Handling Controlled Handling Controlled SubstancesSubstances

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only.only.

Course ObjectivesCourse Objectives

Detail compliance requirements for Detail compliance requirements for manufacturers, distributors and individuals manufacturers, distributors and individuals conducting activities with Drug conducting activities with Drug Enforcement Agency (DEA) controlled Enforcement Agency (DEA) controlled substances and List I & II Chemicalssubstances and List I & II Chemicals

Diversion of Controlled ChemicalsDiversion of Controlled Chemicals Most of the drugs in the illicit traffic are products of illicit Most of the drugs in the illicit traffic are products of illicit

processing or synthesis. Cocaine, for example, can be processing or synthesis. Cocaine, for example, can be extracted and converted to its preferred form only by extracted and converted to its preferred form only by using a tremendous quantity of industrial chemicals. using a tremendous quantity of industrial chemicals. Heroin must be synthesized by using an acetylating agent Heroin must be synthesized by using an acetylating agent after the morphine has been extracted from raw, after the morphine has been extracted from raw, harvested opium. Methamphetamine, PCP, LSD, MDMA harvested opium. Methamphetamine, PCP, LSD, MDMA and methaqualone are purely synthetic drugs and methaqualone are purely synthetic drugs manufactured from chemical precursors. manufactured from chemical precursors.

Until recently, there were virtually no legal impediments to Until recently, there were virtually no legal impediments to obtaining the chemicals necessary to manufacture drugs obtaining the chemicals necessary to manufacture drugs of abuse, no records required to be maintained for of abuse, no records required to be maintained for inspection, and no penalties for negligence or willful inspection, and no penalties for negligence or willful diversion.diversion.

Origins of the Laws and RegulationsOrigins of the Laws and Regulations Chemical Diversion and Trafficking Act (CDTA) of Chemical Diversion and Trafficking Act (CDTA) of

19881988 As a result of government controls, ephedrine and other chemicals As a result of government controls, ephedrine and other chemicals

used to manufacture methamphetamine became more difficult to used to manufacture methamphetamine became more difficult to divert. Traffickers then began using over-the-counter capsules and divert. Traffickers then began using over-the-counter capsules and tablets that contained these ingredients.tablets that contained these ingredients.

Domestic Chemical Diversion Control Act of 1993 Domestic Chemical Diversion Control Act of 1993 (DCDCA)(DCDCA)

closed the loophole of over-the-counter capsules and tabletsclosed the loophole of over-the-counter capsules and tablets that that contained List I Chemicals, and required DEA registration for all contained List I Chemicals, and required DEA registration for all manufacturers, distributors, importers and exporters of List I manufacturers, distributors, importers and exporters of List I chemicals.chemicals.

Comprehensive Methamphetamine Control Act of Comprehensive Methamphetamine Control Act of

1996 (MCA)1996 (MCA) expanded regulatory control of lawfully marketed drug products expanded regulatory control of lawfully marketed drug products

containing ephedrine, pseudoephedrine, and phenylpropanolaminecontaining ephedrine, pseudoephedrine, and phenylpropanolamine

Pg 6Pg 6

Chemical ProgramChemical ProgramThe mission of DEA's Chemical Control Program is to The mission of DEA's Chemical Control Program is to

disrupt the illicit production of controlled substances by disrupt the illicit production of controlled substances by preventing diversion of chemicals used to make drugs. The preventing diversion of chemicals used to make drugs. The production of illegal drugs such as methamphetamine, production of illegal drugs such as methamphetamine, cocaine, heroin, and MDMA (ecstasy) requires enormous cocaine, heroin, and MDMA (ecstasy) requires enormous quantities of precursor and essential chemicals. quantities of precursor and essential chemicals.

The Chemical Control Program seeks to minimize the The Chemical Control Program seeks to minimize the regulatory burden on the legitimate chemical industry regulatory burden on the legitimate chemical industry while instituting effective anti-diversion policies. DEA while instituting effective anti-diversion policies. DEA registration, record keeping and suspicious order reporting registration, record keeping and suspicious order reporting requirements apply to importers, exporters, manufacturers, requirements apply to importers, exporters, manufacturers, distributors and certain retailers of 34 listed chemicals. distributors and certain retailers of 34 listed chemicals. Through a combination of industry outreach and voluntary Through a combination of industry outreach and voluntary compliance measures, DEA strives to control chemical compliance measures, DEA strives to control chemical diversion in partnership with industry and the public.diversion in partnership with industry and the public.

