United States Department of Justice 

Drug Enforcement Administration

Office of Diversion Control

Pharmacist’s Manual

An Informational Outline of the 

Controlled Substances Act

Revised 20101

 

1 This manual replaces all previous editions of the Pharmacist’s Manual issued by the Drug Enforcement 

Administration, both hard copy and electronic.
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Pharmacist’s Manual -----------------------------------------------------------------------------------------------------------------------------------

2010 Edition

ii

Michele Leonhart 

Acting Administrator 

Drug Enforcement Administration

Joseph T. Rannazzisi 

Deputy Assistant Administrator/

 Deputy Chief of Operations

Office of Diversion Control

Mark W. Caverly 

Chief, Liaison and Policy Section

This manual has been prepared by the Drug Enforcement Administration, Office of Diversion 

Control, as a guide to assist pharmacists in their understanding of the Federal Controlled 

Substances Act and its implementing regulations as they pertain to the pharmacy profession.

The 2010 edition replaces all previous editions of the Pharmacist’s Manual issued by the Drug 

Enforcement Administration, both hard copy and electronic.

 
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Table of Contents

Section I - Introduction Disclaimer......................................................................................................................................... 1

Authorization for Public Dissemination.............................................................................................. 1

Message from the Administrator....................................................................................................... 2

Preface ............................................................................................................................................. 3

Section II – Schedules of Controlled Substances Schedule I Controlled Substances.................................................................................................... 5

Schedule II Controlled Substances................................................................................................... 5

Schedule III Controlled Substances.................................................................................................. 5

Schedule IV Controlled Substances.................................................................................................. 6

Schedule V Controlled Substances................................................................................................... 6

Scheduled Listed Chemical Products (SLCP)................................................................................... 6

Section III – Registration Requirements

New Pharmacy Registration ............................................................................................................. 7

Renewal of Pharmacy Registration................................................................................................... 8

Affidavit for Renewal of Retail Chain Pharmacy Registration............................................................ 9

Change of Business Address............................................................................................................ 9

Termination of Registration............................................................................................................... 9

Transfer of Business....................................................................................................................... 10

Denial, Suspension, or Revocation of Registration......................................................................... 11

Denial of Registration in the Public Interest .................................................................................... 11

Chemical Registration Requirements ............................................................................................. 11

Section IV – Transfer or Disposal of Controlled Substances

Transfer of Controlled Substances.................................................................................................. 13

Transfer to a Pharmacy .................................................................................................................. 13

Transfer to the Original Supplier or Original Manufacturer.............................................................. 13

Disposal of Controlled Substances ................................................................................................. 14

Reverse Distributors Authorized to Dispose Controlled Substances............................................... 14

Disposal of Controlled Substances by Persons Not Registered with DEA...................................... 14

Section V – Security Requirements Requests for Employment Waivers for Certain Pharmacy Employees ........................................... 15

Controlled Substance Theft or Significant Loss .............................................................................. 15

In-Transit Loss ................................................................................................................................ 17

In-Transit Loss from Central Fill Pharmacy..................................................................................... 18

Breakage and Spillage.................................................................................................................... 18

Robberies and Burglaries Involving Controlled Substances ........................................................... 18 
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Table of Contents (continued)

Section VI – Recordkeeping Requirements Required Records........................................................................................................................... 19

Central Recordkeeping ................................................................................................................... 20

Prescription Records....................................................................................................................... 20

Section VII – Inventory Requirements Initial Inventory................................................................................................................................ 22

Biennial Inventory ........................................................................................................................... 22

Newly Scheduled Controlled Substance Inventory ......................................................................... 22

Section VIII – Ordering Controlled Substances Ordering Schedule II Controlled Substances .................................................................................. 23

Requesting Official Order Forms..................................................................................................... 23

Completing Official Order Forms .................................................................................................... 23

Cancellation and Voiding an Official Order Form............................................................................ 24

Power of Attorney to Sign an Official Order Form ........................................................................... 24

Lost or Stolen Order Forms............................................................................................................. 26

Controlled Substance Ordering System (CSOS) – Electronic Order Forms..................................... 26

Unaccepted and Defective Electronic Orders ................................................................................. 27

Cancellation and Voiding of Electronic Orders................................................................................ 27

Lost Electronic Orders .................................................................................................................... 27

Ordering Schedules III-V Controlled Substances............................................................................ 28

Section IX – Valid Prescription Requirements Who May Issue ............................................................................................................................... 29

Purpose of Issue............................................................................................................................. 29

Corresponding Responsibility ......................................................................................................... 30

Electronic Prescriptions .................................................................................................................. 30

Verification of Practitioner Registration........................................................................................... 32

Construction of Valid DEA Registration Number for Practitioners................................................... 32

Practitioner’s Use of a Hospital’s DEA Registration Number .......................................................... 32

Exemption of Federal Government Practitioners from Registration ................................................ 33

Registration Requirements for Mid-Level Practitioners................................................................... 33

Schedule II Controlled Substances................................................................................................. 33

Refills.............................................................................................................................................. 34

Issuance of Multiple Prescriptions for Schedule II Controlled Substances...................................... 34

Facsimile Prescriptions for Schedule II Controlled Substances ...................................................... 34

Exceptions for Schedule II Facsimile Prescriptions......................................................................... 35

Schedules III-V Controlled Substances........................................................................................... 35

Refills.............................................................................................................................................. 35

Electronic Recordkeeping of Schedules III-IV Prescription Information .......................................... 36

Facsimile Prescriptions for Schedules III-V Controlled Substances................................................ 37

Telephone Authorization for Schedules III-V Prescriptions ............................................................. 37
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Table of Contents (continued)

 

Section IX – Valid Prescription Requirements (continued) Transfer of Schedules III-V Prescription Information....................................................................... 37

Prescription Monitoring Programs................................................................................................... 39

Section X – Dispensing Requirements

Required Information for Prescription Labels.................................................................................. 40

Schedule II Controlled Substance Prescriptions ............................................................................. 40

Emergency Dispensing................................................................................................................... 40

Partial Dispensing........................................................................................................................... 41

Partial Filling of Schedule II Prescriptions for Terminally Ill or Long Term Care Facility Patients.... 41

Schedules III-V Controlled Substance Prescriptions....................................................................... 42

Partial Dispensing........................................................................................................................... 42

Dispensing Without a Prescription .................................................................................................. 42

Delivery of a Controlled Substance to Persons in Other Countries................................................. 43

 

Section XI – Ryan Haight Online Pharmacy Consumer Protection 

 Act of 2008 Summary of the Act’s Major Provisions .......................................................................................... 44

Definition of an Online Pharmacy.................................................................................................... 44

Online Pharmacy Registration Exemptions..................................................................................... 45

Notification Requirements............................................................................................................... 46

How to Register as an Online Pharmacy ........................................................................................ 46

State Licensure Requirements........................................................................................................ 46

Online Pharmacy Website Requirements ....................................................................................... 47

Reporting Requirements................................................................................................................. 48

Prescription Requirements.............................................................................................................. 48

Definition of Prescriptions Terms .................................................................................................... 49

Filling New Prescriptions for Controlled Substances in Schedules III-V.......................................... 49

Refilling Prescriptions for Controlled Substances in Schedules III-V .............................................. 49

Section XII – Other Pharmacy Operations Central Fill Pharmacy...................................................................................................................... 50

Long Term Care Facilities............................................................................................................... 51

Use of Automated Dispensing Systems by Retail Pharmacies at Long Term Care Facilities ......... 52

Emergency Kits for Long Term Care Facilities................................................................................ 52

Opioid (Narcotic) Addiction Treatment Programs............................................................................ 52

Dispensing Controlled Substances for the Treatment of Pain......................................................... 53
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Table of Contents (continued)

 

Section XIII – Other Controlled Substance Regulations Controlled Substance Distribution by a Pharmacy – “Five Percent Rule” ........................................ 54

United States Postal Service Mailing Requirements for Controlled Substances............................. 54

 

Section XIV – Combat Methamphetamine Epidemic Act of 2005

Summary of the Act’s Major Provisions .......................................................................................... 55

Scheduled Listed Chemical Products ............................................................................................. 55

Recordkeeping Requirements ........................................................................................................ 56

Loss or Theft of Scheduled Listed Chemical Products.................................................................... 56

Proof of Identity Requirements........................................................................................................ 57

Product Placement.......................................................................................................................... 58

Self-Certification ............................................................................................................................. 58

Required Training ........................................................................................................................... 59

Training Records ............................................................................................................................ 59

Self-Certification Fee ...................................................................................................................... 59

Appendices

Appendix A Summary of Controlled Substances Act Requirements ............................................. 61

Appendix B Definitions Based on the Controlled Substances Act and the Code of Federal 

 Regulations.............................................................................................................. 62

Appendix C Definitions of Abbreviations ....................................................................................... 65

Appendix D Pharmacist’s Guide to Prescription Fraud ................................................................. 66

Appendix E Affidavit for a New Pharmacy..................................................................................... 69

Appendix F Affidavit for Transfer of a Pharmacy........................................................................... 70

Appendix G Equivalency Tables for Ephedrine, Pseudoephedrine, and Phenylpropanolamine

 Under the Combat Methamphetamine Epidemic Act of 2005.................................. 71

Appendix H Guidelines for Emergency Kits in Long Term Care Facilities..................................... 72

Appendix I Guidelines for Completing the DEA Form 106........................................................... 73

Appendix J DEA Registration Specialists in Field Divisions......................................................... 75

Appendix K DEA Diversion Field Offices....................................................................................... 76

Appendix L Internet Resources.................................................................................................... 77

Appendix M Small Business and Agriculture Regulatory Enforcement Ombudsman.................... 78

Appendix N Additional Assistance and Plain Language Statements............................................. 79
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SECTION I – INTRODUCTION 

Disclaimer 

This pharmacist’s manual is intended to summarize and explain the basic requirements for 

prescribing, administering, and dispensing controlled substances under the Controlled Substances 

Act (CSA), Title 21 United States Code (21 U.S.C.) 801-971 and the DEA regulations, Title 21, 

Code of Federal Regulations (21 C.F.R.), Parts 1300 to 1316. Pertinent citations to the law and 

regulations are included in this manual.

Printed copies of the complete regulations implementing the CSA (21 C.F.R. Part 1300 to end) may 

be obtained from:

Superintendent of Documents

U.S. Government Printing Office

Washington, D.C. 20402

Both the C.F.R. and the Federal Register (which includes proposed and final rules implementing 

the CSA) are available on the internet through the U.S. Government Printing Office website. This 

website, which provides information by section, citation, and keywords, can be accessed at:

www.gpoaccess.gov

Unofficial copies of pertinent C.F.R. citations and this pharmacist’s manual may be found on the 

internet at DEA’s Diversion website (under “publications”): 

www.DEAdiversion.usdoj.gov

Should any pertinent provisions of the law or regulations be modified in the future, DEA will issue a 

revised electronic version of this document, which will be posted on the DEA Diversion website. 

If you encounter errors in this document, please notify:

Drug Enforcement Administration

Attn: Liaison and Policy Section/ODL

8701 Morrissette Drive

Springfield, Virginia 22152

Inquiries regarding topics within this document may be addressed to your local DEA Diversion 

Field Office (Appendix K) or the address above.

Authorization for Public Dissemination 

All material in this publication is in the public domain and may be reproduced without the express 

permission of the Drug Enforcement Administration. 
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Message from the Acting Administrator 

The Drug Enforcement Administration is pleased to provide you with the 2010 edition of the 

Pharmacist's Manual to assist you in understanding the provisions of the Controlled Substances 

Act (CSA) and its implementing regulations. This manual will answer questions you may encounter 

in the practice of pharmacy and provide guidance in complying with the CSA regulations. This 

edition has been updated to include information on the provisions of the Combat 

Methamphetamine Epidemic Act of 2005, the Ryan Haight Online Pharmacy Consumer Protection 

Act of 2008, and the Interim Final Rule entitled Electronic Prescriptions for Controlled Substances.

Your role in the proper dispensing of controlled substances is critical to the health of patients and 

helps protect society against drug abuse and diversion. Your adherence to the CSA, together with 

its objectives and your compliance, is a powerful resource for protecting the public health, assuring 

patient safety, and preventing the diversion of controlled substances and drug products containing 

listed chemicals.

Sincerely,
Drug Enforcement Administration

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Preface 

The Drug Enforcement Administration (DEA) was established in 1973 to serve as the primary

agency responsible for the enforcement of federal drug laws. The Controlled Substances Act 

(CSA) and its implementing regulations establish federal requirements regarding both illicit and licit 

controlled substances. With respect to pharmaceutical controlled substances, DEA’s responsibility 

is twofold: to prevent diversion and abuse of these substances while ensuring an adequate and 

uninterrupted supply is available to meet the country’s legitimate medical, scientific, and research 

needs. In carrying out this mission, DEA works closely with state and local authorities and other 

federal agencies.

Under the framework of the CSA, all controlled substance transactions take place within a “closed 

system” of distribution established by Congress. Within this “closed system” all legitimate handlers 

of controlled substances – manufacturers, distributors, physicians, pharmacies, and others, must be 

registered with DEA (unless exempt) and maintain strict accounting for all controlled substance 

transactions.

To carry out this mission effectively, DEA seeks to educate its registrants regarding their legal 

obligations. It is DEA’s goal to maintain a positive working relationship with all of its registrants, 

including pharmacies. DEA understands that it can best serve the public interest by working with 

the pharmacy community to prevent the diversion of pharmaceutical controlled substances and 

scheduled listed chemical products (SLCPs) into the illicit market.

Federal controlled substance laws are designed to function in tandem with state controlled 

substance laws. DEA works in cooperation with state professional licensing boards and state and 

local law enforcement officials to make certain that pharmaceutical controlled substances are 

prescribed, administered, and dispensed for a legitimate medical purpose in the usual course of 

professional practice. Within this framework, the majority of investigations into possible violations 

of controlled substance laws are carried out by state authorities. DEA focuses its investigations on 

cases involving violators of the highest level or most significant impact.

In the event a state board revokes the license of a pharmacy, DEA will request a voluntary 

surrender of the pharmacy’s DEA registration. If the pharmacy refuses to surrender its registration, 

DEA will seek administrative action to revoke its DEA registration based on lack of state 

authorization. Additional administrative remedies that may be utilized to correct a lack of 

compliance include a letter of admonition or an administrative hearing. DEA may also pursue civil 

or criminal sanctions if there is sufficient evidence to justify a prosecution. All such actions are 

designed to protect the public health and safety. 

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. Chemicals such as 

ephedrine and pseudoephedrine contained in over the counter and prescription substances are 

immediate precursors used in the illicit manufacture of methamphetamine and amphetamine. 

These products may be purchased or stolen from retail outlets, including pharmacies, for use in 

clandestine laboratories.
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Pharmacies that sell over the counter products containing ephedrine and pseudoephedrine must 

be “self-certified” as required by the Combat Methamphetamine Epidemic Act of 2005 (CMEA). 

The CMEA created a new category of products designated as SLCPs. SLCPs are products 

containing ephedrine, pseudoephedrine, or phenylpropanolamine that may be marketed or 

distributed lawfully in the United States as a non-prescription drug under the Food, Drug, and 

Cosmetic Act. The retail provisions of the CMEA went into effect on September 30, 2006 and 

require, among other things, employee training, self certification, placement of SLCPs out of 

customer reach, required identification, sales logbooks, sales and purchase limits, and others.

DEA and the pharmacy profession have strong common interests in the appropriate use of 

controlled substances and SLCPs. An effective working relationship to ensure compliance with 

CSA requirements will continue to produce lasting benefits on a national scale. 
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SECTION II – SCHEDULES OF CONTROLLED SUBSTANCES 

The drugs and other substances that are considered controlled substances under the CSA are 

divided into five schedules. A listing of the substances and their schedules is found in the DEA 

regulations, 21 C.F.R. Sections 1308.11 through 1308.15. A controlled substance is placed in its 

respective schedule based on whether it has a currently accepted medical use in treatment in the 

United States and its relative abuse potential and likelihood of causing dependence. Some 

examples of controlled substances in each schedule are outlined below.

NOTE: Drugs listed in schedule I have no currently accepted medical use in treatment in the 

United States and, therefore, may not be prescribed, administered, or dispensed for medical use. 

In contrast, drugs listed in schedules II-V have some accepted medical use and may be prescribed, 

administered, or dispensed for medical use.

Schedule I Controlled Substances 

Substances in this schedule have a high potential for abuse, have no currently accepted medical 

use in treatment in the United States, and there is a lack of accepted safety for use of the drug or 

other substance under medical supervision. 

Some examples of substances listed in schedule I are: heroin, lysergic acid diethylamide (LSD),

marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine 

(“ecstasy”).

Schedule II Controlled Substances

Substances in this schedule have a high potential for abuse which may lead to severe 

psychological or physical dependence.

Examples of single entity schedule II narcotics include morphine and opium. Other schedule II 

narcotic substances and their common name brand products include: hydromorphone (Dilaudid®),

methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®), and fentanyl 

(Sublimaze® or Duragesic®).

Examples of schedule II stimulants include: amphetamine (Dexedrine®, Adderall®),

methamphetamine (Desoxyn®), and methylphenidate (Ritalin®). Other schedule II substances 

include: cocaine, amobarbital, glutethimide, and pentobarbital.

