h:manmed change 133 - chapter - navy medicine p-117...28 jan 2009 change 133 21-5 2....

Chapter 21

Pharmacy Operationand Drug Control

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Chapter 21CONTENTS

Sections PageSection I. Pharmacy Administration 21-3

Section II. Controlled Substances 21-19

Section III. Forms, Records, and Reports 21-29

Section IV. Drug Dispensing without a Pharmacist 21-33

Chapter 21 Manual of the Medical Department

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Section IPHARMACY ADMINISTRATION

Section I

Article Page21-1 Facilities (Regulatory) 21-3

21-2 Personnel (Regulatory) 21-3

21-3 Responsibilities (Regulatory) 21-4

21-4 Prescribers (Regulatory) 21-7

21-5 Outpatient Prescriptions (Regulatory) 21-8

21-6 Inpatient Dispensing (Regulatory) 21-14

21-7 Drug Stock (Regulatory) 21-15

21-1 Facilities(Regulatory)

(1) Naval medical treatment facilities (MTFs)dispensing drugs range from large hospitals to sup-port stations aboard the ships of the fleet and ashore.The overall mission of each facility, in addition toregulatory and accreditation authority, will determinethe type and quantity of pharmacy personnel assignedand the drugs to be stocked. Established nationalpharmacy practice standards will be utilized asguidelines for pharmacy operations.

21-2 Personnel(Regulatory)

(1) Pharmacists are graduates of accredited (bythe Accreditation Council for Pharmacy Education(ACPE)) pharmacy colleges or have a Foreign Phar-macy Graduate Examination Committee (FPGEC)certificate and are actively licensed in one of the 50United States, the District of Columbia, or PuertoRico. Alicensed pharmacist will provide professionaloversight of pharmacy services at all fixed MTFs(Budget Submitting Office (BSO-18) facilities) in theUnited States and overseas where a pharmacy isoperated.

Pharmacy Operation and Drug Control Article 21-2

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(2) The number of pharmacists and techniciansassigned to a facility is determined by the Bureau ofMedicine and Surgery (BUMED) Pharmacy StaffingStandard.

(3)At fixed MTFs where a pharmacist is not avail-able, pharmacies may be operated:

(a) By military-trained pharmacy techniciansoperating under the Department of Defense (DoD)/The Joint Commission (TJC) protocol (referenceInterim Protocol dated 2006).

(b) Using a telepharmacist option (e.g., alicensed pharmacist at a central pharmacy site checksprescriptions prior to dispensing to the patient at aremote telepharmacy site through the use of videoconferencing technology. This technology shall beable to support two-way communication between thepharmacist and the patient).

(c) By the use of remote pharmacists to supp-ort inpatient pharmacy operations to ensure adher-ence to TJC medical management standards ofprospectively checking medication orders. MTFswill ensure that inpatient pharmacy policies andprocedures provide for maximum patient safety when24/7 pharmacist coverage is not available due tostaffing shortfalls.

21-3 Responsibilities(Regulatory)

(1) The commanding officer (CO) is responsiblefor the operation of the pharmacy. The pharmacyshall be operated per Federal and State law, serviceregulations, and accepted standards of practice, suchas those defined by TJC and other professionalorganizations. Supervision is normally exercisedthrough a commissioned pharmacy officer. When acommissioned officer (pharmacist) is not assignedto an MTF, a civilian pharmacist or HM-8482pharmacy technician will be assigned supervisoryresponsibilities. The CO and/or officer in charge(OIC) responsible for a BSO-18 MTF, without anactive duty pharmacist assigned (e.g., branch clinic),

shall ensure that pharmacy operations are revisedthrough site visits and inspections. For non-BSO-18 activities without a pharmacist, the CO may assignresponsibility to an enlisted pharmacy technician(NEC 8482), under the supervision of a physician ornurse practitioner.

(2) The CO shall:

(a) Establish policies to ensure rationalprescribing, ensure quantities of drugs prescribed arenot excessive, and ensure drug dispensing is basedon the established DoD and local medicationformulary that matches the scope of care at the MTF.

(b) Ensure that the staffing levels, funding,and pharmacy scope of practice are aligned to meetthe mission of the MTF.

(c) Ensure that the pharmacy department headand subordinate staff keep abreast of newdevelopments in the field of pharmacy and serve assubject matter experts.

(d) Ensure safe medication use in compliancewith pharmacy regulatory and accreditationstandards.

(e) Ensure safeguards are adequate to miti-gate or prevent drug diversion. See article 21-24,Drug Diversion Guidance.

(f) Delineate pharmacy department responsi-bilities to include, but not limited to:

1. Providing drug information and policyassistance to authorized individuals in the properwriting of prescriptions. In particular, advisereference to pharmacology and toxicology, dosageforms and strengths, precautions, side effects andadverse drug reactions, pharmacokinetics, parenteralnutrition support, availability of ingredients, size ofstandard packages, equivalent agents, therapeutic andphysical incompatibilities, therapeutic equivalents,storage requirements, drug stability, and dosagecalculations and any information that would assistthe user. Additionally, support providers withinformation and recommendations regarding pharma-ceutical elegance and palatability, use of agents andquantities for maximum effectiveness and economy,refill authorizations, and any matter involving the useor misuse of medications.

Article 21-3 Manual of the Medical Department

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2. Providing inspections, at least monthly,of all areas where pharmaceuticals are dispensed,administered, or stored. The inspections shouldinclude, but not necessarily be limited to: adequatelabeling, appropriate storage conditions, stock level,evaluation of condition and potency based onexpiration dates and check markings of storage areasfor expired drugs.

3. Maintaining current drug informationresources, and routinely disseminating druginformation to medical provider staff and patients.

4. Providing information concerningadvances in the field of pharmacy and related matters.

5. Maintaining and publicizing, eitherelectronic or hard copy, an MTF formulary for usein the facility and by its patients and external cus-tomers (e.g., civilian network providers, other localMTFs, etc.). MTFs shall have the DoD basic coreformulary as the basis for their individual MTFformulary. A pharmacy newsletter may be used topublish timely information on pharmaceuticals andpreparations available for use, along with otherprescribing policies and items of interest to theprofessional staff.

6. For MTFs conducting research withinvestigational drugs:

a. Providing proper and separatestorage, safeguarding, labeling, and dispensing ofinvestigational drugs.

b. Maintaining investigational drugfiles.

c. Publishing essential informationconcerning investigational drugs to personnel whoadminister such drugs or care for patients receivingsuch drugs.

d. Maintaining a reference file copyin the pharmacy of the current protocols for allinvestigational drugs utilized in the MTF.

7. Where required to support inpatientcare: Operating a pharmacy sterile products programto include the preparation and delivery ofpharmaceutical sterile products in compliance withthe United States Pharmacopeia (USP) standards.

Maintaining laminar flow hood, biological safetycabinet (BSC) quality control requirements whichshall include cleaning of the equipment used on eachshift, and periodic certification of the BSC foroperational efficiency by a qualified inspector at leasttwice yearly, or when the BSC is moved or repaired.Changing high-efficiency particulate air (HEPA)filters when air flow is restricted (as indicated by thecontinuous monitor) or when the filters arecontaminated by an accidental spill. Maintainingwritten records of these actions. Centralizing allsterile compounding procedures within the pharmacydepartment or its satellites.

8. Providing, for the safety and economy,a unit-dose system as the preferred method forpackaging pharmaceuticals for distribution tohospital patients at fixed MTFs. Key elements of aunit-dose system are:

a. Medications are contained in andadministered from single-unit or unit-dose packages.

b. Medications are dispensed inready-to-administer form to the maximum extentpossible.

c. For most medications, not morethan a 24-hour supply of doses is provided to oravailable at the patient care area at any time, unlessan automated dispensing system is in place.

d. A patient medication profile isconcurrently maintained by the pharmacy for eachpatient.

e. Minimize the use of floor stockmedications.

9. Ensuring maximum use of electronicprescription order entry utilizing the current DoDenterprise system to enhance patient safety. Thissystem also includes adequate safeguards to maintainthe confidentiality of patient records. Data oncontrolled substances shall be readily retrievable inprinted form from the system.

Note: Auxiliary procedures must be in place to continuepharmacy functions during equipment downtime. Such auxiliaryprocedures shall ensure all appropriate data is retained for on-line data entry as soon as possible when the computer system isavailable.


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10. Ensuring prescriptions are filled onlyfor eligible beneficiaries. Use TRICARE EligibilityWeb site at: http://www.tricare.mil/mybenefit/ -select overview tab, then select eligibility.

11. Assuring, as part of the command’squality improvement program, the quality andappropriateness of patient care services provided bythe pharmacy department are monitored andevaluated, by using a planned and systematic processto identify and resolve problems.

12. Assuring the scope of pharmaceuticalservices is consistent with the mission of thecommand, and the medication needs of the patientsit serves. This will include promoting a relationshipwith the Fleet and Marine Forces within theresponsible catchment area to determine and assistwith pre-deployment and post-deployment medicalneeds. This may include, but not be limited to:

a. An assessment of therapeuticdisease state management of shipboard and fieldpersonnel.

b. Obtaining access to deployableforces current medication information.

c. Ensuring appropriate types andquantities of medication are available and storedfollowing current standards and regulations.

13. Ensuring security measures areadequate to prevent unauthorized entry into thepharmacy. Such measures will include, but not belimited to, utilization and maintenance of a logbookfor visitors entering and leaving and appropriatepharmacy key accountability by the Key Custodianwith a sign out log. Use of surveillance cameras andalarm protection to the maximum practical extent isencouraged. Maintain records of pharmacy door lockand alarm code changes and their frequency.

14. Ensuring the facility provides phar-maceutical care consistent with Service regulations,medical staffing, and standards of practice definedby TJC and other professional pharmacy organiza-tions.

15. Ensuring written cautionary informa-tion is provided with prescription medications dis-pensed to patients, as required by law (e.g., hormoneproducts). Drug information to include appropriatecautions on medication usage, possible side effects,

and potentially hazardous interactions with foods,should be available or provided to patients for allmedications dispensed. Patient counseling along withmedication labels, cautionary labels, and writtenpharmaceutical manufacturer guidelines shall beprovided to the patient to the maximum extentpossible following Federal Law and applicable pro-fessional guidelines.

16. Generally, if a specific pharmaceuti-cal is not on a government contract, the MTF shallpurchase the item that offers the best value for thegovernment. Most often, this means buying a genericproduct. Authorized generics are those rated A/B inthe Orange Book.

Exceptions: A trade name medication may be dispensed whenmedically indicated, supported by current literature, anddocumented in the patient’s medical record.

17. Pharmacies shall honor governmentcontracts, if established, when purchasing pharma-ceuticals. Additional blanket purchase agreementsbetween the MTF and a pharmaceutical companycannot be made when a DoD contract is already inplace. When necessary to maintain efficient opera-tions and in the best interest of patient care, pur-chasing of non-contracted items are allowed.

18. MTFs shall utilize an inventorymanagement ordering system (e.g., Defense MedicalLogistics Standard Support (DMLSS)) to managetheir credit memos and order pharmaceuticals fromtheir Prime Vendor credit account.