Principal Provisions of the Chemical Principal Provisions of the Chemical Diversion Control Laws and RegulationsDiversion Control Laws and Regulations

The laws and regulations require regulated The laws and regulations require regulated persons (manufacturers, distributors, importers, persons (manufacturers, distributors, importers, and exporters of listed chemicals) to implement and exporters of listed chemicals) to implement

measures which prevent diversion by:measures which prevent diversion by: obtaining proof of identity from their customersobtaining proof of identity from their customers maintaining retrievable receipt and distribution recordsmaintaining retrievable receipt and distribution records reporting to the Drug Enforcement Administration (DEA) reporting to the Drug Enforcement Administration (DEA)

any suspicious ordersany suspicious orders

Manufacturers who distribute or export, Manufacturers who distribute or export, distributors, importers, and exporters of List I distributors, importers, and exporters of List I

chemicals are also required tochemicals are also required to: : register with DEAregister with DEA provide controls and procedures to guard against theft provide controls and procedures to guard against theft

and diversion.and diversion. Pg 8Pg 8

Controlled Substances Act Controlled Substances Act (CSA)(CSA)

Controlled Substances ActControlled Substances Act The law that regulates the prescribing and The law that regulates the prescribing and

dispensing of dangerous substances, dispensing of dangerous substances, especially psychoactive drugs, including especially psychoactive drugs, including narcotics, hallucinogens, depressants and narcotics, hallucinogens, depressants and stimulants.stimulants.

Controlled Substances Act Controlled Substances Act (CSA)(CSA)

The CSA mandates that DEA prevent, The CSA mandates that DEA prevent, detect and investigate the diversion of detect and investigate the diversion of legally manufactured controlled legally manufactured controlled substances and make sure legitimate substances and make sure legitimate medical needs are met.medical needs are met.

Schedule I - VSchedule I - V

The CSA established The CSA established five schedules into five schedules into which controlled which controlled substances are substances are separated according separated according to their approved to their approved medical use and medical use and abuse potential. abuse potential.

Schedule Schedule I – NP, HAI – NP, HA II – P, HAII – P, HA III – VIII – V

• Prescription and Prescription and decreasing potential for decreasing potential for abuseabuse

CSACSA

Schedule I controlled substances are those Schedule I controlled substances are those deemed not to have legitimate medical uses and deemed not to have legitimate medical uses and have a very high potential for abuse. have a very high potential for abuse.

Schedule II substances are approved for Schedule II substances are approved for medical use and also have a very high abuse medical use and also have a very high abuse potential.potential.

Schedules III, IV and V include controlled Schedules III, IV and V include controlled substances that have all been approved for substances that have all been approved for medical use and have diminishing potential for medical use and have diminishing potential for abuse.abuse.

ExamplesExamples

Schedule ISchedule I Not for medical use in Not for medical use in

USUS GHBGHB Cannibas(Marijuana)Cannibas(Marijuana) HeroinHeroin MDMA(3,4 MDMA(3,4

methylenedioxymethamethylenedioxymethamphetamine)mphetamine)

Schedule IISchedule II Cleared for medical Cleared for medical

use in USuse in US FentanylFentanyl Cocaine (topical)Cocaine (topical) Methylphenidate Methylphenidate

(Ritalin)(Ritalin) Codeine (pure)Codeine (pure) Phencyclidine (PCP)Phencyclidine (PCP) Phenobarbital Phenobarbital

ExamplesExamples

Schedule IIISchedule III Anabolic SteroidsAnabolic Steroids DihydrocodeineDihydrocodeine Xyrem (prep of GHB)Xyrem (prep of GHB)

Schedule IVSchedule IV XanaxXanax ValiumValium

Schedule VSchedule V Cough Suppressant Cough Suppressant

(codeine)(codeine) Diphenoxylate (diarr[h]ea)Diphenoxylate (diarr[h]ea)

CSACSA

The CSA also established a The CSA also established a closed system of distribution closed system of distribution that includes the registration that includes the registration of controlled substances of controlled substances handlers, including handlers, including manufacturers, distributors, manufacturers, distributors, importers, exporters, importers, exporters, practitioners and pharmacists. practitioners and pharmacists.

What are List I & II ChemicalsWhat are List I & II Chemicals??

The Chemical Diversion & Trafficking Act The Chemical Diversion & Trafficking Act (CDTA) also cites chemicals that are used (CDTA) also cites chemicals that are used in the manufacture of controlled in the manufacture of controlled substances/illicit drugs. These chemicals substances/illicit drugs. These chemicals are also subject to regulation and control are also subject to regulation and control measures.measures.