Schedule III Controlled Substances 

Substances in this schedule have a potential for abuse less than substances in schedules I or II 

and abuse may lead to moderate or low physical dependence or high psychological dependence. 

Examples of schedule III narcotics include combination products containing less than 15 milligrams 

of hydrocodone per dosage unit (Vicodin®) and products containing not more than 90 milligrams of 

codeine per dosage unit (Tylenol with codeine®). Also included are buprenorphine products 

(Suboxone® and Subutex®) used to treat opioid addiction.
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Examples of schedule III non-narcotics include benzphetamine (Didrex®), phendimetrazine, 

ketamine, and anabolic steroids such as oxandrolone (Oxandrin®). 

Schedule IV Controlled Substances

Substances in this schedule have a low potential for abuse relative to substances in schedule III.

An example of a schedule IV narcotic is propoxyphene (Darvon® and Darvocet-N 100®). 

Other schedule IV substances include: alprazolam (Xanax®), clonazepam (Klonopin®),

clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®),

temazepam (Restoril®), and triazolam (Halcion®).

Schedule V Controlled Substances 

Substances in this schedule have a low potential for abuse relative to substances listed in schedule 

IV and consist primarily of preparations containing limited quantities of certain narcotics. These are 

generally used for antitussive, antidiarrheal, and analgesic purposes. 

Examples include cough preparations containing not more than 200 milligrams of codeine per 100 

milliliters or per 100 grams (Robitussin AC® and Phenergan with Codeine®). 

Scheduled Listed Chemical Product (SLCP) 

An SLCP is defined as a product that contains ephedrine, pseudoephedrine, or 

phenylpropanolamine and may be marketed or distributed lawfully in the United States under the 

Federal Food, Drug, and Cosmetic Act as a nonprescription drug.
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SECTION III – REGISTRATION REQUIREMENTS

New Pharmacy Registration 

Every pharmacy that dispenses a controlled substance must be registered with the DEA. First, a 

state license must be obtained.

To register as a new pharmacy, the DEA Form 224 must be completed. The cost of the application 

fee is indicated 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.

The DEA Form 224 should be completed online (www.DEAdiversion.usdoj.gov). 

 

A paper version of the DEA Form 224 may be requested by writing to:

Drug Enforcement Administration

Attn: Registration Section/ODR

P.O. Box 2639

Springfield, Virginia 22152-2639

If a pharmacy needs a duplicate Certificate of Registration (DEA Form 223), a copy may be 

requested online via DEA’s Diversion website, www.DEAdiversion.usdoj.gov, or contact DEA 

Headquarters at 1-800-882-9539 or via e-mail at DEA.Registration.Help@usdoj.gov. 
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Renewal of Pharmacy Registration 

A pharmacy registration must be renewed every three years utilizing DEA Form 224a, Renewal 

Application for DEA Registration. The cost of the application fee is indicated on the application 

form. 

To renew a registration, the most current information from the pharmacy’s existing registration must 

be utilized. A registrant can renew online no more than 60 days prior to the current expiration date. 

The DEA Form 224a should be completed online and can be found at 

www.DEAdiversion.usdoj.gov. 

 

If the registrant has not renewed online approximately 50 days before the registration expiration 

date, a renewal application is sent to the registrant at the mailing address listed on the current 

registration. If the renewal form is not received by the 30th day before the expiration date of the 

current registration, the pharmacy should contact the local DEA Registration Specialist (Appendix 

J) or DEA Headquarters at 1-800-882-9539 and request a renewal registration form.
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NOTE: Once the expiration date has passed and no renewal has been received by DEA, the 

pharmacy has no authority to handle controlled substances.

 

Affidavit for Renewal of Retail Chain Pharmacy Registration 

Corporations that own or operate a chain of pharmacies may submit a single DEA Form 224b

The original affidavit along with the registration application fee and the list of registrations should 

be mailed to:

,

Retail Pharmacy Registration Affidavit for Chain Renewal. This affidavit, along with a list of the 

corporation's registrations, is provided in lieu of a separate registration 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 registrations covered by the affidavit. A responsible individual must answer the 

questions listed on the affidavit on behalf of the corporation as they pertain to each registrant.

Registration Chain Renewal

Drug Enforcement Administration

Attn: Registration Section/ODR

P.O. Box 2639

Springfield, Virginia 22152-2639

Change of Business Address 

A pharmacy that moves to a new physical location must request a modification of registration. 

Modifications are handled in the same manner as applications and must be approved by DEA. 

A modification of registration can be requested online at www.DEAdiversion.usdoj.gov or in writing 

to the local DEA Registration Specialist (Appendix J) responsible for the area in which the 

pharmacy is located. If the change of address involves a change in state, the proper state issued 

license and, if applicable, controlled substances registration must be obtained prior to the approval 

of modification of the federal registration. If the modification is approved, DEA will issue a new 

certificate of registration and, if requested, new schedule II order forms (DEA Form 222). The 

registrant should maintain the new certificate with the old certificate until expiration. A Renewal 

Application for Registration (DEA Form 224a) will only be sent to the mailing address on file with 

DEA. It will not be forwarded.

Termination of Registration 

A pharmacy that discontinues business activities either completely or only regarding controlled 

substances must return its DEA registration certificate and unused official order forms (DEA Form 

222) to the local DEA Registration Specialist (Appendix J). In addition, DEA may ask for the 

location of where inventories, prescriptions, and other required controlled substance records will be 

stored during the requisite two-year retention period. 

Unwanted controlled substances in the pharmacy’s possession must be disposed of in accordance 

with DEA regulations (see Section IV, Transfer or Disposal of Controlled Substances).
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Transfer of Business 

A pharmacy registrant that transfers its business operations to another pharmacy registrant must 

submit in person or by registered or certified mail, return receipt requested, to the Special Agent in 

Charge in his/her area, at least 14 days in advance of the date of the proposed transfer (unless the 

Special Agent in Charge waives this time limitation in individual instances), the following 

information:

1. The name, address, registration number, and authorized business activity of the registrant 

discontinuing the business (registrant-transferor);

2. The name, address, registration number, and authorized business activity of the person 

acquiring the business (registrant-transferee);

3. Whether the business activities will be continued at the location registered by the person 

discontinuing business, or moved to another location (if the latter, the address of the new 

location should be listed); and 

4. The date on which the transfer of controlled substances will occur.

On the day the controlled substances are transferred, a complete inventory must be taken and a 

copy of the inventory must be included in the records of both the person transferring the business 

and the person acquiring the business. This inventory will serve as the final inventory for the 

registrant going out of business and transferring the controlled substances. It will also serve as the 

initial inventory for the registrant acquiring the controlled substances. It is not necessary to send a 

copy of the inventory to the DEA unless requested by the Special Agent in Charge. 

To transfer schedule II controlled substances, the receiving registrant must issue an official order 

form (DEA Form 222) or an electronic equivalent to the registrant transferring the drugs. The 

transfer of schedules III-V controlled substances must be documented in writing to show the drug 

name, dosage form, strength, quantity, and date transferred. The document must include the 

names, addresses, and DEA registration numbers of the parties involved in the transfer of the 

controlled substances. 

All controlled substance records required to be kept by the registrant-transferor shall be transferred 

to the registrant-transferee. Responsibility for the accuracy of records prior to the date of transfer 

remains with the transferor, but responsibility for custody and maintenance shall be upon the 

transferee.

If the registrant acquiring the pharmacy owns at least one other pharmacy licensed in the same 

state as the pharmacy being transferred, the registrant may apply for a new DEA registration prior 

to the date of transfer. DEA will issue a registration which will authorize the registrant to obtain 

controlled substances at the time of transfer, but the registrant may not dispense controlled 

substances until the pharmacy has been issued a valid state pharmacy license.

A DEA registration application to transfer ownership of an existing pharmacy can be facilitated if 

the applicant includes an affidavit 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.
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Denial, Suspension, or Revocation of Registration 

Under the CSA (21 U.S.C. § 824 (a)), DEA has the authority to deny, suspend, or revoke a DEA 

registration upon a finding that the registrant:

1. Has materially falsified the application;

2. Has been convicted of a felony relating to a controlled substance or a List I chemical;

3. Had a State license or registration suspended, revoked, or denied by a competent State 

authority and is no longer authorized by State law to engage in the manufacturing, 

distribution, or dispensing of controlled substances or List I chemicals or has had the 

suspension, revocation, or denial of a registration recommended by competent State 

authority;

4. Has committed an act which would render the DEA registration inconsistent with the public 

interest; or

5. Has been excluded (or directed to be excluded) from participation in a program pursuant to 

Title 42 U.S.C. § 1320a-7(a), that is, a Medicaid or Medicare program.

Denial of Registration in the Public Interest 

In determining the public interest, the CSA states the following factors are to be considered

(21 U.S.C. § 823 (f)): 

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.

Chemical Registration Requirements 

Registration is not required for regulated sellers of SLCPs. However, a regulated seller must selfcertify with DEA pursuant to federal law (see Section XIV, Self-Certification). A regulated seller is 

defined as a grocery store, general merchandise store, drug store, or other entity engaged in overthe-counter sales of ephedrine (both single-entity and combination products), pseudoephedrine, or 

phenylpropanolamine products, directly to walk-in customers or in face-to-face transactions by 

direct sales. A mobile retail vendor is defined as a person or entity that makes sales at retail from a 

stand that is intended to be temporary or is capable of being moved from one location to another. 

Federal law requires any person who is engaged in the wholesale distribution of an SLCP to obtain 

a registration as a chemical distributor. A distributor who does not meet all the requirements for a

regulated seller of SLCPs, or who does not meet the requirements for distributors required to 

submit “mail-order” reports, is a wholesale distributor. 
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Note: this would include those pharmacies that sell quantities of SLCPs to institutions, including 

long term care facilities, jails, and other institutional-type settings for non-patient specific use. Such 

pharmacies are often referred to as “closed door” pharmacies.

Retail pharmacies that are registered to handle controlled substances need not obtain a separate 

DEA chemical registration for retail distribution of SLCPs. If a pharmacy desires to engage in the 

wholesale distribution of bulk quantities of SLCPs, the pharmacy is required to register with DEA as 

a chemical distributor because these activities fall outside the definition of a regulated seller. 

Therefore, the pharmacy would be subject to the registration requirements that apply to wholesale 

distributors for those distribution activities, and subject to the pharmacy requirements for its 

pharmacy activities. To obtain a DEA chemical distributor registration, a pharmacy may complete 

the DEA Form 510 online at www.DEAdiversion.usdoj.gov. A paper version may be requested by 

writing to:

Drug Enforcement Administration

Attn: Registration Section/ODR

P.O. Box 2639

Springfield, Virginia 22152-2639
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SECTION IV – TRANSFER OR DISPOSAL OF CONTROLLED SUBSTANCES 

Transfer of Controlled Substances 

A pharmacy may hire an outside firm to inventory, package, and arrange for the transfer of its 

controlled substances to another pharmacy, the original supplier, or the original manufacturer. The 

pharmacy is responsible for the actual transfer of the controlled substances and for the accuracy of 

the inventory and records. The records involving the transfer of controlled substances must be 

kept readily available by the pharmacy for two years for inspection by the DEA. 

To transfer schedule II substances, the receiving registrant must issue an official order form (DEA 

Form 222) or an electronic equivalent to the registrant transferring the drugs. The transfer of 

schedules III-V controlled substances must be documented in writing to show the drug name,

dosage form, strength, quantity, and date transferred. The document must include the names, 

addresses, and DEA registration numbers of the parties involved in the transfer of the controlled 

substances.

Transfer to a Pharmacy 

If a pharmacy goes out of business or is acquired by a new pharmacy, it may transfer the controlled 

substances to another pharmacy. On the day the controlled substances are transferred, a 

complete inventory must be taken which documents the drug name, dosage form, strength, 

quantity, and date transferred. In addition, DEA Form 222 or the electronic equivalent must be 

prepared to document the transfer of schedule II controlled substances. This inventory will serve 

as the final inventory for the registrant going out of business and transferring the controlled 

substances. It will also serve as the initial inventory for the registrant acquiring the controlled 

substances. A copy of the inventory must be included in the records of each pharmacy. It is not 

necessary to send a copy of the inventory to the DEA. The pharmacy acquiring the controlled 

substances must maintain all records involved in the transfer of the controlled substances for two 

years.

 

Transfer to the Original Supplier or Original Manufacturer 

Any pharmacy may transfer controlled substances to the original supplier or the original

manufacturer that is appropriately registered with the DEA. The pharmacist must maintain a 

written record showing:

1. The date of the transaction.

2. The name, strength, dosage form, and quantity of the controlled substance.

3. The supplier or manufacturer’s name, address, and registration number.

The DEA Form 222 or the electronic equivalent will be the official record for the transfer of 

schedule II controlled substances.
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Disposal of Controlled Substances 

A pharmacy may transfer controlled substances to a DEA registered reverse distributor who 

handles the disposal of controlled substances. The pharmacy should contact the local DEA 

Diversion Field Office (Appendix K) for an updated list of DEA registered reverse distributors. 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 disposal of controlled substances must not be 

construed as altering in any way the state laws or regulations for the disposal of controlled 

substances. 

Reverse Distributors Authorized to Dispose Controlled Substances 

A pharmacy may forward controlled substances to a DEA registered reverse distributor who 

handles the disposal of controlled substances. When a pharmacy transfers schedule II controlled 

substances to a reverse distributor for destruction, the reverse distributor must issue an official 

order form (DEA Form 222) or the electronic equivalent to the pharmacy. When schedules III-V 

controlled substances are transferred to a reverse distributor for destruction, the pharmacy must 

maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date 

transferred. The DEA registered reverse distributor who will destroy the controlled substances is 

responsible for submitting a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the 

DEA when the controlled substances have been destroyed. A DEA Form 41 should not be used to 

record the transfer of controlled substances between the pharmacy and the reverse distributor 

disposing of the drugs.

A paper version of the DEA Form 41 may be requested by writing to:

Drug Enforcement Administration

Attn: Registration Section/ODR

P.O. Box 2639

Springfield, Virginia 22152-2639

Disposal of Controlled Substances by Persons Not Registered with DEA 

On January 21, 2009, DEA published in the Federal Register an Advance Notice of Proposed 

Rulemaking (ANPRM), Disposal of Controlled Substances by Persons Not Registered with the 

Drug Enforcement Administration. This ANPRM sought comments on how to address the issue of 

disposal of dispensed controlled substances held by DEA nonregistrants (i.e., ultimate users, long 

term care facilities). DEA was interested in the possible options that would enable nonregistrants 

to dispose of unwanted controlled substances, while also protecting public health and public safety, 

and minimizing the possibility of diversion. The public comment period for this ANPRM ended on 

March 23, 2009.

 
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SECTION V – SECURITY REQUIREMENTS 

Requests for Employment Waivers for Certain Pharmacy Employees 

Under 21 C.F.R. § 1301.76(a), a registrant must not employ in a position which allows access to 

controlled substances any person who has been convicted of a felony relating to controlled 

substances, or who, at any time, has had an application for DEA registration denied, revoked, or 

surrendered for cause. "For cause" means surrendering a registration in lieu of, or as a 

consequence of, any federal or state administrative, civil, or criminal action resulting from an 

investigation of the individual’s handling of controlled substances.

However, 21 C.F.R. § 1307.03 does permit registrants desiring to employ an individual who meets 

this definition to request an exception to this requirement. The employer must have a waiver 

approved before allowing such an employee or prospective employee to have access to controlled 

substances. A waiver request should be sent by the employer to the following address:

Drug Enforcement Administration

Attn: Regulatory Section/ODG

8701 Morrissette Drive

Springfield, Virginia 22152

A registrant that applies for such a waiver should understand that the following factors will be 

considered by the DEA in the approval process and should provide details relevant to each factor 

as part of the waiver request submitted, since a waiver will not be considered unless there are valid 

reasons to believe that diversion is unlikely to occur:

1. A detailed description of the nature and extent of the individual’s past controlled 

substances violations, including all pertinent documentation;

2. Current status of the individual’s state licensure;

3. Extent of individual’s proposed access to controlled substances. “Access” is not 

limited to only physical access to controlled substances, but includes any influence 

over the handling of controlled substances;

4. Registrant’s proposed physical and professional safeguards to prevent diversion by 

the individual;

5. Status of employing registrant regarding handling of controlled substances;

6. Other pertinent information uncovered by DEA in its investigation of the individual’s 

or registrant’s handling of controlled substances; and

7. All other relevant factors or materials.

Controlled Substance Theft or Significant Loss 

Should a theft or significant loss of any controlled substance occur at a pharmacy, the following 

procedures must be implemented within one business day of the discovery of the theft or loss.
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A. Notify DEA and Local Police

The theft of controlled substances from a registrant is a criminal act and a source of diversion that 

requires notification to DEA. A pharmacy must notify in writing the local DEA Diversion Field Office 

(Appendix K) within one business day of discovery of a theft or significant loss of a controlled 

substance. Although not specifically required by federal law or regulations, the registrant should 

also notify local law enforcement and state regulatory agencies. Prompt notification to 

enforcement agencies will allow them to investigate the incident and prosecute those responsible 

for the diversion. 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 and local law enforcement 

authorities.

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 or 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 in writing within one 

business day upon discovery and keep a copy of that notice for its records. The notice must be 

signed by an authorized individual of the registrant.