(3) Pharmacy and Therapeutics (P&T)Committee:

(a) Each parent MTF, with an organic phar-macy department, shall establish a P&T Committeeto advise the CO on the selection and use of drugs inthe facility. The P&T Committee is a function of themedical staff and will meet at least quarterly. TheCommittee will be composed of an interdisciplinaryteam with representatives from the medical, nursing,risk management, and pharmacy communities.Others disciplines (e.g., administrative and logisticscommunities) may be appointed as needed. The localP&T Committee shall ensure compliance with theTRICARE Uniform Formulary policies and DoDP&T Committee formulary management determina-tions.


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(b) Functions of the P&T Committee:

1. Develops and recommends policiesand procedures relating to the selection, distribution,handling, use and administration of drugs, anddiagnostic materials.

2. Evaluates clinical data on drugs or pre-parations requested for use in the MTF that have notbeen evaluated by the DoD P&T Committee. TheMTF P&T Committee shall maximize its use of theBasic Core Formulary (BCF) and Extended CoreFormulary (ECF) DoD P&T Committee decisionsto avoid duplication of efforts.

3. Minimizes unnecessary duplication ofdrugs, drug combinations, or therapeutic equivalents.

4. Reviews all reported medication andmisadventures (e.g., adverse drug reactions, adversedrug events) and medication errors includingevaluation of all errors and trend analyses with riskmanagement. A near-miss is defined as an event orsituation that could have resulted in harm to a patient,if it had reached the patient..

5. Recommends policies to ensure thesafe use of drugs in the facility, including the initialand annual review of pharmaceuticals approved forfloor stock including items stored in automateddispensing cabinets.

6. Oversees drug usage evaluations andreviews.

7. Approves and reviews annually all pre-printed paper and electronic forms that includemedications prior to their use in the MTF.

8. Complies with all National PatientSafety Goals (NPSG), TJC medication managementstandards, and other guidelines as directed byBUMED.

9. Recommends policies, to providereason-able access to the facility by manufacturerrepresentatives, to govern their conduct and activitieswhile at the MTF.

10. Participates in risk management andquality improvement activities related to medicationuse.

11. Recommends policies and proceduresfor evaluation and acquisition of non-formularymedications in compliance with DoD UniformFormulary decisions. (See article 21-5(10)).

12. Reviews and approves formulariesfor providers with limited prescribing privilege (e.g.,Independent Duty Hospital Corpsmen (IDCs) and ifapplicable, nurse practitioners, physician assistants,and other mid-level practitioners.).

21-4 Prescribers(Regulatory)

(1) Prescriptions from MTF and DoD authorizedproviders for formulary drugs will be honored.Authorized prescribers may include: Medical andDental Corps officers, optometrists, physicianassistants, pharmacists, physical therapists,podiatrists, nurse practitioners (certified nurseanesthetists, nurse midwives, women’s health nursepractitioners, family and pediatric nurse practi-tioners), veterinarians (when prescribing medicationsfor military working animals), or civilian physiciansemployed by the Navy or the Military Health System.Authorized prescribers also include Navy Indepen-dent Duty Hospital Corpsmen (IDC) personnelauthorized in Section IV of this chapter, and othersauthorized in writing by the CO (or delegatedrepresentative) to prescribe in their official capacitiesand defined by the MTF Professional Affairs office.

(2) Prescriptions written by civilian practitioners,other than those employed by the DoD, may be filledfor authorized beneficiaries, providing the prescribeditem is on the MTF formulary and a pharmacistverifies the prescription per current regulations.

(3) Pharmacies will fill all valid non-controlledprescriptions that are presented, regardless of thegeographic location of the beneficiary or prescriber,providing the medication is on the MTF formulary,and the prescription conforms to applicable laws andregulations. Valid prescriptions will be filledfollowing quantity restrictions and refill limitations.


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(4) Medical Department personnel shall notcountersign nor rewrite non-MTF practitioners’prescriptions without the provider assuming care forthe patient for the diagnosis supporting the specificmedication need, which includes a full assessmentof the patient. The policy of filling prescriptionswritten by civilian prescribers, and those written byMTF staff authorized prescribers, should coincideexcept for the following conditions:

(a) In MTFs located in a State where genericproduct selection by the pharmacist is not authorized,(or if the prescription is from another State wherethe authorization for product selection is unclear),the generic equivalent will not be substituted for abrand name drug on a civilian prescription, withoutprior approval of the prescriber. (TRICARE policyon generic medications is available at: http://www.tricare.mil/mybenefit/home/Prescriptions/Medications/GenericMedications?)

(b) A distance factor or geographic boundarylimitation will not be the reason for the denial ofprescription services for outside of the continentalUnited States (OCONUS) MTFs. Dispensing host-nation provider prescription memorandum, April 10,2007, provides guidance. Inside of the continentalUnited States (CONUS), MTFs may only acceptcivilian prescriptions from CONUS providers.

(c) Civilian practitioner prescription servicemay not be withdrawn or curtailed without consentof BUMED via your respective Regional Command.

(5) IDCs shall be authorized in writing by his orher assigned physician supervisor to prescribe orprovide medications carried on the IDC specific MTFformulary or authorized medical allowance list(AMAL). Any restrictions or exceptions (e.g., con-trolled substances) shall be plainly stated. A copy ofthe letter shall be retained in the IDC Certificationand Training Record with a copy provided to thepharmacy. OPNAVINST 6400.1 series providesguidance for training, certifying, and supervisingIDCs.

(6) Prescriptions from civilian optometrists, nursepractitioners, physician’s assistants, pharmacists, orother non-physician health care providers authorizedto prescribe by State law and not under the employof the Navy will be dispensed following the law ofthe governing State where the MTF resides.

21-5 Outpatient Prescriptions(Regulatory)

(1) Authorized prescribers in the employ of, orserving in, the Navy as described in article 21-4 willuse electronic-order-entry, DD Form 1289, DoDPrescription, or NAVMED 6710/6, Poly Prescriptiononly be used during periods of electronic-order entrysystem downtime. See special provisions for IDCpersonnel in article 21-50(1). Prescriptions fromcivilian practitioners and from the Department ofVeteran’s Affairs for dual-eligible patients are alsoaccepted if the medication is a formulary item. Pre-scriptions are acceptable when written by authorizedprescribers on prescription forms authorized by otherservices and forms conforming to the State pharmacylaws from civilian practitioners. Retired militaryphysicians, possessing a current license, may use theDD Form 1289 to write prescriptions for personaluse, except for controlled substances. (See article21-22(6).)

(2) Prescriptions must be written in ink, indeliblepencil, typewritten, or a printed form generated froma computerized program and shall show thefollowing:

(a) Patient’s full name.

(b) Date prescription was written.

(c) Patient’s age or date of birth and weight(if 12 years or younger). If the child’s age or weightis omitted, the pharmacy may record the child’s ageor weight on the prescription.

(d) Name of drug, form of drug, dosage sizeor strength written in the metric system, and quantityto be dispensed. Prescriptions should be written withgeneric name.

(e) Clear directions use for the patient.

(f) Additional patient specific data/para-meters (e.g., pregnancy/lactation status, weight,appropriate laboratory values) as required by regula-tion when appropriate.

(g) Valid legible signature of the prescriber.


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Electronic signatures are accepted only for non-controlled substances if authorized by pharmacy lawin the State where the prescriber is located. Consultlocal State Board of Pharmacy for clarification at:http://www.nabp.net/ftpfiles/NABP01/ROSTER.pdf.

(h) Refill authorization (as applicable).

(i) Additional requirements for controlledsubstances are found in article 21-27.

(j) When prescriber-order-entry electronicpharmacy systems are used, the electronic signatureis acceptable for all prescriptions, non-controlledsubstances, and for controlled substances inSchedules II through V. However, if a patient choosesto have a prescription filled in a community pharmacyor through the TRICARE Mail Order Program (e.g.,TMOP), the physician is required to write a tradi-tional prescription and sign it as required by 21 CFR1306.05(a). Prescriptions for Drug EnforcementAdministration (DEA) scheduled medications filledoutside the MTF must also have the practitioner’sgovernment sponsored DEA number on theprescription.

(k) Other requirements per Federal law.

(3) Outpatient prescription containers must belabeled properly and include:

(a) The MTF dispensing the prescription,including the pharmacy telephone number.

(b) Identifying prescription number.

(c) Patient’s name.

(d) Date the prescription is originally filledand date refilled, if applicable.

(e) Clear, concise directions to the patient.

(f) Full name of drug, strength, and quantitydispensed. Pharmaceutical preparations will norm-ally be identified and labeled with the generic name.However, trade or brand names may be used if thetrade or brand name product actually is in the con-tainer. The use of the word “type” or “equivalent” isacceptable on the label (such as, Tenormin “type”).

(g) Prescriber’s name.

(h) Filler’s and checker’s initials (when notsupported through automation).

(i) Number of refills remaining.

(j) Beyond-use date, if applicable.

(k) Proper auxiliary or cautionary labels asindicated.

(l) Other requirements per Federal law.

(4) Telephone or oral prescriptions will not beaccepted, except in an emergency or under extra-ordinary situations, directly from an authorizedprescriber. Telephone and oral prescriptions shallbe immediately reduced to writing and read back tothe provider for verification. Orders from providersmay be faxed, and will be considered as the originalorder with approval of the MTF, provided dataintegrity, patient privacy, security, and audit cap-abilities and policies have been established. Forelectronic prescribing, a prescription is deemed validif it is delivered from an external system havingundergone a certification process consistent withDoD regulations to ensure data integrity, patientprivacy, security, and full transaction auditcapabilities. Each transaction shall comply with therequirements in article 21-5(2).

(5) Prescriptions will be personalized. If morethan one member of a family is prescribed the samemedication, a separate prescription shall be enteredinto each patient’s electronic medication profile.

(6) Prescriptions for animals, other than thoseowned by the Government, will not be filled.

(7) MTFs will not routinely dispense pre-scriptions by mail. A TRICARE and Department ofVeteran’s Affairs (in certain areas only) mail orderbenefit (e.g., TMOP/consolidated mail out pharmacy(CMOP)) has been established as an option, andshould be used by eligible beneficiaries. Pharmacystaff will refer patients who choose to use a mail orderprogram to the TRICARE program for maintenancemedications. Exceptions, with prior approval by thepharmacy department head may be authorized, buteach situation should be evaluated on an individualbasis. In all cases, an individual’s eligibility andentitlement to prescription services will be deter-mined before filling and mailing any prescriptions.Mailing of prescriptions will follow the United StatesPostal Service Domestic Mail Manual.


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(8) MTFs pharmacies should direct patients withcivilian prescriptions to use the mail order programor retail pharmacies to fill certain special medicationsnot routinely provided by the MTF formulary. Note:Most over-the-counter medication and non-Food andDrug Administration (FDA) approved products arenot covered under the TRICARE benefit.

(9) MTF pharmacies shall fill, or provide theopportunity to have filled, all MTF formulary andapproved non-MTF formulary prescriptions writtenby its providers. Unapproved non-MTF formularyrequests may be filled using mail order benefits or aretail pharmacy if covered by the patient’s TRICAREbenefit and listed on the Uniform Formulary Website at: http://www.pec.ha.osd.mil/MTF/UF_Info.htm, otherwise an alternative medication should beprescribed. This does not preclude the patient fromchoosing to have the prescription filled else-where.Under the Uniform Formulary guidance, cer-tainmedications require the completion of either aMedical Necessity form and/or a Prior Authorizationform to be obtained by TRICARE patients with aformulary co-pay (see above Uniform FormularyWeb site for additional information).

