Pharmacist’

An Information O

 Controlled Substanc

April 20

ii
An Informational Outline of the Controlled 

Substances Act of 1970 

Message from the AdministDear Pharmacist: 

John D. AshcroftAttorney General The Drug Enforcement Adm

provide you the eighth edition of the assist you in understanding the provSubstances Act (CSA) and its implemanual will answer questions you mpractice of pharmacy and provide guthe CSA regulations. This edition hainformation on the provisions of the Methamphetamine Control Act of 19

Karen P. TandyAdministrator William J. WalkerDeputy Assistant Administrator Office of Diversion Control Patricia M. GoodChief, Liaison and Policy Section Your role in the proper dispe

substances is critical to the health osafeguard society against drug abusadherence to the Controlled Substavoluntary compliance with its objectresource for protecting the public hesafety, and preventing the diversion and drug products containing listed 

This manual has been prepared by the Drug Enforcement Administration's Office of Diversion Control to assist pharmacists in their understanding of the Federal Controlled Substances Act of 1970 and its implementing regulations as they pertain to pharmacy practice. 

Sincerely, 

Karen P. TanAdministrator Drug Enforce

iii iv
compliance may result in a need for 

administrative action (i.e., Letter of Ahearing or licensing action), or in excriminal action. 

Preface 

The Drug Enforcement Administration (DEA) is responsible for advising DEA registrants how to comply with the federal law1

regarding the handling of controlled substances and regulated chemicals. It is DEA’s goal to maintain a positive working relationship with its pharmacy registrants. The DEA respects the professional integrity of pharmacists, the vast majority of whom comply with the law and its regulations in a responsible manner. The DEA understands that it can best serve the public interest by working with these pharmacists to develop cooperative programs for preventing diversion of legal pharmaceutical controlled substances into the illicit market. 

The DEA is greatly concerne

abuse of controlled substances and listed chemicals. Most drug diversiowhere the pharmacist plays a criticaproper control of prescription and ovBecause the pharmacist dispenses the patient, he/she is in a key positioof the patient and prevent diversionprescribing practitioner share respotherapeutic drug usage of patients, wconcerned and knowledgeable profe

DEA does not routinely inspect pharmacies for 

controlled substance violations, since this function is usually conducted by state authorities. However, DEA does investigate complaints of diversion from pharmacies and also investigates "doctor shoppers" and prescription forgers whose activities are confirmed through records located at the numerous pharmacies they patronize. 

Experience has shown that p

familiar with the regulations are moswith the Controlled Substances Act. pharmacists to dispense controlled fide prescription orders are issued bto prescribe controlled substances. prescription must be issued for a lega practitioner acting in the usual coupractice. While this responsibility rescorresponding responsibility rests udispenses the prescription medicationot written for a legitimate medical pbe a valid prescription within the meindividual who knowingly dispenses prescription, as well as the individuato criminal and /or civil penalties. 

DEA would prefer to assist pharmacists to avoid and 

correct potential compliance violations, rather than seek administrative, civil or criminal action. However, when repeated efforts to remedy violations have not been successful, DEA is authorized under federal law to pursue legal action to correct these problems, prevent diversion related drug abuse, and protect the public safety. A lack of 1 Controlled Substances Act of 1970 (Title 21, United States Code, Section 800 et. 

seq.) and its implementing regulations (Title 21, Code of Federal Regulations, Part 1300 to end). The pharmacist and the prac

the various techniques drug abusers obtain controlled substances and dr

v vi
listed chemicals for illicit purposes. The primary method is a 

falsified prescription (see Appendix O, "Pharmacist’s Guide to Prescription Fraud"). State and local law enforcement agencies, as well as pharmaceutical industry representatives, cite prescription fraud as a substantial part of the diversion problem. The DEA recognizes that attempts to obtain legitimately manufactured controlled substances by misrepresentation, such as forged prescriptions and stolen prescription blanks, are significant problems confronting practitioners, pharmacists, and local law enforcement agencies. "Doctor shoppers," who pose as patients to obtain controlled substances from multiple practitioners, are also a common source of diversion. Other methods for diverting controlled substances and drug products containing listed chemicals include theft from a pharmacy and diversion by pharmacy personnel. 

Consequently, these chemic

registration, recordkeeping and reporule, pharmacies are retail outlets anrequired to have a chemical registradiversion of drug products containinoccur at the retail level, appropriate to prevent diversion. Close cooperaprofession and law enforcement will chemicals used in the production of remain in legitimate channels. (For m

Chemical Requirements as well as AIf you need additional clarification concerning the CSA regulations othe material in this manual, pleasDiversion Field Office (see Appen

New Chemical Control Requirements DEA’s Internet Website: 

www.D

E

A.gov In addition to the diversion of controlled substances, 

DEA is concerned with the diversion of certain chemicals used in the clandestine manufacture of controlled substances. Most pharmacies do not stock significant quantities of these chemicals. Chemicals such as ephedrine, pseudoephedrine, and phenylpropanolamine (PPA)2 which are contained in 

prescription and over-the-counter preparations are sold at retail stores. Drug products containing these chemicals are commonly used to illegally manufacture amphetamine and methamphetamine. Quantities of these drug products may be sought from retail outlets for use in clandestine manufacturing operations. 

You can access the diversion controDEA’s website by hyperlink. DEA Diversion Control Program’s 

www.D

E

A

diversion.usdoj.

This site includes Diversion 

newsletters, Federal Register Noticepublications; progress reports recommerce initiatives, listings of DRegistration Field Offices, conferDiversion’s major program areas regulated chemicals, scheduling 

2 Due to concerns regarding harmful side effects of phenypropanolamine (PPA), the 

Food and Drug Administration initiated action in November 2000 to remove PPA from the market. These changes in the status of PPA are not yet reflected in the regulation or this manual 

The complete text of the Pha

found on the Diversion Control Prog

vii viii
Publications. The manual will be updated periodically so that 

current information is available on the DEA website. Therefore the manual can be downloaded and reproduced at your convenience without having to request a print copy by mail from DEA. The manuals for physicians, mid-level practitioners, researchers and chemical handlers will also be available on this website. 

Contents

Application of State and Federal LawDrug Enforcement Administration.....Schedules of Controlled Substances.

Schedule I Substances..................Schedule II Substances.................Schedule III Substances................Schedule IV Substances ...............

GPO Federal Register Internet Website: Schedule V Substances ................http://www.access.gpo.gov/nara/cfr/index.html Registration Requirements ...............

Chemical Registration Requiremen

DEA Regulations and Notices in the Federal Register New Pharmacy Registration..........

Change of Business Address........

DEA regulations and notices published in the Federal 

Register are available online through the U.S. Government Printing Office (GPO) Internet website. The current Code of Federal Regulations3 as well as proposed and finalized 

amendments to the CFR concerning controlled substances and regulated chemicals, can be found at this website. 

Affidavit for Renewal of Retail ChaDenial, Revocation or Suspension 

Denial of Registration in the Public Termination of Registration ...........Transfer of Business .....................

Disposal of Controlled Substances....

Transfer of Controlled Substances.To Another Pharmacy5 ..................

In addition, a hard copy of the CFR may also be 

obtained through the GPO in your local area, or by writing to the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. 

To Another Supplier or ManufactuTo a Reverse Distributor RegistereSubstances....................................Destruction of Controlled SubstancOnce-a-Year DEA Authorization fo

3 To find the Code of Federal Regulations pertaining to controlled substances and regulated chemicals use 21 CFR, Part 1300 to end. 

x

Exception to DEA Authorization foReverse Distributors Authorized to Substances...................................."Blanket Authorization" for Destruc

.......................................................

Security Requirements......................

Request for Employment Waiver foEmployees.....................................Controlled Substance Theft or LossIn-Transit Loss...............................Breakage/Spillage .........................

Controlled Substance Registrant PFederal Investigation.....................

ix
Penalties Upon Conviction ......................................................... 22 

Recordkeeping Requirements ....................................................... 22 

Records that Must be Maintained .............................................. 23 Central Recordkeeping............................................................... 24 

Prescription Records .................................................................. 24 

Inventory Requirements................................................................. 25 

Initial Inventory ........................................................................... 25 

Biennial Inventory....................................................................... 26 Inventorying Newly Scheduled Controlled Substances ............. 26 Inventory of Drugs for Destruction or No Longer Saleable ........ 27 

Ordering Controlled Substances.................................................... 27 

Schedule II Substances.............................................................. 27 Requesting Official Order Forms................................................ 28 Completing Official Order Forms................................................ 28 Power of Attorney to Sign an Official Order Form...................... 29 

Lost or Stolen Order Forms........................................................ 31 Schedule III-V Substances......................................................... 32 

Prescription Requirements............................................................. 32 

Who May Issue........................................................................... 32 Verification of Practitioner Registration...................................... 33 Practitioner’s Use of a Hospital’s DEA....................................... 33 

Registration Number .................................................................. 33 Exception to the Registration Requirement for Public Health Service or Bureau of Prisons Personnel .................................... 34 

Registration Requirement for Military Personnel ....................... 35 Mid-Level Practitioners............................................................... 36 Purpose of Issue ........................................................................ 36 Schedule II Substances.............................................................. 37 Refills.......................................................................................... 37 Facsimile Prescriptions for Schedule II Substances .................. 37 Exceptions for Schedule II Facsimile Prescriptions ................... 38 Schedule III-V Substances......................................................... 39 Refills.......................................................................................... 39 Computerization of Prescription Information.............................. 40 

Facsimile Prescriptions for Schedule III-V Substances ............. 42 Telephone Authorization for Schedule III-V Prescriptions ......... 42 Transfer of Prescription Information........................................... 42 Prescription Monitoring Programs.............................................. 43 

Dispensing Requirements.............................................................. 43 

Required Information for Prescription LabelsSchedule II Substances

............................. 43 

.............................................................. 44 

xii

Emergency Dispensing .................Partial Dispensing .........................Exception for Schedule II PrescriptFacilities.........................................Internet Pharmacy .........................Electronic Transmission of Prescrip

Schedule III-V Controlled SubstancPartial Dispensing .........................Dispensing Without a Prescription Delivery of a Controlled Substance Listed Chemicals to Persons in AnoCentral Fill Pharmacy....................

Long Term Care Facilities.................

Emergency Kits for Long Term Car

Narcotic Treatment Programs...........

Use of Methadone Outside a Narco

Narcotics for Patients with Terminal IOther Controlled Substance Regulati

Controlled Substances for Medical Charitable Solicitations..................Controlled Substance Distribution b

U.S. Postal Service Mailing RequirSubstances....................................

Chemical Requirements: ComprehenControl Act of 1996 ...........................

Summary of MCA’s Major ProvisioPharmacists (including amendmenAnti-Proliferation Act (MAPA) of 20

Regulated Chemicals ....................Records for List I Chemicals .........Proof of Identity Requirement for P

.......................................................

Excessive or Unusual Purchases oOrders) ..........................................List I Chemical Security.................

xi
Appendices

Appendix A.................................................................................... 65

Number if Tablets that Equal a Threshold (Regulated) 

Transaction for Dosage Units of Marketed Products................ 65

Appendix B.................................................................................... 66

List I Chemicals With Domestic Threshold Amounts................ 66

Appendix C.................................................................................... 67

List II Chemicals With Domestic Threshold Amounts............... 67

Appendix D.................................................................................... 68

Summary of Controlled Substances Act Requirements ........... 68

Appendix E.................................................................................... 69

DEA Form-224........................................................................... 69

Application for new registration under Controlled Substances 

Act of 1970................................................................................. 69

Appendix F .................................................................................... 70

DEA Form-224a – Renewal Application for DEA registration 

under Narcotic Addict Treatment Act of 1974........................... 70

Appendix G................................................................................... 71

DEA From- 224b – Sample of Retail pharmacy renewal affidavit 

for chain renewal ....................................................................... 71

Appendix H.................................................................................... 72

DEA Form 222 – U.S. Official Order Form Schedules I & II..... 72

Appendix I..................................................................................... 73

DEA Form 41 – Registrants Inventory of Drugs Surrendered .. 73

Appendix J .................................................................................... 74

DEA Form 106 – Report of Theft or Loss of Controlled 

Substances................................................................................ 74

Appendix K.................................................................................... 75

DEA Form 363 – New Application Registration – Narcotic 

Treatment Program.................................................................... 75

Appendix L .................................................................................... 76

DEA Form-363a......................................................................... 76

Application for DEA Registration – NTP Renewal .................... 76

Appendix M................................................................................... 77

DEA Form-510........................................................................... 77

Application for Registration – Chemical Registration................ 77

Appendix N.................................................................................... 78

The Pharmacists Corresponding Responsibility for Controlled 

Substance Prescriptions............................................................ 78

Appendix O ................................................................................... 80

Pharmacist’s Guide to Prescription Fraud................................. 80

 xiv

Appendix P.................................................................................... 86

Affidavit for a New Pharmacy.................................................... 86

Appendix Q ................................................................................... 87

Affidavit for Transfer of a Pharmacy.......................................... 87

Appendix R.................................................................................... 89

Guidelines for Emergency Kits in Long Term Care Facilities ... 89

Appendix S.................................................................................... 90

CFR Definitions.......................................................................... 90

Appendix T .................................................................................... 94

Appendix U.................................................................................... 95
1

Application of State and 

Nothing in this manual shall b

permitting any person to do any act wpermitted under federal or state laws. policy statements and information in tconstrued as authorizing or permitting which is not authorized. Use of a DEA registration for activities not authoviolation of both federal and state l

Furthermore, this manual doe

to refuse to meet any requirements in of Title 21, Chapter II of the Code of F

CFR, Part 1300 to end). The CFR is tPharmacist’s Manual. Printed copies implementing the Controlled Substanobtained from:

Superintendent of DocU.S. Government PrintWashington, D.C. 204

Both the Code of Federal Reg

Register (which includes proposed animplementing the CSA) are available U.S. Government Printing Office (GPprovides information by section, citatiaccessed at: 

http://www.access.gpo.gov/naDEA registration grants pharm

controlled substances. However, DEA only engage in those activities which law in the jurisdiction where the pharmcases state law is more stringent than complied with in addition to federal lasure they understand their state and regulations. 
Drug Enforcement Administration Schedules of Controlled 

The controlled substances an

under the CSA can be found in the CTitle 21 under "Part 1308--Schedules 

The Drug Enforcement Administration (DEA) is the primary 

agency within the Federal Government responsible for the enforcement of the Controlled Substances Act (CSA). In cooperation with state authorities and other federal agencies, DEA is tasked with preventing the diversion of controlled substances for illicit purposes. In carrying out its mission, DEA complies with international treaty obligations, works closely with foreign as well as domestic state and local governments, private industry, and other organizations concerned with drug abuse and diversion. 

