Office of Diversion Control, US Department of Justice, Drug Enforcement Administration

Practitioner's Manual - SECTION IV

SECTION IV – RECORDKEEPING REQUIREMENTS

Recordkeeping Requirements

Each practitioner must maintain inventories and records of controlled substances listed in Schedules I and II separately from all other records maintained by the registrant. Likewise, inventories and records of controlled substances in Schedules III, IV, and V must be maintained separately or in such a form that they are readily retrievable from the ordinary business records of the practitioner. All records related to controlled substances must be maintained and be available for inspection for a minimum of two years.

A registered practitioner is required to keep records of controlled substances that are dispensed to the patient, other than by prescribing or administering, in the lawful course of professional practice. A registered practitioner is not required to keep records of controlled substances that are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment. A registered practitioner is not required to keep records of controlled substances that are administered in the lawful course of professional practice unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered. A registered practitioner is also required to keep records of controlled substances administered in the course of maintenance or detoxification treatment of an individual.

Inventory

Each registrant who maintains an inventory of controlled substances must maintain a complete and accurate record of the controlled substances on hand and the date that the inventory was conducted. This record must be in written, typewritten, or printed form and be maintained at the registered location for at least two years from the date that the inventory was conducted. After an initial inventory is taken, the registrant shall take a new inventory of all controlled substances on hand at least every two years.

Each inventory must contain the following information:

  1. Whether the inventory was taken at the beginning or close of business
  2. Names of controlled substances
  3. Each finished form of the substances (e.g., 100 milligram tablet)
  4. The number of dosage units of each finished form in the commercial container (e.g., 100 tablet bottle)
  5. The number of commercial containers of each finished form (e.g., four 100 tablet bottles)
  6. Disposition of the controlled substances

It is important to note that inventory requirements extend to controlled substance samples provided to practitioners by pharmaceutical companies.

Disposal of Controlled Substances

A practitioner may dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples, by transferring them to a registrant who is authorized to receive such materials. These registrants are referred to as "Reverse Distributors." The practitioner should contact the local DEA field office (See Appendix E) for a list of authorized Reverse Distributors. Schedule I and II controlled substances should be transferred via the DEA Form 222, while Schedule III–V compounds may be transferred via invoice. The practitioner should maintain copies of the records documenting the transfer and disposal of controlled substances for a period of two years.

Section III Table of Contents | Section V

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Office of Diversion Control  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539