LIST I ChemicalsLIST I Chemicals (1)  Anthranilic acid, its esters, and its salts (2)  (1)  Anthranilic acid, its esters, and its salts (2) 

Benzyl cyanideBenzyl cyanide (3)  Ephedrine, its salts, optical isomers, and salts of (3)  Ephedrine, its salts, optical isomers, and salts of

optical isomersoptical isomers (4)  Ergonovine and its salts(4)  Ergonovine and its salts (5)  Ergotamine and its salts(5)  Ergotamine and its salts (6)  N-Acetylanthranilic acid, its esters, and its salts (6)  N-Acetylanthranilic acid, its esters, and its salts

(7)  Norpseudoephedrine, its salts, optical isomers, (7)  Norpseudoephedrine, its salts, optical isomers, and salts of optical isomersand salts of optical isomers

(8)  Phenylacetic acid, its esters, and its salts (9)  (8)  Phenylacetic acid, its esters, and its salts (9)  Phenylpropanolamine, its salts, optical isomers, and Phenylpropanolamine, its salts, optical isomers, and salts of optical isomerssalts of optical isomers

(10) Piperidine and its salts(10) Piperidine and its salts (11) Pseudoephedrine, its salts, optical isomers, and (11) Pseudoephedrine, its salts, optical isomers, and

salts of optical isomerssalts of optical isomers

LIST I Chemicals (cont’d)LIST I Chemicals (cont’d)

(12) 3,4-Methylenedioxyphenyl-2-propanone(12) 3,4-Methylenedioxyphenyl-2-propanone (13) Methylamine and its salts(13) Methylamine and its salts (14) Ethylamine and its salts(14) Ethylamine and its salts (15) Propionic anhydride(15) Propionic anhydride (16) Isosafrole(16) Isosafrole (17) Safrole(17) Safrole (18) Piperonal(18) Piperonal (19) N-Methylephedrine, its salts, optical isomers, (19) N-Methylephedrine, its salts, optical isomers,

and salts of optical isomers (N-Methylephedrine)and salts of optical isomers (N-Methylephedrine) (20) N-Methylpseudoephedrine, its salts, optical (20) N-Methylpseudoephedrine, its salts, optical

somers, and salts of optical isomerssomers, and salts of optical isomers (21) Hydriodic Acid(21) Hydriodic Acid (22) Benzaldehyde(22) Benzaldehyde

LIST I Chemcials (cont’d)LIST I Chemcials (cont’d) (23) Nitroethane(23) Nitroethane (24) Gamma-Butyrolactone (Other names include: (24) Gamma-Butyrolactone (Other names include:

GBL; Dihydro-2 (3H)-furanone; 1,2-Butanolide; 1,4-GBL; Dihydro-2 (3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid lactone; Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid lactone) gamma-hydroxybutyric acid lactone)

(25) Red Phosphorus (25) Red Phosphorus (26) White phosphorus (Other names: Yellow (26) White phosphorus (Other names: Yellow

Phosphorus)  Phosphorus)  (27) Hypophosphorous acid and its salts (including (27) Hypophosphorous acid and its salts (including

ammonium hypophosphite, calcium ammonium hypophosphite, calcium hypophosphite, iron hypophosphite, potassium hypophosphite, iron hypophosphite, potassium hypophosphite, manganese hypophosphite, hypophosphite, manganese hypophosphite, magnesium hypophosphite, and sodium magnesium hypophosphite, and sodium hypophosphitehypophosphite

LIST II ChemicalsLIST II Chemicals 1) Acetic anhydride1) Acetic anhydride (2) Acetone(2) Acetone (3) Benzyl chloride (3) Benzyl chloride (4) Ethyl ether (4) Ethyl ether (5) Potassium permanganate (5) Potassium permanganate (6) 2-Butanone (or Methyl Ethyl Ketone or MEK) (6) 2-Butanone (or Methyl Ethyl Ketone or MEK) (7) Toluene (7) Toluene (8) Hydrochloric acid (including anhydrous hydrogen (8) Hydrochloric acid (including anhydrous hydrogen

chloride) chloride) (9) Sulfuric acid (9) Sulfuric acid (10) Methyl Isobutyl Ketone (MIBK) (10) Methyl Isobutyl Ketone (MIBK) (11) Iodine(11) Iodine

Methamphetamine:Methamphetamine: “Perhaps more than any other drug this country has experienced,methamphetamine affects everybody in the community. The first challenge of the meth trade is that we can’t blame it on

our South American neighbors….It is locally produced inclandestine laboratories.