The drugs and drug products 

CSA are divided into five schedules. CSchedules II-V have an accepted mStates, and Schedule I substances and some examples of the drugs in ebelow. 

The CSA, which became effective May 1, 1971, 

consolidates into one piece of legislation many diverse laws passed by Congress since the Harrison Narcotics Act of 1914, the first comprehensive federal legislation to control addicting drugs. Subsequent amendments to the CSA include the 1984 Diversion Control Amendments, the Controlled Substance Registrant Protection Act of 1984, the Narcotic Addict Treatment Act of 1984, the Chemical Diversion and Trafficking Act of 1988, the Domestic Chemical Diversion Control Act of 1993, and the Comprehensive Methamphetamine Control Act of 1996. 

Schedule I Substances The substances in this schedu

potential and no accepted medical 

This is the only schedule that includefor prescribing, dispensing or adminisresearch involving Schedule I substaseparate registration as a researcher

Examples of substances classified 

include heroin, certain clandestinely mpropiram Some hallucinogenic substainclude heroin, LSD, marijuana, and M

The provisions of the CSA are designed to improve the administration and regulation of the manufacture, import/export, 

distribution and dispensing of controlled substances by providing a "closed system" for distribution. Under this closed system, a controlled substance can be traced from the time it is manufactured to the time it is dispensed to the ultimate user. This system has proven effective in reducing the diversion of these substances from legitimate channels to the illicit market. 

Other examples of Schedule I 

depressants methaqualone and gamm(GHB) and the stimulant methcathino

Schedule II Substances Substances in Schedule II hav

severe psychological or physical depeaccepted medical use in the United Spractitioners to prescribe, dispense a

Some examples of single entit

include morphine, codeine, hydrocod

2 3
Schedule II narcotic substances and their common name brand 

products include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (Percodan®) and fentanyl (Sublimaze®). 

Some examples of Schedule II stimulants include 

amphetamine (Dexedrine®), Adderall ®), methamphetamine (Desoxyn®) and methylphenidate (Ritalin®). Other Schedule II substances include cocaine, amobarbital, glutethimide, pentobarbital and secobarbital. 

Schedule III Substances The substances in this schedule have an abuse potential 

which is less than those in Schedule II, but more than Schedule IV substances. 

Some examples of Schedule III narcotics include products 

containing less than 15 milligrams of hydrocodone per dosage unit (i.e., Vicodin®, Lorcet®, Tussionex®, and products containing not more than 90 milligrams of codeine per dosage unit (i.e., codeine with acetaminophen, aspirin or ibuprofen). 

Other Schedule III substances include anabolic steroids 

benzphetamine (Didrex®) phendimetrazine, and any compound, mixture, preparation or suppository dosage form containing amobarbital, secobarbital, pentobarbital, dronabinol (Marinol ®) or ketamine and buprenorphine (Buprenex®). 

Schedule IV Substances The substances in this schedule have an abuse potential 

less than those listed in Schedule III and more than substances in Schedule V. Some examples of Schedule IV narcotics include propoxyphene (Darvon®), butorphanol (Stadol®), and pentazocine (Talwin-NX®). 

The following benzodiazepine substances are also found in 

Schedule IV. They include alprazolam (Xanax®), clonazepam 

(Klonopin®), clorazepate (Tranxene®flurazepam (Dalmane®), halazepam (Ativan®), midazolam (Versed®), ora(Verstran®), temazepam (Restoril®), quazepam (Doral®). 

Other Schedule IV substances 

phenobarbital, chloral hydrate, ethchlchlordiazepoxide (Librium®), ethinamparaldehyde, methohexital, phenterm(Cylert®), mazindol (Sanorex®), and 

Schedule V SubstanceThe substances in this schedu

less than those listed in Schedule IV preparations containing limited quantstimulant drugs generally for antitussianalgesic purposes. Some examples containing not more than 200 milligramilliliters or per 100 grams (Robitussicodeine®). 

Registration RequiremeEvery pharmacy which dispenses any be registered with the DEA. Since DEpharmacists, they must obtain their lic

from their state regulatory authority. Ta pharmacy can request a DEA FormRegistration, see Appendix E) from aOffice (see Appendix T) or from the DRegistration Unit in Washington, D.C(Registration Call Center). DEA Form and in PDF format at www.DEAdiversForm 224 is fully interactive, including credit card payments. The completed DEA Form-224 must b

4 5
6

Drug Enforcement Administration Registration Unit Central Station P.O. Box 28083 Washington, D.C. 20038-8083 

Pharmacy registrations must be renewed every three 

years. The cost of the registration is annotated on the application form. The certificate of registration must be maintained at the registered location and kept available for official inspection. If a person owns and operates more than one pharmacy, each place of business must be registered. 

Every pharmacy currently registered with DEA will receive 

a renewal application approximately 45 days before the registration expiration date. The renewal application will be sent to the address listed on the current registration certificate. If the renewal form is not received within 30 days before the expiration date of the current registration, the pharmacy should contact the DEA registration unit for their state (see Appendix T), and request a renewal registration form. 

Chemical Registration Requirements 

Under DEA’s Chemical Control regulations there is an 

exemption from the registration requirement for a retail distributor. A retail distributor is defined as a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor of legal drug products containing listed chemicals pseudoephedrine, phenylpropanolamine (PPA), combination ephedrine and single-entity ephedrine are limited almost exclusively to sales for personal use, both in number and volume of sales, either directly to walk-in customers or in face to face transactions. Personal use means the distribution of below "threshold quantities"4 in a single transaction to an individual for 

legitimate medical use. 

7

4 The quantity of a particular chemical, above which recordkeeping and other control 

provisions of the CSA apply. See Appendix A "Number of Tablets that Equal a Threshold (Regulated) Transaction for Dosage Units of Marketed Products" 

Federal law requires any pers

wholesale distribution of drug productto obtain a registration as a chemical does not meet all the requirements fowholesale distributor. 

Retail pharmacies that are reg

substances need not obtain a separafor retail distribution of the drug produpseudoephedrine, phenylpropanolamephedrine and single-entity ephedrine I chemicals. If a pharmacy desires to distribution of bulk quantities of these pharmacy will have to register with DEbecause these activities fall outside odistributor. Therefore, the pharmacy wregistration requirements that apply to 

To obtain a DEA Chemical Dis

pharmacy can request DEA Form-510 Registration, see Appendix M) from aOffice (see Appendix T) 

For additional information see 

Comprehensive Methamphetamine C

New Pharmacy RegistrPharmacies seeking to becom

must request a DEA Form-224 (Applisee Appendix E) from any DEA RegisDEA Registration Unit in Washingtonunder Registration Requirements. 

Any pharmacy engaged in co-

substances must also register as a diobtain this registration, a pharmacy m(wholesaler) security and recordkeep
An affidavit system for expediting pharmacy applications 

may be used to obtain a DEA registration number for a new pharmacy or for transferring ownership of an existing pharmacy. If the pharmacy has been registered by the state licensing agency, the applicant may include an affidavit (see Appendix P) to verify the existence of the state license with their application (21 CFR 1301.17). 

Change of Business Address 

Any time a pharmacy moves to a new physical location or 

the postal address changes at the same location, a new DEA certificate reflecting the new address must be obtained. It is the pharmacy's responsibility to notify DEA about a change of address before the effective date of the move. A written request for modification of registration should be sent to the DEA Registration Field Office responsible for their state (see Appendix T). If the modification is approved, DEA will issue a new certificate of registration and, if requested, new Schedule II order forms (DEA Form-222, Official Order Form). A Renewal Application for Registration (DEA Form-224a) will only be sent to the registered address on file with DEA. It cannot be forwarded. 

Affidavit for Renewal of Retail Chain Pharmacy Registration 

Corporations that own or operate a chain of pharmacies 

may submit a single DEA Form-224b (Retail Pharmacy 

Registration Affidavit for Chain Renewal, see Appendix G) that 

covers all the chain's pharmacy registrants. This affidavit along with a list of the corporation's registrations is provided in lieu of a separate DEA application for each pharmacy registration. No registration may be issued unless the completed affidavit is received by DEA. The corporation should retain a copy of this affidavit with their readily retrievable records for the duration of the registration covered by the affidavit. The corporation 

must answer the questions listed on teach registrant. 

The original affidavit along wit

list of registrations should be mailed t

Registration Chain Renewal United States Department of JDrug Enforcement AdministraCentral Station P.O. Box 28083 Washington, D.C. 20038-808 

Denial, Revocation or Suspe

Diversion of legitimately manufactureserious problem in the United States. nation's primary guardians for prevenlegitimate access to these drugs. The Government with additional legal resoagainst those registrants who contribuThe U.S. Attorney General has the aua DEA registration upon a finding tha

1. Materially falsified any applica2. Been convicted of a felony rel

substance or a List I Chemica

3. Had his/her state license or re

revoked or denied. 

4. Committed an act which would 

registration inconsistent with t

5. Been excluded from participat

Medicare program. 

8 9
10

Any registrant who discontinues his/her business or 

transfers it to another person must notify the nearest DEA Registration Field Office (see Appendix T) in writing before terminating the pharmacy's registration. Along with the notification of termination of registration, the pharmacist should send the DEA Certificate of Registration and any unused Official Order Forms (DEA Form-222). The pharmacist should write or stamp the word "VOID" across the face of each Official Order Form before returning them to DEA. The notification to DEA should also indicate where the controlled substance inventories and records will be kept and how the controlled substances were transferred or destroyed. Records involving controlled substances must be kept 

available for two years for inspection This requirement applies even though 

Denial of Registration in the Public Interest discontinued. 

The CSA gives the U.S. Attorney General authority to deny any application for DEA registration or renewal if it is determined that issuing a controlled substance registration would be inconsistent with the public interest. In determining the public interest, the CSA states the following factors will be considered: 

1. The recommendation of the appropriate state 

licensing board or professional disciplinary authority. 

2. The applicant's experience in dispensing or 

conducting research with respect to controlled substances. 

3. The applicant's conviction record under federal or 

state laws relating to the manufacture, distribution or dispensing of controlled substances. 

4. Compliance with applicable state, federal or local 

laws relating to controlled substances. 

5. Such other conduct which may threaten the public 

health and safety. 

Termination of Registration 

If the registrant acquiring the p

other pharmacy licensed in the same transferred, the registrant may apply fprior to the date of transfer. DEA will authorize the registrant to obtain contof transfer. But the registrant may not substances until the pharmacy has bepharmacy license. 

11

Transfer of Business 

A registrant transferring a pharmacy bshall notify the nearest DEA Registradays before the date of the proposed following information: 

1. The name, address, registratio

registrant discontinuing busine

2. The name, address, registratio

registrant acquiring the pharm

3. Whether the business activitie

the location registered by the owner or moved to another locgive the address of the new lo

4. The date on which the control

transferred to the person acqu(see Transfer of Controlled S10). 

On the day the controlled substan

complete controlled substances invencopy of the inventory must be includeperson transferring the business and business. Procedures for transferring pharmacy and a model format for an process are outlined in Appendix Q. 
To transfer Schedule II substances, the receiving 

registrant must issue an Official Order Form (DEA Form-222, 

U.S. Official Order Forms - Schedules I & II) to the registrant transferring the drugs. 

12

A DEA registration application for transferring ownership of 

an existing pharmacy can be expedited if the applicant includes an affidavit (see Appendix Q) verifying that the pharmacy has been registered by the state licensing agency. The affidavit verifying the existence of the state license should be attached to the initial application for registration. 

Disposal of Controlled Substances 

The pharmacy may hire an outside firm to inventory, 

package and arrange for the transfer of its controlled substances to another pharmacy, supplier or manufacturer. The pharmacy is responsible for the actual transfer of the controlled substances and for the accuracy of the inventory and records. The pharmacy may also transfer the drugs to a distributor registered with DEA to destroy drugs (reverse distributor). The pharmacy may not turn over any controlled substances to a distributor unless the reverse distributor is registered to destroy controlled substances. The pharmacy is responsible for verifying that the reverse distributor is registered with DEA.

The records involving the transfer or destruction of 

controlled substances must be kept readily available for two years for inspection and copying by the DEA. The two primary methods for disposing of controlled substances are transfer to another registrant or destruction as explained in the following section. 

Transfer of Controlled Substances If a pharmacy goes out of business or is acquired by a new 

pharmacy, it may transfer the controlled substances to another pharmacy, supplier, manufacturer or distributor registered to dispose of controlled substances. 

13

The transfer of Schedule III-V 

must be documented in writing to shoform, strength, quantity and date traninclude the names, addresses and DEthe parties involved in the transfer of 

To Another Pharmacy5

On the day the controlled sub

complete inventory must be taken whname, dosage form, strength, quantityaddition DEA Form-222 (Official Ordedocument the transfer of Schedule II inventory will serve as the final inventout of business and transferring the calso serve as the initial inventory for tcontrolled substances. A copy of the the records of each person. It is not nthe inventory to the DEA. The person substances must maintain all records the controlled substances for two yea

To Another Supplier or Manufacturer 

Any pharmacy may transfer contr

supplier or a manufacturer. The pharmwritten record showing: 

1. The date of the transaction. 2. The name, strength, form and 

substance. 