B. Complete DEA Form 106

A pharmacy must also complete a DEA Form 106 (Report of Theft or Loss of Controlled 

Substances) which can be found online at www.DEAdiversion.usdoj.gov under the Quick Links 

section. The DEA Form 106 is used to document the actual circumstances of the theft or 

significant loss and the quantities of controlled substances involved. A paper version of the form 

can be obtained by writing to:

Drug Enforcement Administration

Attn: Registration Section/ODR

8701 Morrissette Drive

Springfield, Virginia 22152

If completing the paper version, the pharmacy should send the original DEA Form 106 to the local 

DEA Diversion Field Office (Appendix K) and keep a copy for its records. Please see the 

Guidelines for Completing the DEA Form 106 (Appendix I) for additional guidance.

The DEA Form 106 must include the following information:

1. Name and address of the firm (pharmacy),

2. DEA registration number,

3. Date of theft or loss (or when discovered if not known),

4. Name and telephone number of local police department (if notified),

5. Type of theft (e.g., night break-in, armed robbery),

6. List of identifying marks, symbols, or price codes (if any) used by the pharmacy on the labels 

of the containers, and

7. A listing of controlled substances missing, including the strength, dosage form, and size of 

container (in milliliters if liquid form) or corresponding National Drug Code numbers.
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C. If Investigation Finds No Theft or Loss

If, after the initial notification to DEA, the investigation of the theft or loss determines no such theft 

or loss of controlled substances occurred, a DEA Form 106 does not need to be filed. However, 

the registrant must notify DEA in writing of this fact in order to resolve the initial report and explain 

why no DEA Form 106 was filed regarding the incident.

D. Registrant’s Responsibility for Identifying "Significant Loss"

Although the CSA regulations do not define the term "significant loss," it is the responsibility of the 

registrant to use his/her best judgment to take appropriate action. Whether a “significant loss” has 

occurred depends, in large part, on the business of the pharmacy and the likelihood of a rational 

explanation for a particular occurrence. What would constitute a significant loss for a pharmacy 

may be viewed as comparatively insignificant for a hospital or manufacturer.

Further, the loss of a small quantity of controlled substances, repeated over a period of time, may 

indicate a significant problem for a registrant, which must be reported. The burden of responsibility 

is on the registrant to identify what is a significant loss and make the required report to DEA. 

When determining whether a loss is significant, a registrant should consider, among others, the 

following factors:

1. The actual quantity of controlled substances lost in relation to the type of business;

2. The specific controlled substances;

3. Whether the loss of the controlled substances can be associated with access to those 

controlled substances by specific individuals, or whether the loss can be attributed to unique 

activities that may take place involving the controlled substances;

4. A pattern of losses over a specific time period, whether the losses appear to be random, and 

the results of efforts taken to resolve the losses; and, if known

5. Whether the specific controlled substances are likely candidates for diversion; and 

6. Local trends and other indicators of the diversion potential of the missing controlled 

substances.

If it is determined that the loss is not significant, the registrant should place a record of the 

occurrence in a theft and loss file for future reference. Miscounts or adjustments to inventory 

involving clerical errors on the part of the pharmacy should not be reported on a DEA Form 106, 

but rather should be noted in a separate log at the pharmacy management’s discretion.

In-Transit Loss 

When all or part of an in-transit shipment of controlled substances fails to reach its intended 

destination, the supplier is responsible for reporting the in-transit loss of controlled substances to 

DEA. The purchaser is responsible for reporting any loss of controlled substances after he/she has

signed for or taken custody of a shipment. If it is discovered after that point that an in-transit loss or 

theft has occurred; the purchaser must then submit a DEA Form 106. If the purchaser does not 

take custody of the shipment and instead returns it to the supplier, it is the supplier’s responsibility 

for reporting any loss of controlled substances in the original shipment.
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In-Transit Loss from Central Fill Pharmacy 

Central fill pharmacies must comply with 21 C.F.R. § 1301.74(e) when selecting private, common 

or contract carriers to transport filled prescriptions to a retail pharmacy for delivery to an ultimate 

user. Pursuant to 21 C.F.R. § 1301.76(d), when a central fill pharmacy contracts with private, 

common or contract carriers to transport filled prescriptions to a retail pharmacy, the central fill 

pharmacy is responsible for reporting the in-transit loss upon discovery of such loss by use of a 

DEA Form 106. In addition, when a retail pharmacy contracts with private, common or contract 

carriers to retrieve filled prescriptions from a central fill pharmacy, the retail pharmacy is 

responsible for reporting in-transit losses upon discovery using a DEA Form 106.

Breakage and Spillage 

The breakage or spillage of controlled substances does not constitute a "loss" of controlled 

substances. When there is breakage, damage, or spillage or some other form of destruction, any 

recoverable controlled substances must be disposed of according to DEA requirements. When this 

disposal occurs, it must be reported to DEA on a DEA Form 41 (Registrants Inventory of Drugs 

Surrendered). Damaged goods may also be disposed of through shipment to a reverse distributor 

or by a DEA approved process as defined in Section IV, Transfer or Disposal of Controlled 

Substances. 

 

A paper version of the DEA Form 41 may be requested by writing to:

Drug Enforcement Administration

Attn: Registration Section/ODR

8701 Morrissette Drive

Springfield, Virginia 22152

Robberies and Burglaries Involving Controlled Substances 

The Controlled Substance Registrant Protection Act of 1984 (CSRPA) was enacted to protect DEA 

registrants against certain crimes (see Title 18 U.S.C. § 2118 for a complete text of CSRPA). The 

CSRPA provides for the federal investigation of controlled substances thefts and robberies if any of 

the following conditions are met:

1. The replacement cost of the controlled substances taken is $500 or more.

2. Interstate or foreign commerce was involved in the execution of the crime.

3. A person was killed or suffered significant bodily injury as a result of the crime.

Penalties Upon Conviction - The perpetrator(s) convicted of violating CSRPA’s provisions may be 

subject to the following penalties:

1. Burglary or robbery - a maximum $25,000 fine and/or 20 years imprisonment.

2. If a dangerous weapon was used to carry out the crime - a maximum $35,000 fine and/or 25 

years imprisonment.

3. If death resulted from the crime - a maximum $50,000 fine and/or life imprisonment.
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SECTION VI – RECORDKEEPING REQUIREMENTS 

Every pharmacy must maintain complete and accurate records on a current basis for each 

controlled substance purchased, received, stored, distributed, dispensed, or otherwise disposed of. 

These records are required to provide accountability of all controlled substances from the 

manufacturing process through the dispensing pharmacy and to the ultimate user. The closed 

system reduces the potential for diversion of controlled substances. 

All required 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 schedules 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. Recordkeeping requirements for prescriptions are 

detailed in Section VI, Prescription Records.

 

Readily retrievable is defined as:

1. Records kept by automatic data processing systems or other electronic or mechanized 

recordkeeping systems in such a manner that they can be separated out from all other 

records in a reasonable time, and/or

2. Records kept in such a manner that certain items are asterisked, redlined, or in some other 

manner visually identifiable apart from other items appearing on the records.

Required Records 

 

The records which must be maintained by a pharmacy are:

1. Executed and unexecuted official order forms (DEA Form 222) or the electronic equivalent

2. Power of Attorney authorization to sign order forms

3. Receipts and/or invoices for schedules III, IV, and V controlled substances

4. All inventory records of controlled substances, including the initial and biennial inventories, 

dated as of beginning or close of business

5. Records of controlled substances distributed (i.e., sales to other registrants, returns to 

vendors, distributions to reverse distributors)

6. Records of controlled substances dispensed (i.e., prescriptions, schedule V logbook)

7. Reports of Theft or Significant Loss (DEA Form 106), if applicable

8. Inventory of Drugs Surrendered for Disposal (DEA Form 41), if applicable

9. Records of transfers of controlled substances between pharmacies

10.DEA registration certificate

11.Self-certification certificate and logbook (or electronic equivalent) as required under the 

Combat Methamphetamine Epidemic Act of 2005 
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Central Recordkeeping 

A registrant desiring to maintain shipping and financial records (but not executed official order 

forms) at a central location rather than the registered location must submit written notification of 

his/her intention by registered or certified mail, return receipt requested, in triplicate, to the Special 

Agent in Charge of the local DEA Diversion Field Office in which the registrant is located (Appendix 

K). 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 DEA receives this 

notification. Central recordkeeping requirements are described in 21 C.F.R. § 1304.04. Central 

recordkeeping permits are no longer issued by the DEA.

Prescription Records 

 

Pharmacies have two options for filing paper prescription records and one option for electronic 

prescription records. 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. All prescription records must be readily retrievable for DEA 

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

 Paper Prescriptions Records Option 1 (Three separate files):

1. A file for schedule II controlled substances dispensed.

2. A file for schedules III, IV and V controlled substances dispensed.

3. A file for all noncontrolled drugs dispensed.

 Paper Prescriptions Records Option 2 (Two separate files):

1. A file for all schedule II controlled substances dispensed.

2. A file for all other drugs dispensed (noncontrolled and those in schedules III, IV and V). If 

this method is used, a prescription for a schedule III, IV or V drug must be made readily 

retrievable by use of a red "C" stamp not less than one inch high. If a pharmacy has an 

electronic recordkeeping system for prescriptions which permits identification by prescription 

number and retrieval of original documents by prescriber’s name, patient’s name, drug 

dispensed, and date filled, the requirement to mark the hard copy with a red “C” is waived.

 Electronic Prescription Records 

 

1. If a prescription is created, signed, transmitted, and received electronically, all records 

related to that prescription must be retained electronically. 

2. Electronic records must be maintained electronically for two years from the date of their 

creation or receipt. However, this record retention requirement shall not pre-empt any 

longer period of retention which may be required now or in the future, by any other Federal 

or State law or regulation, applicable to pharmacists or pharmacies.

3. Records regarding controlled substances must be readily retrievable from all other records. 

Electronic records must be easily readable or easily rendered into a format that a person 

can read.
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Records of electronic prescriptions for controlled substances shall be maintained in an application 

that meets the requirements of 21 C.F.R. §1311. The computers on which the records are 

maintained may be located at another location, but the records must be readily retrievable at the 

registered location if requested by the DEA or other law enforcement agent. The electronic 

application must be capable of printing out or transferring the records in a format that is readily 

understandable to an Administration or other law enforcement agent at the registered location. 

Electronic copies of prescription records must be sortable by prescriber name, patient name, drug 

dispensed, and date filled.
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SECTION VII – INVENTORY REQUIREMENTS 

An “inventory” is a complete and accurate list of all stocks and forms of controlled substances in 

the possession of the registrant as determined by an actual physical count for schedule II 

controlled substances and an estimated count or measure of the contents of a schedule III, IV, or V 

controlled substance (unless the container holds more than 1,000 tablets or capsules in which case 

an exact count of the contents must be made). The CSA also requires that all inventory records be 

maintained at the registered location in a readily retrievable manner for at least two years for 

copying and inspection. In addition, the inventory records of schedule II controlled substances 

must be kept separate from all other controlled substances.

Initial Inventory 

When issued a DEA registration, a registrant must take an initial inventory, which is an actual 

physical count of all controlled substances in their possession. If there are no stocks of controlled 

substances on hand, the registrant should make a record showing a zero inventory. There is no 

requirement to submit a copy of the inventory to the DEA. The C.F.R. requires that the inventory 

include:

1. The date of the inventory,

2. Whether the inventory was taken at the beginning or close of business,

3. The name of each controlled substance inventoried,

4. The finished form of each of the substances (e.g., 10 milligram tablet),

5. The number of dosage units of each finished form in the commercial container

 (e.g., 100 tablet bottle),

6. The number of commercial containers of each finished form (e.g., four 100 

 tablet bottles), and 

7. A count of the substance - if the substance is listed in schedule II, an exact count 

or measure of the contents or if the substance is listed in schedules III, IV, or V, an 

estimated count or measure of the contents, unless the container holds more than 

1,000 tablets or capsules in which case, an exact count of the contents is required.

DEA recommends, but does not require, an inventory record include the name, address, and DEA 

registration number of the registrant, and the signature of the person or persons responsible for 

taking the inventory.

Biennial Inventory 

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.

Newly Scheduled Controlled Substance Inventory

When a drug not previously listed as a controlled substance is scheduled or a drug is rescheduled, 

the drug must be inventoried as of the effective date of scheduling or change in scheduling.
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SECTION VIII – ORDERING CONTROLLED SUBSTANCES 

Ordering Schedule II Controlled Substances 

Only schedules I and II controlled substances are ordered with an official order form, DEA Form 

222, or the electronic equivalent (see below, Controlled Substance Ordering System (CSOS) –

Electronic Order Forms). A DEA Form 222 is required for each distribution, purchase, or transfer of 

a schedule II controlled substance.

When a controlled substance has been moved by DEA from schedule II to another schedule at the 

federal level, in many states it may remain a schedule II controlled substance pending any 

legislative or administrative action that may result from the federal action. Many states require 

transactions that involve substances they classify as schedule II be made via official order forms 

(DEA Form 222) or the electronic equivalent. When federal law or regulations differ from state law 

or regulations, a pharmacy is required to abide by the more stringent aspects of both the federal 

and state requirements. When the use of DEA Form 222 or the electronic equivalent for the 

transfer of a controlled substance is not required under federal law, its use as mandated by these 

states does not violate federal law and is therefore permitted.

Requesting Official Order Forms 

The unexecuted DEA Form 222 can be requested initially by checking "block 3" on the application 

for a new registration (DEA Form 224). The DEA Form 224 can be found online at 

www.DEAdiversion.usdoj.gov.

Once a registrant has received a DEA registration number, additional DEA Forms 222 may be 

ordered online at www.DEAdiversion.usdoj.gov. When requesting additional DEA Forms 222

online, a valid DEA registration number, business name, and contact telephone number are 

required. The registrant may also request DEA Forms 222 by calling the DEA Headquarters 

Registration Section at 1-800-882-9539 or by contacting the local DEA Registration Specialist

(Appendix J).

Each book of DEA Form 222 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 local DEA Registration Specialist (Appendix J) to request additional books.

Completing Official Order Forms 

When ordering schedule II controlled substances, the purchaser is responsible for filling in the 

number of packages, the size of the package, and the name of the item. Each DEA Form 222 must 

be signed and dated by a person authorized to sign a registration application or a person granted 

power of attorney (see below, Power of Attorney to Sign an Official Order Form). When the items 

are received, the pharmacist must document on the purchaser’s copy (copy three) the actual 

number of packages received and the date received.
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The executed DEA Form 222 must be maintained separately from the pharmacy’s other business 

records. However, this does not preclude a registrant from attaching a copy of the supplier's 

invoice to the related DEA Form 222.

Title 21 C.F.R. § 1305.15(a)(1) requires that, for orders using the DEA Form 222, an order must not 

be filled if the order is not complete, legible, or properly prepared, executed, or endorsed, or if the 

order shows any alteration, erasure, or change of any description. For a discussion of the 

circumstances in which an electronic order must not be filled see below, Controlled Substance 

Ordering System (CSOS) – Electronic Order Forms.

A supplier may refuse to accept an order for any reason as set forth under 21 C.F.R. § 1305.15(c). 

If a supplier refuses to accept an order, a statement that the order is not accepted is sufficient. If 

an order is refused, the supplier must return copies one and two of the DEA Form 222 to the 

purchaser with a statement explaining the reason the order was refused. For electronic orders, the 

supplier must notify the purchaser and provide a statement as to the reason (see below, Controlled 

Substance Ordering System (CSOS) – Electronic Order Forms).

DEA policy does not preclude the substitution of identical products differing in packaging size from 

those initially ordered, provided that the actual quantity received does not exceed the amount 

initially ordered and that the National Drug Code number reflected is that of the actual product 

shipped. For example, a distributor may substitute five bottles of 100, 2 milligram tablets for one

bottle of 500, 2 milligram tablets or any variation thereof.

Cancellation and Voiding an Official Order Form

A purchaser may cancel an order (or partial order) on a DEA Form 222 by notifying the supplier in 

writing. The supplier must indicate the cancellation on Copies 1 and 2 of the DEA Form 222 by 

drawing a line through the cancelled item(s) and printing “cancelled” in the space provided for the 

number of items shipped.

A supplier may void part or all of an order on a DEA Form 222 by notifying the purchaser in writing. 

The supplier must indicate the voiding in Copies 1 and 2 of the DEA Form 222 by drawing a line 

through the cancelled item(s) and printing “void” in the space provided for the number of items 

shipped. For information regarding cancelled electronic orders, see below, Controlled Substance 

Ordering System (CSOS) – Electronic Order Forms.

Power of Attorney to Sign an Official Order Form 

Any registrant (pharmacy) may authorize one or more individuals, whether or not they are located 

at the registered location, to obtain and execute DEA Forms 222 by granting a power of attorney to 

each such individual. The power of attorney must be signed by the same person who signed the 

most recent application for registration or renewal registration, as well as the individual being 

authorized to obtain and execute the DEA Forms 222. 

The power of attorney may be revoked at any time by the person who granted and signed the 

power of attorney. Only if the renewal application is signed by a different person is it necessary to
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grant a new power of attorney when the pharmacy completes a renewal registration. The power of 

attorney should be filed with executed DEA Forms 222 as a readily retrievable record. The power 

of attorney is not submitted to DEA.

Suggested formats for granting and revoking a power of attorney follow:

Power of Attorney for DEA Forms 222 and Electronic Orders

 

_________________________ (Name of registrant)

_________________________(Address of registrant)

_________________________(DEA registration number)

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 presents, do make, constitute, and appoint 

_________________________________(name of attorney-in-fact), 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.

_____________________________

(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.