(10) Prescriptions will be honored when writtenby military medical facility acting in a consultantcapacity. If the drug is not on the formulary, it willbe processed according to the MTFs policies andprocedures for evaluation and acquisition of non-formulary drugs. Prescriptions from non-referralMTFs and civilian providers for non-formulary drugsneed not be honored. See paragraph 1b under “Gene-ral Policies” in the TRICARE Pharmacy Policy Guid-ance (ASD(HA) Policy Memo 95-011 of 26 Jul1995) available at: http://www.tricare.mil/policy/fy95/pharmpol.html.

(11) Prescription medications for oral use byoutpatients will normally be dispensed in childresistant containers, unless the patient or prescribingpractitioner requests conventional (non-childresistant) closures. These requests for non-childproof containers shall be authorized by a notation inCHCS for the individual prescriptions or in thepharmacy comment section following the PoisonPrevention Packaging Act of 1970 (as amended in2008) available at: http://www.cpsc.gov/businfo/pppa.pdf. If CHCS is not available, then these

prescriptions shall be authorized by the patient’ssignature and such documentation shall remain onfile within the MTF.

(12) MTF pharmacies will not provide medica-tions intended for the purpose of home intravenousinfusion. Patients should be referred to case manage-ment staff/health benefits advisory staff to coordinatehome health care services.

(13) Acceptance of pharmaceutical samples fromsales representatives for dispensing to patients isprohibited. Should a practitioner desire to evaluatea pharmaceutical, the practitioner’s department headwill request a review by the P&T Committee. Ifapproved by the P&T Committee:

(a) Parameters will be established to allowevaluation.

(b) The product will be purchased via estab-lished procedures.

(c) After a reasonable evaluation period, theP&T Committee must determine if the product war-rants formulary status.

(14) Pharmacy personnel will not fill prescrip-tions that are illegible, incompatible, or if there isquestion of dosage, interaction, allergy, or methodof administration. Pharmacy personnel may clarifythese prescriptions with the prescriber, and fill theprescription after the patient safety concerns havebeen addressed.

(15) Asystem designed to protect patient privacyand assure accurate identification of outpatients atthe time they receive prescribed medications shallbe established. Identification shall involve the useof two identifiers, the patient’s name on the DoD mili-tary identification (ID) card and birth date or SocialSecurity Number. Apharmacist may use professionaljudgment and experience with common practice tomake reasonable inferences of the patient’s bestinterest in allowing a person, other than the patient,to pick up the prescription. Individuals receivingmedications for beneficiaries other than themselvesor their minor children should provide reasonableproof of patient consent (e.g., authorization letter andfront and back photocopy of patient’s ID) for therelease of medical information and prescriptions.Expired IDs will be confiscated via local MTF policy.


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Eligibility can be confirmed temporarily by a DefenseEnrollment Eligibility Reporting System (DEERS)check in the CHCS and a copy of the expired ID canbe provided as a reference to obtain a new ID.Children under age 10 can generally use a parent’sor guardian’s ID card, but they shall be registered inDEERS. At age 10, the sponsor shall obtain an IDcard for the child. DEERS ID Card Policies areavailable at: http://www.tricare.mil/mybenefit/ -select Overview; select Eligibility; then select IDCards (on the left side bar).

(16) The parent MTF CO may authorize a limitednumber of over-the-counter (OTC) drugs to be dis-pensed from the pharmacy in conjunction with ahealth care screener. Under no circumstances will apatient be authorized to select their own medications.A non-physician health care screener, identified bythe MTF shall assess a patient’s symptoms then eitherenters a prescription into CHCS for recommendedOTC drugs, selects the appropriate item(s) on theapproved list, and sends it with the patient to thepharmacy, or refers the patient for more definitivecare. Guidelines for an OTC health care screenerprogram include:

(a) Quantities dispensed are limited to onetreatment regimen or a few days supply for relief ofa current condition.

(b) OTC items are limited to treatment ofminor problems such as headaches, common cold,indigestion, or mild dermatitis.

(c) OTC items shall be labeled per Federalregulations and provide adequate directions to thelayman for safe and effective use and also providewarnings and cautions against misuse. OTC itemsshall be dispensed in the manufacturer’s originalcontainer.

(d) OTCs dispensed in these programs shallbe recorded into the patient’s pharmacy profile.

(e) Products containing pseudoephedrine orother OTC medications with FDA restrictions shallnot be dispensed as an OTC. MTFs will onlydispense pseudoephedrine-containing products as aprescription item.

(f) The following items shall be included onthe locally developed pharmacy dispensing form:

1. Title - OTC medication request.2. Sponsor’s name.3. Sponsor’s social security number.4. Recipient’s name.5. Duty or home telephone number.6. Date.7. List OTC items approved by the P&T

Committee.8. Signature of health care screener.

(17) MTFs shall have written procedures forobtaining drugs when the pharmacy is closed andpharmacy personnel are unavailable as defined bycurrent Joint Commission standards.

(18) Report and record all medication errors,including near-misses, via command’s error reportingmechanism, and BUMED guidance.

(19) When a pharmacy receives a prescriptionrefill request but no further refills are authorized, andthe patient is unable to readily obtain a new prescrip-tion, the pharmacist may use professional judgementto dispense a one-time limited fill of a maintenancemedication. The amount should be reasonable tomaintain the patient until the patient can contact theprescriber, but not greater than 30-day supply. Thedecision should be guided by:

(a) The prescription is not for a controlledsubstance drug listed in DEA Schedules II throughV. An exception: Controlled substance medicationsused for seizure control may be provided in a quantitynot to exceed a 72-hour supply (e.g., Clonazepamand Phenobarbital).

(b) Documentation in the CHCS prescriptioncomment field will include that the fill was providedon a one-time basis.

(20) Time and quantity limitations for filling andrefilling prescriptions.

(a) Schedule II medications. A prescriptionfor a controlled substance classified as a DEASchedule II shall be filled within 30 days of the dateoriginally written. Based on the clinical judgementof the pharmacist, exceptions for controlledsubstances can be made beyond the 30-day timeframeif allowable within the limits of State or Federal Law.Note: State law or command policy may be morerestrictive. Schedule II medications are normally


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limited to a reasonable quantity of medication asdefined by MTF policy, usually not exceeding a 30-day supply. Up to a 100-day supply of stimulantmedications is also authorized. Exceptions to the30-day limit can be made based on medical necessitybased on MTF policy within the limits of State andFederal regulation. Schedule II prescriptions shallnot be refilled. Deploying members may receive upto a 90-day supply of Schedule II medications.

(b) Schedule III, IV, and V medications. Aprescription for a controlled substance classified inDEA Schedule III, IV, or V shall be filled within 6months of the date originally written. These pre-scriptions may be refilled, if authorized by theprescriber, up to five times within a 6-month periodfrom the date originally written. Schedule II-Vmedications are normally limited to a reasonablequantity of medication as defined by MTF policy,not to exceed a 100-day supply. Deploying membersmay receive up to a 180-day supply of Schedule III-V medications.

(c) Non-controlled medications. A pre-scription for a non-controlled medication shall befilled within 1 year of the date originally written.These prescriptions may be refilled, if authorized bythe prescriber, up to 12 months from the dateoriginally written. Prescription quantities will befilled as written up to a 100-day supply for main-tenance medications at all MTFs. Active dutybeneficiary prescriptions may be dispensed largerquantities to meet readiness requirements. Sincethere are many reasons the prescriber may want tolimit drug supplies to certain patients, MTF policiesshall retain enough flexibility for the provider to limitthe quantity of medication dispensed to an individualpatient.

Note: Whenever possible, women who take oralcontraceptives on a long-term basis should be given aprescription for six packages with one refill.

(d) Non-controlled prescriptions marked withPRN refills may be refilled up to 1 year from thedate originally written.

(e) If an MTF is located in a State with a lawthat provides a more restrictive time limit, the Statelaw will be followed when filling or refilling a pre-scription written by a civilian practitioner notemployed by the DoD.

(21) The Prescribers Medication DispensingProgram (PMDP) is usually associated with militarysick calls or specialized outpatient clinics (e.g., thedispensing of prenatal vitamins in obstetrics clinicsand operated under the supervision of the prescriberor designee. Unless included in the PMDP or theOTC health care screener program, article 21-5(16),outpatient medications will be dispensed only onreceipt of a prescription. With the exception ofcontrolled substances, medications may be dispenseddirectly to the patient by an approved prescriber ordesignee after appropriate medical evaluation andappropriate medical record entrees providing that:

(a) A specific protocol is used, whichincludes a method to monitor the distribution of themedications and a mechanism to certify and monitorthe dispensing activities of the approved prescriberdesignee. For example, a log can be used thatincludes the date, patient’s name, and sponsor’sSocial Security Number with patient identifyingprefix, medication and strength, prescriber, anypatient drug allergies, and name of the dispenser.

(b) The list of medications used in the PMDPhas been reviewed by the P&T Committee or otherappropriate medical staff committee and approvedby the CO.

(c) All drug products are provided by thepharmacy and properly labeled.

(d) If required, the patient’s name, prescriber,and date shall be affixed to the label when the productis dispensed.

(e) The prescriber-dispenser is responsiblefor implementing quality control measures to ensurethe safe dispensing of all drugs in the PMDP. Thesemeasures must include, but are not limited to:

1. An annual review and revision of theprotocol for dispensing the medications, that includesthe list of medications.

2. Written criteria-based quality improve-ment reviews to ensure personnel dispensing medica-tions from the PMDP comply with the protocol.

3. Appropriate designed medication useevaluations to ensure proper use of the medications.

4. Necessary security measures are fol-lowed to prevent unauthorized dispensing of drugproducts from the PMDP.


28 Jan 2009 Change 133 21-13

(f) The effective and efficient operation ofthe PMDP shall be included in the planned and syste-matic monitoring and evaluation of the MTF’sQuality Improvement Program.

(g) The effective and efficient operation ofPMDP shall include a process to document the pre-scribed medication into the patient’s electronicmedication profile.

(22) All prescriptions originally filled at one DoDMTF may be refilled at another as long as thepharmacy takes into account the type of medicationand the method used for recording refills. MTFs withpharmacy data processing systems, that do not accessthe same prescription records electronically, willnotify the original facility of transfer of remainingrefills, thus voiding any remaining refills at theoriginal MTF. An electronic record will be made ofthe prescription such as: Transferred to “(name ofMTF)” with date of transfer. Schedule II medicationprescriptions, originally written electronically at oneDoD MTF may be filled and dispensed at anotherMTF if the pharmacy data processing systems accessthe same prescription records, and verification ismade that the prescription was not dispensed andreceived by the patient (or his or her representative)at the originating MTF.

(23) When requested by the patient, a pharmacistmay transfer a prescription for a Schedule III, IV, orV controlled substance or, any non-controlled pre-scription, to another pharmacy point of service (retail,mail order program, or MTF). The date of transferand the phrase, “Transferred to (name of pharmacyreceiving the copy)” will be recorded in the activitylog comment field of the electronic prescriptionrecord when discontinuing the prescription to voidremaining refills. Once a Schedule III to V prescrip-tion has been transferred to a civilian pharmacy, thesame prescription cannot be accepted for transferback into the MTF. When a prescription originallyfilled at a retail pharmacy is transferred to an MTF(taking into account the type of medication), the MTFwill make a notification in the electronic record suchas: “Transferred from (name/contact telephonenumber of retail pharmacy and name of pharmacist)with date of transfer.” Date of prescription entry shallbe the date of original prescription.

