DEA Practitioners Manual: Disposal of Controlled Substances
Drug Enforcement Administration (DEA) rules for the disposal of controlled substances by registered practitioners in the United States. These regulations are crucial for ensuring safe and compliant handling of these substances. Let's break it down:
Key Points on Disposal Procedures:
- Reverse Distributors: Registered practitioners can transfer unwanted controlled substances to a reverse distributor, who is authorized to receive them for destruction or return to the manufacturer.
- Record Keeping: For Schedule II substances, the reverse distributor must issue an official DEA Form 222. For Schedule III-V substances, the practitioner needs to maintain a record specifying details like the date of disposal, the name and address of the reverse distributor, and the quantity disposed of.
- DEA Form 41: Reverse distributors are responsible for filling out a DEA Form 41, documenting the destruction of the substances. Practitioners must keep records of the disposal for at least two years.
- Alternative Disposal: If not using a reverse distributor, practitioners can list the substances being disposed of on a DEA Form 41. This record should also be kept for at least two years.
- Environmental Compliance: All disposal methods must adhere to federal, state, local, and tribal environmental laws and regulations.
- Public Disposal Methods: DEA registrants cannot use public drop boxes or take-back events for disposal.
- Authorized Collectors: Certain types of registrants can modify their registration to become authorized collectors, capable of maintaining collection receptacles or operating a mail-back program. Individual practitioners like doctors and dentists are not eligible.
- Pharmaceutical Wastage: Substances remaining after patient administration should not be disposed of in collection receptacles. They should be destroyed in accordance with 21 CFR 1304.21(e) and other applicable laws.
- Special Circumstances: For unique situations where no authorized person can handle the disposal, such as controlled substances abandoned at a school, local DEA or law enforcement should be contacted for guidance.
This comprehensive framework aims to ensure that controlled substances are disposed of in a way that minimizes the risk of misuse, while also considering environmental concerns.
CLICK HERE to read the DEA Practitioner's Manual - Part 1: Detailed Guidelines on Certificate of Registration and Other Requirements.
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