ment filed July 9, 2010, effective Sept. 28,2010, expired March 26, 2011. Amended:Filed June 29, 2010, effective Jan. 30, 2011.

*Original authority: 195.017, RSMo 1971, amended 1987,1989, 1994, 1996, 1997, 1998, 2001, 2005, 2006, 2008;195.030, RSMo 1939, amended 1971, 1989, 1993, 1995,1997, 1999; 195.050, RSMo 1939, amended 1971, 1989;195.195, RSMo 1957, amended 1971, 1989, 1993; and195.417, RSMo 2001, amended 2003, 2005, 2008.

19 CSR 30-1.076 Emergency Distributionby a Pharmacy

PURPOSE: This rule provides for dispensingof controlled substances by a pharmacy inemergency situations.

(1) An emergency means a situation where aquantity of a controlled substance must bedispensed by a pharmacy to a patient whodoes not have an alternative source for thatsubstance reasonably available to him/her andthe pharmacy cannot obtain that substancethrough its normal distribution channelswithin the time required to meet the immedi-ate needs of the patient for that substance. Inthe event of an emergency, a pharmacy maydistribute (without being registered as a dis-tributor) a controlled substance in ScheduleIII, IV or V to a second pharmacy in orderfor that pharmacy to dispense the substance;provided, that—

(A) The amount distributed does notexceed the amount required by the secondpharmacy for his/her immediate dispensing;

(B) The distribution is recorded as beingdispensed by the first pharmacy and the sec-ond pharmacy records the substance as beingreceived. Each pharmacy will retain a signedreceipt of the distribution;

(C) The second pharmacy is registered todispense the controlled substance to be dis-tributed to him/her;

(D) If the substance is a Schedule II con-trolled substance, the official order form des-ignated by the federal Drug EnforcementAdministration must be used to document thetransfer.



19 CSR 30-1.078 Disposing of UnwantedControlled Substances

PURPOSE: This rule establishes proceduresfor disposing of unwanted controlled sub-stances.

(1) A registrant in possession of any con-trolled substance(s) and desiring or requiredto dispose of such substance(s) shall:

(A) Return the controlled substances to theoriginal supplier;

(B) Transfer the controlled substances to adistributor authorized to accept controlledsubstances for the purpose of disposal;

(C) Retain a DEA Form 41 in compliancewith federal regulations;

(D) Become an Authorized Collector ofControlled Substances. Registrants shall dis-pose of all unwanted controlled substancesand keep records in accordance with federalregulations. Only manufacturers, distributors,reverse distributors, narcotic treatment pro-grams, hospitals/clinics with an on-site phar-macy, and retail pharmacies that have modi-fied their state and federal controlledsubstances registrations may possess a collec-tion receptacle for medication disposal orparticipate in the DEA approved mail-backsystem;

(E) Contact the Bureau of Narcotics andDangerous Drugs (BNDD), Department ofHealth and Senior Services for informationpertaining to subsections (1)(A), (B), (C) or(D) of this rule.

(2) Destruction of controlled substances inpatient care areas.

(A) Controlled substances that have beencontaminated by patient contact are to be destroyed on site. An excess volume of a con-trolled substance which must be discardedfrom a dosage unit just prior to administra-tion shall also be destroyed on site.

(B) Controlled substances that have notbeen contaminated by patient contact or arenot excess volumes of a dosage unit shall notbe destroyed on site unless the registrantmaintains a DEA Form 41 in compliancewith federal regulation. Unwanted controlledsubstances that have been expired, discontin-ued, or are otherwise unwanted shall be dis-posed of by methods listed previously in sec-tion (1) of this rule.

(C) In a patient care area of a hospital withan on-site pharmacy, unwanted controlledsubstances that have not been contaminatedby patient contact shall be returned to thepharmacy for final disposal.

(D) The destruction of controlled sub-stances shall be in such a manner that it ren-ders the medication unrecoverable andbeyond reclamation so that it cannot bediverted.

(E) The destruction and documentation ofdestruction shall be performed and completedby two (2) people. One of the people must bea licensed physician, nurse, pharmacist, internpharmacist, or pharmacy technician, assistantphysician, physician assistant, podiatrist,optometrist, dentist or veterinarian. The sec-ond person, the witness, is not required to bea licensed medical professional, but must be


Secretary of State


an employee of the registrant, unless in anEMS setting.