(24) Prior to releasing patient sensitive informa-tion, all requests shall be approved through the

command legal office or appropriate authority. Apolice officer, agent of the Naval Criminal Investiga-tive Service, agent of the CO, or any agent of higherauthority may remove an original prescription fromthe pharmacy’s files for the purpose of an investiga-tion. Whenever this occurs, a photocopy of theoriginal prescription and a receipt from the agent orpolice officer shall be kept in the pharmacy’s files.

(25) A pharmacy may use a photographic repro-duction, carbon copy, or electronically transmittedfacsimile of discharge orders as a prescription orderfor outpatient dispensing when patients are beingdischarged from the facility, to include prescriptionsfor Schedules II through V controlled substances.The discharge order shall meet the minimum require-ments of article 21-5(2) and be filed following article21-27(6) and (7).

(26) If a multiple prescription (civilian) is pre-sented for filling and the pharmacy does not stockall the medications ordered, the pharmacy will makea copy of the prescription for the pharmacy’s files.Pharmacy staff will indicate “filled at (name ofMTF)” on the original prescription, draw a linethrough the prescriptions filled, and return to thepatient. The annotation should also include theMTF’s prescription number and telephone number.The pharmacist or senior technician dispensing theprescription will sign the copy. For controlledsubstances, see article 21-27(2)(e).

(27) Non-FDA approved products such asneutraceuticals, homeopathic, and therapeutic dietarysupplements are not a TRICARE-covered benefit,therefore, not dispensed by the pharmacy department.These agents are not subject to FDA regulationregarding good manufacturing processes whichpresents legal risks to the MTF. If required, theseagents are subject to review by the P&T Committeeand approval by the MTF CO. These items aretypically provided by departments outside of thepharmacy or brought into the facility by the patient.

(28) Injectable medications to be administeredby home health care agencies will not be dispensedby the MTF pharmacy. Patients receiving homehealth pharmacy services should be referred to a casemanager or health benefits advisor for coordinationof care. MTF pharmacists shall ensure patientsreceiving injectable medications for self-administra-tion have been trained on proper storage, use, anddisposal.


21-14 Change 133 28 Jan 2009

(29) Refills for maintenance medications may berequested when 75 percent or more of the prior pre-scription has been used. A pharmacy officer mayauthorize an early refill, under special circumstances(e.g., patient on travel out of the area, disasters, orcontingency operations).

(30) Prescriptions for formulary medications,written by physician extenders who are dulycredentialed at one MTF, may be filled or refilled atother MTFs at the discretion of the CO.

(31) Prescriptions for formulary and approvednon-formulary medications written by MTF pre-scribers shall be dispensed from that facility unlessthe beneficiary chooses another option.

(32) All new and refill prescriptions will bedispensed to include a printed Patient EducationMonograph from CHCS along with any appropriateFDA-approved Medication Guide to distribute theside effect statement as required by the FederalRegister 21 CFR Parts 201, 208, and 209 [DocketNo. 2003N-0342]. Pharmacies may also in additionto but not in lieu of; distribute the side effectsstatement on a sticker attached to the unit package,vial, or container of the drug product or on apreprinted pharmacy prescription vial cap.

(33) The MTF CO and P&T Committee shallreview the alignment of the MTF formulary to themission of the MTF, DoD P&T guidance, and theneeds of population the MTF serves. The MTF COshall consider the enterprise impact of formularydecisions. Cost-effective formulary managementdoes not include selective deletion of medicationscommonly prescribed by MTF providers, but thatare required for optimal patient care.

(34) When the enterprise data entry system(CHCS) is down, only prescriptions written bycivilian and MTF providers for urgent medications(i.e., antibiotics, pain medications) may be filledunless an adequate downtime system is available thatoffers complete patient medication profile informa-tion. Labeling will include elements specified byparagraphs 21-5(2) and 21-5(3). All pharmacy ser-vices may be ceased at the direction of the MTF COuntil system is operational at the recommendation ofthe pharmacist as deemed necessary to support safeand effective patient care.

21-6 Inpatient Dispensing(Regulatory)

(1) The primary means of inpatient drug distribu-tion in fixed inpatient treatment facilities will be theunit-dose system or automated medication dispensingsystems, which shall include the pharmacistinterpreting the physician’s orders and monitoringinpatient medication needs.

(2) The preparation of sterile products, (e.g.,chemotherapeutics, large and small volume intra-venous admixtures, and irrigations) is an importantpart of the drug delivery system. Centralizing allsterile compounding within the pharmacy departmentis recommended where resources permit. COs willensure USP 795 and 797 are observed. The pharmacydepartment head is responsible for providing writtenguidelines and approving procedures for preparing,sterilizing, and labeling parenterals, whenever thesefunctions are not performed under direct pharmacysupervision. (View latest revision to USP 797Standards at: http://www.usp.org/pdf/EN/USPNF/PF797.pdf.)

(3) Monthly checks will be made by the pharmacyof all nursing care units or other areas where medica-tions are dispensed, administered, or stored, to verifythat at the minimum:

(a) Drugs for external use and disinfectantshave been stored separately from internal and inject-able medications.

(b) Drugs are not overstocked.

(c) Drugs are stored following currentestablished standards.

(d) Once discovered, outdated or unusabledrugs should be segregated and returned to thepharmacy immediately.

(e) There is an adequate and proper supplyof P&T Committee-approved emergency drugs.

(f) All drugs in the area are properly labeled.


28 Jan 2009 Change 133 21-15

(4) Automatic stop orders for drugs dispensed toinpatients are to be determined by the medical staffand the P&T Committee. Recommended drugs tobe included in automatic stop order policies areantibiotics, anticoagulants, controlled substances,hypnotics, and sedatives. There shall be a system tonotify the practitioner responsible for the patient ofthe impending expiration of a drug order, so thepractitioner may determine whether the drugadministration is to be continued or altered.

(5) When a patient transfers to a different levelof care, all orders shall be automatically canceledand rewritten (i.e., ward transfers, ward to surgery,etc.). National Patient Safety Goals (NSPG) andmedication reconciliation procedures shall befollowed.

(6) The pharmacy is responsible for labelingmedications. All medications issued in bulk con-tainers to nursing care units or clinics, not dispensedin the original container, shall be labeled by thepharmacy with the date of issue, generic and tradename, strength, quantity, beyond use date, name ofthe manufacturer, and lot number or appropriate codeto identify the drugs. Arepackaging beyond use datewill comply with current USP requirements not toexceed 1 year or the actual manufacturers expirationdate whichever is less, will be added to drugsdistributed in other than the original manufacturerpackage. To minimize contamination, waste, andfloor stocks, the use of unit-dose drugs available incommercial packages is recommended for fixedMTFs. This permits drug identification up to theactual time of administration.

(7) Drugs issued to clinics for subsequent reissueto patients will be properly labeled with adequatedirections for patient use. Information listed in article21-5(3)(a), (e), (f), (j), and (k) shall be included onthe label in the pharmacy or shall be added in theclinic.

(8) Inpatient self-care and discharge medicationsshould be labeled as outpatient prescriptionsfollowing article 21-5(3). The MTF shall assess thatself-administered medications are safely andaccurately administered.

(9) Nursing personnel shall collect all medicationsbrought to the hospital by patients admitted to nursingcare units. When possible, these drugs will be givento a member of the patient’s family to return to the

patient’s home for safekeeping. Medicationscollected in this manner will not be retained by thepatient, unless an order is written by the practitionerresponsible for the patient that the patient may usehis or her own medication following established MTFpolicy (e.g., “keep personal medications at bedside,”“patient may take own medications”). Thosemedications not given to a family member shall bereviewed by a pharmacist prior to being authorizedfor patient bedside use and shall be stored in alockable storage cabinet at the patient’s bedside, orin the pharmacy. All medications will be identified,inventoried, secured, and held until the patient isdischarged. The medications may be returned to thepatient upon discharge. Any medications remaining15 days after date of discharge shall be destroyedfollowing locally established destruction procedures.

21-7 Drug Stock(Regulatory)

(1) Personnel filling and dispensing medicationsshall understand their actions and shall have generalknowledge regarding the dosage range and contrain-dications.

(2) The Prime Vendor System shall be used forpharmaceutical purchasing. Exceptions may be madefor small purchases of products unavailable from thePrime Vendor.

(3) Pharmaceutical inventory will be managedto ensure the stock levels of pharmaceuticals on-handare not excessive (in general, not to exceed 30-daysupply), based on historic utilization patterns,potential urgency of medication use, administrativecosts, in addition to considering the limits of thesupply system.

(a) Annually, at a minimum, MTFs will estab-lish drug inventory par or stock levels that reflectthe level of care, prescription workload, and mission.

(b) MTFs shall conduct an annual inventoryof all drugs stocked in the pharmacy however, shouldresource constraints be an impediment, MTFs maychoose to perform a monthly sampling and/or a riskbased approach until a perpetual inventory system is


21-16 Change 133 28 Jan 2009

implemented. Risk-based approach focuses onidentifying drugs with high cost, high volume, or highabuse potential.

(c) Pharmacies will segregate duties forordering, receiving, and inventorying medications tothe maximum practicable extent.

(4) Only those items, which have been licensedand approved by FDA for sale in the United States,are authorized for use in CONUS MTFs. (The useof investigational drugs is included in BUMEDINST6710.69 series). Executive Order 13139 and 10 USC1107 prohibit use of non-FDA approved drugs onservice members, whether CONUS or OCONUS,unless the member signs a consent form, or thePresident waives the requirement for memberconsent.

(5) Each MTF will have a written policy regard-ing borrowing drugs from another MTF or civilianfacility, (e.g., an emergency or temporary out-of-stock situation, requirement for a non-formularyitem). Policies and procedures will include namesand telephone numbers of emergency suppliers, (e.g.,community pharmacies, hospitals), and methods ofreimbursement to the loaner, (e.g., replacing the sametype item at a later date, or with similar items basedupon wholesale value).

(6) Investigational drugs shall be stored and pro-cessed through the pharmacy following BUMED-INST 6710.69 series.

(7) Cytotoxic drugs will be controlled, prepared,administered, and disposed of following BUMED-INST 6570.3 series.

(8) Caustic substances such as glacial acetic,sulfuric, nitric, concentrated hydrochloric, trichloro-acetic acid, or oxalic acid, and concentrated pot-assium hydroxide shall be submitted and approvedby the MTF CO prior to being issued to nursing careunits, clinics, or outpatients. They shall be stored inseparate lockers and contents shall be clearly marked.

(9) Flammable drugs shall be stored followingaccepted fire safety regulations.

(10) Each MTF shall have written procedures fordrugs recalled by the FDA. These procedures shallbe implemented readily and the results documented.

Such procedures shall include obtaining recallnotifications from United States Army MedicalMaterial Agency (USAMMA) and documentation ofresponses to such notifications through the use ofthe inventory ordering and management system (e.g.,DMLSS) to the maximum extent practicable. Therecall procedures will require the inspection of allMTF areas and quarantine of products recalled. Drugrecalls affecting outpatients will apply only if directedby the recall notice or the FDA. Informationpertaining to drug manufacturer, lot number, andexpiration date is not required if there is a drug recallprocedure that can be readily implemented.