_______________________

(Signature of attorney-in-fact)

Witnesses:

1. _______________________

2. _______________________

Signed and dated on the ___ day of ____________in the year____ at .

Notice of Revocation

The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign 

the current application for registration of the above-named registrant under the Controlled 

Substances Act. Written notice of this revocation has been given to the attorney-in-fact 

____________________________ this same day.

_____________________________

(Signature of person revoking power)
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Witnesses:

1. ______________________

2. ______________________

Signed and dated on the ___ day of ____________in the year____ at . 

Lost or Stolen Order Forms 

When a pharmacist has not received an expected shipment of controlled substances, he/she 

should first contact the supplier to determine whether the original DEA Form 222 was received. If 

the original order form has been lost or stolen, the pharmacist must complete a second order form 

so the supplier can fill the original order. The pharmacist must also prepare a statement which 

includes the first order form’s serial number and date, and verify that the drugs ordered were never 

received. The pharmacy must attach a copy of the statement to the second order form that is sent 

to the supplier. In addition, the pharmacist must keep a copy of the statement with copy three from 

the first and second order forms.

A pharmacy, upon discovery of the loss or theft of used or unused order forms, must immediately 

report the loss to the local DEA Diversion Field Office (Appendix K) and provide the serial numbers 

of each lost or stolen order form. If an entire book or multiple books of order forms are lost or 

stolen, and the serial numbers of the missing forms cannot be identified, the pharmacist must 

report the approximate date of issuance (in lieu of the serial numbers) to the DEA. If an unused 

order form reported stolen or lost is later recovered or found, the pharmacy must immediately notify 

the local DEA Diversion Field Office.

Controlled Substance Ordering System (CSOS) – Electronic Order Forms 

Any registrant permitted to order schedule II controlled substances may do so electronically via the 

DEA Controlled Substance Ordering System (CSOS) and maintain the records of these orders 

electronically for two years. The use of electronic orders is optional; registrants may continue to 

issue orders on a paper DEA Form 222. CSOS allows for secure electronic transmission of 

controlled substance orders without the supporting paper DEA Form 222. The adoption of the 

CSOS standards is the only allowance for the electronic transmission of schedule II controlled 

substance orders between controlled substance manufacturers, distributors, pharmacies, and other 

DEA authorized entities. CSOS uses Public Key Infrastructure (PKI) technology, which requires 

CSOS users to obtain a CSOS digital certificate for electronic ordering. The electronic orders must 

be signed using a digital signature issued by a Certification Authority (CA) run by the DEA. 

Digital certificates can be obtained only by registrants and individuals granted power of attorney by 

registrants to sign orders. A registrant must appoint a CSOS coordinator who will serve as that 

registrant's recognized agent regarding issues pertaining to issuance of, revocation of, and 

changes to, digital certificates issued under that registrant's DEA registration. A CSOS digital 

certificate will be valid until the DEA registration under which it is issued expires or until the CSOS 

CA is notified that the certificate should be revoked. Certificates will be revoked if the certificate 

holder is no longer authorized to sign schedule II orders for the registrant, if the information on 

which the certificate is based changes, or if the digital certificate used to sign electronic orders has 

been compromised, stolen, or lost.
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A “Questions and Answers” page about the CSOS certificate is available on the DEA E-Commerce 

Program website at www.DEAecom.gov. Applicants can download the Diversion PKI CSOS 

Enrollment document and the CSOS Subscriber’s Manual for assistance on the enrollment 

process. DEA maintains a support line to assist applicants and subscribers with issues pertaining 

to certificate enrollment, issuance, revocation, and renewal. Staff is available from 8:00 a.m. to 

6:00 p.m. (Eastern Time), Monday through Friday at 1-877-332-3266 if further assistance is 

needed.

Unaccepted and Defective Electronic Orders 

 

An electronic order for controlled substances may not be filled if any of the following occurs:

1. The required data fields have not been completed.

2. The order is not signed using a digital certificate issued by DEA.

3. The digital certificate used has expired or been revoked prior to signature.

4. The purchaser’s public key will not validate the digital certificate.

5. The validation of the order shows that the order is invalid for any reason.

If an order cannot be filled, the supplier must notify the purchaser and provide a statement as to the 

reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any 

order. If a supplier refuses, a statement that the order is not accepted is sufficient.

When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must 

electronically link the statement of nonacceptance to the original order. The original statement 

must be retained for two years. Neither a purchaser nor a supplier may correct a defective order. 

The purchaser must issue a new order for the order to be filled.

Cancellation and Voiding of Electronic Orders 

A supplier may void all (or part) of an electronic order by notifying the purchaser of the voiding. If 

the entire order is voided, the supplier must make an electronic copy of the order and indicate 

“Void” on the copy and return it to the purchaser. The supplier is not required to retain a record of 

orders that are not filled. The purchaser must retain an electronic copy of the voided order. Should 

a supplier partially void an order, the supplier must indicate in the linked record that nothing was 

shipped for each item voided.

Lost Electronic Orders 

If a purchaser determines that an unfilled electronic order has been lost before or after receipt, the 

purchaser must provide, to the supplier, a signed statement. This statement must include the 

unique tracking number and date of the lost order and state that the goods covered by the first 

order were not received through loss of that order. If the purchaser executes a new order to 

replace the lost order, the purchaser must electronically link an electronic record of the second 

order and a copy of the statement with the record of the first order and retain them both. If the 

supplier to whom the order was directed subsequently receives the first order, the supplier must 

indicate that it is “not accepted” and return it to the purchaser. The purchaser must link the 

returned order to the record of that order and the statement.
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Ordering Schedules III-V Controlled Substances 

The registrant must keep a receipt (invoice or packing slip) on which it records the date the drugs 

were received and confirm that the order is accurate. These receipts must also contain the name 

of each controlled substance, the finished form, the number of dosage units of finished form in 

each commercial container, and the number of commercial containers ordered and received. In 

addition, these receipts must be maintained in a readily retrievable manner for inspection by the 

DEA.
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SECTION IX – VALID 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 (i.e., 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 full name, 

address, and DEA registration number. 

The prescription must also include:

1. Drug name

2. Strength

3. Dosage form

4. Quantity prescribed

5. Directions for use

6. Number of refills authorized (if any)

A prescription must be written in ink or indelible pencil or typewritten and must be manually signed 

by the practitioner on the date when issued. An individual (i.e., secretary or nurse) may be 

designated by the practitioner to prepare prescriptions for the practitioner’s signature. The 

practitioner is responsible for ensuring the prescription conforms to all requirements of the law and 

regulations, both federal and state.

Who May Issue 

A prescription for a controlled substance may only be issued by a physician, dentist, podiatrist, 

veterinarian, mid-level practitioner, or other registered practitioner who is:

1. Authorized to prescribe controlled substances by the jurisdiction in which the practitioner is 

licensed to practice, and 

2. Registered with DEA or exempted from registration (e.g., Public Health Service, Federal 

Bureau of Prisons, military practitioners), or

3. An agent or employee of a hospital or other institution acting in the normal course of 

business or employment under the registration of the hospital or other institution which is 

registered in lieu of the individual practitioner being registered, provided that additional 

requirements as set forth in the C.F.R. are met.

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 professional practice. The practitioner is 

responsible for the proper prescribing and dispensing of controlled substances.
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A prescription may not be issued in order for an individual practitioner to obtain controlled 

substances for supplying the individual practitioner for the purpose of general dispensing to 

patients.

Corresponding Responsibility 

A pharmacist also needs to know there is a corresponding responsibility for 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 an invalid prescription within the 

meaning and intent of the CSA (21 U.S.C. § 829). 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 

ignores a questionable prescription when there is reason to believe it was not issued for a 

legitimate medical purpose may be prosecuted along with the issuing practitioner, for knowingly 

and intentionally distributing controlled substances. Such action is a felony offense, which may 

result in the loss of one’s business or professional license (see United States v. Kershman, 555 

F.2d 198 [United States Court Of Appeals, Eighth Circuit, 1977]).

Electronic Prescriptions 

 

On March 31, 2010 the DEA published in the Federal Register an interim final rule Electronic 

Prescriptions for Controlled Substances which became effective June 1, 2010. The rule revises 

DEA regulations to provide practitioners with the option of writing prescriptions for controlled 

substances electronically. The regulations also permit pharmacies to receive, dispense, and 

archive these electronic prescriptions. These regulations are an addition to, not a replacement of, 

the existing rules. 

Persons who wish to dispense controlled substances using electronic prescriptions must select 

software that meets the requirements of this rule. As of June 1, 2010, only those electronic 

pharmacy applications that comply with all of DEA’s requirements as set forth in 21 C.F.R. §1311 

may be used by DEA-registered pharmacies to electronically receive and archive controlled 

substances prescriptions and dispense controlled substances based on those prescriptions.

A registered pharmacy may process electronic prescriptions for controlled substances only if the 

following conditions are met:

1. The pharmacy uses a pharmacy application that meets all of the applicable requirements of 

21 C.F.R. §1311, and

2. The prescription is otherwise in conformity with the requirements of the CSA and 21 C.F.R. 

§1311.
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A pharmacy cannot process electronic prescriptions for controlled substances until its pharmacy 

application provider obtains a third party audit or certification review that determines that the 

application complies with DEA’s requirements and the application provider provides the 

audit/certification report to the pharmacy. The audit report the pharmacy will receive from the 

pharmacy application provider will indicate if the application is capable of importing, displaying, and 

storing DEA-required prescription information accurately and consistently. If the third-party auditor 

or certification organization finds that a pharmacy application does not accurately and consistently 

import, store, and display the information related to the name, address, and registration number of 

the practitioner, patient name and address, and prescription information (drug name, strength, 

quantity, directions for use), the indication of signing, and the number of refills, the pharmacy must 

not accept electronic prescriptions for the controlled substance. 

If the third-party auditor or certification organization finds that a pharmacy application does not 

accurately and consistently import, store, and display other information required for prescriptions, 

the pharmacy must not accept electronic prescriptions for controlled substances that are subject to 

the additional information requirements. For example, until the audit or certification report indicates 

that the pharmacy application can import, display, and store both a hospital DEA number and the 

individual practitioner’s extension number, the pharmacy must not accept electronic prescriptions 

that include only a hospital DEA registration number. The pharmacy may, however, use the 

application to process other controlled substance prescriptions if the audit or certification report has 

found that the pharmacy application meets all other requirements.

The pharmacy must determine which employees are authorized to enter information regarding the 

dispensing of controlled substance prescriptions and annotate or alter records of these 

prescriptions (to the extent such alterations are permitted under DEA regulations). The pharmacy 

must ensure that logical access controls in the pharmacy application are set so that only such 

employees are granted access to perform these functions.

When a pharmacist fills a prescription in a manner that would require, under 21 C.F.R. §1306, the 

pharmacist to make notation on the prescription if the prescription were a paper prescription, the 

pharmacist must make the same notation electronically when filling an electronic prescription and 

retain the annotation electronically in the prescription record or linked files. When a prescription is 

received electronically, the prescription and all required annotations must be stored electronically. 

 

When a pharmacist receives a paper or oral prescription that indicates that it was originally 

transmitted electronically to the pharmacy, the pharmacist must check the pharmacy’s records to 

ensure that the electronic version was not received and the prescription dispensed. If both 

prescriptions were received, the pharmacist must mark one as void.

When a pharmacist receives a paper or oral prescription that indicates that it was originally 

transmitted electronically to another pharmacy, the pharmacist must check with that pharmacy to 

determine whether the prescription was received and dispensed. If the pharmacy that received the 

original electronic prescription had not dispensed the prescription, that pharmacy must mark the 

electronic version as void or cancelled. If the pharmacy that received the original electronic 

prescription dispensed the prescription, the pharmacy with the paper version must not dispense the 

paper prescription and must mark the prescription as void.
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Verification of Practitioner Registration 

A pharmacist has a responsibility to ensure that a prescription has been issued by an appropriately 

registered or exempt practitioner (see above, Who May Issue). As such, it is helpful to be familiar 

with how a DEA registration number is constructed and to whom such registrations are issued. 

Construction of Valid DEA Registration Number for Practitioners 

Knowing how a DEA registration number is constructed can be a useful tool for recognizing a 

forged prescription (see Appendix D, Pharmacist’s Guide to Prescription Fraud). Prior to October 

1, 1985, DEA registration numbers for physicians, dentists, veterinarians, and other practitioners 

started with the letter A. New registration numbers issued to practitioners after that date begin with 

the letter B or F. Registration numbers issued to mid-level practitioners begin with the letter M. 

The first letter of the registration number is almost always followed by the first letter of the 

registrant’s last name (e.g., J for Jones or S for Smith) and then a computer generated sequence of 

seven numbers (such as MJ3614511). 

Practitioner’s Use of a Hospital’s DEA Registration Number 

Practitioners (e.g., intern, resident, staff physician, mid-level practitioner) who are agents or 

employees of a hospital or other institution, may, when acting in the usual course of business or 

employment, administer, dispense, or prescribe controlled substances under the registration of the 

hospital or other institution in which he or she is employed, in lieu of individual registration, 

provided that:

1. The dispensing, administering, or prescribing is in the usual course of professional practice.

2. The practitioner is authorized to do so by the state in which they practice.

3. The hospital or institution has verified that the practitioner is permitted to administer, 

dispense, 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 administer, dispense, or prescribe 

under its registration and assigns a specific internal code number for each practitioner.

An example of a specific internal code number is depicted below:

A current list of internal codes and the corresponding individual practitioners is to be maintained 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 filling such a prescription.
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Exemption of Federal Government Practitioners from Registration 

The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air 

Force, Coast Guard, Public Health Service, or Bureau of Prisons, who is authorized to administer, 

dispense, or prescribe, but not to procure or purchase controlled substances in the course of his or 

her official duties. Such officials must follow procedures set forth in 21 C.F.R. part 1306 regarding 

prescriptions, but must also state the branch of service or agency (e.g., "U.S. Army" or "Public 

Health Service") and the service identification number of the issuing official in lieu of the 

registration number required on prescription forms. The service identification number for a Public 

Health Service employee is his or her Social Security identification number. 

If federal government practitioners wish to maintain a DEA registration for a private practice, which 

would include prescribing for private patients, these practitioners must be fully licensed to handle 

controlled substances by the state in which they are located. 

Registration Requirements for Mid-Level Practitioners 

Mid-level practitioners (MLPs) 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 (see Appendix B, Definitions). Examples of MLPs include, but are not limited 

to, nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, physician 

assistants, optometrists, ambulance services, animal shelters, euthanasia technicians, nursing 

homes, and homeopathic physicians.

MLPs may apply for an individual DEA registration granting controlled substance privileges. 

However, such registration is contingent upon the authority granted by the state in which they are 

licensed. The DEA may register MLPs whose states clearly authorize them to prescribe, dispense,

and administer controlled substances in one or more schedules. 

It is incumbent upon the pharmacist who fills the prescription to ensure that the MLP is prescribing 

within the parameters established by the state in which he/she practices. MLP authority to 

prescribe controlled substances varies greatly by state. Pharmacists should check with the state 

licensing or controlled substances authority to determine which MLP disciplines are authorized to 

prescribe controlled substances in the state. Pharmacists may also visit the DEA Diversion 

website at www.DEAdiversion.usdoj.gov for a chart indicating the prescribing authority of MLPs by 

state (click on Registration Support and scroll down to Mid-Level Practitioners Authorization by 

State).

For electronic prescriptions written by mid-level practitioners, if required by State law, a 

supervisor’s name and DEA number may be listed on the prescription, provided the prescription

clearly indicates who is the supervisor and who is the prescribing practitioner.

Schedule II Controlled Substances 

Schedule II controlled substances require a written prescription which must be manually signed by 

the practitioner or an electronic prescription that meets all DEA requirements for electronic 

prescriptions for controlled substances. There is no federal time limit within which a schedule II 
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prescription must be filled after being signed by the practitioner. However, the pharmacist must 

determine that the prescription is still needed by the patient. While some states and many 

insurance carriers limit the quantity of controlled substances dispensed to a 30-day supply, there 

are no express federal limits with respect to the quantities of drugs dispensed via a prescription. 

However, the amount dispensed must be consistent with the requirement that a prescription for a 

controlled substance be issued only for a legitimate medical purpose by a practitioner acting in the 

usual course of professional practice. For a schedule II controlled substance, an oral order is only 

permitted in an emergency situation (see Section X, Emergency Dispensing).

Refills 

The refilling of a prescription for a controlled substance listed in schedule II is prohibited 

(21 U.S.C. § 829(a)).

Issuance of Multiple Prescriptions for Schedule II Controlled Substances 

The DEA has revised its regulations regarding the issuance of multiple prescriptions for schedule II 

controlled substances. Under the new regulation, which became effective December 19, 2007, an 

individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of 

up to a 90-day supply of a schedule II controlled substance provided the following conditions are 

met:

1. Each prescription must be issued on a separate prescription blank.

2. Each separate prescription must be issued for a legitimate medical purpose by an individual 

practitioner acting in the usual course of professional practice.

3. The individual practitioner must provide written instructions on each prescription (other than 

the first prescription, if the prescribing practitioner intends for that prescription to be filled 

immediately) indicating the earliest date on which a pharmacy may fill each prescription.