3. The supplier’s or manufacture

known, registration number. 

5 See also the section entitled "Controlled Substance Dis
4. The DEA Form-222 will be the official record for the 

transfer of Schedule II substances. 

To a Reverse Distributor Registered to Dispose of Controlled Substances Any pharmacy may forward controlled substances to DEAregistered reverse distributors who handle the disposal of drugs. 

For further instructions see, Disposal of Controlled Substances. 

Destruction of Controlled Substances DEA recommends that any pharmacy seeking to 

dispose of controlled substances first contact the nearest DEA Diversion Field Office (see Appendix T) for disposal instructions. In no case should drugs be forwarded to the DEA unless the registrant has received prior approval from the DEA. The DEA procedures established for the destruction of controlled substances shall not be construed as altering in any way the state laws or regulations for the disposal of controlled substances. Requests from registrants seeking authorization to destroy controlled substances without DEA presence, or requests from non-registrants desiring to dispose of controlled substances will be handled as follows: 

Once-a-Year DEA Authorization for DestructionOnce each calendar year retail pharmacies may request 

DEA authorization to destroy damaged, outdated or otherwise unwanted controlled substances. The pharmacy must complete DEA Form-41 (Registrants Inventory of Drugs Surrendered, see Appendix I), listing all drugs to be destroyed. In addition, the 

pharmacy must prepare a letter requesting permission to destroy the controlled substances, proposing a date and method of destruction, and listing the names of at least two people who will 

witness the destruction. The witnessephysician, pharmacist, mid-level praclocal law enforcement officer. Both doby the nearest DEA Diversion Field Oto the proposed destruction date. Afteinformation, the DEA office will then nof its decision. Once the controlled sudestroyed, signed copies of the DEA to DEA. The pharmacist should contaauthorities prior to implementing the pdestruction to ascertain that hazards destruction. 

Exception to DEA Authorization for DestrPrior DEA authorization to des

not necessary when an authorized menforcement authority or regulatory adestruction. Copies of a DEA Form-4substance destruction form must be fDiversion Office after the destruction. 

Reverse Distributors ADestroy Controlled SubA pharmacy may at any time f

substances to DEA registered reverse disposal of drugs. The pharmacist maDiversion Field Office for an updated distributors in their area. When a phasubstances to a reverse distributor fomust issue an Official Order Form (DEpharmacy. When Schedule III-V contransferred to a reverse distributor for should document in writing the drug nquantity and date transferred. The DEdistributor who will destroy the contro

14 15
responsible for submitting a DEA Form-41 to DEA when the drugs 

have been destroyed. A DEA Form-41 should not be used to record the transfer of controlled substances between the pharmacy and the registered reverse distributor disposing the drugs. 

"Blanket Authorization" for Destruction of Controlled Substances 

DEA will issue a "Blanket Authorization" for destruction of 

controlled substances on a very limited basis to those registrants who are associated with hospitals, clinics or other registrants having to dispose of used needles, syringes or other injectable objects only. This limited exception is granted because of the probability that those objects have been contaminated by hazardous bodily fluids. The pharmacist should contact their local DEA Diversion Field Office for information about how to request such an authorization. DEA will evaluate requests for a blanket authorization based on the following guidelines: 

1. Frequency of destruction (i.e., daily, weekly) and 

volume of drugs involved that warrant such authorization. 

2. Method of destruction. Drugs must be destroyed in 

such a manner that they are beyond reclamation. 

3. Registrant’s past history. 4. Security at the pharmacy or registered location. 5. Name and position of the individual responsible for 

the destruction. 

Those registrants granted blanket authorization to destroy 

controlled substances must complete DEA Form-41 (Registrants Inventory of Drugs Surrendered, see Appendix I). 

Security Requirements The DEA requires pharmacies to keep Schedules II, III, IV and V controlled substances in a locked cabinet or dispersed through the 

non-controlled stock to deter theft. An recommended. 

Request for Employ

me

Certain Pharmacy EmpA pharmacy registrant (i.e., th

which owns the pharmacy) must not eallows access to controlled substanceconvicted of a felony relating to controany time, has had an application for Drevoked, or surrendered for cause. "Fsurrendering a registration in lieu of, ofederal or state administrative, civil or from an investigation of the individualsubstances. 

However, pharmacies desiring 

meets this definition may request an e(see 21 CFR 1307.03) from DEA. The waiver approved before hiring the appshould be sent to DEA HeadquartersWashington, D.C. 20537. A pharmacy registrant who applies founderstand that the following factors w

1. A detailed description of th

applicant’s past controlled 

2. Activities of the applicant s3. Current status of the appli4. Extent of applicant’s propo

substances. 

5. Registrant’s proposed phy

safeguards to prevent diveemployed. 

6. Status of employing regist

handling of controlled subs

16 17
7. Other pertinent information uncovered by DEA in its 

investigation of the applicant’s or registrant’s handling of controlled substances. 

8. Such a waiver should not be considered unless 

there are valid reasons to believe that diversion is unlikely to occur. 

Controlled Substance Theft or Loss 

1. Notify DEA and Local Police 

Immediately upon discovery of a theft or significant loss of 

controlled substances, a pharmacy, as required by regulation, must contact the nearest DEA Diversion Field Office (see Appendix T) by telephone, facsimile or by a brief written message explaining the circumstances. A pharmacy should also notify the local police as may be required by state law. If there is a question as to whether a theft has occurred or a loss is significant, a registrant should err on the side of caution and report it to DEA. 

DEA must be notified directly. This requirement is not 

satisfied by reporting the theft or significant loss in any other manner. For example, a corporation which owns/operates multiple registered sites and wishes to channel all notifications through corporate management or any other internal department responsible for security must still provide notice directly to DEA "upon discovery" and keep a copy for its records. 

2. Complete DEA Form-106 

A pharmacy shall also complete a DEA Form-106 (Report of 

Theft or Loss of Controlled Substances). To obtain a DEA Form-106 (see Appendix J), contact the nearest DEA Diversion Field Office (see Appendix T). The DEA Form-106 will formally document the actual circumstances of the theft or significant loss and the quantities of controlled substances involved, once this information has been determined conclusively. The pharmacy should send the original DEA 

Form-106 and a copy to the DEA Dkeep a copy for its records. 

The DEA Form 106 must includinformation: 1. Name and address of firm (ph2. DEA registration number 3. Date of theft 4. Name and telephone number 

department notified 

5. Type of theft (night break in, a6. Listing of symbols or cost cod

in marking containers (if any) 

7. Listing of controlled substance

or significant loss 

3. If Investigation Finds No Theft o

If after an investigation of the 

the theft or significant loss it is deteor significant loss occurred, no DE

However, the registrant should 

this fact in order to resolve the initino DEA Form-106 was filed regard

4. Registrant’s Responsibility for IdLoss" 

Although the CSA regulations 

"significant loss," it is the responsibhis/her best judgment to take apprloss depends, in large part, on the and the likelihood of a rational expoccurrence. What would constitute pharmacy may be viewed as comphospital or distributor. 

18 19
20

When all or part of a shipment disappears, or never 

reaches its intended destination, the supplier is responsible for reporting the in-transit loss of controlled substances to DEA. A pharmacy is responsible for reporting any loss of controlled substances after a pharmacist has signed for or taken custody of a shipment. If it’s discovered after that point that an in-transit loss 

or theft has occurred, the pharmacist 106. Further, the loss of a small quantity of controlled substances, repeated over a period of time, may indicate a 

significant problem for a registrant, a problem which must be reported to DEA, even though the individual amounts of missing controlled substances are not, in and of themselves, significant. Registrants must report a loss upon discovery. In particular, a pharmacist should be alert for suspicious or unexplained losses. Any signs of a break in, physical entry or armed robbery should be reported. The burden of responsibility is on the registrant to identify what is a significant loss and make the required report to DEA. 

Some factors to consider for determining significant 

loss include: 

1. The schedule of the missing items. 2. The abuse potential of the missing items. 3. The abuse potential in your area of the missing 

substance. 

4. The quantity missing (one tablet vs. one bottle or 

container). 

5. Is this the first time this loss has occurred? Has a 

similar loss occurred before? 

6. Was this loss reported to local law enforcement 

authorities? 

7. If there is a question as to whether a loss is 

significant, a registrant should err on the side of caution and report it to DEA. 

If it is determined that the loss is not significant, place a record of the occurrence in your theft and loss file for future reference. 

In-Transit Loss 

21

Breakage/Spillage 

DEA further wishes to clarify t

controlled substances does not constsubstances. When there is breakage, other form of destruction, any recovermust be disposed of according to DEA goods may be disposed of through shdistributor" or by a DEA approved pro(Destruction of Controlled Substanoccurs, it must be reported to DEA on (Registrants Inventory of Drugs Surre

Controlled Substance Act of 1984 Robberies, burglaries and ass

other registrants by those seeking coserious problem in the United States. property loss, serious injury to profestrafficking which serves to fuel the dru

Federal Investigation The Controlled Substances R

1984 (CSRPA) provides for the federpharmaceutical thefts and robberies iconditions are met: 

1. Replacement cost of the co

$500 or more. 

2. A registrant or other person 

"significant" bodily injury durobbery or theft of a contro

3. Interstate or foreign comme

or executing the crime.
Penalties Upon Conviction 

The perpetrator convicted of violating the CSRPA’s 

provisions is subject to the following penalties: 

1. Conviction for commission of burglary or robbery can 

result in a maximum $25,000 fine and/or 20 years imprisonment. 

2. Conviction for use of a dangerous weapon in the 

commission of the crime can result in a maximum $35,000 fine and/or 25 years imprisonment. 

3. If death results from the crime, the convicted person 

can receive a maximum $50,000 fine and/or life imprisonment. 

Recordkeeping Requirements 

Every pharmacy must maintain complete and accurate 

records on a current basis for each controlled substance purchased, received, distributed, dispensed or otherwise disposed of. All records of controlled substances must be maintained for two years. This recordkeeping system allows a controlled substance to be tracked from the time it is manufactured to the time it is dispensed to the ultimate user. (Recordkeeping requirements for List I Chemicals are contained in the Chemical Requirements section.) 

All records concerning controlled substances must be 

maintained for at least two years for inspection and copying by duly authorized DEA officials. Records and inventories of Schedule II controlled substances must be maintained separately from all other records of the registrant. All records and inventories of Schedule III, IV and V controlled substances must be 

maintained either separately from all other records or in such a form that the information required is readily retrievable from the 

ordinary business records. (Recordkeprescriptions are detailed in the PresReadily retrievable means that: 

1. Certain records are kept by au

systems or other electronic or systems in such a manner thafrom all other records in a rea

2. And/or records are kept on wh

asterisked, redlined or in somidentifiable apart from other iterecords. 

Records that Must be Mai1. Official Order Forms (DEA Fo

2. Power of Attorney authorizatio3. Receipts and invoices for Sch

substances as well as "thresh

chemicals. 

4. All inventory records of contro

the initial and biennial invento

5. Records of controlled substan

(i.e., prescriptions) and threshchemicals distributed. 

6. Report of Theft or Loss (DEA 7. Inventory of Drugs Surrendere

41). 

8. Records of transfers of contro

pharmacies. 

9. DEA registration certificate. 

7 The quantity of a particular chemical, above which 

provisions of the CSA apply. See Appendix B "List 

Amounts"

23

6 DEA's Official Order Forms are the required recorcontrolled substances

22
Option 3 (Two separate files) 

Central Recordkeeping • A file for all Schedule II-V controll

is used, a prescription for a Schedbe made readily retrievable by usthan one inch high. 8 

A registrant desiring to maintain shipping and financial 

records at a central location other than the registered location must notify the nearest DEA Diversion Field Office (see Appendix T). Unless the registrant is informed by the DEA that the permission to keep central records is denied, the registrant may begin maintaining central records 14 days after notifying DEA. Central recordkeeping requirements are described in 21 CFR, 1304.04. Central recordkeeping permits are no longer issued by the DEA. 

• A file for prescription orders for al

dispensed. 

Inventory Requirements 

Inventory means a complete a

and forms of controlled substances in registrant as determined by an actual also requires that all inventories be mlocation in a readily retrievable mannecopying and inspection. In addition, th

Prescription Records 

Pharmacies have three options for filing prescription records under the Code of Federal Regulations. If there is a conflict between federal and state requirements for filing prescriptions, DEA recognizes that the pharmacy must choose a filing system that would comply with both federal and state law (Title 21 USC, Section 903). 

controlled substances must be kept sother controlled substances. 

All prescription records m Initial Inventory ust be readily retrievable for 

DEA inspection. Controlled substance prescriptions must be filed in one of the following three ways: 

When issued a DEA registrati

initial inventory, which is an actual phsubstances in their possession. If thesubstances on hand, the registrant sha zero inventory. There is no requirethe inventory to the DEA. 

Option 1 (Three separate files) 

• A file for Schedule II drugs dispensed, • A file for Schedule III, IV and V drugs dispensed, and 

The Code of Federal Regulations (CFinventory include: 

• A file for prescription orders for all noncontrolled drugs 

dispensed.

1. The inventory date. Option 2 (Two separate files) 2. The time the inventory 

opening or close of bu

• A file for all Schedule II drugs dispensed, • A file for all other drugs dispensed (noncontrolled and those in 

Schedule III, IV and V). If this method is used, a prescription for a Schedule III, IV and V drug must be made readily retrievable by use of a red "C" stamp not less than one inch high.8

25

8 If a pharmacy has an electronic recordkeeping s

identification by prescription number and retrieval name, patient's name, drug dispensed and date filhard copy prescription with a red "C" is waived.

24
Inventory of Drugs for 

Longer Saleable 

3. The drug name. 4. The drug strength. 5. The drug form (e.g., tablet, capsule, etc.). Each controlled substance tha

or impure and is awaiting disposal, (2purposes, or (3) maintained for extemmust be inventoried. 