(11) Facilities will minimize the potential for thedispensing of expired drugs through effective inven-tory management (see article 21-7(3)), identificationof expired drugs, prompt removal of expired drugs,and tracking of expired drugs.

(a) When only a month and year of expirationare provided for a drug, the drug may be used untilthe last day of that month.

(b) Pharmaceutical inventory will beinspected at least monthly.

(c) Pharmaceuticals that will expire first shallbe placed in a position to be used first.

(d) During the monthly inspections, pharma-ceutical items that will expire within 30 days will beremoved from inventory, isolated, and securely storedin an area away from in-date pharmaceuticals.Special consideration should be given to medicationsnormally dispensed in 90-day supply or greater. Tothe maximum extent when possible, expired medica-tions should be inventoried when removed duringthe monthly inspections.

(e) The storage area and container for expiredpharmaceuticals will be clearly marked to preventaccidental dispensing.

(f) Prior to transfer of drugs to a contractedreverse distributor, an inventory of all returnedpharmaceuticals shall be validated with the con-tractor. The inventory shall be conducted simultan-eously with both an MTF representative and thecontractor, before the shipment leaves the facility.If the contractor cannot conduct a simultaneousinventory with MTF personnel prior to a shipment


28 Jan 2009 Change 133 21-17

leaving the MTF, the MTF shall ensure that an MTF-prepared inventory listing accompanies the shipmentand is maintained on file to compare to thecontractor’s records.

1. Credits will be monitored to ensureutilization within 90 days after posting at the PrimeVendor. (Otherwise, unused credits are sent to theU.S. Treasury.)

2. BUMED MTFs and activities shall notreceive nor deposit any checks received directly frompharmaceutical manufacturers as part of the reversedistribution (credit returns) program. Pharmaceuticalmanufacturer checks for returned goods creditdelivered directly to pharmacy department will berouted to the respective reverse distributor contractorfor processing following the standard operating pro-cedure posted on the Defense Supply Center Phila-delphia (DSCP) Web site at: http://www.dmmonline.dscp.dla.mil/pharm/reversedistribution.asp.

3. MTFs shall utilize inventory manage-ment ordering system (e.g., DMLSS) to managecredit memos and order pharmaceuticals from thePrime Vendor credit account.

(12) Manufacturing and handling of sterile pro-ducts shall follow current USP 797 recommenda-tions.

(13) Multiple dose vials (MDV) containingparenteral medications may be reused if the followingprocedures are followed to eliminate the risk ofinfection:

(a) Use strict aseptic technique.

(b) Upon reconstitution, date an MDV thatrequires addition of a diluent, label with a beyond-use date, store, and discard following the manu-facturer’s stability data, not to exceed the currentreference standard as stated in USP 797. For multiple-dose vial vaccines, follow BUMEDINST 6230.15series and CDC guidance for vaccines as it is specificfor each agent (the Centers for Disease Control(CDC) Vaccine Management Book is available at:http://www.cdc.gov/vaccines/pubs/downloads/bk-vac-mgt.pdf). If CDC, FDA, or manufacturer’s litera-ture does not exist, then follow USP 797.

(c) Date any opened or entered (e.g., needlepunctured) MDV, which does not require additionof a diluent and discard according to the currentreference standard as stated in USP 797. The beyond-use date for MDVs with an antimicrobial pre-servative is 28 days, unless otherwise specified bythe manufacturer. Opened or needle punctured singledose containers shall be used within 1 hour and anyremaining contents discarded. Date and time forsingle dose must be marked upon opening orpuncture.

(d) Discard contaminated vials immediatelyupon detection.

(e) Include observation of adherence to thisarticle in the monthly inspections required by article21-3(2)(f)(2).

(14) Alog or electronic record of all medicationsplaced in storage counting cells (e.g., Baker Cells,Drug-o-Matic) will be maintained to include initialsof the pharmacist or senior technician checking thefilled cell, manufacturer, lot number, and expirationdate.

Note: There are no articles 21-8 through 21-19.


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21-18 Change 133 28 Jan 2009

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28 Jan 2009 Change 133 21-19

(a) Schedule I. Drugs with no acceptablemedical use and a very high abuse potential.

(b) Schedule II. Drugs having an acceptablemedical use and a very high abuse potential.

(c) Schedules III, IV, and V. Drugs having anacceptable medical use which are considered to havelessening degrees of abuse potential.

Note: Products may migrate between schedules and newproducts may be added.

21-20 General(Regulatory)

(1) Controlled substances, as used herein, aredrug schedules in the Controlled Substance Act of1970 (Public Law 91-513).

(2) There are five schedules designated by section202 of the Federal Act:

Section IICONTROLLED SUBSTANCES

Article Page21-20 General (Regulatory) 21-19

21-21 Accountability (Regulatory) 21-20

21-22 Prescribing (Regulatory) 21-20

21-23 Custody (Regulatory) 21-21

21-24 Security (Regulatory) 21-21

21-25 Reporting Theft or Loss (Regulatory) 21-23

21-26 Deterioration (Regulatory) 21-24

21-27 Dispensing by Pharmacy (Regulatory) 21-24

21-28 Control by Nursing Care Units and Clinics (Regulatory) 21-25

21-29 Control by Branches to Pharmacy Service (Regulatory) 21-26


21-20 Change 133 28 Jan 2009

(3) Local commands may designate certain drugsas having abuse potential and requiring security mea-sures similar to those for controlled substances. TheCO will establish special security and accounting pro-cedures for these command-sensitive items desig-nated as “drugs with a high potential for diversion(DHPD).”

(4) Alcoholic beverages shall not be stocked ordispensed from Navy MTFs.

21-21 Accountability(Regulatory)

(1) Schedule I and II controlled substancesrequire vault or safe storage and inventory by theControlled Substance Inventory Board (CSIB) (perarticle 21-24). Working stock may be kept in a lockedarea within the pharmacy. At the CO’s discretion, acopy of the safe combination shall be stored in asealed envelope deposited with the CO or representa-tive. The combination shall be changed every 6months or upon change in custodian or any suspectedcompromise of the combination. Command shalllimit the number of personnel who can access thebulk stock vault to the minimum necessary and a vaultaccess list shall be maintained.

(2) Schedule III, IV, and V controlled substancesrequire locked cabinet security for storage of bulkdrugs. The appointed pharmacy custodian will con-duct a biennial inventory, on or about 1 May of oddnumbered years, of all controlled substances follow-ing DEAlaw, and if needed, a quarterly audit, or morefrequently, of high abuse potential Schedule III, IV,and V controlled medications. See article 21-7(3)for inventory management control and stock levelrequirements.

21-22 Prescribing(Regulatory)

(1) All prescribers authorized in section I of thischapter shall prescribe controlled substances eitherby electronic-order-entry; DD Form 1289, Pre-scription Form; NAVMED 6710/6, Poly Prescription;or coded facsimile, if appropriate.

(2) Authorized prescribers, when prescribingdrugs in an official capacity within the scope of theControlled Substances Act, are exempt from registra-tion under provision of 2l CFR 1301.25 of theControlled Substances Act. A prescriber exemptedfrom registration under 2l CFR 1301.25 shall includeon all prescriptions the prescriber’s branch of serviceor agency (e.g., “United States Navy” or “PublicHealth Service”) and must include the practitioner’sservice identification number or Social SecurityNumber as required by 21 CFR 1306.05(h). Otherpractitioners’ identifiers (National Provider Identi-fier) may not be substituted for the DEA number. Inaddition, 2l CFR 1306.05 of the Controlled Sub-stances Act requires each prescription have the nameof the prescriber stamped, typed, or hand printed onit, as well as the signature of the prescriber.Practitioners using prescriber-order-entry electronicpharmacy systems are exempt from the signaturerequirement of 2l CFR 1306.05(a) and 21 CFR1306.11 when the prescription is filled at the MTF.This exemption does not apply when the prescriberprovides professional treatment outside officialduties. (The TMA policy on DEA Numbers for DoDproviders is available at: http://www.tricare.mil/policy/ha00pol/000407.htm. Written prescriptionsfilled by the mail order program or retail pharmaciesmust contain the provider’s government sponsoredDEA number.

(3) An officer or civilian employed by the Navy,who has been designated by the command to purchaseor procure from commercial sources controlledsubstances or preparations for official use, shall beso designated on the command’s registration filedwith the Registration Branch, Drug EnforcementAdministration, Department of Justice, Washington,DC 20537. Only individuals so designated may signthe official order form for Schedule II substances.


28 Jan 2009 Change 133 21-21

Government registration is for 3 years, but indivi-duals designated may be changed as necessary byletter to DEA, signed by the CO.

(4) Ordering, receipt, custody, and issuance shallfollow Navy audit and chain of custody businesspractices to include segregation of duties to the maxi-mum practicable extent.

(5) Authority for physician assistants and nursepractitioners to prescribe Schedule II through V con-trolled substances may be granted by the CO, if withintheir scope of practice and designated in theirprivileging documents.

(6) No authorized provider shall prescribe orfurnish a controlled substance for themselves ormembers of their immediate family.

(7) Providers shall prescribe controlled sub-stances only for patients under their direct care. Onlyunder extraordinary circumstances will controlledsubstances be prescribed for a patient that was notpersonally evaluated by the prescriber at the time acontrolled substance was prescribed.

(8) Prescriptions for controlled substances willbe filled only from prescribers in the local area,exception to be made at the discretion of the phar-macy department head or as defined by the MTF CO.

(9) When electronic medical records are notutilized, all controlled substances prescribed will benoted in the member’s health or dental record at thetime prescribed.

21-23 Custody(Regulatory)

(1) Custodial responsibility for controlledsubstances and those drugs designated as locally-controlled drugs by the CO, shall be vested in acommissioned pharmacy officer, a civil servicepharmacist, or a commissioned officer who isappointed in writing. At remote branch clinics thatdo not have a commissioned officer or a civilianpharmacist, the CO shall designate, in writing, amember of the branch clinic as the custodian.

21-24 Security(Regulatory)

(1) Controlled substances listed in Schedules II,III, IV, and V shall be stored in a securely locked,substantially constructed cabinet. However, MTFsmay disperse a minimal working stock containingno more than 4 days of Schedules III through V basedon the stock level criteria in article 21-7(3)throughout the stock of non-controlled substancesin such a manner as to obstruct the theft or diversionof the controlled substances. COs and OICs maydirect stricter storage requirements based on risk ofdiversion at a specific facility. MTF Commandersshould strongly consider closed-caption videotechnology and controlled access technology tominimize the risk of drug diversion.

(2) Controlled substances classified as DEASchedule I through V require special handling andaccounting to provide adequate protection againstdrug abuse, carelessness, theft, and misappropriation.Mitigating diversion of controlled substances andDrugs with High Potential for Diversion (DHPD)should be accomplished using the followingguidelines:

(a) MTFs should develop and regularlyreview a list of DHPD that include controlledsubstances Schedules II through V and other legendor OTC drugs that represent a risk for drug diversion.The use of functional, strategically placed securitycameras in areas where DHPDs are stored,distributed, and administered may act as a usefuldeterrent and investigative tool to mitigate drugdiversion.