4. The individual practitioner concludes that providing the patient with multiple prescriptions in 

this manner does not create an undue risk of diversion or abuse.

5. The issuance of multiple prescriptions is permissible under applicable state laws.

6. The individual practitioner complies fully with all other applicable requirements under the 

CSA and C.F.R., as well as any additional requirements under state law.

It should be noted that the implementation of this change in the regulation should not be construed 

as encouraging individual practitioners to issue multiple prescriptions or to see their patients only 

once every 90 days when prescribing schedule II controlled substances. Rather, individual 

practitioners must determine on their own, based on sound medical judgment, and in accordance 

with established medical standards, whether it is appropriate to issue multiple prescriptions and 

how often to see their patients when doing so.

Facsimile Prescriptions for Schedule II Controlled Substances 

In order to expedite the filling of a prescription, a prescriber may transmit a schedule II prescription 

to the pharmacy by facsimile. The original schedule II prescription must be presented to the 

pharmacist and verified against the facsimile at the time the controlled substance is actually 
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dispensed. The pharmacist must make sure the original document is properly annotated and filed 

with the records that are required to be kept.

Exceptions for Schedule II Facsimile Prescriptions 

DEA has 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:

1. A practitioner prescribing a schedule II narcotic controlled substance to be

compounded for the direct administration to a patient by parenteral, intravenous, 

intramuscular, subcutaneous or intraspinal infusion may transmit the prescription by 

facsimile. The pharmacy will consider the facsimile prescription a “written prescription” 

and no further documentation is required. All normal requirements of a legal 

prescription must be followed.

2. Practitioners prescribing schedule II controlled substances for residents of Long Term

Care Facilities may transmit a prescription by facsimile to the dispensing pharmacy. 

The facsimile prescription serves as the original written prescription for the pharmacy. 

No further documentation is required.

3. A practitioner prescribing a schedule II narcotic controlled substance for a patient 

enrolled in a hospice care program certified and/or paid for by Medicare under Title 

XVIII or a hospice program which is licensed by the state, may transmit a prescription 

to the dispensing pharmacy by facsimile. The practitioner will note on the prescription 

that it is for a hospice patient. The facsimile serves as the original written prescription. 

No further documentation is required.

 

Schedules III-V Controlled Substances 

A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V only 

pursuant to either a paper prescription signed by a practitioner, a facsimile of a signed paper 

prescription transmitted by the practitioner or the practitioner's agent to the pharmacy, an electronic 

prescription that meets DEA’s requirements for such prescriptions, or a call-in as indicated below

(see Telephone Authorization for Schedules III-V Controlled Substances).

Refills

Schedules III and IV controlled substances may be refilled if authorized on the prescription. 

However, the prescription may only be refilled up to five times within six months after the date of 

issue. After five refills or after six months, whichever occurs first, a new prescription is required.

When a prescription for any controlled substance in schedules III or IV is refilled, the following 

information must be entered on the back of the prescription: the dispensing pharmacist’s initials,

the date the prescription was refilled, and the amount of drug dispensed on the refill. If the 

pharmacist only initials and dates the back of the prescription, the pharmacist will be deemed to 

have dispensed a refill for the full face amount of the prescription.

 
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Electronic Recordkeeping of Schedules III-IV Prescription Information 

A pharmacy is permitted to use an electronic recordkeeping system as an alternative to the manual 

method for the storage and retrieval of original paper prescription orders for schedules III and IV 

controlled substances.

The electronic system must provide online 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 quantity dispensed if different from the 

quantity prescribed); and the total number of refills authorized by the prescriber.

In addition, the electronic system must provide online retrieval of the current refill history for 

schedules III or IV 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 must be maintained for a period of two years from the dispensing date. To meet the 

C.F.R. recordkeeping requirements, the pharmacy’s electronic system 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 must verify his/her 

accuracy by signing and dating the printout as he/she would sign a check or legal 

document.

2. The printout must be provided to each pharmacy that uses the computer system within 

72 hours of the date on which the refill was dispensed. The printout must be verified 

and signed by each pharmacist who dispensed the refills.

3. In lieu of such a printout, the pharmacy must maintain a bound logbook or a separate file 

in which each pharmacist involved in the day’s dispensing signs a statement, verifying 

that the refill information entered into the computer that day has been reviewed by 

him/her and is correct as shown.

4. A pharmacy’s electronic system must have the capability of printing out any refill data 

which the pharmacy must maintain under the CSA. For example, this would include a 

refill-by-refill audit trail for any specified strength and dosage form of any controlled 

substance, by either brand or generic name or both, dispensed by the pharmacy. Such 

a printout must include:

• Prescribing practitioner’s name

• Patient’s name and address

• Quantity and date dispensed on each refill

• Name or identification code of the dispensing pharmacist

• Original prescription number
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 In any electronic system employed by a user pharmacy, the central recordkeeping

location must be capable of providing a printout to a requesting pharmacy of the above 

information within 48 hours.

5. In case a pharmacy's electronic system experiences downtime, the pharmacy must 

have a back-up procedure to document in writing refills of schedules III or IV controlled 

substances. This procedure must ensure that refills are authorized by the original 

prescription, that the maximum number of refills has not been exceeded, and that all 

required data is retained for online entry as soon as possible.

A pharmacy may use only one of the two systems described (i.e., manual or electronic) for storage 

and retrieval of prescription order refill information of schedules III or IV controlled substances. 

 

Facsimile Prescriptions for Schedules III-V Controlled Substances 

Prescriptions for schedules III-V controlled substances may be transmitted by facsimile from the 

practitioner or the practitioner’s agent to the dispensing pharmacy. The facsimile is considered to 

be equivalent to an original prescription as long as the practitioner has manually signed the 

prescription.

Telephone Authorization for Schedules III-V Prescriptions 

A pharmacist may dispense a controlled substance listed in schedules III, IV, or V pursuant to an 

oral prescription made by an individual practitioner and promptly reduced to writing by the

pharmacist containing all information required for a valid prescription except for the signature of the 

practitioner (see Appendix D, Pharmacist’s Guide to Prescription Fraud).

Transfer of Schedules III-V Prescription Information 

 

A DEA registered pharmacy may transfer original prescription information for schedules III, IV, and 

V controlled substances to another DEA registered pharmacy for the purpose of refill dispensing 

between pharmacies, on a one time basis only. However, pharmacies electronically sharing a realtime, on-line database may transfer up to the maximum refills permitted by law and the prescriber’s 

authorization. 

Transfers are subject to the following requirements:

The transfer must be communicated directly between two licensed pharmacists and the 

transferring pharmacist must record the following information: 

 

1. Write the word “VOID” on the face of the invalidated prescription; for electronic 

prescriptions, information that the prescription has been transferred must be added to the 

prescription record.

2. Record on the reverse of the invalidated prescription the name, address, and DEA 

registration number of the pharmacy to which it was transferred and the name of the 

pharmacist receiving the prescription information; for electronic prescriptions, such 

information must be added to the prescription record.
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3. Record the date of the transfer and the name of the pharmacist transferring the 

information.

For paper prescriptions and prescriptions received orally and reduced to writing by the pharmacist, 

the pharmacist receiving the transferred prescription information must write the word “transfer” on 

the face of the transferred prescription and reduce to writing all information required to be on a 

prescription and include:

1. Date of issuance of original prescription.

2. Original number of refills authorized on original prescription.

3. Date of original dispensing

4. Number of valid refills remaining and date(s) and locations of previous refill(s).

5. Pharmacy’s name, address, DEA registration number, and prescription number from 

which the prescription information was transferred.

6. Name of pharmacist who transferred the prescription.

7. Pharmacy’s name, address, DEA registration number, and prescription number from 

which the prescription was originally filled.

For electronic prescriptions being transferred electronically, the transferring pharmacist must 

provide the receiving pharmacist with the following information in addition to the original electronic 

prescription data:

 1. The date of the original dispensing

2. The number of refills remaining and the date(s) and locations of previous refills

3. The transferring pharmacy’s name, address, DEA registration number, and prescription 

number for each dispensing.

4. The name of the pharmacist transferring the prescription.

5. The name, address, DEA registration number, and prescription number from the 

pharmacy that originally filled the prescription, if different.

The pharmacist receiving a transferred electronic prescription must create an electronic record for 

the prescription that includes the receiving pharmacist’s name and all of the information transferred 

with the prescription (listed above).

The original and transferred prescription(s) must be maintained for a period of two years from the

date of last refill.

Pharmacies electronically accessing the same prescription record must satisfy all information 

requirements of a manual mode for prescription transferal.

The procedure allowing the transfer of prescription information for refill purposes is permissible 

only if allowable under existing State or other applicable law.
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Prescription Monitoring Programs 

A prescription monitoring program is a state-administered data collection system used to gather 

prescription information. This information may be made available to state and federal investigators 

on a need-to-know basis.

Many states have established an electronic prescription drug monitoring program because it has

proven to be an effective tool for detecting pharmaceutical diversion and for developing pharmacist 

and physician medical education programs. These programs heighten awareness about diversion, 

prescription drug abuse, drug trends, and are useful for tracking prescription medication dispensed 

within a state. In some states, the data can be used by pharmacists to identify potential "doctor 

shoppers" and those who attempt to obtain controlled substances by fraud, forgery, or deceit.

In the states that have adopted these programs, a large part of their success has been attributed to 

the pharmacists’ participation. The DEA strongly endorses prescription monitoring programs.
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SECTION X – DISPENSING REQUIREMENTS 

Required Information for Prescription Labels 

The pharmacist dispensing a prescription for a controlled substance listed in schedules II, III, IV, or 

V must affix to the package a label showing date of filling, the pharmacy name and address, the 

serial (prescription) number, the name of the patient, the name of the prescribing practitioner, and 

directions for use and cautionary statements, if any, contained in such prescription or required by 

law. If a prescription is filled at a central fill pharmacy, the central fill pharmacy must affix to the 

package a label showing the retail pharmacy name and address and a unique identifier (i.e., the 

central fill pharmacy's DEA registration number) indicating that the prescription was filled at the 

central fill pharmacy.

Federal Food and Drug Administration regulations require that the label of any drug listed as a 

"controlled substance" in schedules II, III, or IV of the CSA must, when dispensed to or for a 

patient, contain the following warning: CAUTION: Federal law prohibits the transfer of this drug to 

any person other than the patient for whom it was prescribed. In addition, a pharmacist who 

receives a prescription for a controlled substance must dispense that prescription to the patient or a 

member of the patient’s household. To provide the controlled substance to anyone other than the 

patient or a member of the patient’s household is distribution, not dispensing.

Schedule II Controlled Substance Prescriptions 

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 emergency situation as described below.

 

Emergency Dispensing 

An “emergency prescription” in this context, is defined to mean 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 pharmacist 

who may then dispense the prescription. The prescribing practitioner must provide a written and 

signed prescription to the pharmacy within seven days and meet the below requirements:

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 prescribing individual practitioner is not known to the pharmacist, he/she must 

make a reasonable effort to determine that the oral authorization came from a 

registered individual practitioner, which may include a call back to the prescribing 

individual practitioner using his or her telephone number as listed in the telephone 

directory and/or other good faith efforts to insure his or her identity.
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4. Within seven days after authorizing an emergency telephone prescription, the 

prescribing practitioner must furnish the pharmacist a written, signed prescription for 

the controlled substance prescribed. The prescription must have written on its face 

“Authorization for Emergency Dispensing” and the date of the oral order. The written 

prescription may be delivered to the pharmacist in person or by mail, but if delivered by 

mail, it must be postmarked within the seven day period. Upon receipt, the dispensing 

pharmacist must attach this written prescription to the oral emergency prescription 

which had earlier been reduced to writing by the pharmacist. By regulation, the 

pharmacist must notify the local DEA Diversion Field Office (Appendix K) if the 

prescriber fails to provide a written prescription within seven days. Failure of the 

pharmacist to do so will void the authority conferred on the pharmacy to dispense the 

controlled substance without a written prescription of a prescribing practitioner.

5. For electronic prescriptions, the pharmacist must annotate the record of the electronic 

prescription with the original authorization and date of the oral order.

Partial Dispensing

A prescription for a schedule II controlled substance may be partially dispensed if the pharmacist is 

unable to supply the full quantity of a written or emergency oral (telephone) prescription, provided 

the pharmacist notes the quantity supplied on the front of the written prescription, on a written 

record of the emergency oral prescription, or in the electronic prescription record. The remaining 

portion may be dispensed within 72 hours of the first partial dispensing. However, if the remaining 

portion is not or cannot be filled within the 72 hour period, the pharmacist must notify the 

prescribing practitioner. No further quantity may be supplied beyond 72 hours without a new 

prescription.

Partial Filling of Schedule II Prescriptions for Terminally Ill or Long Term Care Facility Patients 

A prescription for a schedule II controlled substance written for a patient in a Long Term Care 

Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness, may be 

filled in partial quantities to include individual dosage units. If there is any question whether a 

patient 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" must be deemed to have been filled in violation of the CSA. For each partial filling, 

the dispensing pharmacist must record on the back of the prescription (or on another appropriate 

record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity 

dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing 

pharmacist. The total quantity of schedule II controlled substances dispensed in all partial fillings 

must not exceed the total quantity prescribed. Schedule II prescriptions for patients in an LTCF or 

terminally ill patients are valid for a period not to exceed 60 days from the issue date unless sooner 

terminated by the discontinuance of medication.

 
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Schedules III-V Controlled Substance Prescriptions

A pharmacist may dispense a controlled substance in schedules III, IV, or V having received either 

a paper prescription signed by a practitioner, a facsimile of that prescription transmitted by the 

practitioner or their agent to the pharmacy, an electronic prescription that meets DEA’s 

requirements for such prescriptions, or an oral prescription made by an individual practitioner. The 

pharmacist must promptly reduce the oral prescription to writing, including all required information

except the signature of the prescribing practitioner. 

Partial Dispensing 

A pharmacist may partially dispense a prescription for schedules III-V controlled substances

provided that each partial filling is recorded in the same manner as a refilling, the total quantity 

dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing 

occurs beyond six months from the date on which the prescription was issued. 

Dispensing Without a Prescription 

Dispensing a controlled substance without a prescription is outlined in 21 C.F.R. § 1306.26. 

The regulation states that a controlled substance listed in schedules II, III, IV, or V which is not a 

prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be 

dispensed by a pharmacist without a prescription to a purchaser at retail, provided that: 

1. Such dispensing is made only by a pharmacist and not by a non-pharmacist employee 

even if under the supervision of a pharmacist (although after the pharmacist has fulfilled 

his or her professional and legal responsibilities, the actual cash, credit transaction, or 

delivery, may be completed by a non-pharmacist);

2. Not more than 240 cc. (8 ounces) of any such controlled substance containing opium, 

nor more than 120 cc. (4 ounces) of any other such controlled substance, nor more than 

48 dosage units of any such controlled substance containing opium, nor more than 24 

dosage units of any other such controlled substance, may be dispensed at retail to the 

same purchaser in any given 48-hour period;

3. The purchaser is at least 18 years of age and the pharmacist requires every purchaser

of a controlled substance under this section not known to him or her to furnish suitable 

identification (including proof of age where appropriate);

4. A bound record book (which must be maintained in accordance with the recordkeeping 

requirement of 21 C.F.R. § 1304.04) for dispensing of controlled substances is 

maintained by the pharmacist, which contains the name and address of the purchaser, 

the name and quantity of the controlled substance purchased, the date of each 

purchase, and the name or initials of the pharmacist who dispensed the substance to 

the purchaser;

5. The prescription is not required for distribution or dispensing of the substance pursuant 

to any other Federal, State or local law; and

6. Central fill pharmacies may not dispense controlled substances at the retail level to a 

purchaser.

 
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Delivery of a Controlled Substance to Persons in Other Countries 

Controlled substances that are dispensed pursuant to a legitimate prescription may not be 

delivered or shipped to individuals in other countries 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:

1. Has registered with DEA as an "exporter" (see 21 C.F.R. §§ 1301 and 1309).

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

for export (21 C.F.R. §§ 1312 or 1313).
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SECTION XI – Ryan Haight Online Pharmacy Consumer Protection Act of 2008 

Summary of the Act’s Major Provisions 

On October 15, 2008, the President signed into law the Ryan Haight Online Pharmacy Consumer 

Protection Act of 2008, often referred to as the Ryan Haight Act. This law amends the CSA by 

adding a series of new regulatory requirements and criminal provisions designed to combat the 

proliferation of so-called “rogue Internet sites” that unlawfully dispense controlled substances by 

means of the Internet. The Ryan Haight Act applies to all controlled substances in all schedules.

This law became effective April 13, 2009. As of that date, it is illegal under federal law to deliver, 

distribute, or dispense a controlled substance by means of the Internet unless the online pharmacy 

holds a modification of DEA registration authorizing it to operate as an online pharmacy. Thus, any 

person who knowingly or intentionally dispenses a controlled substance by means of the Internet 

that does not have a modification of DEA registration allowing such activity is in violation of 21 

U.S.C. § 841(h)(1) and subject to potential criminal prosecution and (in the case of DEA 

registrants) loss of DEA registration.

Note: The information contained in this section is meant to summarize the Ryan Haight Act but 

should not be relied upon as setting forth all the requirements. As is always the case, pharmacies 

are responsible for complying with the actual text of the CSA and DEA regulations. 

