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