(b) MTFs should develop methods to auditand monitor DHPDs from receipt into inventory untildispensed to outpatients or administered to inpatients.Further, MTFs should establish percent thresholdsfor DHPDs that are not controlled substancesSchedule IIs, along with a process to track DHPDinventory from receipt to dispensing oradministration to the patient. The percent thresholdis defined as percent of inventory unaccounted forwhen comparing the difference between the amountordered and amount dispensed for a particular


21-22 Change 133 28 Jan 2009

DHPD, Percent thresholds should be as low aspossible, but taking into consideration the volumesdispensed, available MTF resources, and patientsafety and efficiency. Exceeding the percentthreshold for DHPDs established by the MTF shouldtrigger further investigation and documentationcauses. MTFs should utilize CHCS and other auto-mated methods to monitor and track DHPD.

1. Auditing and Monitoring

a. MTFs must develop a list ofDHPDs. The DHPD list should be reviewed annuallyfor additions and deletions based on MTF monitoringtechniques and external factors such as newlyidentified illegitimate uses for drugs.

b. For monitoring DHPDs that arenot classified as a controlled substance Schedule II,Navy MTFs should establish a percent threshold totrigger further investigation. This percentage shouldbe as low as possible, but will vary depending on thevolume of DHPDs dispensed and available MTFresources.

c. MTFs should develop proceduresand reports to audit and monitor DHPDs from receiptinto inventory until dispensed to outpatients oradministered to inpatients.

d. All pharmacies with CHCS and anarcotic vault should be required to use the electronicinventory provided in the vault functions of CHCSand required to follow the procedures outlined in theAppendix, for the drugs deemed DHPDs at their siteand at the determined interval.

e. All pharmacies, without CHCS,will keep a perpetual inventory on all controlledsubstances II through V and on all non-controlleddrugs deemed DHPDs.

f. The use of functional, strategicallyplaced security cameras in areas where DHPDs arestored, distributed, and administered may act a usefuldeterrent and investigative tool to mitigate drugdiversion.

g. Current and new contract em-ployee pharmacy positions shall include a drugtesting provision equal to that required for GS orNSPS employees. This should include personnel indirect contact with narcotic, controlled, and other

DHPDs. Contracted personnel shall read and signthe Notice of Random Drug Testing under the Depart-ment of the Navy Drug-Free Workplace Program.

h. A “Transaction Report (specific)”should be run via <PRM-->NRR-->STR>, printedand attached to the invoice after DHPD items areadded to the vault inventory in CHCS. The reportshould be run specific to the supply voucher number(usually the invoice number).Asecond person shouldverify the quantities added to the vault comparingthis report against the invoice. If all entries arecorrect, the report is signed and dated by the secondperson and filed with the invoice, and kept on filefor at least 2 years. Either the pharmacy departmenthead or their designee will verify these reports.

i. For pharmacies that use NAVMED6710/5, Perpetual Inventory of Narcotics, Alcoholand Controlled Drugs, each entry on the inventoryrecord should be verified against the invoice and co-initialed by an authorized person.

2. Automated Dispensing Machine(Pyxis). Allows for dispensing using user ID andpassword or BioID technology. Reports can begenerated in Pyxis to track the medication from thePyxis to the patient including filler demographics.

3. Controlled Prescription Menu. Is apaperless controlled prescription tracking system inCHCS. It may be used in conjunction with thebreakout locker or Pyxis dispenser and provides aperpetual inventory of controlled medications withinCHCS. Tracking of controlled medications from thevault to the patient using the NAVMED 6710/5,Perpetual Inventory of Narcotics, Alcohol and Con-trolled Drugs, is no longer necessary. After eachcontrolled prescription transaction is completed inCHCS, the inventory is decremented automaticallyand reflects the new quantity. Reports can begenerated to track the medication from the Pyxisdispenser or breakout locker to the patient.

a. The controlled substance custodianshall account for all quantities of schedule I and IIcontrolled substances received and expended througha physical inventory. The frequency of thecustodian’s inventory accounting should be guidedby the transaction frequency, but shall occur at leastweekly. The bulk stock of Schedule I through Vsubstances shall be secured using a double-lock


28 Jan 2009 Change 133 21-23

system. Steps shall be taken to restrict access tocontrolled substances. Keys and combinations shallbe safeguarded appropriately.

b. Ward Emergency kits and auto-mated pharmacy breakouts are authorized providingthe practice is approved by the CO or OIC or thefacility, and the following procedures are in place:

- Controlled substances (of allschedules) at the ward or in the automated dispensingcabinet (ADC) shall be obtained from the mainpharmacy per the requirements of article 21-28.

- Access to each emergency kit orADC shall be restricted. The type and quantity ofcontrolled substances placed in the emergency kitshall be limited to the mission of the facility andapproved by the CO through the P&T Committee.

- The main pharmacy, whichsupplied the controlled substances for the emergencykit or ADC, shall maintain complete and accuraterecords and inventories of the substances placed inthe kit per article 21-28.

- Hospital corpsmen may removecontrolled substances from the kit or ADC inemergent/urgent situations or in special circum-stances as approved by the pharmacy departmenthead, only when under direct supervision of aprivileged provider who is authorized to prescribecontrolled substances, and shall conduct theappropriate documentation of the controlledsubstance transaction.

c. Quarterly (or more frequently,depending on the activity), an unannounced inventoryof Schedules I and II controlled substances, and thosedrugs designated by local command shall be madeby the CSIB. The CSIB will have a minimum ofthree members. The CO may approve exceptions tothe minimum requirement. At least one member ofthe board shall be a commissioned officer. The COwill appoint each member, in writing. Senior enlistedpersonnel in pay grades E-7 through E-9 and DONcivilians in grades GS-7 and above or equivalentNSPS may serve as members at the discretion of theCO. Additional members may be appointed perarticle 21-29. The senior officer assigned to the boardwill be designated as the senior member. At leastone officer of the board shall be a Medical Corps,

Dental Corps, Medical Service Corps, or Nurse Corpsofficer, except when not available. No member ofthe board may be directly responsible for thesubstances being inventoried. A sample of allprescribed accounting records and prescriptions forthe accountable substances for the audit period willbe checked for compliance with regulations, parti-cularly as to dating, proper preparation, and requiredsignature. The board shall ensure the recordsinspected constitute a complete audit trail and reflecttransactions that occurred during the accountingperiod. Pharmacy stock, perpetual inventory records,requisitions, receipts, and issue documentation shallbe audited. The identity of any questionable itemsof inventoried stock shall be ascertained. Nursingrecords and outpatient clinics that store controlledsubstances shall be checked to verify proper account-ing for all documents and medications. CSIB willalso ensure physical security of pharmacy spaces andmonitor controlled access. Supply departmentrecords shall be reviewed, as required, to verify pro-per accounting for all documents. For this purpose,the supply department shall provide, directly to thesenior member of the board, a copy of all issuedocuments for Schedules I and II controlledsubstances.

4. See article 21-45 concerning Con-trolled Substances Inventory Report. BUMEDINST6710.70 series provides guidance for CSIBs.

21-25 ReportingTheft or Loss(Regulatory)

(1) Notify the nearest DEA regional office uponthe discovery of theft or significant loss of anycontrolled substance following DEAregulations. Thehead of the pharmacy department, in conjunction withthe senior member of the CSIB or other appropriatehigher authority, will determine if a significant lossoccurred. Report a theft or significant lossimmediately, using Report of Theft of ControlledSubstances, DEA Form 106. Prepare an original and


21-24 Change 133 28 Jan 2009

three copies. Send the original and one copy to thenearest DEA regional office, one copy to BUMEDPharmacy Specialty Leader, one copy to the MTFregion pharmacy representative, and one copy to thenearest field representative of the Naval CriminalInvestigative Service. The consignee shall submit asworn statement of facts with the DEA Form 106, ifthe controlled substances are stolen or lost in transit.

(2) Report any unresolved narcotic inventorydiscrepancies to the senior member of the CSIB orappropriate higher authority.

21-26 Deterioration(Regulatory)

(1) Return of expired Schedule I through Vcontrolled substances and locally controlled drugswill be accomplished through a contracted reversedistributor that is authorized to perform this functionby the DEA. Products that are not returnable (e.g.,products that have deteriorated and are not usable,are of questionable purity or potency, or have hadtheir identity compromised) through the contractorshall be inventoried for destruction. The appointedcustodian may request authorization to destroy non-returnable controlled products and recommend amethod of destruction (e.g., incineration). Ifdestruction is indicated and approved by the CO,destruction shall be accomplished in the presence ofa member of the CSIB. A certification shall includethe complete nomenclature and quantity of thesubstances to be destroyed, together with the methodto be used to accomplish destruction. After thecertification is completed, approved by the CO, andsigned by the members witnessing destruction, thecertification shall be retained in the files as authorityfor dropping the items from the appropriate record.DEA notification is not necessary.

(2) Appropriate modification of electronicinventories shall be conducted at the time thatdeteriorated inventory is segregated from the regularinventory. A separate inventory of controlledsubstances awaiting destruction/return shall bemaintained.

21-27 Dispensing byPharmacy

(Regulatory)

(1) The pharmacy shall serve as the source fromwhich nursing care units, clinics, and otherdepartments of a facility obtain controlled substancesfor use in connection with the treatment of patients.Authorized outpatient prescriptions for controlledsubstances shall be filled by the pharmacy. Ethylalcohol may be issued directly to the laboratoryproviding such stocks are included in the quarterlyaudit conducted by the CSIB.

(2) Controlled substances shall be dispensed tooutpatients on receipt of a prescription completedfollowing article 21-22 with the following additionalrequirements:

Exception: Schedules II through V controlled substanceswhen prescribed via prescriber-order-entry electronicpharmacy system.

(a) Prescriptions for controlled substancesshall be written in ink, typewritten, or entered throughprescriber-order-entry electronic pharmacy system.Duplicate, carbon copy, photographic reproduction,preprinted, rubber-stamped, or addressographedorders are not valid prescriptions for controlledsubstances, unless authorized by the law of the Statein which the MTF resides, and approved by the MTFCO or OIC. In all cases, the prescriber’s signatureshall be handwritten.

Exception: See article 21-5(25).

(b) Shall contain the complete address of theperson for whom the prescription is written and maybe supplied by patient or agent at time of dispensing.

(c) The legible signature and identifyinginformation of the provider authorized to prescribeper article 21-5. In addition, the name of the pre-scriber shall be stamped, typed, or hand printed onthe written prescription or verifiable throughadditional means.


28 Jan 2009 Change 133 21-25

(d) Erasures or interlineations on prescrip-tions for controlled substances are prohibited, unlessinitialed by the prescriber. This does not precludepharmacy personnel from annotating, after contactingthe prescriber that a therapeutic substitution isnecessary due to the unavailability of the productprescribed, if such practice is allowable per localState law.

(e) Each controlled substance prescriptionshall be a separate document for documentation andfiling purposes. The original of a controlled substanceprescription written on a prescription in combinationwith other medications should be copied, with theoriginal filed in the controlled substance file and thecopy filed with the non-controlled prescriptions.

(3) Controlled prescriptions will be reviewed forauthenticity before dispensing the prescription.

(4) Prescriptions for Schedule II controlledsubstances shall not be refilled. (See article 21-5(22)for time and refill limits on prescriptions.) If asufficient supply of a Schedule II controlledsubstance is unavailable to fill a prescription, a partialquantity may be dispensed if requested by the patient.In cases where the prescription cannot be completelyfilled within 72 hours, the provider will be notified,and a new prescription will be required for thebalance. The quantity dispensed shall be noted onthe front of the prescription, or by appropriate meansfor provider-order-entry prescriptions.