The second challenge meth presents is that international traffickersare aggressively targeting rural areas…Traffickers think they canescape law enforcement in rural areas. But we have to make surethat’s not true.

The third challenge of methamphetamine lies in the very nature ofthis drug. It is intense, it is highly addictive, and it isoverwhelmingly dangerous…The drug has a phenomenal rate ofaddiction, with some experts saying users often get hooked afterjust one use. Recent studies have demonstrated thatmethamphetamine causes more damage to the brain than heroin,alcohol, or cocaine. Methamphetamine takes over the wholeperson. One former user described its effect on her life by saying,‘I went against every moral and every belief I ever had when I wason meth.’”

Current Major Drug ThreatsCurrent Major Drug ThreatsMethamphetamine

Street Names: Meth, Speed, Ice, Chalk, Crank, Fire, Glass, and Crystal. Physical Effects: Methamphetamine is a toxic, addictive stimulant. Meth

use dilates the pupils and produces temporary hyperactivity, euphoria, asense of increased energy, and tremors.

Dangers: Methamphetamine use increases the heart rate, blood pressure,body temperature, and rate of breathing, and it frequently results inviolent behavior in users. Methamphetamine is neurotoxic, meaning thatit causes damage to the brain. High doses or chronic use have beenassociated with increased nervousness, irritability, and paranoia.Withdrawal from high doses produces severe depression. Chronic abuseproduces a psychosis similar to schizophrenia and is characterized byparanoia, picking at the skin, self absorption, and auditory and visualhallucinations. Violent and erratic behavior is frequently seen amongchronic, high-dose methamphetamine abusers.

Description: Meth can be smoked, snorted, injected, or taken orally, andits appearance varies depending on how it is used. Typically, it is a white,odorless, bitter-tasting powder that easily dissolves in beverages. Anothercommon form of the drug is crystal meth, or “ice,”named for itsappearance (that of clear, large chunky crystals resembling rock candy).Crystal meth is smoked in a manner similar to crack cocaine and about10 to 15 “hits” can be obtained from a single gram of the substance.

Distribution Methods: Meth is frequently sold through social networksand is rarely sold on the streets.

What are the Closed System of What are the Closed System of Controls?Controls?

RegistrationRegistration ReceiptReceipt ReportingReporting StorageStorage DisposalDisposal

Registration

Security/Storage

Disposal

Receipt/Handling

Reporting

RegistrationRegistration

Who Must RegisterWho Must Register Every person (unless specifically exempted below) who engages or Every person (unless specifically exempted below) who engages or

proposes to engage in any of the following activities is required to proposes to engage in any of the following activities is required to register annually with DEA: register annually with DEA:

manufacturing a List I chemical for distributionmanufacturing a List I chemical for distribution distribution of a List I chemical distribution of a List I chemical importation of a List I chemicalimportation of a List I chemical

exportation of a List I chemicalexportation of a List I chemical

Separate Registration for Separate LocationsSeparate Registration for Separate Locations A separate registration is required for each principal place of A separate registration is required for each principal place of

business where a List I chemical is manufactured for distribution, business where a List I chemical is manufactured for distribution, distributed, imported, or exported. distributed, imported, or exported.

Pg 15Pg 15

RegistrationRegistration

Entities manufacturing, distributing and/or Entities manufacturing, distributing and/or dispensing controlled substances and/or List dispensing controlled substances and/or List I or II chemicals need to register with DEA. I or II chemicals need to register with DEA. (21CFR 1301 & 1309)(21CFR 1301 & 1309) Assigned forms based on business activity Assigned forms based on business activity

(Form 225/225a or 510/510a)(Form 225/225a or 510/510a) Separate registrations for separate sites unless Separate registrations for separate sites unless

approved for under control of one locationapproved for under control of one location Include administration controlled substances Include administration controlled substances

code #code # Annual registration (for manufacturers)Annual registration (for manufacturers) Fee based on type of business activityFee based on type of business activity

DocumentationDocumentation

Production quotas as well as Production quotas as well as recordkeeping and security requirements recordkeeping and security requirements are designed to enable DEA to track and are designed to enable DEA to track and safeguard potentially dangerous controlled safeguard potentially dangerous controlled substances as they are transferred from substances as they are transferred from the manufacturer to the ultimate user.the manufacturer to the ultimate user.