6. The number of units/volume. 7. The total quantity. 

The Code of Federal Regulations (CF

DEA recommends that the inventory record include: inventory include: 

1. The name, address and DEA registration 

number of the registrant. 

1. The inventory date. 2. The drug name. 2. The signature of the person or persons 

responsible for taking the inventory. 3. The drug strength. 

4. The drug form (e.g., tablet

Biennial Inventory 5. The total quantity or total n

6. The reason why the subst

Following the initial inventory, the registrant is required to 

take a biennial inventory (every two years), which requires the same information as the initial inventory (see list above) of all controlled substances on hand. The biennial inventory may be taken on any date which is within two years of the previous inventory date. There is no requirement to submit a copy of the inventory to DEA. 

7. Whether substance is cap

manufacture of any controform. 

Ordering Controlled Sub

When taking the inventory of Schedule II controlled Schedule II Substances 

substances, an actual physical count must be made. For the inventory of Schedules III, IV and V controlled substances, an estimated count may be made. An actual physical count must be made if the container holds more than 1,000 dosage units and has been opened. 

Only Schedule I and II control

with a DEA Form-222 (Official Order Official Order Form is required for eactransfer of a Schedule II controlled su

When a controlled substance 

from Schedule II to another Schedule states it remains in Schedule II pendiadministrative actions that may result Many states require that transactions they classify as Schedule II be made Order Forms. Where federal and statthe stricter applies. When the use of DForms for the transfer of a controlled 

Inventorying Newly Scheduled Controlled Substances When a drug not previously controlled is scheduled, the 

drug must be inventoried as of the effective date of scheduling. 

26 27
under federal law, its use as mandated by these states does not 

violate federal law and is therefore permitted. 

Requesting Official Order Forms 

Official Order Forms can be initially requested by checking "block 3" on the application for new registration (DEA Form-224). There is no charge. Send the form to: 

Drug Enforcement Administration Registration Unit Central Station P.O. Box 28083 Washington, D.C. 20038-8083 Once a registrant has received Official Order Forms (DEA 

Form-222), a separate requisition form (DEA Form-222a) will be mailed to the registrant to request additional Official Order Forms. The registrant may also request Official Order Forms by calling either the DEA Headquarters Registration Unit (toll free: 1-800-882-9539) or the nearest DEA Registration Field Office (See Appendix T). 

Each book of DEA Official Order Forms consists of seven 

sets of forms. Each pharmacy is provided a maximum of six books at one time unless its needs exceed this limit. In such a case, the pharmacy should contact the DEA Registration Field Office serving their state (Appendix T). 

Completing Official Order Forms When ordering Schedule II substances, the pharmacist is 

responsible for filling in the number of packages, the size of the package and the name of the item. Each Official Order Form must be signed and dated by a person authorized to sign a registration application. (See Power of Attorney to Sign an Official Order Form) When the items are received, the pharmacist must document on the purchaser’s copy (copy 3) the actual number of packages received and the date received. 

Official Order Forms must be maintained separately from 

the pharmacy’s other business records. However, this does not 

preclude a registrant from attaching a invoice to the related Order Form. 

The Code of Federal Regulati

Order Form must be "complete, legibwith no signs of alteration, erasure or A supplier may refuse to accept an orHowever, DEA has acknowledged soalterations may be accepted by a supmay correct Official Order Forms that • Minor errors, which lack inconseq• An incorrect date unintentionally a

If an order is refused, the supp

Order Form copies 1 and 2 to the purexplaining the reason the order was r

DEA policy does not preclude 

products differing in packaging size frprovided that the actual quantity receamount initially ordered and that the Nreflected is that of the actual product distributor may substitute 5 bottles of of 500, 2mg tablets or any variation th

Power of Attorney to SForm Any registrant (pharmacy) ma

individuals, whether or not they are lolocation, to obtain and execute Officiapower of attorney to each such individmust be signed by the same persorecent application for registration owell as the individual being authorOfficial Order Forms. 

The power of attorney may be 

person who signed the power of attora new power of attorney when the ph

28 29
registration, only if the renewal application is signed by a different 

person. The power of attorney should be filed with executed Official Order Forms as a readily retrievable record. The power of attorney is not submitted to DEA. 

NOTICE OF REVOCATION OThe foregoing power of attorn

undersigned, who is authorized to sigregistration of the above-named regisSubstances Act or the Controlled SubAct. Written notice of this revocation hattorney-in-fact _________________(Signature of person revoking power) 

Suggested formats for granting and revoking power of 

attorney follow: 

POWER OF ATTORNEY FOR DEA ORDER FORMS 

_________________________(Name of registrant) _________________________(Address of registrant) _________________________(DEA registration number) Witnesses: I, _______________________________________________(name of person granting power), the undersigned, who is authorized to sign the current application for registration of the above named registrant under the Controlled Substances Act or Controlled Substances Import and Export Act, have made, constituted, and appointed, and by these present, do make, constitute, and appoint _________________________________(name of attorney-infact), my true and lawful attorney for me in my name, place, and stead, to execute applications for books of official order forms and to sign such order forms in requisition for Schedule I and II controlled substances, in accordance with Section 308 of the Controlled Substances Act (21 U.S.C. 828) and part 1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and confirm all that said attorney shall lawfully do or cause to be done by virtue hereof. 

1. ______________________ 2. ______________________ Signed and dated on the _____ day oyear_____ at ___________________

Lost or Stolen Order FoWhen the pharmacist has not 

controlled substances, he/she should determine whether the original DEA Foriginal order form has been lost or stcomplete a second order form so the order. The pharmacist must also prepincludes the first order form’s serial nthat the drugs ordered were never recstatement to the second order form thThe pharmacist must keep a copy of from the first and second order forms

(Signature of person granting power) I, _______________________(name of attorney-in-fact), hereby affirm that I am the person named herein as attorney-in-fact and that the signature affixed hereto is my signature. A pharmacy, upon discovery o

order forms, must immediately report Diversion Field Office (Appendix T), anumbers of each lost or stolen order fmultiple books of order forms are lost numbers of the missing forms cannot must report the approximate date of inumbers) to the DEA. If an unused or

Witnesses: 1. _______________________ 2. _______________________ Signed and dated on the ____ day of ______________in the year_____ at _______________________________. 

30 31
lost is later recovered or found, the pharmacy must immediately 

notify the nearest DEA Diversion Field Office. 

1. Authorized to prescribe contro

jurisdiction in which he/she is 

2. Registered with DEA or exem

Schedule III-V Substances Public Health Service and BurThe registrant (pharmacy) must keep a receipt (i.e., invoice 

or packing slip) on which they record the date the drugs were received and confirm that the order is accurate. These receipts must be maintained in a readily retrievable manner for inspection by the DEA. 

Verification of PractitioneConstruction of Valid DEA RPractitioners 

Knowing how a DEA registration numuseful tool for recognizing a forged prinformation regarding forged prescripto October 1, 1985, DEA registration dentists, veterinarians and other pracletter A. New registration numbers issdate begin with the letter B. Registratlevel practitioners begin with the lette

registration number is followed by the last name. (e.g., J for Jones or S for S

generated sequence of seven numbe(See Mid-Level Practitioner [MLP], re

prescribe controlled substances.) 

Prescription Requirements 

To dispense controlled substances, a pharmacist must 

know the requirements for a valid prescription which are described in this section. A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription.) 

A prescription for a controlled substance must be dated 

and signed on the date when issued. The prescription must include the patient’s full name and address, and the practitioner’s name, address, and registration number. The prescription must also include the drug name, strength, dosage form, quantity prescribed, directions for use, and number of refills. Where an oral prescription is not permitted, a prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner. An individual (i.e., secretary or nurse) may be designated by the practitioner to prepare prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulations. 

Practitioner’s Use of a Registration Number 

An individual practitioner (e.g., intern, mid-level practitioner) who is an agenor other institution may, when acting ibusiness or employment, administer, controlled substances under the regisother institution in which he or she is 

1. The dispensing, administe

usual course of profession

Who May Issue 

2. The practitioner is authoriz

which he or she is practici

A prescription order for a controlled substance may be issued only by a physician, dentist, podiatrist, veterinarian, mid-level practitioner or other registered practitioner who is: 

32 33
34

Any official of the Public Health Service or Bureau of 

Prisons who is authorized to prescribe, dispense or administer, but not to procure or purchase, controlled substances in the course of his or her official duties, is not required to be registered 

3. The hospital or institution has verified that the 

practitioner is permitted to dispense, administer or prescribe controlled substances within the state; 

4. The practitioner acts only within the scope of 

employment in the hospital or institution; 

5. The hospital or institution authorizes the practitioner to 

dispense or prescribe under its registration and assigns a specific internal code number for each practitioner so authorized (See example of a specific internal code number below); 

6. A current list of internal codes and the corresponding 

individual practitioners is to be kept by the hospital or other institution. This list is to be available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner. Pharmacists should contact the hospital or other institution for verification if they have any doubts in dispensing such a prescription.

Exception to the Registration Requirement for Public Health Service or Bureau of Prisons Personnel 

35

with DEA. Such officials must specify identification number of the issuing ofregistration number on any prescriptiosubstances. The service identification Service employee is his/her Social Se

Registration RequiremePersonnel 

The requirement for registratio

physicians who prescribe, dispense, oprocure or purchase, controlled substduties. Military physicians issuing prebranch of service or agency and the sin lieu of the registration number requprescriptions may be filled off base at 

Many computer systems at ph

accept a DEA registration number anidentification number causes delays wprescription. As a result, DEA has beregistrations to active duty military phof prescriptions at community pharmaprescription from a military physician service identification number or a DEA prescriber. 

DEA will not issue registration

(MLP) in the military unless they are sstate where they are stationed and thdispense controlled substances. 

Physicians and MLPs must ob

registration for any work outside of offollow the requirements of the jurisdicperforming the non-official work. 
Mid-Level Practitioners 

Mid-level practitioners (MLP) are registered and authorized 

by the DEA and the state in which they practice to dispense, administer and prescribe controlled substances in the course of professional practice. Examples of MLPs include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, physician assistants, optometrists, ambulance services, animal shelters, veterinarian euthanasia technicians, nursing homes and homeopathic physicians. 

MLPs may receive individual DEA registration granting 

controlled substance privileges. However, such registration is contingent upon authority granted by the state in which they are licensed. DEA registers MLPs whose states clearly authorize them to prescribe, dispense and administer controlled substances in one or more schedules. The fact that an MLP has been issued a valid DEA registration number (beginning with the letter M) will be evidence that he/she is authorized to prescribe, dispense and/or administer at least some controlled substances. 

However, it will still be incumbent upon the pharmacist 

who fills the prescription to ensure that the MLP is prescribing within the parameters established by the state in w

hich he/she practices. MLP authority to prescribe controlled 

substances varies greatly by state. Check with your state licensing or controlled substances authority to determine w

hich MLP disciplines are authorized to prescribe controlled 

substances in your state. 

Purpose of Issue To be valid, a prescription for a controlled substance must 

be issued for a legitimate medical purpose by a practitioner acting in the usual course of sound professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances. However, a corresponding responsibility rests with the pharmacist who dispenses the prescription. An order for controlled substances which purports to be a valid prescription, but is not issued in the usual course of 

professional treatment, or for legitimais not a valid prescription within the mCSA. The individual who knowingly dprescription, as well as the individual criminal and/or civil penalties and adm

A prescription may not be issu

practitioner to obtain a supply of contpurpose of general dispensing to his/prescription written for office stock or valid. 

Schedule II Substances Schedule II substances requir

must be signed by the practitioner. ThSchedule II prescription must be filled physician. However, the pharmacist mprescription is still needed by the patiprescription filled several weeks after regulations place no quantity limits on Schedule II substances, an oral order emergency situation. (See EmergencControlled Substances.) 

Refills Refilling a Schedule II prescFacsimile PrescriptionSubstances 

In order to expedite filling the 

may fax the Schedule II prescription tauthorized in a final rule published in that the original Schedule II prescriptipharmacist and verified against the facontrolled substance is actually dispe

36 37
make sure the original document is properly annotated and filed 

with the records that are required to be kept. 

3. A practitioner prescribing a Sc

for a patient in hospice care under Title X

VIII or licensed b

prescription to the dispensing regardless of whether the patifacility or other care setting. Talso transmit the prescription tpractitioner will note on the hospice patient. The facsimwritten prescription. 

In an emergency, a practitioner may transmit a 

prescription for a Schedule II controlled substance by facsimile or telephone to the pharmacy, and the pharmacist may dispense the prescription. However, the prescribing practitioner must provide a written, signed prescription to the pharmacist within seven days, and the pharmacist must notify DEA if he/she does not receive the prescription. (See Emergency Dispensing of Schedule II Controlled Substances.) 

Schedule III-V Substances Exceptions for Schedule II Facsimile 

Prescriptions A prescription for controlled su

and V issued by a practitioner may be in writing or by facsimile to the pharmauthorized on the prescription. 

DEA also granted three exceptions to the facsimile prescription requirements for Schedule II controlled substances. The facsimile of a Schedule II prescription may serve as the original prescription as follows: Refills 

1. A practitioner prescribing Schedule II narcotic controlled 

substances for a patient undergoing home infusion/intravenous (IV) pain therapy, may transmit the prescription by facsimile. The practitioner’s agent may also transmit the prescription to the pharmacy. The pharmacy will consider the facsimile prescription a "written prescription" and no further prescription is required. All 

normal requirements of a legal prescription must be followed. 

