Disposal and/or Destruction Q&A
Question: Do controlled substances that are broken, spilled, and/or damaged need to be reported to the Drug Enforcement Administration (DEA)?
Answer: While neither the Controlled Substances Act nor DEA’s regulations specifically address reporting the breakage and/or spillage of a controlled substance, on August 12, 2005, DEA published in the Federal Register (FR) a Final Rule, Reports by Registrants of Theft or Significant Loss of Controlled Substances, 70 FR 47094. In that rule, DEA remarked that previous guidance on the topic, given in a July 8, 2003 Notice of Proposed Rulemaking and Guidance Document, Reports by Registrants of Theft or Significant Loss of Controlled Substances, 68 FR 40576, was adequate and sufficiently clear: the witnessed breakage or spillage of a controlled substance does not constitute a loss of controlled substances because the registrant can account for the controlled substances; these types of incidents do not require notification to DEA. 70 FR 47096; see also 68 FR 40578. DEA also stated that registrants "should continue to employ common sense, good faith approaches to their reporting and recordkeeping obligations in the case of breakage and spillage." 70 FR 47096. DEA registrants are also reminded of their recordkeeping obligations with respect to controlled substances that are disposed of by destruction. See 21 CFR 1304.22(a)(2)(ix). EO-DEA144. DEA-DC-051, June 17, 2021
Question: How are controlled substances in a registrant's inventory to be handled when a registrant dies?
Answer: When a registrant dies, the DEA registration terminates and the inventory of controlled substances must be disposed of. Per 21 CFR 1301.52(a), a DEA registration terminates when a person dies, as well as when the business ceases legal existence, a business or professional practice is discontinued, or a registrant surrenders their registration. DEA regulations do not permit controlled substances in a registrant's inventory to be disposed of by way of drug take-back collection. See 21 CFR 1317.05, 1317.65. For individuals or entities handling a deceased registrant's affairs, local or State law enforcement should be contacted to assist in picking up controlled substances inventory for disposal. For uncommon situations, such as those involving the location of controlled substance inventories subsequent to a registrant death, local DEA Diversion offices can be contacted and consulted for guidance on next-steps. EO-DEA224, October 5, 2020
Question (Chemical Digester Disposal): Some pharmaceutical disposal products on the market, like a chemical digester, say they meet DEA’s "non-retrievable" standard. May I use it to destroy my controlled substance inventory?
Answer: To comply with the DEA regulations when disposing of a controlled substance, registrants must use a method which renders the substance "non-retrievable" (21 CFR 1317.90(a)) and otherwise complies with relevant law and regulations. The term "non-retrievable" is defined in a results oriented manner as DEA requires the substance to be permanently rendered to an unusable state. 21 CFR 1300.05. The performance standard is that the method irreversibly renders the substance such that it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. Thus, regardless of whether the product claims to render controlled substances non-retrievable, to comply with the DEA regulations, a registrant that disposes of a controlled substance must use a product or method that actually does render the controlled substance non-retrievable within the meaning of the DEA regulations. Much like DEA does not evaluate, review, or approve the specific processes or methods utilized to produce, synthesize or propagate a controlled substance, DEA will not evaluate, review, or approve the processes or methods utilized to render a controlled substance "non-retrievable," as long as the desired result is achieved. EO-DEA178, October 5, 2020
Question: May a Long-Term Care Facility (LTCF) dispose of controlled substances on behalf of an LTCF resident or decedent?
Answer: Yes. An LTCF may dispose of controlled substances in schedules II-V on behalf of a resident or decedent of the facility who is or was in lawful possession of that controlled substance. 21 CFR 1317.30(b)(3). The controlled substances must be disposed of by transferring them into an authorized collection receptacle located at that LTCF within three business days after the permanent discontinuation of use as directed by the prescriber, or the resident’s transfer from that facility, or as a result of death. 21 CFR 1317.80. An LTCF must also ensure disposal is done in accordance with all applicable State, tribal and local controlled substance disposal laws and regulations. EO-DEA174, October 5, 2020
Question: What alternatives to incineration do I have to destroy controlled substances in my inventory?
Answer: A registrant can transfer expired or unwanted controlled substances to a reverse distributor for final destruction; the reverse distributor will typically use incineration or a method that renders the controlled substance non-retrievable. A registrant also has the option of destroying controlled substances on-site at their registered location provided the destruction method meets the non-retrievable standard. Registrants who destroy their controlled substance inventory must document the destruction on a DEA Form 41 (see 21 CFR 1304.21(e). EO-DEA200, October 5, 2020
Question: I am a pharmacist and my pharmacy has some outdated controlled substances that need to be destroyed. Is there another method I can use, other than incineration, to dispose of these controlled substances?
Answer: Not at this time. The controlled substances you are referring to are part of your inventory. The regulations enforced by DEA require that controlled substances, which are part of a DEA registrant’s inventory, be disposed of to the point of being non-retrievable. 21 CFR 1317.90(a). EO-DEA221, October 5, 2020
Disclaimer: Guidance documents, like this document, are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance document that is not accessible through the Department's guidance portal, or similar guidance portals for other Executive Branch departments and agencies, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department's complete discretion, consistent with applicable laws.