(5) Prescriptions for Schedule II controlledsubstances shall be dated, have the quantity dispensedannotated, numbered, and signed by the dispenseron the prescription at the time of filling. The pre-scription shall also include the date, address, tele-phone number, and signature of the recipient of thedrug item.

(6) A separate prescription file shall be main-tained for prescription records of Schedule II con-trolled substances.

(7) Prescription records of controlled substanceslisted in Schedules III, IV, and V shall be maintainedseparately from all other records of the pharmacy.

(8) Schedule II controlled substances issued tonursing care units, outpatient clinics, and branchmedical clinics shall be accompanied by requiredforms as outlined in section III of this chapter, unless

electronically controlled via an automated medicationdispensing cabinet (AMDC) or a BUMED-approvedelectronic form is used.

(9) Controlled substances shall be dispensed withlabels affixed following Section I of this chapter. Alabel with a clear, concise warning that Federal lawprohibits transfer of the controlled substance to anyperson other than the patient for whom it was pre-scribed shall be affixed to the containers. In addition,controlled substances dispensed to nursing care unitsand clinics shall identify the DEA schedule on thepharmacy label or manufacturer’s label.

(10) NAVMED 6710/1 forms will be used toaccount for all controlled substances used in thecompounding of pharmaceutical preparations. Suchorders shall be authenticated and signed by thepharmacists in charge of compounding and filed inthe appropriate prescription file. The product shallbe assigned a local prescription, batch, and lot num-ber. The scheduled product shall be posted to thepharmacy stock record, unless it is an extempora-neous compound dispensed for a specific singlepatient prescription, or a product containing alcoholwhere the only controlled substance in the productis alcohol.

21-28 Control by NursingCare Units and Clinics

(Regulatory)

(1) To provide effective and adequate custodyand audit trail accountability for controlled substancedistribution and protection, the following controlsshall be enforced:

(a) A registered nurse, medical, or dentalofficer will be charged with custodial responsibilityfor controlled substances following this article andother directives that may be issued.

(b) The custodian of these substances shallnot permit any such substances to be placed in thepossession of other personnel in quantities greaterthan the amount required for immediate consumptionby the patients.


21-26 Change 133 28 Jan 2009

(c) The custodian shall maintain a lockedcontainer, cabinet, or compartment of an approvednature to keep such substances. Medication storageand preparation areas shall be locked unlesspersonnel working in the area have a continuous,unobstructed view of the area. Keys, unless notrequired (e.g., AMDCs), to the containers shallremain in the custody of the individual responsibleand transferred only to another authorizedprofessional.

(2) Each nursing care unit, clinic, or other activitydrawing controlled substances from the pharmacyshall maintain a loose-leaf notebook containing theNAVMED 6710/4, Narcotic and Controlled DrugInventory-24 Hour and the NAVMED 6710/1,Narcotic and Controlled Drug Account Record orsimilar automated forms following article 21-42.Those facilities using anAMDC for inventory controlare exempted from maintaining the written forms,provided policies and procedures are in placecovering security, discrepancy resolution, anddowntime procedures. Such a system shall provideaccurate documentation of the audit trail, includingall information that would otherwise be documentedon the written form described in section III of thischapter.

(3) Controlled substances may be ordered fromthe pharmacy on a form approved by the command,and shall be signed by an authorized officialfollowing article 21-4(1) or by the nursing care unitcharge nurse. The supply of controlled substancesto nursing care units and clinics may also be byautomatic replacement of dispensed stock at a setlevel by the pharmacy without a signed form.

(4) Pharmacy personnel may deliver controlledsubstances from the pharmacy to various nursing careunits and MTF clinics. If time does not permit,controlled substances ordered for nursing care unitsand ambulatory clinics shall be picked up bypersonnel with custodial responsibility followingarticle 21-28(1). Personnel accepting controlled sub-stances delivery from pharmacy cannot be the sameindividual who submitted the request of the saidsubstances. For branch clinic pharmacies refer toarticle 21-29.

(5) Upon receipt of these substances from thepharmacy, the nurse in charge, medical officer, ordental officer shall check the amount of drug and

compare serial numbers on the NAVMED 6710/1,Narcotic and Controlled Drug Account Record andthe order form or prescription. This step may bewaived in an MTF with a pharmacy controlledautomatic replenishment system.

(6) The NAVMED 6710/1, Narcotic and Con-trolled Drug Account Record and the reverse side ofthe DD Form 1289 or other order form, shall besigned and dated in the appropriate space. (Seearticles 21-42 and 21-43 for information.)

(7) Regulations governing the automatic stoporder for controlled substances are in article 21-6(4).

(8) If a discrepancy exists and cannot be resolved,a report shall be made immediately through thenursing supervisor to the director of nursing servicesor respective head of service (medical officercustodian). Unresolved discrepancies shall also bereported to the head of the pharmacy department andthe senior member of the CSIB.

(9) Scheduled controlled substances shall not bestocked in emergency crash carts.

21-29 Control by Branchesto Pharmacy Service

(Regulatory)

(1) For branch clinic pharmacies not able to ordercontrolled substances directly from a Prime Vendor,controlled substances shall be requested anddelivered to pharmacy branches by the main phar-macy in the same manner as hospital nursing careunits and clinics are supplied. The branch pharmacyshall send a prescription or authorized ordering form,signed by responsible pharmacy personnel for bulkquantities, to the main pharmacy. Per section III ofthis chapter, a NAVMED 6710/1, Narcotic andControlled Drug Account Record, shall accompanyissue of Schedule II controlled substances. Thecommand is responsible for delivery methods. Allreceipts shall be signed for by a commissionedofficer, pharmacist, or a pharmacy staff memberappointed by the CO who is separate from the personrequesting the controlled substance(s).


28 Jan 2009 Change 133 21-27

(2) Unannounced CSIB inventories of ScheduleII controlled substances at branch pharmacies shallbe performed at least quarterly. Such inventoriesshall be called by the senior member of the CSIBboard and the results included in the MTF CSIBreport, with copies to the branch clinic OIC, seniormedical officer, or representative, as applicable, andthe parent MTF pharmacy department. At thosebranch clinics with insufficient staff to form a CSIB,following article 21-24(2), personnel from the parentcommand may be used to comprise the CSIB.



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21-28 Change 133 28 Jan 2009

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28 Jan 2009 Change 133 21-29

Section IIIFORMS, RECORDS, AND REPORTS

Article Page21-40 General (Regulatory) 21-29

21-41 Prescription Forms (Regulatory) 21-29

21-42 Controlled Substances Forms (Regulatory) 21-30

21-43 Quality Control Forms (Regulatory) 21-32

21-44 Availability of Forms (Regulatory) 21-32

21-45 Disposition on Records (Regulatory) 21-32


21-40 General(Regulatory)

(1) Records shall be maintained describing certainprocedures conducted within all Navy medical anddental facilities. Among mandatory requirements forrecord keeping are the prescribing of drugs, handlingof controlled substances, quality control procedures,and investigational drug handling. Standardizedforms are available for all procedures except qualitycontrol.

(2) All requirements for record keeping may beaccomplished by using pharmacy automated datasystems capable of producing readily retrievablereports.

21-41 Prescription Forms(Regulatory)

(1) When electronic provider-order-entry is notavailable, use DD Form 1289, except as provided inarticles 21-50(10) and 21-5(2)(i) for all singleprescriptions. More than one non-controlledmedication may be written on a DD Form 1289. Allcontrolled or investiga-tional drugs shall be writtenon individual DD Form 1289.

(2) Prescription blanks provided by or preprintedby a commercial company (i.e., drug manufactureror distributor) shall not be used in an MTF. Rubberstamp or addressograph plate may be used on DDForm 1289 for commonly prescribed items, except

21-30 Change 133 28 Jan 2009


controlled substances, providing the rubber stampor addressograph plate has been reviewed andapproved by the pharmacy department head and MTFP&T Committee. Any preprinted prescription blankor medication order form will be reviewed andapproved by the pharmacy department head and MTFP&T Committee prior to use in the MTF. Article21-27(2)(a) applies.

21-42 Substances Forms(Regulatory)

(1) NAVMED 6710/4, Narcotic and ControlledDrug Inventory-24 Hour

(a) All NAVMED 6710/4, Narcotic and Con-trolled Drug Inventory-24 Hour forms shall be keptin a controlled substance book. See article 21-42(3).

(b) The oncoming shift custodian shall signthe NAVMED 6710/4, Narcotic and Controlled DrugInventory-24 Hour accountability record. This is onlydone after completing the end of shift inventory ofall controlled drugs and prior to being relieved.When the nursing unit uses an automatic narcotic andcontrolled substance dispensing unit, no NAVMED6710/1, Narcotic and Controlled Drug AccountRecord or NAVMED 6710/4, Narcotic and Con-trolled Drug Inventory-24 Hour sheets are issued tonursing units, and no requirement exists for thetraditional end of shift counts of controls andnarcotics. The automatic systems shall be capableof tracking and recording each narcotic and con-trolled medication transaction. In this circumstance,nursing supervisors are required to access a dis-pensing discrepancy report through the dispensingunit at least daily. If it is determined that no trans-actional discrepancies are found, all narcotic and con-trolled medication counts are assumed correct by thenursing unit, unless otherwise notified by thepharmacy. The nurse reporting for duty and the nursebeing relieved shall check the drugs concurrently.Report any discrepancies immediately to the nursingsupervisor and the MTF pharmacy department headfor resolution or appropriate action.

(c) The nurse custodian is responsible for theaddition of all serial numbers of new NAVMED6710/1s on the NAVMED 6710/4. The serial numberof completed NAVMED 6710/1s returned to thepharmacy shall be entered in the appropriate column,and the pharmacist or authorized representative shallsign to acknowledge receipt.

(d) At least weekly, the nursing unit super-visor shall audit the nursing care unit controlled sub-stances supplies. After the audit, the nursing super-visor shall date and sign the NAVMED 6710/4.

(e) AMDCs shall be inventoried by the phar-macy department weekly to ensure controlled andDHPD are accurately accounted for.

(2) NAVMED 6710/1, Narcotic and ControlledDrug Account Record:

(a) Upon receipt of a properly completed pre-scription or order form, the pharmacy shall preparea separate NAVMED 6710/1 or similar automatedform for each Schedule II controlled substance andany command controlled drug.

(b) If used, all NAVMED 6710/1s shall befiled in a controlled substance book. See article 21-42(3).

(c) All entries shall be made in indelible ink.Errors shall be corrected by drawing a single linethrough the erroneous entry and legibly signing it.The correct entry shall be recorded on the followingline, if necessary.

(d) If a new issue is received before the oldissue is completely expended, the new NAVMED6710/1 shall be inserted in back of the current record.The serial number of the new NAVMED 6710/1 shallbe entered on the NAVMED 6710/4.

(e) The heading for each NAVMED 6710/1shall be completed at the time of issue. The body ofthe form shall be used for recording expendituresand balances only.

(f) Each time a drug is expended, completeinformation shall be recorded: date, time, patient,doctor’s name, by whom given, amount expended,and the balance on hand (NAVMED 6710/1). Seearticle 21-42(l)(b).