Schedule III and IV controlled 

authorized on the prescription. Howevbe refilled up to five times within six mAfter five refills or after six months, wprescription is required. A patient is pan existing Schedule III-V controlled ssending an e-mail to the pharmacy or 

Schedule V controlled substan

authorized on the prescription by the 

2. Practitioners prescribing Schedule II controlled substances 

for patients in Long Term Care Facilities (LTCF), which are normally filled and delivered to the facility by the pharmacy, may transmit a prescription by facsimile to the dispensing pharmacy. The practitioner’s agent may also transmit the prescription to the pharmacy. The facsimile prescription serves as the original written prescription for the pharmacy. No further original prescription is required.

When a prescription for any co

Schedule III, IV, or V is refilled, the foentered on the back of the prescriptiopharmacist’s initials, the date the presamount of drug dispensed on the refilinitials and dates the back of the presbe deemed to have dispensed a refill the prescription. 

38 39
Computerization of Prescription Information 

A pharmacy is permitted to use a data processing system as an alternative to the manual method for the storage and retrieval of prescription order refill information for Schedules III, IV and V controlled substances. The computer system must provide on-line retrieval of original prescription information for those prescriptions which are currently authorized for refill. The information must include, but is not limited to the original prescription number, date of issuance, full name and address of the patient, the prescriber’s name, address, and DEA registration number; the name, strength, dosage form and quantity of the controlled substance prescribed; and the total number of refills authorized by the prescriber. In addition, the computer system must provide on-line retrieval of the current refill history for Schedule III, IV, or V controlled substance prescriptions. This information must include, but is not limited to: the name of the controlled substance, the date of refill, the quantity dispensed, the dispensing pharmacist’s identification code, or name/initials for each refill, and the total number of refills dispensed to date for that prescription. The pharmacist must verify and document that the refill data entered into the system is correct. All computer generated prescription/refill documentation must be stored in a separate file at the pharmacy and be maintained for a two-year period from the dispensing date. To meet the CFR recordkeeping requirements, the pharmacy’s computer must comply with the following guidelines: 

1. If the system provides a hard copy printout of each day’s 

controlled substance prescription refills, each pharmacist who refilled those prescriptions shall verify their accuracy by signing and dating the printout as he/she would sign a check or legal document. 

2. This printout must be provided to each pharmacy which 

uses the computer system within 72 hours of the date on 

which the refill was dispensedverified and signed by each phrefills. 

3. In lieu of such a printout, the p

bound log book, or separate fiinvolved in the day’s dispensinthat the refill information enterhas been reviewed by him/her 

4. A pharmacy computer system 

printing out any refill data whicmaintain under the Controlled example, this would include a any specified strength and dosubstance, by either brand or dispensed by the pharmacy. S

• Prescribing practitioner’s nam• Patient’s name and address. • Quantity dispensed on each re• Dispensing date for each refill• Name or identification code of • Original prescription number. 

In any computerized system epharmacy, the central recordkbe capable of providing a prinpharmacy of the above inform

5. In case a pharmacy's compute

downtime, the pharmacy must to document in writing refills osubstances. This procedure mauthorized by the original presnumber of refills has not been required data is retained for opossible. 

40 41
6. A pharmacy may use only one of the two systems 

described (i.e., manual or computer). Prescription Monito

A prescription monitoring prog

data collection system used to gather This information may be made availainvestigators on a need-to-know basis

Facsimile Prescriptions for Schedule III-V Substances Prescriptions for Schedules III-V controlled substances 

may be transmitted by facsimile from the practitioner or an employee or agent of the individual practitioner. The facsimile is considered to be equivalent to an original prescription. 

Many states have adopted eit

prescription program or an electronic because they have proven to be an epharmaceutical diversion, for developphysician medical education programabout diversion, prescription drug abutracking effective use of prescription mthe pharmacist, the data can be used shoppers," and those who attempt to by fraud, forgery or deceit. 

Telephone Authorization for Schedule III-V Prescriptions Only the practitioner can prescribe controlled substances 

and this authority cannot be delegated to anyone else. A prescription issued by a practitioner may be called in to a pharmacist by the practitioner or an employee or agent of the individual practitioner. It is the pharmacist’s responsibility to insure that these telephone prescriptions are valid and properly authorized by the practitioner. (See Pharmacist’s Guide to Prescription Fraud, Appendix O) 

In the states that have adopte

part of their success has been attribuparticipation. DEA strongly endorses programs and works closely with the Dispensing Requiremen

Transfer of Prescription Information Required Information for 

The pharmacist dispensing a 

substance must affix to the container pharmacy name and address, the serdate of initial dispensing, the name of prescribing practitioner, and directionstatements, if any, contained on the plaw. 

DEA will allow the transfer of original prescription 

information for Schedules III, IV and V controlled substances for the purpose of refill dispensing between pharmacies on a one time basis, if permissible under state law. (See Prescription 

Requirements.) 

Pharmacies electronically sharing a real time, online 

database may transfer up to the maximum refills permitted by law and the prescriber’s authorization. Such systems must contain the information required for a valid prescription. 

Federal Food and Drug Admin

require that the label of any drug listeSubstance" in Schedules II, III, or IV oAct must, when dispensed to or for a 

42 43
warning: CAUTION: Federal law prohibits the transfer of this drug 

to any person other than the patient for whom it was prescribed. 

Schedule II Substances 

A pharmacist may dispense a Schedule II controlled substance, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except in an emergencysituation as described in the following section. 

Emergency Dispensing 

Emergency means that the immediate administration of the drug is necessary for proper treatment of the intended ultimate user, that no alternative treatment is available (including a drug which is not a Schedule II controlled substance), and it is not possible for the prescribing practitioner to provide a written prescription for the drug at that time. In a bona fide emergency, a practitioner may telephone a Schedule II prescription to the pharmacy or transmit the prescription by facsimile to the pharmacy, and the pharmacist may dispense the prescription provided that: 

1. The drug prescribed and dispensed must be limited to the 

amount needed to treat the patient during the emergency period. Prescribing or dispensing beyond the emergency period must be pursuant to a written prescription order. 

2. The prescription order must be immediately reduced to 

writing by the pharmacist and must contain all information, except for the prescribing practitioner’s signature. 

3. If the prescriber is not known to the pharmacist, the 

pharmacist must make a reasonable effort to determine that the phone authorization came from a valid practitioner, by verifying the practitioner’s telephone number with that 

listed in the directory and by mefforts to insure proper identity

4. Within seven days after autho

telephone prescription, the prefurnish the pharmacist a writtecontrolled substance prescribehave written on its face "AuthoDispensing." The written prescperson or by mail, which must seven day period. Upon receipmust attach this written prescrreduced to writing by the pharpharmacist must notify the neOffice if the prescriber fails to within seven days. If the pharmauthority to dispense without a void. Partial Dispensing The pharmacist may partially 

Schedule II controlled substance if hefull quantity in a written or emergency prescription, provided the pharmacist on the front of the written prescription emergency oral prescription). The remdispensed within 72 hours of the first if the remaining portion is not or cann72-hour period, the pharmacist must practitioner. No further quantity may bhours, except on a new prescription. 

Exception for Schedule Long Term Care FacilitAn exception has been made 

Care Facilities (LTCF) and patients wwith a terminal illness. If there is any 

44 45
may be classified as having a terminal illness, the pharmacist 

must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" will be deemed to have been filled in violation of the CSA. In such cases, prescriptions may be filled in partial quantities, including single dosage units. For each partial filling, the pharmacist must note on the prescription (or other uniformly maintained, readily retrievable record) the date the prescription was partially filled, the quantity dispensed, the remaining quantity and the identification of the dispensing pharmacist. Such prescriptions are valid for a maximum of 60 days from the date of issue, unless terminated earlier by discontinuance of the medication. 

Internet Pharmacy

The actual physical location of the pharmacy which 

purchases, stores, and dispenses controlled substances pursuant to prescription orders processed by the Internet site must be registered with DEA. The web site itself would not require a separate registration unless it is the same physical location, since the web site does not store or dispense controlled substances. For example, some Internet pharmacies maintain a central pharmacy warehouse site and offices where prescriptions are verified and substances shipped; this location must be registered with DEA as a retail pharmacy. Other Internet sites allow patients to pick up their prescriptions for controlled substances from a local pharmacy; these pharmacies must be registered with DEA. In this case, the Internet "pharmacy" has no obligations under DEA regulations because the responsibility for assuring compliance with DEA regulations rests with the actual pharmacy where controlled substances are dispensed. 

The pharmacy must have a license from the state in which 

the controlled substances are stored and dispensed and, in most 

instances, from any state in which yowith customers. Pharmacists should astates require licenses for the web sitoften provide services like patient coupharmacy does not change the pharmDEA regulations. The pharmacy is stisubstances only when there is a valid registered practitioner who issued the course of his or her professional prac

A pharmacist may dispense a 

substance only after the patient or presigned prescription prior to dispensingprescription filled must indicate the locontrolled substance. 

Some Internet pharmacies ha

substances based on an on-line quesrequires that "A prescription for a coneffective must be issued for a legitimaindividual practitioner acting in the uspractice" (21 CFR 1306.04(a)). Every similar acting requirement under its lalaw, for a doctor to be acting in the uspractice, there must be a bona fide do

For purpose of state law, man

endorsement of medical societies, cofollowing four elements as an indicatidoctor/patient relationship has been e

-A patient has a medical comp-A medical history has been ta-A physical examination has b-Some logical connection exismedical complaint, the medicaexamination, and the drug pre

46 47
Electronic Transmission of Prescriptions 

DEA is currently engaged in a project to establish the 

requirements for secure electronic transmission of all controlled substance prescriptions between the practitioner and the pharmacy. 

Proposed security requirements include: - Authentication of the prescriber - Content integrity - Non-repudiation of involvement by parties to a transaction Schedule III-V Controlled Substance Prescriptions A pharmacist may dispense a Schedule III, IV, or V 

controlled substance having received either a written prescription signed by a practitioner, a facsimile of that prescription transmitted by the practitioner or his/her agent to the pharmacy, or an oral prescription made by an individual practitioner. The pharmacist must promptly reduce the oral prescription to writing, including all required information. At this time, DEA does not permit a prescription received via the internet to be filled. If prescription information in received via the internet, the pharmacist must contact the prescriber via telephone and receive an oral prescription for the controlled substance including the full name and address of the patient, the drug name, strength, dosage form, quantity, prescribed directions for use, and the name, address, and registration number of the practitioner. The pharmacist must then immediately reduce the oral prescription to writing. 

Partial Dispensing 

The pharmacist may partially dispense a prescription for a 

Schedule III-V controlled substance if the pharmacist notes the quantity dispensed and initials the back of the prescription order. The partial dispensing may not exceed the total amount 

authorized in the prescription order. Tmust be within the six month limit. It is permissible to dispense a prescrithe face amount prescribed resulting dispensings being greater than the nuthe prescription. 

Dispensing Without 

In states where limited quantities 

may be sold over-the-counter, the phmaking sure that such sales comply wcontrolled substances or any controlleSchedule II, III or IV which is not a preFederal Food, Drug, and Cosmetic Aca prescription at retail provided that: 

1. Such distribution is made only 

a non-pharmacist employee, esupervision of a pharmacist. Hhas fulfilled professional and lactual cash, credit transaction completed by a non-pharmaci

2. Because there is no physician 

necessity for a Schedule V ovpharmacist must ensure the mfor the product. 

3. Not more than 240 ml. (8 fluid 

solid dosage units of any subsmore than 120 ml. (4 fluid ounsolid dosage units of any othebe distributed at retail to the s48-hour period without a valid 

48 49
4. The purchaser at a retail outlet is at least 18 years of age. Central Fill Pharmacy

A "central fill" pharmacy fills p

substances on behalf of retail pharmapharmacies have a contractual agreeservices or with which the pharmacieWhen one retail pharmacy receives a pharmacy prepares and subsequently substance medication to the first retathe patient, the second pharmacy is eactivity". Records must be maintained pharmacy and the retail pharmacy thadisposition of all controlled substance Central fill pharmacies are required to security requirements applicable to regeneral requirement to maintain effecto guard against theft and diversion oRetail pharmacies that also perform callowed to do so without a separate Dinventories, or separate records. 

5. For the retail purchase of a Schedule V controlled 

substance, every customer the pharmacist does not know should be required to provide suitable identification, including proof of age, where appropriate. 

6. A Schedule V bound record book is maintained which 

contains the name and address of the purchaser, name and quantity of controlled substance purchased, date of each sale, and initials of the dispensing pharmacist. This record book must be maintained for a period of two years from the date of the last transaction entered in such record book, and it must be made available for inspection and copying by officers of the United States, as authorized by the U.S. Attorney General.

7. Other federal, state or local law does not require a 

prescription. 

Central fill pharmacies are per

and refill prescriptions, subject to all aregulations. Only a licensed pharmacBoth the pharmacist employed by the pharmacist who dispenses the prescrcorresponding responsibility to ensure issued for a legitimate medical purpospractitioner acting in the usual course otherwise in the manner specified by 

Delivery of a Controlled Substance or Drug Product Containing Listed Chemicals to Persons in Another CountryControlled substances that are dispensed pursuant to a 

legitimate prescription may not be delivered or shipped to individuals in another country without proper authorization. Any such delivery or shipment is an export under the CSA, and cannot be conducted unless the person sending the controlled substances: 

51

A central fill pharmacy will not 

prescriptions provided directly by the practitioner or to mail or otherwise dedirectly to a patient or individual practare permitted to transmit prescription pharmacy in two ways. First, a facsimcontrolled substance in Schedule II-V retail pharmacy to the central fill pharmust maintain the original hard copy central fill pharmacy must maintain th

1. Has registered with DEA as an "exporter" (see 21 CFR 

1301 or 21 CFR 1309 for chemicals), and 

2. Has obtained the necessary permit(s), or submitted the 

necessary declaration(s) for export as outlined in 21 CFR 1312 or 21 CFR 1313 for chemicals. 

50
prescription. DEA is also allowing for the prescription information 

to be transmitted electronically by the retail pharmacy to the central fill pharmacy. Both pharmacies must maintain the prescription information in a readily retrievable manner and comply with all applicable federal and state recordkeeeping requirements. 