Definition of an Online Pharmacy 

An online pharmacy is a person, entity, or Internet site, whether in the United States or abroad, that 

knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, 

distribute, or dispense, a controlled substance by means of the Internet. Examples of an online 

pharmacy include (but are not limited to) the following:

• Any website that sells, or offers to sell, any controlled substance or a prescription 

therefor to a person in the United States. 

• Any person who operates such a website. 

• Any person who pays a practitioner to write prescriptions for controlled substances 

for customers of such a website.

• Any person who pays a pharmacy to fill prescriptions for controlled substances that 

were issued to customers of such a website. 

• Any pharmacy that knowingly or intentionally fills prescriptions for controlled 

substances that were issued to customers of such a website. 

• Any person who sends an e-mail that: 

(1) offers to sell a controlled substance or a prescription for a controlled substance 

in a manner not authorized by the Act; 
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(2) directs buyers to a website operating in violation of the Act; 

(3) or otherwise causes or facilitates the delivery, distribution, or dispensing of a 

controlled substance in a manner not authorized by the Act. 

Online Pharmacy Registration Exemptions 

The following are exempt from the Ryan Haight Act's definition of an “online pharmacy” so long as 

their activities are limited solely to the exemptions provided:

• Manufacturers or distributors registered under 21 U.S.C. § 823(a), (b), (d), or (e) who do 

not dispense controlled substances to nonregistrants.

• Nonpharmacy practitioners who are registered under 21 U.S.C. § 823(f) and whose 

activities are authorized by that registration, provided that any website operated by such 

nonpharmacy practitioners complies with 21 C.F.R.§ 1304.50, which requires the 

website to post in a visible and clear manner on its homepage, or on a page directly 

linked thereto in which the hyperlink is also visible and clear on the homepage, a list of 

the DEA-registered nonpharmacy practitioners who are affiliated with the website.

• Any hospital or other medical facility registered under 21 U.S.C. § 823(f) that is operated 

by an agency of the United States (including the Armed Forces).

• A health care facility owned or operated by an Indian tribe or tribal organization carrying 

out a contract or compact under the Indian Self-Determination and Education 

Assistance Act.

• Any agent or employee of any hospital or facility that is operated by an agency of the 

United States, and any agent or employee of any hospital or facility owned or operated 

by an Indian tribe or tribal organization carrying out a contract or compact under the 

Indian Self-Determination and Education Assistance Act, provided such agent or 

employee is lawfully acting in the usual course of business or employment, and within 

the scope of the official duties of such agent or employee, with such hospital or facility, 

and, with respect to agents or employees of such health care facilities only to the extent 

such individuals are furnishing services pursuant to those contracts or compacts.

• Mere advertisements that do not attempt to facilitate an actual transaction involving a 

controlled substance.

• A person, entity, or Internet site that is not in the United States and does not facilitate 

the delivery, distribution, or dispensing of a controlled substance by means of the 

Internet to any person in the United States.

• A pharmacy registered under 21 U.S.C. § 823(f) whose dispensing of controlled 

substances via the Internet consists solely of "refilling prescriptions for controlled 

substances in schedule III, IV, or V," as that term is defined in 21 C.F.R. § 1300.04(k). 

(This definition is set forth at the end of this section.) 
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• A pharmacy registered under 21 U.S.C. § 823(f) whose dispensing of controlled 

substances via the Internet consists solely of "filling new prescriptions for controlled 

substances in schedule III, IV, or V," as that term is defined in 21 C.F.R. § 1300.04(d). 

(This definition is set forth at the end of this section.)

• Any registered pharmacy whose delivery, distribution, or dispensing of controlled 

substances by means of the Internet consists solely of filling prescriptions that were 

electronically prescribed in a manner authorized by the CSA. 

• Any registered pharmacy whose delivery, distribution, or dispensing of controlled 

substances by means of the Internet consists solely of the transmission of prescription 

information between a pharmacy and an automated dispensing system located in a 

Long Term Care Facility when the registration of the automated dispensing system is 

held by that pharmacy as described in 21 C.F.R §§ 1301.17 and 1301.27 and the 

pharmacy is otherwise complying with the DEA regulations. 

Notification Requirements 

Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing by 

means of the Internet, the online pharmacy shall notify DEA and the State boards of pharmacy in 

any States in which the online pharmacy offers to sell, deliver, distribute, or dispense controlled 

substances. Completion of the Application for Modification of Registration for Online Pharmacies

serves as the notification requirement to DEA. 

The online pharmacy must make a separate thirty-day advance notice to the State boards of 

pharmacy in each State in which it intends to offer to sell, deliver, distribute, or dispense controlled 

substances. Online pharmacies that apply for the modification of registration are required to certify 

that the applicable State boards of pharmacy have been notified.

How to Register as an Online Pharmacy 

To operate legally as an online pharmacy, the online pharmacy must first be registered with DEA 

as a pharmacy. Once registered with DEA as a pharmacy, the pharmacy may apply for a 

modification of registration to operate as an online pharmacy. To apply for a modification of 

registration, complete the Application for Modification of Registration for Online Pharmacies online 

at www.DEAdiversion.usdoj.gov. There is no fee to apply to modify a DEA registration to an online 

pharmacy.

If the modification of registration is approved, the pharmacy will be issued a modified DEA 

Certificate of Registration with the new business activity listed as online pharmacy. The registrant 

will keep the same DEA registration number. A pharmacy may perform the activities of a retail 

pharmacy and an online pharmacy at the same time. 

State Licensure Requirements 

An online pharmacy must comply with the requirements of all applicable State laws concerning the 

licensure of pharmacies in each State from which it, and in each State to which it, delivers, 
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distributes, or dispenses, or offers to deliver, distribute, or dispense, controlled substances by 

means of the Internet. In addition, online pharmacies must certify they are in compliance with 

these requirements when completing the Application for Modification of Registration for Online 

Pharmacies.

The requirement that an online pharmacy list the States in which it is licensed to dispense 

controlled substances is designed to ensure that an online pharmacy only dispenses controlled 

substances to patients in States in which it is authorized to practice pharmacy. Dispensing beyond 

the scope of State licensure is one of the recurring transgressions of some rogue online 

pharmacies and generally violates State law. Under this Act, a State may bring civil action in 

federal court to enjoin any violation of the Ryan Haight Act – not merely those violations of State law 

– and to obtain other appropriate legal or equitable relief. 21 U.S.C. § 882(c). 

Online Pharmacy Website Requirements 

When a pharmacy applies for a modification of registration to become an online pharmacy, it must 

display on its homepage a declaration that it has done so. This declaration must state the 

following:

“In accordance with the Controlled Substances Act and the DEA regulations, this 

online pharmacy has made the notifications to the DEA Administrator required by 

21 U.S.C. § 831 and 21 C.F.R. § 1304.40.”

Once approved to operate as an online pharmacy, the online pharmacy must display at all times on 

the homepage of its Internet site a declaration of compliance with the requirements of 21 U.S.C. § 

831 with respect to the delivery or sale or offer for sale of controlled substances. This statement 

must include the name of the pharmacy as it appears on the DEA Certificate of Registration.

An online pharmacy is required to post Internet Pharmacy Site Disclosure Information on the 

homepage of each Internet site it operates. It must be posted in a visible and clear manner and 

contain the following information:

1. The name and address of the pharmacy as it appears on the pharmacy’s DEA 

Certificate of Registration.

2. The pharmacy’s telephone number and e-mail address.

3. Name of pharmacist-in-charge, professional degree, States of licensure, and telephone 

number.

4. List of State(s) in which the pharmacy is licensed to dispense controlled substances.

5. Certification that the pharmacy is registered to deliver, distribute, or dispense 

controlled substances by means of the Internet.

6. The name, address, telephone number, professional degree, and States of licensure of 

any practitioner who has a contractual relationship to provide medical evaluations or 

issue prescriptions for controlled substances, through referrals from the website or at 

the request of the owner or operator of the website, or any employee or agent thereof.

7. The following statement must be visible on the website:
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“This online pharmacy is obligated to comply fully with the Controlled Substances Act 

and DEA regulations. As part of this obligation, this online pharmacy has obtained a 

modified DEA registration authorizing it to operate as an online pharmacy. In 

addition, this online pharmacy will only dispense a controlled substance to a person 

who has a valid prescription issued for a legitimate medical purpose based upon a 

medical relationship with a prescribing practitioner. This includes at least one prior 

in-person medical evaluation in accordance with section 309 of the Controlled 

Substances Act (21 U.S.C. § 829), or a medical evaluation via telemedicine in 

accordance with section 102(54) of the Controlled Substances Act (21 U.S.C. § 

802(54)).”

If at any time an online pharmacy should change its Internet site web address, the online pharmacy 

must notify DEA at least thirty days in advance of this change. 

Reporting Requirements 

Each online pharmacy must submit a monthly report to DEA of the total quantity of each controlled 

substance that the online pharmacy has dispensed the previous calendar month. The report is 

required for every month in which the total amount of dispensing of controlled substances by the 

pharmacy is either (i) over 100 prescriptions filled or (ii) 5,000 or more dosage units dispensed of 

all controlled substances combined. Should an online pharmacy’s total quantity of dispensed 

controlled substances fall below both of the thresholds listed above, a report is still required that 

indicates a negative response for that given month.

The report must include the total amount of such dispensing by any means including all controlled 

substances dispensed via Internet transactions, mail-order transactions, face-to-face transactions, 

or any other means. It is not required that the online pharmacy identify the means of the 

dispensing in its report. Reporting will be by National Drug Code (NDC) numbers. Report the total 

number of dosage units dispensed for each NDC number.

This report is due on or before the 15th day of the following month. For example, an online 

pharmacy would submit its report for the month of January no later than February 15th. Reports 

must be submitted electronically via online reporting, electronic upload, or other means as 

approved by DEA. All reports must be kept for at least two years and be readily retrievable for 

inspection. 

Should an online pharmacy revert back to a retail pharmacy, the pharmacy is still required to report 

the monthly sales for the month in which it changes back to a retail pharmacy.

Prescription Requirements 

In order for a prescription to be valid, it must be issued for a legitimate medical purpose in the usual 

course of professional practice by a practitioner who has conducted at least one in-person medical 

evaluation of the patient or by a covering practitioner. An in-person medical evaluation is a medical 

evaluation that is conducted with the patient in the physical presence of the practitioner, without 

regard to whether portions of the evaluation are conducted by other health professionals. 

 
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Definition of Prescription Terms 

A pharmacy website is exempted from the Ryan Haight Act's definition of an "online pharmacy" if 

its Internet-facilitated activity relating to controlled substances is limited to filling new and/or refilling 

prescriptions for controlled substances in schedules III, IV, or V. If the pharmacy is so exempted 

from the definition of an "online pharmacy," it is not required under the Act to obtain a modification 

of its DEA registration authorizing it to operate as an online pharmacy. Thus, it is important to 

understand precisely the definitions of the following terms.

Filling New Prescriptions for Controlled Substances in Schedules III-V 

As stated in 21 C.F.R. § 1300.04 (d), the term "filling new prescriptions for controlled substances in 

schedule III, IV, or V" means filling a prescription for an individual for a controlled substance in 

schedule III, IV, or V, if:

1. The pharmacy dispensing that prescription has previously dispensed to the patient a 

 controlled substance other than by means of the Internet and pursuant to the valid 

 prescription of a practitioner that meets the applicable requirements of [21 U.S.C. § 829(b) 

 and (c)] and [21 C.F.R. §§ 1306.21 and 1306.22] (for purposes of this definition, such a 

 prescription shall be referred to as the “original prescription”);

2. The pharmacy contacts the practitioner who issued the original prescription at the request 

 of that individual to determine whether the practitioner will authorize the issuance of a 

 new prescription for that individual for the controlled substance described in [paragraph 

 (1) of this definition] (i.e., the same controlled substance as described in [paragraph (1)]); 

 and

3. The practitioner, acting in the usual course of professional practice, determines there is a 

 legitimate medical purpose for the issuance of the new prescription.

Refilling Prescriptions for Controlled Substances in Schedules III-V

As stated in 21 C.F.R. § 1300.04(k), the term "refilling prescriptions for controlled substances in 

schedule III, IV, or V”:

1. Means the dispensing of a controlled substance in schedule III, IV, or V in accordance with 

refill instructions issued by a practitioner as part of a valid prescription that meets the 

 requirements of [21 U.S.C. § 829(b) and (c)] and [21 C.F.R. §§ 1306.21 and 1306.22], as 

 appropriate; and

2. Does not include the issuance of a new prescription to an individual for a controlled 

 substance that individual was previously prescribed.
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SECTION XII – OTHER PHARMACY OPERATIONS 

Central Fill Pharmacy 

A "central fill pharmacy” (see Appendix B, Definitions) fills prescriptions for controlled substances 

on behalf of retail pharmacies with which it has a contractual agreement to provide such services or 

with pharmacies who share a common owner. When one retail pharmacy receives a prescription 

and a second pharmacy prepares and subsequently delivers the controlled substance medication 

to the first retail pharmacy for dispensing to the patient, the second pharmacy is engaging in a 

"central fill” activity. Records must be maintained by both the central fill pharmacy and the retail 

pharmacy that completely reflect the disposition of all controlled substance prescriptions 

dispensed. Central fill pharmacies are required to comply with the same security requirements 

applicable to retail pharmacies including the general requirement to maintain effective controls and 

procedures to guard against theft and diversion of controlled substances. Retail pharmacies that 

also perform central fill activities are allowed to do so without a separate DEA registration, separate 

inventories, or separate records.

Central fill pharmacies are permitted to prepare both initial and refill prescriptions, subject to all 

applicable state and federal regulations. Only a licensed pharmacist may fill the prescription. Both 

the retail and central fill pharmacists have a corresponding responsibility to ensure that the 

prescription was issued for a legitimate medical purpose by an individual practitioner acting in the 

usual course of professional practice and otherwise in the manner specified by DEA regulations.

Prescription information may be provided to an authorized central fill pharmacy by a retail 

pharmacy for dispensing purposes. Prescriptions for controlled substances listed in schedules II, 

III, IV, or V may be transmitted electronically from a retail pharmacy to a central fill pharmacy 

including via facsimile. The retail pharmacy transmitting the prescription information must:

1. Write the word "CENTRAL FILL'' on the face of the original prescription and record

the name, address, and DEA registration number of the central fill pharmacy to which 

the prescription has been transmitted and the name of the retail pharmacy pharmacist 

transmitting the prescription, and the date of transmittal;

2. Ensure that all information required to be on a prescription is transmitted to the

central fill pharmacy (either on the face of the prescription or in the electronic 

transmission of information);

3. Maintain the original prescription for a period of two years from the date the 

prescription was last refilled;

4. Keep a record of receipt of the filled prescription, including the date of receipt, the

method of delivery (private, common, or contract carrier) and the name of the retail 

pharmacy employee accepting delivery;

5. For schedules III-V prescriptions, indicate in the information transmitted the number

of refills already dispensed and the number of refills remaining (refills for schedule II 

prescriptions are not permitted).
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The central fill pharmacy receiving the transmitted prescription must:

1. Keep a copy of the prescription (if sent via facsimile) or an electronic record of all the 

information transmitted by the retail pharmacy, including the name, address, and the 

DEA registration number of the retail pharmacy transmitting the prescription;

2. Keep a record of the date of receipt of the transmitted prescription, the name of the 

licensed pharmacist filling the prescription, and dates of filling or refilling of the 

prescription; and

3. Keep a record of the date the filled prescription was delivered to the retail pharmacy 

and the method of delivery (i.e. private, common, or contract carrier).

Central fill pharmacies must affix to the package a label showing the retail pharmacy name and 

address and a unique identifier (i.e. the central fill pharmacy's DEA registration number) indicating 

that the prescription was filled at the central fill pharmacy. Central fill pharmacies must comply with 

the provisions of the C.F.R. when selecting private, common, or contract carriers to transport filled 

prescriptions to a retail pharmacy (and likewise for retail pharmacies retrieving filled prescriptions 

from a central fill pharmacy) for delivery to the ultimate user. 

For electronic prescriptions, the name, address, and DEA registration number of the central fill 

pharmacy to which the prescription has been transmitted, the name of the retail pharmacy 

pharmacist transmitting the prescription, and the date of transmittal must be added to the electronic 

prescription record.

Long Term Care Facilities 

A Long Term Care Facility (LTCF) is defined in the C.F.R. 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 health care facilities routinely 

maintain controlled substances issued via prescription to their residents. These controlled 

substances are already outside the CSA’s closed drug distribution system since they have been 

dispensed to the ultimate user. 

LTCFs frequently need to dispose of unused medications due to a change in the resident’s 

medication or the resident’s death. Accordingly, LTCFs should contact the local DEA Diversion 

Field Office (Appendix K) for drug disposal instructions. The DEA is aware of issues currently 

facing LTCFs concerning the dispensing and handling of controlled substances, which are affected 

by a variety of state laws and circumstances. Pharmacists should check with their state agency for 

guidelines concerning controlled substances at LTCFs.