(F) The following shall be entered in thecontrolled substance administration record ora separate controlled substance destructionrecord when the controlled substance isdestroyed in the patient care area: the dateand hour of destruction, the drug name andstrength, the amount destroyed, the reasonfor destruction, and the patient’s name androom number if applicable, and the names orinitials of the two (2) persons performing thedestruction. The controlled substance admin-istration and destruction records are to beretained for two (2) years and available forinspection by the Department of Health andSenior Services;

(3) In the event the registrant is a hospital,the following procedures are to be used forthe destruction of controlled substance(s):

(A) When disposal of controlled sub-stance(s) is in patient care areas—

1. Controlled substances which are con-taminated by patient body fluids are to bedestroyed by a physician, nurse, or a pharma-cist in the presence of another hospitalemployee;

2. An excess volume of a controlled sub-stance which must be discarded from adosage unit just prior to use shall bedestroyed by a nurse, pharmacist, or physi-cian in the presence of another hospitalemployee;

3. The remaining contents of openedglass ampules of controlled substance(s) shallbe destroyed by a nurse, pharmacist, orphysician in the presence of another hospitalemployee;

4. Single units of single dose packagesof controlled substance(s) which are contam-inated other than by patient body fluids andare not an infectious hazard, have beenremoved from their original or security pack-aging, are partially used, or are otherwiserendered unsuitable for patient use shall bedestroyed by a nurse, pharmacist, or physi-cian in the presence of another hospitalemployee or returned to the pharmacy fordestruction;

5. The following shall be entered in thecontrolled substance administration record ora separate controlled substance destructionrecord when the controlled substance(s) isdestroyed in the patient care area: the dateand hour of destruction, the drug name andstrength, the amount destroyed, the reasonfor destruction, and the patient’s name androom number. The nurse, pharmacist, orphysician and the witnessing hospital employ-ee shall sign the entry. The drug shall bedestroyed so that it is beyond reclamation.The controlled substance administration ordestruction records are to be retained for two

(2) years and available for inspection byDepartment of Health investigators;

6. All other controlled substances whichare not patient contaminated but which are tobe disposed of shall be returned to the phar-macy for disposal;

(B) When disposal of controlled sub-stance(s) is in the pharmacy—

1. Single units of controlled substance(s)which are contaminated other than by patientbody fluids and are not an infectious hazard,have been removed from their original orsecurity packaging, are partially used, or areotherwise rendered unsuitable for patient useshall be destroyed by a pharmacist in thepresence of another hospital employee or heldfor later destruction;

2. All other controlled substances whichare not patient contaminated but are to be dis-posed of shall be placed in a suitable con-tainer for storage and disposed of asdescribed in section (1) of this rule.

(4) Collection Receptacle Boxes and Mail-Back Programs for Patients’ Unwanted Con-trolled Substance Prescriptions.

(A) Manufacturers, distributors, reversedistributors, narcotic treatment programs,hospitals/clinics with an on-site pharmacy,and retail pharmacies are authorized to installcollection receptacle boxes or participate in aDEA approved mail-back method to collectunwanted controlled substance prescriptionmedications from patients. Registrants mustcomply with federal regulations regardingsecurity and record keeping. Collectionreceptacles shall be used only for patients’unwanted medications and not for the expiredor unwanted stock of a practitioner or facili-ty.

(B) All facilities and locations with collec-tion receptacle boxes and mail-back systemsshall comply with federal regulations.

1. Patients’ medications from long-termcare facilities and narcotic treatment pro-grams shall be placed in a receptacle withinthree (3) days of the expiration date on themedication; or upon a discontinuation of useauthorized by a prescriber; or upon the deathof a patient.

(C) Record keeping for collection recepta-cle boxes. Registrants or their employeesshall not inventory the contents of the collec-tion receptacle box. The collection receptaclebox is to be opened by two (2) people; oneshall be an employee of the pharmacy and theother may be an employee of the facilityreceiving pharmaceutical services. All regis-trants with collection receptacle boxes shallmaintain a perpetual log that documents entryinto the collection receptacle box, changingof liners, and transfers of drugs from the reg-istrant to a reverse distributor. These logsshall be maintained on file at the registered

location for inspection and shall documentthe date of entries into the collection recepta-cle box, the names of the employees enteringthe collection receptacle box, the reason forentering the receptacle, the serial number ofa liner being removed, and the serial numberof a new liner being installed. This log shallalso be used to document the transfer of aliner from the registrant to a reverse distribu-tor by documenting the date of transfer, seri-al number of the liner, names of the personsinvolved in the transfer, and the DEA numberof the reverse distributor. The log shall alsodocument when the pharmacy changes outthe interior liner bags and document the seri-al number of the bag being removed and ofthe new bag being installed.

AUTHORITY: sections 195.050 and 195.195,RSMo Supp. 2018.* Original rule filed April14, 2000, effective Nov. 30, 2000. Emergen-cy amendment filed Sept. 17, 2018, effectiveSept. 27, 2018, expired March 25, 2019.Amended: Filed Sept. 17, 2018, effectiveMarch 30, 2019.

*Original authority: 195.050, RSMo 1939, amended1971, 1989, 2014 and 195.195, RSMo 1957, amended1971, 1989, 1993, 2014.