Documentation & Records Documentation & Records RequirementsRequirements

LabelingLabeling Containers should have labels of appropriate Containers should have labels of appropriate

size & location - visible from shelfsize & location - visible from shelf Sealed to determine if opened or tamperingSealed to determine if opened or tampering

RecordkeepingRecordkeeping Records should be kept of manufacturing and Records should be kept of manufacturing and

other transactions involving controlled other transactions involving controlled substances or listed chemicals – tableting substances or listed chemicals – tableting machines, encapsulating machinesmachines, encapsulating machines

Documentation & Records Documentation & Records RequirementsRequirements

RecordkeepingRecordkeeping Keep records of said transactions for 2 years Keep records of said transactions for 2 years

after transactionsafter transactions Located at site with transactions (can be Located at site with transactions (can be

centralized if approved)centralized if approved) Need to be retrievable Need to be retrievable Ensure tracking to satisfy application Ensure tracking to satisfy application

indications and manufacturing levels/quotas if indications and manufacturing levels/quotas if specified. (21 CFR 1310.04)specified. (21 CFR 1310.04)

Documentation & Records Documentation & Records RequirementsRequirements

Report to DEA special agent:Report to DEA special agent: Transactions with extraordinary quantitiesTransactions with extraordinary quantities Atypical methods of payment or deliveryAtypical methods of payment or delivery Any transaction with and entity noted by DEAAny transaction with and entity noted by DEA Any unusual or excessive loss/disappearance Any unusual or excessive loss/disappearance

of listed chemicals.of listed chemicals.• If loss is in transit, supplier is responsible to notify If loss is in transit, supplier is responsible to notify

agency, verbally ASAP and in writing within 15 agency, verbally ASAP and in writing within 15 days.days.

Security (1301.71, 1309.71)Security (1301.71, 1309.71)

Limited AccessLimited Access Physical means or electronic monitoringPhysical means or electronic monitoring System should consider type/form/quantity of substanceSystem should consider type/form/quantity of substance Location of site factored into security needsLocation of site factored into security needs Type of building/constructionType of building/construction Electronic detection/alarmsElectronic detection/alarms Appropriate supervisionAppropriate supervision Procedures for handling guest/visitors in areas with Procedures for handling guest/visitors in areas with

controlled substances/chemicalscontrolled substances/chemicals Tracking system for receipt, distribution, manufacture Tracking system for receipt, distribution, manufacture

and dispositionand disposition

Security (1301.71, 1309.71)Security (1301.71, 1309.71)

Limited AccessLimited Access Modifications to facility/construction will need Modifications to facility/construction will need

to maintain security integrity. (May need to be to maintain security integrity. (May need to be approved)approved)

ReportingReporting

Annual ReportsAnnual Reports Submitted to Drug & Chemical Evaluation Submitted to Drug & Chemical Evaluation

Section of DEA on or before March 15 of next Section of DEA on or before March 15 of next yearyear• Tracking informationTracking information• Manufacturing & Inventory DataManufacturing & Inventory Data• Use DataUse Data

Company ResponsibilitiesCompany Responsibilities

Evaluate personnel who will work in Evaluate personnel who will work in controlled substance/drug/chemical controlled substance/drug/chemical environment;environment; Background checksBackground checks

Evaluate continued employment of Evaluate continued employment of personnel conducting illicit activity.personnel conducting illicit activity.

Maintain confidentiality of personnel that Maintain confidentiality of personnel that inform appropriate points of contacts of inform appropriate points of contacts of illicit activity.illicit activity.

Employee ResponsibilitiesEmployee Responsibilities

Working in such a controlled environment, Working in such a controlled environment, employees subject themselves to State & employees subject themselves to State & Federal prosecution for any illicit activity Federal prosecution for any illicit activity (violating regulations).(violating regulations).

Employee is responsible to report illicit Employee is responsible to report illicit activity to security point of contact (POC). activity to security point of contact (POC). Failure to do so may jeopardize Failure to do so may jeopardize employment.employment.

InspectionsInspections

Administrator has authority to inspectAdministrator has authority to inspect Inspect, copy, verify recordkeeping Inspect, copy, verify recordkeeping

• Receipt, Inventory, distributionReceipt, Inventory, distribution Inspections at reasonable hoursInspections at reasonable hours Typically 1 visit per year (I &II) Typically 1 visit per year (I &II)

• III- V frequency as neededIII- V frequency as needed

Ensuring Closed System of Ensuring Closed System of ControlsControls

Registration

Security/Storage

Disposal

Receipt/Handling

Reporting

Maintain awareness Maintain awareness of regulationsof regulations

Establish and enforce Establish and enforce policies and policies and proceduresprocedures

Conduct internal Conduct internal auditsaudits

Implement follow-up Implement follow-up actions to enhance actions to enhance controls.controls.