Emergency Kits for LoFacilities 

The DEA has issued a policy 

individual state licensing and regulatoguidelines for establishing specific rusubstances used in emergency kits aFor a copy of this policy statement, seKits in Long Term Care Facilities, App

Long Term Care Facilities 

A Long Term Care Facility (LTCF) is defined in the Code of 

Federal Regulations as a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients. In most cases, these facilities are not registered with DEA. Yet these care facilities routinely maintain controlled substances issued via prescription to their residents. These controlled substances are already outside the CSA closed drug distribution system since they have been dispensed to the ultimate user (i.e., patient). LTCFs frequently need to dispose of unused medications due to a change in patient medication or the patient’s demise. For drug disposal instructions, contact your nearest DEA Diversion Field Office (see Appendix T). In most cases these LTCFs are regulated by state agencies and other federal mandates (FDA, Federal Nursing Home Guidelines, etc.). DEA is aware of the issues currently facing most LTCFs concerning the dispensing and handling of controlled substances. These are affected by a variety of state laws and circumstances. Pharmacists should check with their state agency for guidelines concerning controlled substances at LTCFs. 

Narcotic Treatment Prog

The Narcotic Addict Treatmen

governs the use of narcotics and the United States. In addition, the law desagencies have responsibility for narcodefines the terms "maintenance" and who has to register to treat patients foThere are separate recordkeeping anNarcotic Treatment Programs. The Ctreatment programs include: 

• Official Order Form

s (DEA Fo

Schedule II narcotic transactiotreatment program and any remanufacturer, distributor, practreatment program. 

In this manual, regulations concerning LTCFs are also 

found in the Prescription Requirements section under Exceptions for Schedule II Facsimile Prescription, and in the Dispensing section under Exception for Schedule II Prescriptions at Long Term Care Facilities. 

• A narcotic treatment program 

handle only the narcotic substDEA Form-363 (New ApplicatAppendix K) and that are appror detoxification.

53

• Controlled substances for trea

than narcotic addiction cannot or stored on the premises of a unless a physician has a valid the program location. 

52
Use of Methadone Outside a Narcotic 

Treatment Program Narcotics for Patients w

Illnesses or Intractable P

1. A practitioner may prescribe methadone or any other 

narcotic to a narcotic addict for analgesic purposes. However, a practitioner may not prescribe methadone or any other narcotic medication solely for the treatment of a patient's narcotic addiction. The individual must receive the narcotics at a registered narcotic treatment program. In this case, the narcotics can be dispensed or administered but not prescribed. (The regulations do not prohibit the prescribing, administering or dispensing of methadone for analgesic purposes for medical conditions other than addiction.) 

Controlled substances, particu

may be used in the treatment of pain with a terminal illness or intractable plegitimate uses and a pharmacist shothem when a prescription indicates thmedical purpose. (The CSA requires prescription must be issued for a legitpractitioner acting in the course of proCFR 1306.04]. The CSA does not defpractice" nor does it set forth "standa

A pharmacist need not fear D

controlled substances in good faith puissued for a legitimate medical purposDEA that controlled substances shoudispensed when there is a legitimate 

2. A practitioner who is not part of a narcotic treatment 

program may administer narcotic substances to an addicted individual to relieve that individual’s acute withdrawal symptoms while the practitioner makes arrangements to refer the individual to a narcotic treatment program. Not more than one day’s medication may be administered at one time. This treatment cannot last more than three days and may not be renewed or extended. 

Inappropriate prescribing and 

substances, including opioid analgesdiversion and abuse by individuals whpurposes other than legitimate medicpharmacists should recognize that drdependence may develop as a consesustained use of opioid analgesics fochronic pain. It is also important to undrugs prescribed and frequency of prnot indicators of fraud or improper pre

3. A hospital that has no narcotic treatment program on the 

premises may administer narcotics to a drug dependent individual for either detoxification or maintenance purposes, if the individual is being treated for a medical condition other than narcotic addiction. If you have questions regarding any part of the Narcotic 

Addict Treatment Act of 1974 or its regulations, contact the nearest DEA Diversion Field Office (see Appendix T). A pharmacist’s professional ju

determining the appropriate course of is presented with a prescription that apharmacist’s judgement, in consultatibest way to verify that the prescription need. The pharmacist, in cooperation practitioner, has a responsibility to coreceiving the controlled substance in diversion. 

54 55
2. The pharmacy records that it d

substances, and the recipient 

Other Controlled Substance Regulations records that they received the 

Controlled Substances for Medical Missions and Humanitarian Charitable Solicitations 3. If a Schedule II controlled sub

transfer must be documented (DEA Form-222). The distribu

DEA assists organizations and practitioners who provide the following information on an 

charitable medical, dental and veterinary treatment in foreign countries. In order for practitioners to hand carry controlled substances overseas, they must obtain approval from DEA and the appropriate authority in the foreign country. Practitioners interested in cooperating with such medical missions should contact their local DEA Diversion Field Office (see Appendix T) or the International Drug Unit, DEA, Office of Diversion Control, Washington, D.C. 20537, for instructions. Allow at least 30 days to obtain the necessary approvals. 

• The name of the subst

form, and the quantity. 

• The name, address an

number of the pharmawhom it is distributed. 

4. Five Percent Rule. The total 

controlled substances distribuexceed five percent of all contby the pharmacy during a calecontrolled substances distribupharmacy is also required to r

If a pharmacy is asked to donate controlled substances to 

charitable organizations, contact your state controlled substance agency to determine if you have state authority to do so and your local DEA Diversion Field Office for further guidance. The shipment of controlled substances abroad is considered to be an export, which may only be done by a DEA registered exporter. 

U.S. Postal Service MailinControlled Substances 

Controlled Substance Distribution by a Pharmacy U.S. Postal Service regulations pe

substances, provided that they are notheir own force could cause injury to a following preparation and packaging s

A pharmacy registered to dispense controlled substances may distribute such substances (without being registered as a distributor) to another pharmacy or to a practitioner to dispense, provided that the following conditions are met: 

1. The inner container of any par

substances is marked and seathe Controlled Substances Acregulations, and placed in a psecurely wrapped in plain pap

1. The pharmacy or practitioner is registered under the CSA 

to dispense controlled substances. 

56 57
Summary of MCA’s Major 

Concern Pharmacists (incby the Methamphetamine (MAPA) of 2000) 

2. If the controlled substances consist of prescription 

medicines, the inner container is also labeled to show the name and address of the pharmacy, practitioner or other person dispensing the prescription. 

3. The outside wrapper or container is free of markings that 

would indicate the nature of the contents. 

1. The MCA defines a retail distr

general merchandise store, drperson whose activities as a dpseudoephedrine, phenylpropcombination ephedrine drug pexclusively to sales for personvolume of sales, either to walkface transactions by direct salas sub-threshold sales in a sinindividual for legitimate medicsingle entity ephedrine are surequirement. 

Chemical Requirements: Comprehensive Methamphetamine Control Act of 1996 

Retail pharmacies that are registered to handle controlled 

substances need not obtain a separate DEA chemical registration 

for retail distribution of pseudoephedrine, phenylpropanolamine (PPA), combination ephedrine and single-entity ephedrine drug products. However, if you are going to handle these products 

containing List I chemicals, you must comply with the recordkeeping and reporting requirements of the Comprehensive Methamphetamine Control Act of 1996 (MCA). Recordkeeping includes documentation of both receipts and sales of threshold amounts of List I chemical drug products. The MCA requirements also include reporting mail order transactions, such as drugs delivered by the U.S. Postal Service or any private or commercial carrier. 

2. Threshold quantities have bee

chemicals contained in drug pengages in any above-threshopseudoephedrine (9 grams), Pephedrine (24 grams) and sinproducts (all transactions are maintain a record of these tranmust also obtain proof of idenreport suspicious above-thresimmediately to DEA. (See Appthat Equal a Threshold (RegDosage Units of Marketed P

It is unlikely that pharmacies will engage in transactions 

involving List II Chemicals (see Appendix C, List II Chemicals with Threshold Amounts) in quantities that meet or exceed thresholds for recordkeeping and reporting requirements, therefore this manual summarizes only the requirements for List I chemicals. If you engage in List II chemical transactions which meet or exceed threshold limits in Appendix C, you should contact your local DEA Diversion Field Office for further information. 

3. While a single transaction of p

drug products in blister packs the-counter pseudoephedrine drug products) is exempt from "regulated transaction," the derequires that the sales of regu

58 59
PPA productsregardless of packaging- are almost 

exclusively to be below the 9 gram threshold (in packages of not more than 3 grams) to individuals for legitimate medical use. An occasional above-threshold sale of blister packs is not subject to the recordkeeping requirement. 

e. Other items of informa

by regulation. 

5. Retail distributors of List I che

not have a DEA registration msmall quantity sales of pseudocombination ephedrine to anoshort supply of these productsshould be extremely cautiouthey are required to limit their "almost exclusively, both in nusales" to "walk-in customers oby direct sales." 

4. All transactions of ephedrine, pseudoephedrine and PPA 

to non-regulated parties by postal, private or commercial carrier must be reported to DEA on a monthly basis,

regardless of size of the transaction 

with the following 

exceptionsExemptions: a. Therefore, depending 

volume of sales, a singto another store could longer satisfies the defdistributor," and would register as a distributo

-Distributions of drug products by retail distributors that may not include face-to-face transactions to the extent that such distributions are consistent with the activities authorized for a retail distributor as specified in the definition of a retail distributor (See number 1.) 

b. Even if a retailer is abl

transaction without afferetail distributor, a recomust be maintained if threshold for pseudoepthe 24 gram threshold ephedrine drug produc

-Distributions of drug products pursuant to valid prescriptions. -Distributions of drug products to a long term care facility for dispensing to or for use by a resident of that facility. -Distributions of sample packages of drug products when such packages contain not more than 2 solid dosage units or the equivalent of 2 dosage units in liquid form, not to exceed 10 liters of liquid per package, and not more than one package is distributed to an individual or residential address in any 30-day period. 

6. A person is subject to crimina

a listed chemical, any other chchemical equipment knowing, to believe, that such chemicalused in the illegal manufacture (See Appendix A, Number of Threshold (Regulated) TransMarketed Products; See Appwith Threshold Amounts, anChemicals with Threshold A

The data required for such reports must include: 

a. Name of the purchaser. b. Quantity and form of the ephedrine, 

pseudoephedrine, or PPA purchased. 

c. The address to which such drug products 

were sent. 

d. Date of each transaction. 

60 61
Before List I chemicals can be 

must obtain proof of identity from casbuying threshold quantities of List I chmust be in the form of a driver’s licenidentification and the purchaser’s signdispensed pursuant to a prescription, will suffice. 

Regulated Chemicals 

Most of the chemicals regulated under the CSA will not be 

encountered in a pharmacy setting or in quantities subject to recordkeeping and reporting requirements. List I chemicals are mostly precursors used for the manufacture of controlled substances and actually become part of the final drug molecule. Examples include anthranilic acid, ephedrine, ergotamine, norpseudoephedrine, phenylacetic acid, PPA and pseudoephedrine. (See Appendix A, Number of Tablets that Equal a Threshold (Regulated) Transaction for Dosage Units of Marketed Products, and Appendix B, List I Chemicals with Threshold Amounts.) 

Excessive or Unusual Chemicals (Suspicious 

Drug products containing eph

PPA are usually sold to individuals in Combination drug products packaged precursor material found at nearly 95laboratories seized by DEA. This fact industry has an important role in prevproducts to methamphetamine produalert for persons who want to buy a lacounter drug products containing thesbe used in the clandestine manufactuPharmacists should also be aware thquantities of List I chemical products claim they will export the products. 

List II chemicals are mostly solvents and reagents that can 

be used in the manufacture of controlled substances. Examples include ethyl ether, potassium permanganate, acetone and toluene. (Appendix C, List II Chemicals with Threshold Amounts.) 

Records for List I Chemicals Records of regulated transactions must be maintained 

separately or distinguished in some manner from records for controlled substances and records for List I chemicals. All such records must be maintained for a period of two years. It is suggested that the required records be maintained in a bound log book like that used to record the dispensing of Schedule V controlled substances. Some states have passed legislation or regulations requiring that certain List I chemicals be dispensed pursuant only to a prescription. In those jurisdictions, the prescription will suffice as the dispensing record. Inventories of List I chemicals are not required. 

Any regulated transaction for 

extraordinarily large quantity, an uncoor delivery, or any other circumstance pharmacist to believe that the listed cviolation of the law, must be reported Field Office (see Appendix T). Each rthe earliest practicable opportunity afaware of the circumstances involved the transaction as possible. Within 15 transaction should be forwarded to yo

Proof of Identity Office and must include the following 

Requirement for 

Purchasers of List I Chemicals 

63

1. The name, address, and, if re

number of each party to the re

62
2. The date of the regulated transaction. 

3. The name, quantity and form of packaging of the listed 

chemical or a description of the tableting machine or encapsulating machine (including make, model, and serial number). 

4. The method of transfer (company truck, picked up by 

customer, etc.). 

5. The type of identification used by the purchaser and any 

unique number on that identification. 

List I Chemical Security

Single-entity ephedrine products must be stocked 

behind a counter where only employees have access. However, there is no such requirement for pseudoephedrine or PPA drug products.

