How does a practice dispose of expired controlled substances?

The four routes

21 CFR 1317.05(a) says a registered practitioner "that desires to dispose of that substance shall do so in one of the following ways":

• On-site destruction: "Promptly destroy that controlled substance in accordance with subpart C of this part using an on-site method of destruction"
• Reverse distributor: "Promptly deliver that controlled substance to a reverse distributor's registered location by common or contract carrier pick-up or by reverse distributor pick-up at the registrant's registered location"
• Return or recall: deliver it to "The registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf"
• Ask DEA: "Request assistance from the Special Agent in Charge of the Administration in the area in which the practitioner is located," by submitting a DEA Form 41 listing the substances

What "non-retrievable" means for you

21 CFR 1317.90(a): substances destroyed by a registrant "shall be destroyed in compliance with applicable Federal, State, tribal, and local laws and regulations and shall be rendered non-retrievable." State and local rules apply on top of DEA's.

On-site destruction takes two people

21 CFR 1317.95(d) for destruction at your registered location:

• "Two employees of the registrant shall handle or observe the handling of any controlled substance until the substance is rendered non-retrievable; and"
• "Two employees of the registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable."

The destruction record

21 CFR 1304.21(e) then requires "a record of destruction on a DEA Form 41," including "the name and signature of the two employees who witnessed the destruction." 21 CFR 1304.21.

Leftover doses after administration

Wastage follows a different rule. 1304.21(e) says destruction of a substance "dispensed by a practitioner for immediate administration at the practitioner's registered location, when the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be further utilized)" is recorded under 1304.22(c), and "such record need not be maintained on a DEA Form 41."

Is a medical waste vendor a reverse distributor?

Not automatically. 21 CFR 1317.15(a): "Any person that reverse distributes a controlled substance shall be registered with the Administration as a reverse distributor, unless exempted by law or otherwise authorized pursuant to this chapter."

When you request service, put controlled substances on their own line and ask any provider for its DEA registration before you hand anything over. Keep patient information out of the request. For other pharmaceutical streams, see Pharmaceutical waste: what to ask before requesting service.

What this page does not decide

This guide doesn't choose a disposal method, confirm any company's DEA registration, or cover your state board's rules. Check with your DEA field office and your state licensing board.

Can a practice throw expired controlled substances in the sharps or pharmaceutical bin?

No. 1317.05(a) gives a practitioner four routes for its own stock, and a sharps or pharmaceutical waste bin isn't one of them. DEA collection receptacles take only substances from ultimate users and other authorized non-registrants (21 CFR 1317.75(c)).

Who has to witness on-site destruction?

"Two employees of the registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable," per 21 CFR 1317.95(d).

Do you need DEA Form 41 for leftover drug in a syringe after a dose?

Not on a Form 41. For a substance dispensed "for immediate administration" that isn't fully used, 1304.21(e) says it's recorded under 1304.22(c) and "such record need not be maintained on a DEA Form 41."

Does a reverse distributor have to be registered with DEA?

Yes. "Any person that reverse distributes a controlled substance shall be registered with the Administration as a reverse distributor, unless exempted by law or otherwise authorized pursuant to this chapter."

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