Regulations concerning LTCFs can also be found under:

• Section IX, Exceptions for Schedule II Facsimile Prescriptions

• Section X, Partial Filling of Schedule II Prescriptions for Terminally Ill or Long 

Term Care Facility Patients

 
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Use of Automated Dispensing Systems by Retail Pharmacies at Long Term Care Facilities 

If state law or regulations permit, the DEA will allow a retail pharmacy to register at the site of the 

LTCF and store controlled substances in an Automated Dispensing System (ADS) as outlined in 21 

C.F.R. § 1301.27. In an ADS, a pharmacy stores bulk drugs in the machine in separate bins or 

containers. The pharmacy programs and controls the ADS remotely. Only authorized LTCF staff

are allowed access to its contents, which are dispensed on a single-dose basis at the time of 

administration pursuant to a valid prescription. The ADS electronically records each dispensing, 

thus maintaining dispensing records for the pharmacy. Because the drugs are not considered 

dispensed until the system provides them, drugs in the ADS are counted as pharmacy stock. A 

registered retail pharmacy that possesses additional registrations for ADS machines at LTCFs may 

keep all records required for those additional registered sites at the retail pharmacy or other 

approved central location.

DEA registered pharmacies wishing to operate an ADS at an LTCF must contact the DEA Office of 

Diversion Control, Registration Section, at 1-800-882-9539 for registration instructions. Additional 

requirements for maintaining an ADS can be found online at www.DEAdiversion.usdoj.gov.

Emergency Kits for Long Term Care Facilities 

The DEA has issued a policy statement which provides individual state licensing and regulatory 

boards with general guidelines for establishing specific rules concerning controlled substances 

used in emergency kits at Long Term Care Facilities (see Appendix H, Guidelines for Emergency 

Kits in Long Term Care Facilities).

Opioid (Narcotic) Addiction Treatment Programs 

The Narcotic Addiction Treatment Act of 1974 and the Drug Addiction Treatment Act (DATA) of 

2000 amended the CSA with respect to the use of controlled substances in the medical treatment 

of opioid addiction. These laws established the procedures for approving and licensing 

practitioners involved in the treatment of opioid addiction as well as improving the quality and 

delivery of that treatment to the segment of society in need. 

Practitioners wishing to prescribe and dispense FDA approved schedule II controlled substances 

(i.e., methadone) for maintenance and detoxification treatment must obtain a separate DEA 

registration as a Narcotic Treatment Program via a DEA Form 363 which may be completed online 

at www.DEAdiversion.usdoj.gov. In addition to obtaining this separate DEA registration, this type 

of activity also requires the approval and certification by the Center for Substance Abuse Treatment 

(CSAT) within the Substance Abuse and Mental Health Services Administration (SAMHSA) of the 

U.S. Department of Health and Human Services as well as the applicable state methadone 

authority.

If a practitioner wishes to prescribe or dispense schedules III, IV, or V controlled substances 

approved by the FDA for addiction treatment (i.e., Suboxone® or Subutex® drug products), the 

practitioner must request a waiver from CSAT which will then notify DEA of all waiver requests. 

These practitioners are referred to as DATA waived practitioners.
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DATA waived practitioners may treat 30 or 100 patients at any one time, dependent on individual 

authorization from CSAT. Upon authorization by CSAT, DEA will issue a new DEA certificate of 

registration bearing (1) the DEA registration number, (2) a unique identification number, and (3) the 

corresponding business activity to identify whether the physician is authorized to treat 30 or 100 

patients. Pursuant to 21 C.F.R. §1301.28(d), the practitioner is required to include the identification 

number on all records when dispensing and on all prescriptions when prescribing Schedules III, IV, 

or V narcotic controlled drugs for use in maintenance or detoxification treatment. The listing of the 

identification number on a prescription is in addition to all other information required on a valid 

prescription to include the practitioner’s DEA registration number (see Section IX, Valid 

Prescription Requirements).

Dispensing Controlled Substances for the Treatment of Pain 

On September 6, 2006, the DEA published in the Federal Register a Policy Statement, Dispensing 

Controlled Substances for the Treatment of Pain. The purpose of the Policy Statement was to 

make clear the longstanding requirement under the law that physicians may prescribe controlled 

substances only for a legitimate medical purpose in the usual course of professional practice. In no 

way should this interfere with the legitimate practice of medicine or cause any physician to be 

reluctant to provide legitimate pain treatment. The second purpose of the Policy Statement was for

the DEA to dispel the mistaken notion among a small number of medical professionals that the 

agency has embarked on a campaign to “target” physicians who prescribe controlled substances 

for the treatment of pain or that physicians must curb their legitimate prescribing of pain 

medications to avoid legal liability.

To achieve these aims, the document summarized the relevant legal principles and provided an 

explanation of DEA’s role with respect to the regulation of controlled substances. The document 

also addressed specific issues and questions that have been raised on a recurring basis by 

physicians who seek guidance on the subject of dispensing controlled substances for the treatment 

of pain.

To review the Policy Statement, it may be accessed at www.DEAdiversion.usdoj.gov. Click on Info 

& Legal Resources, then Federal Register Notices, then Notices 2006, then Policy Statement: 

Dispensing Controlled Substances for the Treatment of Pain, September 6, 2006. For additional 

guidance on the responsibilities of the pharmacist where it pertains to the treatment of pain, see 

Section IX, Corresponding Responsibility.
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SECTION XIII - OTHER CONTROLLED SUBSTANCE REGULATIONS 

Controlled Substance Distribution by a Pharmacy – “Five Percent Rule” 

A pharmacy registered to dispense controlled substances may distribute such substances (without 

being registered as a distributor) to another pharmacy or to a registered practitioner for the purpose 

of general dispensing by the practitioner to patients, provided that the following conditions are met:

1. The pharmacy or practitioner that will receive the controlled substances is registered

under the CSA to dispense controlled substances;

2. The distribution is recorded by the distributing practitioner in accordance with 21 C.F.R. 

§ 1304.22(c) and the receipt is recorded by the receiving practitioner in accordance with 

21 C.F.R. § 1304.22(c);

3. If the pharmacy distributes a schedule II controlled substance, it must document the

transfer on an official order form (DEA Form 222) or the electronic equivalent. For 

instructions on completing this form, see Section VIII, Ordering Controlled Substances.

4. “Five Percent Rule” - total number of dosage units of all controlled substances 

distributed by a pharmacy may not exceed five percent of all controlled substances 

dispensed by the pharmacy during a calendar year. If at any time the controlled 

substances distributed exceed five percent, the pharmacy is required to register as a 

distributor.

United States Postal Service Mailing Requirements for Controlled Substances 

United States Postal Services regulations permit the mailing of controlled substances by drug 

manufacturers or their agents, pharmacies, or other authorized handlers when distribution is lawful 

under DEA regulations and if the mailer or the addressee meets one of the following conditions:

1. The mailer or the addressee is registered with DEA.

2. The mailer or the addressee is exempt from DEA registration as permissible by law.

United States Postal Service regulations permit mailing of any controlled substance, provided it is

not outwardly dangerous and will not cause injury to a person’s life or health, and if the following 

preparation and packaging standards are met:

1. The inner container of any parcel containing controlled substances is marked and 

sealed as required by the provisions of the CSA and its implementing regulations, and 

is placed in a plain outer container or securely wrapped in plain paper.

2. If the controlled substance consists 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.
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SECTION XIV – COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005 

Summary of the Act’s Major Provisions 

In March 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA). 

As a result of the new law, the DEA issued an Interim Final Rule in the Federal Register on 

September 26, 2006, which outlined the retail provisions of the CMEA. 

Under the CMEA, regulated sellers must follow new requirements for retail sales of over-thecounter products containing the List I chemicals ephedrine, pseudoephedrine, and 

phenylpropanolamine (PPA), which can be used to manufacture methamphetamine illegally. The 

CMEA defined "regulated seller" to mean a retail distributor (including a pharmacy and mobile retail 

vendors) and "at retail" to mean sale or purchase for personal use.

Scheduled Listed Chemical Products 

The CMEA created a new category of products called “scheduled listed chemical product (SLCP).” 

It includes any product that may be marketed or distributed lawfully in the United States under the 

Federal Food, Drug, and Cosmetic Act as a nonprescription drug that contains ephedrine, 

pseudoephedrine, or PPA (includes salts, optical isomers, and salts of optical isomers) (21 U.S.C. 

§ 802(45)). This applies to nonprescription drug products only, not prescription drug products. 

Retail sales of SLCPs are excluded from the definition of a “regulated transaction” and from the 

registration requirement under 21 U.S.C. § 823, but are subject to a separate system of retail sales 

controls under 21 U.S.C. § 830. 

Other requirements of the law include:

• Requirement of regulated sellers to place the products behind the counter or in locked 

cabinets.

• Requirement of regulated sellers to check the identity of purchasers and maintain a log of 

each sale that includes the purchaser's name and address, signature of the purchaser, 

product sold, quantity sold, date, and time.

• Requirement of regulated sellers to maintain the logbook for at least two years.

• Requirement of regulated sellers to train employees in the requirements of the law and 

certify to DEA that the training has occurred.

• Places a quantity limit of each of the chemicals that may be sold to an individual in a day 

to 3.6 grams of the chemical (base) without regard to the number of transactions.

• For nonliquids, product packaging is limited to blister packs containing no more than 2 

dosage units per blister. Where blister packs are not technically feasible, the product 

must be packaged in unit dose packets or pouches.

• For individuals, purchases in a 30-day period are limited to 9 grams, of which not more 

than 7.5 grams may be imported by means of a common or contract carrier or the U.S. 

Postal Service. 

While many states have enacted their own legislation regarding the regulation of these products, 

the federal law also requires regulated sellers to complete a self-certification process with the DEA 

that includes training their employees on the new regulations and procedures. The self-certification 
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process must be completed online at www.DEAdiversion.usdoj.gov. If state law differs from federal 

law regarding the regulation of these products, retail outlets are to adhere to the stricter provisions 

of both.

Copies of the Interim Final Rule are available at www.DEAdiversion.usdoj.gov (click on the Combat 

Meth Act of 2005, then Interim Final Rule – Retail Sales of Scheduled Listed Chemical Products). 

Details on specific provisions of the CMEA that may impact a pharmacy that engages in retail sales 

of SLCPs are outlined below.

 

Recordkeeping Requirements 

Regulated sellers are required to maintain a written (bound logbook) or electronic list of sales that 

identifies the transactions with the following information:

1. The name of the purchaser

2. The address of the purchaser

3. The date and time of the sale

4. The amount of product sold

The logbook requirement does not apply to any purchase by an individual of a single sales

package that contains not more than 60 milligrams of pseudoephedrine.

Concurrently, purchasers are required to:

1. Present a photo identification issued by a State or the Federal Government (see Proof of 

Identity Requirements below for a complete list of acceptable forms of identification).

2. Sign a logbook and enter his or her name, address, date, and time of sale.

Once identification of the purchaser is presented to the seller, the seller is required to:

1. Determine that the name in the logbook corresponds to the name on the identification and 

that the date and time are correct.

2. Enter into the logbook the name of the product and the quantity sold.

The logbook must include a notice to purchasers that entering false statements or 

misrepresentations in the logbook may subject purchasers to criminal penalties under 18 U.S.C. 

§ 1001. Sellers must maintain each entry in the logbook for not fewer than two years after the date 

on which the entry is made.

Loss or Theft of Scheduled Listed Chemical Products 

A report should be made orally to the local DEA Diversion Field Office (Appendix K) in the area 

where the pharmacy is located. Per 21 C.F.R. § 1314.15(c), a written report of losses must be filed 

within 15 days after the pharmacist becomes aware of the loss or theft. A written report should 

include the DEA registration number (if applicable), name, business address, date of loss, type of 

loss, and a description of the circumstances of the loss (e.g., in-transit, theft from premises). 
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Proof of Identity Requirements 

The CMEA requires an individual to present an identification card that includes a photograph and is 

issued by a State or the Federal Government or a document considered acceptable under 8 C.F.R.

§ 274a.2(b)(1)(v)(A) and (B). Those documents currently include the following:

• United States passport;

• Alien Registration Receipt Card or Permanent Resident Card, Form I-551;

• An unexpired foreign passport that contains a temporary I-551 stamp, or temporary I–

551 printed notation on a machine-readable immigrant visa;

• An Employment Authorization Document which contains a photograph (Form I–766);

• In the case of a nonimmigrant alien authorized to work for a specific employer incident 

to status, a foreign passport with form I-94 or Form I-94A bearing the same name as 

the passport and containing an endorsement of the alien's nonimmigrant status, as 

long as the period of endorsement has not yet expired and the proposed employment 

is not in conflict with any restrictions or limitations identified on the Form;

• A passport from the Federated States of Micronesia (FSM) or the Republic of the 

Marshall Islands (RMI) with Form I–94 or Form I–94A indicating nonimmigrant 

admission under the Compact of Free Association Between the United States and the 

FSM or RMI;

• In the case of an individual lawfully enlisted for military service in the Armed Forces 

under 10 U.S.C. § 504, a military identification card issued to such individual may be 

accepted only by the Armed Forces.

For individuals 16 years of age or older:

• A driver's license or identification card containing a photograph, issued by a state or 

an outlying possession of the United States. If the driver's license or identification 

card does not contain a photograph, identifying information shall be included such as: 

name, date of birth, sex, height, color of eyes, and address;

• School identification card with a photograph;

• Voter's registration card;

• U.S. military card or draft record;

• Identification card issued by federal, state, or local government agencies or entities. If 

the identification card does not contain a photograph, identifying information shall be 

included such as: name, date of birth, sex, height, color of eyes, and address;

• Military dependent's identification card;

• Native American tribal documents;

• United States Coast Guard Merchant Mariner Card;

• Driver's license issued by a Canadian government authority.

For individuals under age 18 who are unable to produce a document from the list above, the 

following documents are acceptable to establish identity only:

• School record or report card;

• Clinic doctor or hospital record;

• Daycare or nursery school record.
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NOTE: The list of acceptable forms of identification, as cited in the CMEA, may change ("in effect 

on or after the date of enactment''). The DEA has no discretion to alter the list. 

Product Placement 

SLCPs must be stored behind the counter or, if in an area where the public has access, in a locked 

cabinet. Although DEA is not including cabinet specifications in the rule, a locked cabinet should 

be substantial enough that it cannot be easily picked up and removed. In a store setting, the 

cabinet should be similar to those used to store items, such as cigarettes, that can be accessed 

only by sales staff.

Self-Certification 

As part of the requirements of CMEA, an annual self-certification is required for all regulated sellers 

of SLCPs. A regulated seller must not sell SLCPs unless it has self-certified with DEA. In selfcertifying, the regulated seller is confirming: 

 

• The employees who will be engaged in the sale of SLCPs have undergone training 

regarding provisions of CMEA.

• Records of the training are maintained.

• Sales to individuals do not exceed 3.6 grams of ephedrine, pseudoephedrine, or 

phenylpropanolamine per day. 

• Nonliquid forms are packaged as required.

• SLCPs are stored behind the counter or in a locked cabinet.

• A written or electronic logbook containing the required information on sales of these 

products is properly maintained.

• The logbook information will be disclosed only to Federal, State, or local law enforcement 

and only to ensure compliance with Title 21 of the United States Code or to facilitate a 

product recall. 

 

The only way to self-certify is through DEA’s Diversion website at www.DEAdiversion.usdoj.gov. 

Self-certification can be accomplished on any computer (e.g., at the store, at home, at the library, 

or at any other location). 

A certificate will be generated by DEA upon receipt of the self-certification application. The 

regulated seller may print this certificate, or if the regulated seller is unable to print it, DEA will print 

and mail the certificate to the regulated seller. Chain stores wishing to file self-certifications for 

more than 10 locations must print or copy the form electronically and submit the information to DEA 

by mail. DEA will work with these persons to facilitate this process. Persons interested in this selfcertification option should contact DEA for assistance at 1-800-882-9539. For current DEA 

registrants, the system will pre-populate the form with basic information if the registrant enters his 

DEA registration number in the field provided.

The regulated seller must self-certify to DEA as described above on an annual basis. It is the 

responsibility of the regulated seller to ensure that all employees have been trained prior to selfcertifying each time. 
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It is the regulated seller’s responsibility to annually renew before the certificate expires if the 

regulated seller intends to continue selling SLCPs at retail. The certificate contains a selfcertification number in the upper right corner. The expiration date of the certificate is listed under 

the self-certification number. Regulated sellers may verify the expiration date of their certificate at 

www.DEAdiversion.usdoj.gov. 

The self-certification requirement is subject to the provisions of 18 U.S.C. § 1001. A regulated 

seller who knowingly or willfully certifies to facts that are not true is subject to fines and 

imprisonment.

Required Training 

Training materials designed by DEA must be used, although a regulated seller may include 

information in addition to that provided by DEA. DEA training materials may be found at 

www.DEAdiversion.usdoj.gov. 

Training Records 

Each employee of a regulated seller who is responsible for delivering SLCPs to purchasers or who 

deals directly with purchasers by obtaining payment for the SLCPs must undergo training and must 

sign an acknowledgement of training received prior to selling SLCPs. This record must be kept in 

the employee's personnel file.

Self-Certification Fee 

On December 29, 2008, the DEA published a Final Rule in the Federal Register entitled Combat 

Methamphetamine Epidemic Act of 2005: Fee for Self-Certification for Regulated Sellers of 

Scheduled Listed Chemical Products. The rule established a self-certification fee for regulated 

sellers of SLCPs that are not DEA pharmacy registrants. 
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APPENDICES
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APPENDIX A 

This summary is provided as a quick reference to the provisions of the Controlled Substances Act. 

It is not intended to replace any statutory or regulatory requirement thereof. For complete guidance 

as to the provisions of each area indicated below, please check the appropriate section of this 

manual.