64
65

Appendix A

Number of Tablets that Equal a Threshold (Regulated) 

Transaction for Dosage Units of Marketed Products

Combination Ephedrine

Threshold (in base) #25 mg Tablets HCL #25 mg Tablets Sulfate

Wholesale: 1,000 

grams

48,827 51,872

Retail: 24 grams 1,172 1,245

Pseudoephedrine

Threshold 

(in base)

#120 

mg 

Tabs

HCL

#120 

mg 

Tabs 

Sulfate

#60 

mg 

Tabs 

HCL

#60 

mg 

Tabs 

Sulfate

#30 

mg 

Tabs 

HCL

#30 mg 

Tabs 

Sulfate

Wholesale:

1,000 grams

10,173 10,807 20,34

5

21,614 40,68

9

43,227

Retail: 9gms

/transaction*

92 98 184 195 367 390

Retail: 3gms

/package*

31 33 62 65 123 130

Phenylpropanolamine

Threshold

 (in base)

#75 mg 

Tabs HCL

#25 mg 

Tabs HCL

#12.5 mg 

Tabs HCL

#6.25 

Tabs 

HCL

Wholesale: 2,500 

grams

41,371 124,113 248,226 496,452

Retail: 9gms 

/transaction*

149 447 894 1,788

Retail: 3gms 

/package*

50 149 298 596

* Thresholds of 9 grams per single transaction and more than 3 grams 

per package are mandated by the Methamphetamine Anti-Proliferation 

Act (Children’s Health Act of 2000).

66

Appendix B

List I Chemicals With Domestic Threshold Amounts

List 1 Chemical Threshold

(by base weight)

N-Acetylanthranilic acid and its salts and esters 40 kg

Anthranilic acid and its salts and esters 30 kg

Benzaldehyde 4 kg

Benzyl cyanide 1 kg

Ephedrine and its salts, optical isomers, and salts of

Optical isomers

0 kg

Ergonovine and its salts 10 gm

Ergotamine and its salts 20 gm

Ethylamine and its salts 1 kg

Gamma-butyrolactone (GBL) 0 kg1

Hydriodic acid (57%) 1.7 kg2

Hypophosphorus acid and its salts 0 kg 3

Isosafrole 4kg

Methylamine and its salts 1kg

3, 4 Methylenedioxyphenyl – 2 propanone 4 kg

N- Methylephedrine and its salts, optical isomers, 

And salts of optical isomers

1 kg

N-Methylpseudoephedrine and its salts, optical 

isomers, and salts of optical isomers

1 kg

Nitroethane 2.5 kg

Norpseduoephedrine and its salts, optical isomers, and 

salts of optical isomers

2.5 kg

Phenylacetic acid and its salts and esters 1 kg

Phenylpropanolamine and its salts, optical isomers, 

And salts of optical isomers

2.5 kg

Phosphorus red,white 0 kg3

Piperidine and its salts 500 gm

Piperonal 4 kg

Propionic anhydrie 1 gm

Pseudoephedrine and its salts, optical isomers, and

salts of optical isomers

1 kg

Safrole (includes Safrole-rich essential oils, such 

as sassafras Oil and camphor oil 1070)

4 kg

 

1

 Until a permanent threshold is established in the Federal Register, all transactions are regulated. 

2

 One liter by volume.

3

 See 65 FR 57577 for transactions that are exempt on an interim basis.
67

Appendix C

List II Chemicals With Domestic Threshold Amounts

List II Chemical Threshold

Volume Weight

Acetic anhydride 250 gallons 1023 kgs

Acetone 50 gallons4150 kegs1

Benzyl chloride Not applicable 1 kg

Ethyl ether 50 gallons 135.8 kgs

Hydrochloric Acid Not regulated Not regulated

Anhydrous hydrogen chloride Not applicable 0.0 kgs

Iodine Not applicable 0.4 kgs

Potassium Permanganate Not applicable 55 kgs

Methyl ethyl ketone (2-Butane) 50 gallons1145 kgs1

Methyl isobutyl ketone Not regulated Not regulated

Sulfuric acid Not regulated Not regulated

Toluene 50 gallons1159 kgs1

 

4

 The cumulative threshold is not applicable to domestic sales of these chemicals.

68

Appendix D

Summary of Controlled Substances Act Requirements5

Requirement Schedule II Schedule III & 

IV

Schedule V

Registration Required Required Required

Receiving Records Order forms (DEA 

Form-222)

Invoices, Readily 

Retrievable

Invoices, Readily 

Retrievable

Prescriptions Signed 

Prescription6

Written, Oral, or 

Fax

Written, Oral, 

Fax, OTC7

Refills No 5 in 6 months Only as 

authorized if a 

prescription is 

issued

Maintenance of 

Prescriptions

Separate or with 

readily retrievable 

Schedules III-v

Separate or 

readily 

retrievable; 

Separate or 

readily 

retrievable; 

Bound 

dispensing log 

book

Distribution 

between 

Registrants

Order forms (DEA 

Form-222)

Invoices Invoices

Security Locked cabinet, 

Dispersed, Other 

secure storage

Locked cabinet, 

Dispersed, Other 

secure storage

Locked cabinet, 

Dispersed, Other 

secure storage

Theft or Significant 

Loss

Report 

immediately 

before filing DEA 

Form 106

Report 

immediately 

before filing DEA 

Form 106

Report 

immediately 

before filing DEA 

Form 106

 

5 All records must be maintained for two years, unless state requires a longer period

6

 Emergency Prescriptions require signed follow-up prescription. Exceptions; Fax prescription 

serves as original prescription for home infusion IV, long term care facility, and hospice.

7

 Where authorized by state controlled substances authority.
69

Appendix E

DEA Form-224

Application for new registration under Controlled 

Substances Act of 1970

Note: This sample form may not be used in place of an actual application.

70

Appendix F

DEA Form-224a – Renewal Application for DEA 

registration under Narcotic Addict Treatment Act of 1974

Note: This sample form may not be used in place of an actual applicatio

n.
71

Appendix G

DEA From- 224b – Sample of Retail pharmacy renewal 

affidavit for chain renewal

Note: This sample form may not be used in place of an actual application.

72

Appendix H

DEA Form 222 – U.S. Official Order Form Schedules I & 

II

Note: This sample form may not be used in place of an actual application.
73

Appendix I

DEA Form 41 – Registrants Inventory of Drugs 

Surrendered

Note: This sample form may not be used in place of an actual application.

74

Appendix J

DEA Form 106 – Report of Theft or Loss of Controlled 

Substances

Note: This sample form may not be used in place of an actual application.
75

Appendix K

DEA Form 363 – New Application Registration – Narcotic 

Treatment Program

Note: This sample form may not be used in place of an actual application.

76

Appendix L

DEA Form-363a

Application for DEA Registration – NTP Renewal

Note: This sample form may not be used in place of an actual application.
77

Appendix M

DEA Form-510

Application for Registration – Chemical Registration

Note: This sample form may not be used in place of an actual application.

78

Appendix N

The Pharmacists Corresponding Responsibility for 

Controlled Substance Prescriptions

Title 21, Code of Federal Regulations, Section 1306.04 provides, 

in pertinent part, that: "A prescription for a controlled substance to 

be effective must be issued for a legitimate medical purpose by an 

individual practitioner acting in the usual course of his professional 

practice. The responsibility for the proper prescribing and 

dispensing of controlled substances is upon the prescribing 

practitioner, but a corresponding responsibility rests with the 

pharmacist who fills the prescription. An order purporting to be 

a prescription issued not in the usual course of professional 

treatment or in legitimate and authorized research is not a 

prescription within the meaning and intent of Section 309 of the 

Act (21 U.S.C. 829) and the person knowingly filling such a 

purported prescription, as well as the person issuing it, shall 

be subject to the penalties provided for violations of the 

provisions of law relating to controlled substances."

A pharmacist is required to exercise sound professional 

judgment when making a determination about the legitimacy of a 

controlled substance prescription. Such a determination is made 

before the prescription is dispensed. The law does not require a 

pharmacist to dispense a prescription of doubtful, questionable, or 

suspicious origin. To the contrary, the pharmacist who deliberately 

looks the other way when there is reason to believe that the 

purported prescription had not been issued for a legitimate 

medical purpose, may be prosecuted along with the issuing 

practitioner, for knowingly and intentionally distributing controlled 

substances, a felony offense which may s business or 

professional license. (See United States v. Kershman, 555 Fed. 

2nd 198 [U.S. Court Of Appeals, Eighth Circuit, 1977]).

To assist the pharmacist in identifying fraudulent 

prescriptions, see Pharmacist’s Guide to Prescription Fraud 

(Appendix O)
79

What is the pharmacist expected to do when presented 

with a prescription that raises questions? Although a pharmacist 

may be reluctant to "get involved," there really is no choice. The 

pharmacist is involved because their professional responsibilities 

makes him or her subject to the requirements of the CSA. If you 

find one or two prescriptions which appear to be irregular, the best 

remedy may be to call the prescribing physician about your 

concern. Often, a friendly bit of advice from a fellow professional 

may be all that is needed to correct an apparent irregularity.

However, where there appears to be a pattern of 

prescription abuses, the pharmacist’s refusing to dispense certain 

prescriptions may not be enough. Abusers will simply go 

elsewhere, possibly to another pharmacist with whom the 

prescriber has an understanding. In such cases, the pharmacist 

should contact the State Board of Pharmacy or the local DEA 

Diversion Field Office. Both DEA and State authorities consider 

retail-level diversion priority problems. Your information will be 

handled confidentially and promptly. DEA cannot, however, get to 

the source of the diversion without your cooperation.

80

Appendix O

Pharmacist’s Guide to Prescription Fraud

The purpose of this guide is to ensure that controlled 

substances continue to be available for legitimate medical and 

scientific purposes while preventing their diversion into the illicit 

market. It is not the intent of this publication to discourage or 

prohibit the use of controlled substances where medically 

indicated. DEA supports the 1998 "Model Guidelines for the Use 

of Controlled Substances for the Treatment of Pain" prepared by 

the Federation of State Medical Boards of the United States, Inc. 

DEA believes that the "Model Guidelines" will protect legitimate 

medical uses of controlled substances while preventing drug 

diversion.

Nothing in this guide should be construed as authorizing or 

permitting any person to conduct any act that is not authorized or 

permitted under Federal or state laws.

Your Responsibilities

The abuse of prescription drugs—especially controlled 

substances—is a serious social and health problem in the United 

States today. As a healthcare professional, you share 

responsibility for solving the prescription drug abuse and diversion 

problem.

You have a legal responsibility to acquaint yourself with the 

state and Federal requirements for dispensing controlled 

substances. You also have a legal and ethical 

responsibility to uphold these laws and to help protect 

society from drug abuse.

• You have a personal responsibility to protect your practice 

from becoming an easy target for drug diversion. You must 

become aware of the potential situations where drug 

diversion can occur and safeguards that can be enacted to 

prevent this diversion.
81

• The dispensing pharmacist must maintain a constant 

vigilance against forged or altered prescriptions. The law 

holds the pharmacist responsible for knowingly dispensing 

a prescription that was not issued in the usual course of 

professional treatment.

This guide will help you meet these responsibilities.

82

Types of Fraudulent Prescriptions

The practiced forger of prescriptions is usually very adept 

at the job. The forger knows what information is needed on the 

prescription to make it appear authentic. Pharmacists should be 

aware of the various kinds of forged prescriptions that may be 

presented for dispensing.

Some patients, in an effort to obtain additional amounts of 

legitimately prescribed drugs, alter the physician’s prescription. 

They will also have prescription pads printed using a legitimate 

doctor’s name, but with a different call back number that is 

answered by an accomplice to verify the prescription. Also, drug 

seeking individuals will call in their own prescriptions and give their 

own telephone number as a call back confirmation.

Legitimate prescription pads are stolen from physicians’ 

offices and hospitals and prescriptions are written using fictitious 

patients names and addresses. In addition, individuals will go to 

emergency rooms complaining of pain in the hopes of receiving a 

controlled substance prescription. The prescription can then be 

altered or copied to be used again. Computers are often used to 

create prescriptions for nonexistent doctors or to copy legitimate 

doctors’ prescriptions.

Note: The quantity of drugs prescribed and frequency of 

prescriptions filled are not alone indications of fraud or improper 

prescribing especially if the patient is being treated with opioids for 

pain management. Pharmacists should also recognize that drug 

tolerance and physical dependence may develop as a 

consequence of the patient’s sustained use of opioid analgesics 

for the legitimate treatment of chronic pain.
83

The following criteria may indicate that a prescription was not 

issued for a legitimate medical purpose.

• The prescriber writes significantly more prescriptions (or in 

larger quantities) compared to other practitioners in your 

area.

• The patient appears to be returning too frequently. 

Prescription which should last for a month in legitimate 

use, is being refilled on a biweekly, weekly or even a daily 

basis.

• The prescriber writes prescriptions for antagonistic drugs, 

such as depressants and stimulants, at the same time. 

Drug abusers often request prescriptions for "uppers and 

downers" at the same time.

• Patient appears presenting prescriptions written in the 

names of other people.

• A number of people appear simultaneously, or within a 

short time, all bearing similar prescriptions from the same 

physician.

• Numerous "strangers," people who are not regular patrons 

or residents of your community, suddenly show up with 

prescriptions from the same physician.

Characteristics of Forged Prescriptions

1. Prescription looks "too good"; the prescriber’s 

handwriting is too legible; 

2. Quantities, directions or dosages differ from usual 

medical usage; 

3. Prescription does not comply with the acceptable 

standard abbreviations or appear to be textbook 

presentations; 

4. Prescription appears to be photocopied; 

5. Directions written in full with no abbreviations; 

84

6. Prescription written in different-color inks or written 

in different handwriting. 

7. Apparent erasure marks. 

Prevention Techniques

• Know the prescriber and his/her signature;

• Know the prescriber’s DEA registration number;

• Know the patient;

• Check the date on the prescription order. Has it been 

presented to you in a reasonable length of time since the 

prescriber wrote it?

When there is a question about any aspect of the prescription 

order, call the prescriber for verification or clarification. Should 

there be a discrepancy, the patient must have a plausible reason 

before the prescription medication is dispensed.

Any time you are in doubt, require proper identification. 

Although this procedure isn’t foolproof (identification papers 

can also be stolen/forged), it does increase the drug abuser’s 

risk.

If you believe that you have a forged, altered, or bogus 

prescription--don’t dispense it--call your local police.

