Message from the Administrator

Dear Pharmacist:

The Drug Enforcement Administration is pleased to provide you the eighth 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 Comprehensive Methamphetamine Control Act of 1996.

Your role in the proper dispensing of controlled substances is critical to the health of the patient and to safeguard society against drug abuse and diversion. Your adherence to the Controlled Substances Act, together with your voluntary compliance with its objectives, are 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,

Karen P. Tandy
Administrator
Drug Enforcement Administration

Preface

The Drug Enforcement Administration (DEA) is responsible for advising DEA registrants how to comply with the federal law¹ regarding the handling of controlled substances and regulated chemicals. It is DEA’s goal to maintain a positive working relationship with its pharmacy registrants. The DEA respects the professional integrity of pharmacists, the vast majority of whom comply with the law and its regulations in a responsible manner. The DEA understands that it can best serve the public interest by working with these pharmacists to develop cooperative programs for preventing diversion of legal pharmaceutical controlled substances into the illicit market.

DEA does not routinely inspect pharmacies for controlled substance violations, since this function is usually conducted by state authorities. However, DEA does investigate complaints of diversion from pharmacies and also investigates "doctor shoppers" and prescription forgers whose activities are confirmed through records located at the numerous pharmacies they patronize.

DEA would prefer to assist pharmacists to avoid and correct potential compliance violations, rather than seek administrative, civil or criminal action. However, when repeated efforts to remedy violations have not been successful, DEA is authorized under federal law to pursue legal action to correct these problems, prevent diversion related drug abuse, and protect the public safety. A lack of compliance may result in a need for corrective action, such as administrative action (i.e., Letter of Admonition, an informal hearing or licensing action), or in extreme cases, civil or criminal action.

The DEA is greatly concerned about the diversion and abuse of controlled substances and drug products containing listed chemicals. Most drug diversion occurs at the retail level, where the pharmacist plays a critical role in supervising the proper control of prescription and over-the-counter drugs. Because the pharmacist dispenses controlled substances to the patient, he/she is in a key position to safeguard the health of the patient and prevent diversion. The pharmacist and the prescribing practitioner share responsibility for monitoring the therapeutic drug usage of patients, whose health depends on concerned and knowledgeable professionals.

Experience has shown that pharmacists who are familiar with the regulations are most successful in complying with the Controlled Substances Act. The CSA permits pharmacists to dispense controlled substances only when bona fide prescription orders are issued by practitioners authorized to prescribe controlled substances. Under the CSA, a valid prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. While this responsibility rests on the prescriber, a corresponding responsibility rests upon the pharmacist who dispenses the prescription medication. A prescription which is not written for a legitimate medical purpose is not considered to be a valid prescription within the meaning of the law. The individual who knowingly dispenses such a purported prescription, as well as the individual issuing it, can be subject to criminal and /or civil penalties.

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

¹ Controlled Substances Act of 1970 (Title 21, United States Code, Section 800 et. seq.) and its implementing regulations (Title 21, Code of Federal Regulations, Part 1300 to end).

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New Chemical Control Requirements

In addition to the diversion of controlled substances, DEA is concerned with the diversion of certain chemicals used in the clandestine manufacture of controlled substances. Most pharmacies do not stock significant quantities of these chemicals. Chemicals such as ephedrine, pseudoephedrine, and phenylpropanolamine (PPA)² which are contained in prescription and over-the-counter preparations are sold at retail stores. Drug products containing these chemicals are commonly used to illegally manufacture amphetamine and methamphetamine. Quantities of these drug products may be sought from retail outlets for use in clandestine manufacturing operations.

Consequently, these chemicals are subject to certain registration, recordkeeping and reporting requirements. As a rule, pharmacies are retail outlets and therefore are not required to have a chemical registration. However, because diversion of drug products containing these chemicals can occur at the retail level, appropriate safeguards are necessary to prevent diversion. Close cooperation between the pharmacy profession and law enforcement will help ensure that the chemicals used in the production of illicit controlled substances remain in legitimate channels. (For more information see Chemical Requirements as well as Appendices A, B and C).

If you need additional clarification or assistance concerning the CSA regulations or wish to comment on the material in this manual, please contact your local DEA Diversion Field Office (see Appendix T).

 ² Due to concerns regarding harmful side effects of phenypropanolamine (PPA), the Food and Drug Administration initiated action in November 2000 to remove PPA from the market. These changes in the status of PPA are not yet reflected in the regulation or this manual

Internet Resources

DEA’s Internet Website:

www.usdoj.gov/dea

You can access the diversion control program website from DEA’s website by hyperlink.

DEA Diversion Control Program’s Internet Website:

www.deadiversion.usdoj.gov 

This site includes Diversion Control Program newsletters, Federal Register Notices, DEA manuals and publications; progress reports regarding DEA’s electronic commerce initiatives, listings of DEA Diversion and Registration Field Offices, conferences, and items on Diversion’s major program areas (e.g., registration, regulated chemicals, scheduling issues, and ARCOS).

The complete text of the Pharmacist’s Manual can be found on the Diversion Control Program website under Publications. The manual will be updated periodically so that current information is available on the DEA website. Therefore the manual can be downloaded and reproduced at your convenience without having to request a print copy by mail from DEA. The manuals for physicians, mid-level practitioners, researchers and chemical handlers will also be available on this website.

DEA regulations and notices published in the Federal Register are available online through the U.S. Government Printing Office (GPO) Internet website. The current Code of Federal Regulations³ as well as proposed and finalized amendments to the CFR concerning controlled substances and regulated chemicals, can be found at this website.

In addition, a hard copy of the CFR may also be obtained through the GPO in your local area, or by writing to the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

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