Summary of Controlled Substances Act Requirements

Schedule II Schedules III & IV Schedule V 

Registration Required Required Required

Receiving 

Records DEA Form 222 Invoices, readily retrievable

Invoices, readily 

retrievable

Prescriptions Written1 prescriptions2 Written, oral, or fax Written, oral, or fax

Refills No No more than 5 within 6 

months

As authorized when 

prescription is issued or if 

renewed by a practitioner

Maintenance of 

Prescriptions Separate file Separate file or readily 

retrievable

Separate file or readily 

retrievable3

Distribution 

Between

Registrants

DEA Form 222 Invoices Invoices

Security

Locked cabinet or 

dispersed among noncontrolled 

pharmaceuticals

Locked cabinet or 

dispersed among noncontrolled 

pharmaceuticals

Locked cabinet or 

dispersed among noncontrolled 

pharmaceuticals

Theft or 

Significant Loss

Report to DEA and 

complete DEA Form 

106

Report to DEA and 

complete DEA Form 106

Report to DEA and 

complete DEA Form 106

Note: All records must be maintained for 2 years, unless state law requires a longer period.

1 Written prescriptions include paper prescriptions and electronic prescriptions that meet DEA’s 

requirements for such prescriptions.

2 Emergency prescriptions require a signed follow-up prescription within seven days. 

Exceptions: A facsimile prescription serves as the original prescription when issued to residents of 

Long Term Care Facilities, hospice patients, or patients with a diagnosed terminal illness, or for 

immediate administration (21 C.F.R. § 1306.11(e), (f) and (g)). 

 

3

 The record of dispensing can also be a schedule V logbook, if state law allows. 
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APPENDIX B 

Definitions Based on the Controlled Substances Act 

and the Code of Federal Regulations 

Administer 

The direct application of a controlled substance to the body of a patient or research subject by 1) 

a practitioner or (in his/her presence) by his/her 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, inhalation, ingestion, or any other means.

Central Fill Pharmacy 

A pharmacy which is permitted by the state in which it is located to prepare controlled substance 

orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail 

pharmacy and to return the labeled and filled prescriptions to the retail pharmacy for delivery to 

the ultimate user. Such central fill pharmacy shall be deemed “authorized” to fill prescriptions on 

behalf of a retail pharmacy only if the retail pharmacy and central fill pharmacy have a 

contractual relationship providing for such activities or share a common owner.

Chemicals 

Please see the definitions for List I Chemical, Retail Distributor and Scheduled Listed 

Chemical Product.

Dispense 

To deliver a controlled substance to an ultimate user 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. 

Individual Practitioner 

A physician, dentist, veterinarian, or other individual licensed, registered or otherwise permitted, 

by the United States or the jurisdiction in which they practice, to dispense a controlled substance 

in the course of professional practice, but does not include a pharmacist, a pharmacy, or an 

institutional practitioner.

Institutional Practitioner 

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 

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 (including stocks 

held by the registrant under separate registration as a manufacturer, importer, exporter, or 

distributor).
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List I Chemical 

A chemical specifically designated by the [DEA] Administrator in 21 C.F.R. § 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.

 

Long Term Care Facility (LTCF) 

A nursing home, retirement care, mental care, or other facility or institution that 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 MLPs include, but are not limited to, 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. Because this authority varies greatly 

by state, check with the state licensing authority to determine which MLP disciplines are 

authorized to dispense controlled substances in a particular state or visit, 

www.DEAdiversion.usdoj.gov (click on Registration Support, then Resources, then Mid-level 

Practitioners Authorization by State).

Online Pharmacy 

An online pharmacy is a person, entity, or Internet site, whether in the United States or 

abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or 

attempts to deliver, distribute, or dispense, a controlled substance by means of the 

Internet. 

 

Pharmacist 

Any pharmacist licensed by a state to dispense controlled substances, and shall include any 

other person (e.g., pharmacist intern) authorized by a state to dispense controlled substances 

under the supervision of a pharmacist licensed by such state.

 

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 a bed patient for immediate administration in a hospital is not a 

prescription).

Readily Retrievable 

Certain records which are kept by automatic data processing systems or other electronic or 

mechanized recordkeeping systems in such a manner that they can be separated out from all 

other records in a reasonable time and/or records kept in such a manner that certain items are 

asterisked, redlined, or in some other manner visually identifiable apart from other items 

appearing on the records.
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Regulated Seller 

A retail distributor (including a pharmacy or a mobile retail vendor), except that the term does not 

include an employee or agent of the distributor.

Retail Distributor 

A grocery store, general merchandise store, drug store, or other entity or person whose activities 

as a distributor relating to drug products containing ephedrine, pseudoephedrine or 

phenylpropanolamine are limited almost exclusively to sales for personal use, both in number of 

sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by 

direct sales. 

Scheduled Listed Chemical Product (SLCP) 

A product that contains ephedrine, pseudoephedrine, or phenylpropanolamine which may be 

marketed or distributed lawfully in the United States under the Federal, Food, Drug, and 

Cosmetic Act as a nonprescription drug. Ephedrine, pseudoephedrine, and 

phenylpropanolamine include their salts, optical isomers, and salts of optical isomers. 

Ultimate User 

A person who has lawfully obtained, and who possesses, a controlled substance for his [her] 

own use or for the use of a member of his [her] household or for an animal owned by him [her] or 

by a member of his [her] household.
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APPENDIX C 

Definitions of Abbreviations 

C.F.R.................Code of Federal Regulations

CMEA................Combat Methamphetamine Epidemic Act of 2005

CSA...................Controlled Substances Act

CSAT ................Center for Substance Abuse Treatment

CSOS................Controlled Substance Ordering System

CSRPA..............Controlled Substance Registrant Protection Act of 1984

DEA...................Drug Enforcement Administration

FDA...................Food and Drug Administration

HHS ..................Department of Health and Human Services 

SAMHSA...........Substance Abuse and Mental Health Services Administration

U.S.C. ...............United States Code
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APPENDIX D 

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 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. However, 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.

Pharmacist’s 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, pharmacists share responsibility

for preventing prescription drug abuse and diversion.

• Pharmacists have a personal responsibility to protect their practice from becoming an easy 

target for drug diversion. They need to know of the potential situations where drug diversion can 

occur, and establish safeguards to prevent drug diversion.

• The dispensing pharmacist must maintain a constant vigilance against forged or altered 

prescriptions. The CSA holds the pharmacist responsible for knowingly dispensing a 

prescription that was not issued in the usual course of professional treatment.

 

Types of Fraudulent Prescriptions 

 

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 practitioner’s prescription. They may 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. Drug seeking individuals may also call in their own prescriptions and give 

their own telephone number as a call-back for confirmation. Drug abusers sometimes steal 

legitimate prescription pads from practitioner’s offices and/or hospitals and prescriptions are written 

using fictitious patient names and addresses. 

In addition, individuals may 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. The quantity of drugs prescribed and frequency of prescriptions filled are 

not lone indications of fraud or improper prescribing, especially if a 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 a patient’s sustained use of opioid analgesics for 

the legitimate treatment of chronic pain.

The following criteria may indicate that a prescription was not issued for a legitimate medical 

purpose:
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• The prescriber writes significantly more prescriptions (or in larger quantities) compared to other 

practitioners in the area.

• The patient appears to be returning too frequently. A 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.

• The patient presents 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.

• People who are not regular patrons or residents of the community, show up with prescriptions 

from the same physician.

 

The following criteria may indicate a forged prescription:

• Prescription looks "too good". The prescriber’s handwriting is too legible.

• Quantities, directions, or dosages differ from usual medical usage.

• Prescription does not comply with the acceptable standard abbreviations or appears to be 

textbook presentations.

• Prescription appears to be photocopied.

• Directions are written in full with no abbreviations.

• Prescription is written in different color inks or written in different handwriting.

 

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 to determine if it has been presented in a reasonable 

length of time since being issued by the prescriber.

When there is a question about any aspect of the prescription order, the pharmacist should contact 

the prescriber for verification or clarification.

If at any time a pharmacist is in doubt, he /she should require proper identification. Although this 

procedure is not foolproof (identification papers can also be stolen/forged), it does increase the 

drug abuser’s risk. If a pharmacist believes the prescription is forged or altered, he/she should not 

dispense it and call the local police. If a pharmacist believes he/she has discovered a pattern of 

prescription abuse, he/she should contact the state Board of Pharmacy or the local DEA Diversion 

Field Office (Appendix K). Both DEA and state authorities consider retail-level diversion a priority 

issue.
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Proper Controls

Dispensing procedures without control and professional caution are an invitation to the drug 

abuser. Proper controls can be accomplished by following common sense, sound professional 

practice, and proper dispensing procedures. In addition, pharmacy staff should have knowledge of 

these safeguards, as it will help prevent and protect the pharmacy from becoming a source of 

diversion.

Most drug abusers seek out areas where communication and cooperation between health care 

professionals are minimal because it makes the drug abuser’s work easier. Thus, a pharmacist 

should encourage other local pharmacists and physicians to develop a working relationship which 

will promote teamwork and camaraderie. In addition, the pharmacist should become familiar with 

those controlled substances that are popular for abuse and resale on the streets in the area and 

should discuss those findings with other pharmacists and practitioners in the community. 
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APPENDIX E 

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 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 ____________, 20______.

____________________________________________

Notary Public

1 21 C.F.R. § 1301.17(a) 
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APPENDIX F 

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.

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 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 ____________, 20______.

____________________________________________

Notary Public

1 21 C.F.R. § 1301.17(b) 
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APPENDIX G 

 

Equivalency Tables for Ephedrine, Pseudoephedrine, and Phenylpropanolamine Under the 

Combat Methamphetamine Epidemic Act of 2005

RETAIL DAILY SALE LIMITS ARE NOT TO EXCEED THE FOLLOWING AMOUNTS 

PER PURCHASER 

Ingredient Number of Tablets = 3.6 grams 

25 mg Ephedrine HCl 175

25 mg Ephedrine Sulfate 186

30 mg Pseudoephedrine HCl 146

60 mg Pseudoephedrine HCl 73

120 mg Pseudoephedrine HCl 36

30 mg Pseudoephedrine Sulfate 155

60 mg Pseudoephedrine Sulfate 77

120 mg Pseudoephedrine Sulfate 38

Phenylpropanolamine (PPA) The Food and Drug Administration issued 

a voluntary recall of this ingredient as 

being unsafe for human consumption. 

Veterinary use is by prescription only.

30-DAY SALE LIMITS ARE NOT TO EXCEED THE FOLLOWING AMOUNTS PER 

PURCHASER 

Ingredient Number of tablets at 

retail = 9 grams

Number of tablets for 

mail orders = 7.5 grams

25 mg Ephedrine HCl 439 366

25 mg Ephedrine Sulfate 466 389

30 mg Pseudoephedrine HCl 366 305

60 mg Pseudoephedrine HCl 183 152

120 mg Pseudoephedrine HCl 91 76

30 mg Pseudoephedrine Sulfate 389 324

60 mg Pseudoephedrine Sulfate 194 162

120 mg Pseudoephedrine Sulfate 97 81

Phenylpropanolamine (PPA) The Food and Drug Administration issued a 

voluntary recall of this ingredient as being unsafe for 

human consumption. Veterinary use is by 

prescription only. 
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APPENDIX H 

Guidelines for Emergency Kits in Long Term Care Facilities 

 

A pharmacy may place an emergency kit with controlled substances in a non-DEA registered Long 

Term Care Facility (LTCF), if the appropriate state agency or regulatory authority specifically 

approves the placement and promulgates procedures that delineate:

1. The source from which the LTCF may obtain controlled substances for emergency kits and 

that the source of supply is a DEA-registered hospital/clinic, pharmacy, or practitioner. 

2. The security safeguards for each emergency kit stored at the LTCF, including who may have 

access to the emergency kit, and specific limitation of the type and quantity of controlled 

substances permitted in the kit.

3. The responsibility for proper control and accountability of the emergency kit within the LTCF, 

including the requirement that the LTCF and the supplying registrant maintain complete and 

accurate records of the controlled substances placed in the emergency kit, the disposition of 

the controlled substances, and the requirement to take and maintain periodic physical 

inventories.

4. The emergency medical conditions under which the controlled substances may be

administered to LTCF patients, including the requirement that controlled substances be 

administered by authorized personnel only as expressly authorized by an individual

practitioner and in compliance with the provisions of 21 C.F.R. §§ 1306.11 and 1306.21.

5. The prohibited activities that if violated could result in state revocation, denial, or suspension 

of the privilege to supply or possess emergency kits containing controlled substances.

The requirements for emergency kits in LTCFs were published in a Federal Register notice on April 

9, 1980 (45 FR 24128). Pharmacies and LTCFs may wish to consult the notice to ensure 

compliance with the requirements.
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APPENDIX I 

 

Guidelines for Completing the DEA Form 106 

Instructions for completing the DEA Form 106 are provided when filling out either the paper or 

electronic version of the form. Listed below are additional guidelines:

• Do not use a DEA Form 106 to report an accidental spillage. Save the broken bottles, 

salvage the product if possible, and contact the local DEA Diversion Field Office (Appendix 

K) for additional instructions. This type of a loss must be reported on a DEA Form 41,

Registrants Inventory of Drugs Surrendered. 

• If thefts have occurred due to employee pilferage over a period of time, document on the 

DEA Form 106 the date of discovery in block 4. Provide estimated beginning and ending 

dates of the thefts in box 17 with an explanation.

• If there are multiple thefts or losses on the same day (e.g. mail-order pharmacy), report 

each theft or loss on a separate DEA Form 106.

• Miscounts or adjustments to inventory involving clerical errors on the part of the pharmacy 

should not be reported on a DEA Form 106. A separate log documenting the discrepancies 

may be kept at the management’s discretion.

• In block 9, enter the number of thefts or losses experienced in the last 24 months, but do not 

include the current theft or loss being reported. If the current theft or loss was the only theft 

or loss in the last 24 months, enter 0 (zero).

• In block 12, enter the amount the pharmacy paid for the controlled substances, not the retail 

value.

• In blocks 14 b & c, if the customer accepted the controlled substance before discovering a 

loss in transit, identify the supplier and its DEA registration number.

• In block 14f, when explaining how many losses occurred from the same carrier, do not 

include the current loss.

 

• The date next to the signature and title on page 2 should be the date the form was 

completed, signed, and sent to the local DEA Diversion Field Office (Appendix K).

• Document the National Drug Code (NDC) number of the controlled substance, and if the 

loss was a partial container, document the actual amount of theft or loss within the 

container.

Guidelines for Completing the DEA Form 106 (continued)
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• If the controlled substance contains hydrocodone, oxycodone or a similar controlled 

substance and contains acetaminophen, aspirin or ibuprofen, indicate the strength of the 

non-controlled substance as well as the strength of the controlled substance contained in 

the product.

• If amending a paper version of a prior DEA Form 106, print Amended in the upper front 

page margin, with the date of the theft.
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APPENDIX J 

DEA Registration Specialists in Field Divisions 

Registration assistants are available during normal business hours to provide information about 

new applications, renewals, order forms, or changes to a DEA registration. Addresses and 

telephone numbers are subject to change. Please refer to the DEA’s Diversion website, 

www.DEAdiversion.usdoj.gov, for the most current listing.

 

 

 

 
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APPENDIX K 

DRUG ENFORCEMENT ADMINISTRATION 

DIVERSION FIELD OFFICE LOCATIONS 

Visit www.DEAdiversion.usdoj.gov for current addresses and telephone numbers. 
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APPENDIX L 

 

Internet Resources 

 

DEA’s Diversion Control Program Website 

 www.DEAdiversion.usdoj.gov 

 

DEA Homepage 

 www.dea.gov 

U.S. Government Printing Office 

 www.gpoaccess.gov/cfr/index.html 

 

Provides access to the C.F.R., Parts 1300 to end, primary source for the Pharmacist’s 

Manual, and the Federal Register which contains proposed and finalized amendments to 

the C.F.R.

Office of National Drug Control Policy (ONDCP) 

 www.whitehousedrugpolicy.gov 

 

Food and Drug Administration 

 www.FDA.gov 

 

HHS & SAMHSA’s National Clearinghouse for Alcohol and Drug Information 

 www.health.org 

 

SAMHSA/CSAT 

 www.csat.samhsa.gov 

 

Federation of State Medical Boards 

www.FSMB.org

National Association of Boards of Pharmacy 

 www.nabp.net 

 

National Association of State Controlled Substances Authorities 

 www.nascsa.org
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APPENDIX M 

 

 Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

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 

and rate each agency’s responsiveness to small business. If you wish to comment on DEA 

enforcement actions, you may contact the Ombudsman at 1-888-REG-FAIR (1-888-734-3247). 
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APPENDIX N

 

Additional Assistance 

This publication is intended to provide guidance and information on the requirements of the CSA 

and its implementing regulations. If you require additional clarification or assistance, or wish to 

comment on any matter regarding the DEA’s requirements or regulatory activities, please contact 

your local DEA Diversion Field Office (Appendix K). Every effort will be made to respond promptly 

to your inquiry.

Plain Language

The Drug Enforcement Administration has made every effort to write this manual in clear, plain 

language. If you have suggestions as to how to improve the clarity of this manual, please contact 

us at:

Drug Enforcement Administration

Attn: Liaison and Policy Section/ODL

8701 Morrissette Drive

Springfield, Virginia 22152

Telephone: 1-202-307-7297