If you believe that you have discovered a pattern of 

prescription abuses, contact your State Board of Pharmacy 

or your local DEA office. Both DEA and state authorities 

consider retail-level diversion a priority issue.

Proper Controls

Dispensing procedures, without control and professional caution, 

are an invitation to the drug abuser. Proper controls against bogus 

prescriptions can best be accomplished by following common 

sense, sound professional practice, and proper dispensing 

procedures and controls.
85

Have your pharmacy staff help protect your practice from 

becoming a source of prescription drug diversion. Become familiar 

with which drugs are popular for abuse and resale on the streets 

in your area. Drug abuse prevention must be an ongoing staff 

activity.

Encourage local pharmacists and physicians to develop a 

network, or at least a working relationship, which promotes 

teamwork and camaraderie. Discuss abuse problems with other 

pharmacists and physicians in the community. Most drug abusers 

seek out areas where communication and cooperation between 

health professionals are minimal because it makes their work so 

much easier.

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Appendix P

Affidavit for a New Pharmacy1

I, _______________________________________, the 

________________________ (Title of officer, official, partner, or other 

position) of _____________________________ (Corporation, 

partnership, or sole proprietor), doing business as 

______________________________________________ (Store name) 

at _______________________________ (Number and Street), 

_____________________ (City) _______________________ (State) 

___________________ (Zip Code), hereby certify that said store was 

issued a pharmacy permit No. __________________ by the 

_____________________________ (Board of Pharmacy or Licensing 

Agency) of the State of ________________________ on 

_________________________ (Date).

This statement is submitted in order to obtain a Drug 

Enforcement Administration registration number. I understand that if any 

information is false, the Administration may immediately suspend the 

registration for this store and commence proceedings to revoke under 21 

U.S.C. 824(a) because of the danger to public health and safety. I further 

understand that any false information contained in this affidavit may 

subject me personally and the above-named 

corporation/partnership/business to prosecution under 21 U.S.C. 843, 

the penalties for conviction of which include imprisonment for up to four 

(4) years, a fine of not more than $30,000.00 or both.

________________________________________________

Signature (Person who signs Application for Registration)

State of ___________________________________

County of __________________________________________

Subscribed to and sworn before me this ________ day of 

____________, 19______.

____________________________________________

Notary Public

 

1 21 CFR, Section 1301.17(a)
87

Appendix Q

Affidavit for Transfer of a Pharmacy1

I, _______________________________________, the 

_________________________ (Title of officer, official, partner, or other 

position) of _______________________________ (Corporation, 

partnership, or sole proprietor), doing business as 

______________________________________________ (Store name) 

hereby certify:

(1) That said company was issued a pharmacy permit No. 

____________________ by the _____________________________ 

(Board of Pharmacy or Licensing Agency) of the State of 

________________________ and a DEA Registration Number 

____________________ for a pharmacy located at 

______________________________________ (Number and Street), 

__________________________ (City) 

____________________________ (State) ___________________ (Zip 

Code),; and

(2) That said company is acquiring the pharmacy business of 

__________________________ ______________ (Name of Seller) 

doing business as ________________________________ with DEA 

Registration Number ____________________________________ on or 

about ______________________ (Date of Transfer) and that said 

company has applied (or will apply on _______________________ 

(Date) for a pharmacy permit from the Board of Pharmacy (or Licensing 

Agency) of the State of _____________________ to do business as 

_____________ _________________________ (Store name) at 

_____________________________ (Number and Street) 

________________________ (City) ____________________ (State) 

___________________ (Zip Code).

This statement is submitted in order to obtain a Drug 

Enforcement Administration registration number.

I understand that if a DEA registration number is issued, the 

pharmacy may acquire controlled substances but may not dispense them 

until a pharmacy permit or license is issued by the State board of 

pharmacy or licensing agency.

 

1 21 CFR, Section 1301.17(a)

88

I understand that if any information is false, the Administration 

may immediately suspend the registration for this store and commence 

proceedings to revoke under 21 U.S.C. 824(a) because of the danger to 

public health and safety. I further understand that any false information 

contained in this affidavit may subject me personally and the abovenamed corporation/partnership/business to prosecution under 21 U.S.C. 

843, the penalties for conviction of which include imprisonment for up to 

four (4) years, a fine of not more than $30,000.00 or both.

_________________________________________________________

Signature (Person who signs Application for Registration)

State of ___________________________________

County of __________________________________________

Subscribed to and sworn before me this ________ day of 

____________, 19______.

____________________________________________

Notary Public

1

 21 CFR, Section 1301.17(a)
89

Appendix R

Guidelines for Emergency Kits in Long Term Care 

Facilities1

The placement of emergency kits containing controlled substances in 

Long Term Care Facilities (LTCF) not registered with DEA will be 

deemed in compliance with the Comprehensive Drug Abuse Prevention 

and Control Act of 1970, if the appropriate state agency or regulatory 

authority specifically approves such placement, and sets forth 

procedures that require the following:

1. Source of Supply: The LTCF must obtain controlled substances for 

the emergency kits from a DEA-registered hospital/clinic, pharmacy or 

practitioner.

2. Security Safeguards: Access to each emergency kit in the LTCF 

must be restricted and the type and quantity of controlled substances 

which may be placed in the emergency kit must be specifically limited.

3. Proper Control, Accountability and Recordkeeping: The LTCF and 

the providing DEA-registered hospital/clinic, pharmacy, or practitioner 

must maintain complete and accurate records of the controlled 

substances placed in the emergency kit including the disposition of these 

controlled substances and take periodic physical inventories of the 

drugs.

4. Administration of Controlled Substances: In emergency medical 

situations when medication is needed from the emergency kit, only LTCF 

personnel who are authorized by an individual practitioner can administer 

the controlled substances. (21 CFR 1306.11 and 21 CFR 2306.21)

5. Prohibited Activities: Prohibited activities can result in the state 

revocation, denial, or suspension of having emergency kits containing 

controlled substances in a LTCF.

 

1 Source: DEA Office of Diversion Control

90

Appendix S

CFR1 Definitions

Administer

The direct application of a controlled substance to the body 

of a patient or research subject by 1) a practitioner (or in 

his presence) by his authorized agent, or 2) the patient or 

research subject at the direction and in the presence of the 

practitioner, whether such application is by injection, 

ingestion or any other means.

Chemicals

(see definitions for List I Chemicals, List II Chemicals, and 

Retail Distributor)

Dispense

Means to deliver a controlled substance to an ultimate user 

(patient) or research subject by, or pursuant to the lawful 

order of a practitioner, including the prescribing and 

administering of a controlled substance and the packaging, 

labeling, or compounding necessary to prepare the 

substance for such delivery. (Under the provisions of the 

CSA, the definition of "dispense" also includes the 

administering of a controlled substance.)

Dispenser

Means an individual practitioner, institutional practitioner, 

pharmacy or pharmacist who dispenses a controlled 

substance.

Individual Practitioner

A physician, dentist, veterinarian or other individual 

licensed, registered or otherwise permitted, by the United 

States or the jurisdiction in which he/she practices, to 

 

1

 From the Code of Federal Regulations, the primary source for the Pharmacist's 

Manual.
91

dispense a controlled substance in the course of his 

professional practice, but does not include a pharmacy.

Institutional Practitioner

Means a hospital or other person (other than an individual) 

licensed, registered or otherwise permitted by the United 

States or the jurisdiction in which it practices, to dispense a 

controlled substance in the course of professional practice, 

but does not include a pharmacy.

Inventory

Means all factory and branch stocks in finished form of a 

basic class of controlled substance manufactured or 

otherwise acquired by a registrant, whether in bulk, 

commercial containers, or contained in pharmaceutical 

preparations in the possession of the registrant under 

separate registration as a manufacturer, exporter, importer 

or distributor.

List I Chemical

The term List I chemical means a chemical specifically 

designated by the (DEA) Administrator in CFR section 

1310.02(a)...that in addition to legitimate uses, is used in 

manufacturing a controlled substance in violation of the 

(Controlled Substances) Act and is important to the 

manufacture of a controlled substance.

(Note: These chemicals are generally essential (and often 

precursors) for the manufacture of a specific controlled 

substance and actually become part of the final drug 

molecule. Examples include anthranilic acid, ephedrine, 

ergotamine, norpseudoephedrine, phenylacetic acid, 

phenylpropanolamine and pseudoephedrine.)

List II Chemical

The term List II chemical means a chemical, other than a 

List I chemical, specifically designated by the (DEA) 

Administrator in (CFR section) 1310.02(b)...that in addition 

92

to legitimate uses, is used in manufacturing a controlled 

substance in violation of the (Controlled Substances) Act.

(Note: These chemicals are solvents and reagents that can 

be used in the manufacture of controlled substances. 

Examples include acetic anhydride, ethyl ether, potassium 

permanganate, acetone and toluene.)

Long Term Care Facility

A nursing home, retirement care, mental care or other 

facility or institution which provides extended health care to 

resident patients.

Mid-level Practitioner (MLP)

An individual practitioner, other than a physician, dentist, 

veterinarian or podiatrist, who is licensed, registered or 

otherwise permitted by the United States or the jurisdiction 

in which he/she practices, to dispense a controlled 

substance in the course of professional practice. Examples 

of mid-level practitioners (MLP) include, but are not limited 

to, health care providers such as nurse practitioners, nurse 

midwives, nurse anesthetists, clinical nurse specialists and 

physician assistants who are authorized to dispense 

controlled substances by the state in which they practice. 

(Other MLP disciplines recognized by DEA as controlled 

substance registrants include: optometrists, ambulance 

services, animal shelters, euthanasia technicians, nursing 

homes, homeopathic physicians and registered

pharmacists. Because this authority varies greatly by state, 

check with your state licensing authority to determine 

which MLP disciplines are authorized to use controlled 

substances in a particular state.)

Pharmacist

Any pharmacist licensed by a state to dispense controlled 

substances and shall include any other person (e.g., 

pharmacist intern) authorized by the state to dispense 

controlled substances under the supervision of a 

pharmacist licensed by the state.
93

Prescription

An order for medication which is dispensed to or for an 

ultimate user but does not include an order for medication 

which is dispensed for immediate administration to the 

ultimate user (e.g., an order to dispense a drug to an 

inpatient for immediate administration in a hospital is not a 

prescription).

Readily Retrievable

Means that certain records are kept by automatic data 

processing systems (i.e., electronic or mechanized 

recordkeeping systems) or a manual system using a red 

"C," asterisk or red underline in such a manner that they 

can be separated from all other records in a reasonable 

time, and/or records are kept on which certain items are 

asterisked, redlined or in some other manner visually 

identifiable apart from other items appearing on the 

records.

Retail Distributor

This refers to a chemical retail distributor which is defined 

as a grocery store, general merchandise store, drug store, 

or other entity or person whose activities as a distributor 

relating to legal drug products containing listed chemicals 

are limited almost exclusively to sales for personal use, 

both in number and volume of sales, either to walk-in 

customers or in face-to-face transactions by direct sales. 

(Personal use is defined as sub-threshold sales in a single 

transaction to an individual for legitimate medical use.)

94

Appendix T

DEA Registration and Field Offices
95

Appendix U

Internet Resources:

DEA Internet Homepage:

www.DEA.gov

DEA's Diversion Control Program Website:

www.DEAdiversion.usdoj.gov

Programs

The Office of Diversion Control page is found under Programs, 

and includes information on:

Drug Registration

Field diversion office locations and phone numbers, offices with 

field registration technicians

Chemical Registration

Provisions of the Methamphetamine Control Act of 1996 and FAQ 

[frequently asked questions] about the Act

ARCOS (Automation of Reports and Consolidated Orders 

System) Reporting requirements for manufacturers and 

distributors of controlled substances

Publications

DEA publications of interest to the pharmacist can be found under 

Publications, including the updated Pharmacist's Manual (as well 

as the DEA manuals for physicians, mid-level practitioners and 

chemical handlers). Drugs of Abuse, which includes information 

on drug identification as well as the psychological effects of 

controlled substances, is also found in this section.

Additional Internet Resources

U.S. Government Printing Office: 

http://www.access.gpo.gov/nara/cfr/index.html

96

Provides access to the Code of Federal Regulations (21 CFR, 

Parts 1300 to end), primary source for the Pharmacist's Manual, 

and the Federal Register which contains proposed and finalized 

amendments to the CFR.

Office of National Drug Control Policy (ONDCP):

http://www.whitehousedrugpolicy.gov

Food and Drug Administration: http://www.FDA.gov

FDA Matrix Page:

http://www.medmarket.com/tenants/rainfo/fda.htm

National Clearinghouse for Alcohol and Drug Information:

http://www.health.org

Internet Source for Health Care Information:

http://www.druginfonet.com
97

(Inside Back Cover)

For Additional Assistance

This publication is intended to provide guidance and information 

on the requirements of the Controlled Substances Act and its 

implementing regulations. If you require additional clarification or 

assistance, or wish to comment on any matter regarding DEA's 

requirements or regulatory activities, please contact your local 

DEA Diversion Field Office. Every effort will be make to respond 

promptly to your inquiry.

Small Business and Agriculture Regulatory Enforcement 

Ombudsman

Furthermore, please be aware that the Small Business and 

Agriculture Regulatory Enforcement Ombudsman and 10 Regional 

Fairness Boards were established to receive comments from small 

businesses about Federal agency enforcement actions. The 

Ombudsman will annually evaluate the enforcement activities an 

rate each agency's responsiveness to small business. If you wish 

to comment on DEA enforcement actions, call 1-888-REG-FAIR 

(1-888-734-3247)

Plain Language

The Drug Enforcement Administration make every effort to write 

this manual in clear, plain language. If you have suggestions as to 

how to improve the clarity of this manual, call or write to:

Drug Enforcement Administration

Office of Diversion Control

Liaison and Policy Section

Washington, D.C. 20537

Telephone: (202) 307-7297