28 Jan 2009 Change 133 21-31


1. All amounts shall be recorded inArabic numerals. Where the unit of measure is amilliliter (ml) and the amount used is less than a ml,record as a decimal, e.g., 0.5 ml.

2. When the unit expended to the patientis a fractional dose, the unit administered shall beplaced in parentheses before the number of units inthe expended column, e.g., an entry of “(35) 1” for aMeperidine 50 mg. tubex indicates that one tubex ofMeperidine 50 mg. was expended and 35 mg. wasadministered or “(35) 2” for Meperidine 25 mg. tubexindicates that two tubexes of Meperidine 25 mg.expended, only 35 mg. was administered. Theremaining unused portion of a whole dosage unit, ifwasted, shall be recorded as destroyed on theNAVMED 6710/1, including the date, amount, newbalance, and signed by the authorized individualinvolved and a second authorized person. See article21-42(l)(b).

3. If a single dose of a controlled sub-stance is accidentally damaged or contaminatedduring preparation for administration, or is refusedby the patient after preparation, the dose shall bedestroyed. A brief statement of the circumstancesshall be entered on the NAVMED 6710/1 or enteredinto the automatic narcotic and controlled substancedispensing unit database by the authorized individualinvolved. Circumstances outlined above and inarticle 21-42(2)(c) shall be signed on the NAVMED6710/1 by the authorized individual involved and asecond authorized person.

4. If multiple doses of a controlled sub-stance are damaged or contaminated, the supervisorshall record the disposition of the drug, includingthe date, amount of drug, brief statement of dis-position, and new balance. The supervisor, thewitnessing nurse, physician or dentist, and theauthorized individual involved shall sign theNAVMED 6710/1.

5. Deteriorated drugs shall be returnedto the pharmacy by nursing care units and clinics.Drugs shall be disposed of following article 21-26.

(g) The completed NAVMED 6710/1 shallbe returned to the pharmacy. The pharmacy officeror authorized representative shall enter on theNAVMED 6710/5 the date the form was returned to

the pharmacy. This information shall be entered onthe appropriate line bearing the same serial number(prescription number) as the NAVMED 6710/1.

(h) Monthly, the pharmacy shall report to theDirector of the Nursing Service or appropriatedepartment head, all NAVMED 6710/1s outstanding30 days from date of issue. The report shall beverified and returned to the pharmacy for reconcilia-tion. Report discrepancies to the CO via report ofthe CSIB.

(i) Alocally prepared form or form generatedby the pharmacy’s automated data system may besubstituted for NAVMED 6710/1, providing theform, at a minimum, bears the same data fields.

(3) Controlled Substance Book (for facilities notusing AMDCs)

(a) Each nursing care unit, clinic, or otheractivity drawing controlled substances from thepharmacy (bulk stock) shall maintain a loose-leafnotebook containing the NAVMED 6710/4, Narcoticand Controlled Drug Inventory-24 Hour in the firstsection, and the individual NAVMED 6710/1,Narcotic and Controlled Account Records in the lattersections. The only exception to this policy is anyunit using and storing all controlled medications inan automatic narcotic and controlled medication-dispensing unit.

(b) The nursing supervisor shall remove allcompleted NAVMED 6710/4s over 3 months oldfrom the Narcotic and Controlled Drug Book, andtransfer the completed NAVMED 6710/4s to thepharmacy for storage for a minimum of 2 years.

(4) NAVMED 6710/5, Perpetual Inventory ofNarcotics, Alcohol, and Controlled Drugs

(a)Aseparate NAVMED 6710/5 shall be pre-pared for each Schedule II controlled substance. Allboxes and columns except as noted below are self-explanatory:

1. Name of Drug. Enter generic name ofdrug or proprietary name as appropriate, e.g.,Codeine Sulfate.

2. Strength. Expressed as gm. or mg.

3. Unit. Enter tablet or ampule, as appro-priate; for liquids or powders enter ml. or gm.

21-32 Change 133 28 Jan 2009

4. Prescription or Requisition Number.Enter appropriate prescription number requisition(voucher) number. For issues returned to the phar-macy, enter the source.

5. Recipient. Enter “pharmacy” forreceipts. Enter nursing care unit number, clinic, orname of patient, as appropriate, for expenditures.

6. NAVMED 6710/1 Returned. Enter thedate the NAVMED 6710/l is returned to the pharmacyon the appropriate line bearing the same serial num-ber or prescription number.

(b) On request of the senior member of theCSIB, the pharmacy department head, or authorizedassistant, shall total the quantity-received column andthe quantity-expended column for inspection by theboard.

(c) Upon completion of inspection, one boardmember shall initial the receipts and expenditurescolumns or document on NAVMED 6710/1 thatinventory was accurate.

(d) The foregoing procedures may be modi-fied to record the information and maintain surveill-ance using computers.

21-43 Quality Control Forms(Regulatory)

(1) The NAVMED 6570/2, Compounding/Pre-pack Log, will be used to provide clearly definablematerial sources (manufacturers’names, lot number,and expiration dates), procedures used, intermediaryand final checks by supervisory personnel, andsample labeling for all compounded and repackagedpharmaceuticals.

21-44 Availability of Forms(Regulatory)

(1) DD Form 1289 (NOV 1971), DoD Pre-scription, S/N 0102-LF-012-6201 and NAVMED6710/6 (Rev. 3-1984), Poly Prescription, S/N 0105-LF-206-7130 are available for order from the NavalForms Online Web site at: https://navalforms.daps.dla.mil/web/public/home.

(2) NAVMED 6570/2 (12-2008), Compounding/Prepack Log; NAVMED 6710/1 (Rev. 1-2002),Narcotic and Controlled Drug Account Record;NAVMED 6710/4 (4-72), Narcotic and ControlledDrug Inventory-24 Hour; and NAVMED 6710/5 (4-72), Perpetual Inventory of Narcotics, Alcohol, andControlled Drugs are available on the Navy MedicineWeb site at: http://navymedicine.med.navy.mil/default.cfm?seltab+directives at the Forms tab.

(3) DEAForm 106, Report of Theft of ControlledSubstances may be obtained from the nearest regionaldrug enforcement office or the Drug EnforcementAdministration, 1405 “I” Street, NW, Washington,DC 20537.

21-45 Dispositionof Records

(Regulatory)

(1) All prescriptions, formularies, and drug listsmay be destroyed when 2 years old or supersededand no longer needed for reference. All SchedulesII through V controlled substance prescriptions andaccounting records will be available for at least 2years.



28 Jan 2009 Change 133 21-33

Section IVDRUG DISPENSING

WITHOUT A PHARMACIST

Article Page21-50 Physician Assistants, Nurse Providers, and Hospital Corps 21-33

Personnel on Independent Duty (Regulatory)

21-51 Operational or Emergency Situations (Regulatory) 21-34

21-50 Physician Assistants,Nurse Providers,

and Hospital CorpsPersonnel on

Independent Duty(Regulatory)

(1) Physician assistants, nurse practitioners, andhospital corps personnel may be assigned to medicalduties on small vessels, shore stations, Fleet MarineForce, and mobile field units to which a medical offi-cer is not attached. They perform all duties requiredof the Medical Department. These duties includeMedical Department administration and to the extentfor which qualified, the professional duties prescribedfor medical officers of ships and stations.

(2) Custodial responsibility for controlled sub-stances shall be vested in a commissioned officer.

(3) Members of the Medical Department of theNavy shall not take nor receive into custody, on boardship or in any Navy or Marine Corps establishment,any controlled substances except as authorized:

(a) For medicinal purposes.

(b) For retention as evidence in disciplinaryactions.

(c) By Navy Regulations.

(4) Working stocks of controlled substances maybe issued from the main pharmacy from time to timefor dispensing purposes to the individual in chargeof this pharmacy. This individual shall be requiredto keep an accurate record of receipts and expendi-tures and to keep these substances under lock whennot in use. Except as provided above, a custodialofficer shall not permit any of these substances to beplaced in the possession of any person in quantitiesother than that required for immediate consumptionby patients, or for use in emergency, such as combat.All drugs must be dispensed under the supervisionof Medical Department representatives at activitieswhere there are no officers of the Medical Depart-ment.

(5) Officers of the Medical Department are autho-rized to issue controlled substances, for medicinalpurposes only, to COs of ships and to pilots of aircraftto which no Medical Corps officer is attached.

(6) An officer of the Medical Department, or ifno such officer is available, then an officer designatedby the CO, shall keep in a separate locked compart-ment, all controlled substances and substances classi-fied as dangerous or otherwise controlled. The CSIB


21-34 Change 133 28 Jan 2009

shall conduct an inventory quarterly or more fre-quently per article 21-24. The inventory will beunannounced. A report will be made to the CO. Thekeys shall always be in the custody of an officer.Personnel of the Medical Department shall assureall such substances under their charge are properlylabeled.

(7) The executive officer, or other designated offi-cer, shall arrange for the care and safe custody of allkeys, and require strict compliance with instructionsconcerning the receipt, custody, and issue of con-trolled substances contained in the law, U.S. NavyRegulations, and this manual.

(8) Custodians, or their designated assistants,shall retain the keys to the place of storage while onduty. When relieved, they shall deliver the keys totheir relief, or to a responsible person designated bylocal instructions. A copy of the combination of asafe, if used, shall be sealed in an envelope anddeposited with the CO or an officer designated bythe CO.

(9) The senior Medical Department representa-tive shall take charge of the medical storeroom andmaintain custody of the key. However, the medicalofficer, if one is assigned, or such other officer orpetty officer designated by the CO, shall be respon-sible for the security of the contents of the medicalstores kept therein. Controlled substances shall bekept in separate lockers and the keys to these lockersshall always be in the custody of an officer.

(10) Directives issued by fleet force, type com-mander, CO, or other appropriate authority, mayauthorize the following deviations from the controlsestablished in this chapter:

(a) Physician assistants, nurse practitioners,or the senior hospital corps member at an activitynot having a medical officer may be authorized todeviate from the control procedures established bythis chapter, but not the intent regarding receipt,custody, and issuance of controlled substances, andother dangerous and controlled drugs. This deviationin no way relieves a command of the responsibilityfor controlled material.

(b) Physician assistants, nurse practitioners,or senior hospital corps members may prescribe andadminister only those controlled substances listed inthe activity’s authorized medical allowance list(AMAL). Only type commanders, medical officers,or their higher authority may make any revision oraugmentation of controlled substances in AMALs ofactivities without medical or dental officers. A DDForm 1289, DoD Prescription, must be prepared andfiled following this chapter. Prescriptions not signedby a medical officer, dental officer, podiatrist, physi-cian assistant, nurse practitioner, or civilian physicianemployed by the Armed Forces shall be countersigned by the CO or a duly appointed officer repre-sentative. See article 21-5.

(11) Physician assistants, nurse practitioners, orhospital corpsmen on independent duty are notrequired to use the DD Form 1289, DoD Prescription,for prescribing drugs, other than controlled drugs,unless directed by the CO or higher authority. Thisdoes not relieve personnel on independent duty fromcomplying with article 21-5(9).

21-51 Operational orEmergency Situations

(Regulatory)

(1) If operational commitments call for deviationfrom the established controls of this chapter, specialinstructions shall be issued by appropriate authorityrelative to the receipt, custody, and issuance of con-trolled substances, ethyl alcohol, and dangerous andcontrolled drugs.


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