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Controlled Substances Destruction: The DEA’s Call for Input
Mar 08, 2024
It may seem obvious that U.S. drug makers and regulators don’t want pharmaceutical controlled drugs that were “destroyed” to be recoverable. The risks of such a scenario are apparent.
Think of the places in which drugs are legally used, such as hospitals, doctors’ offices, and even research and development labs. Invariably, there are amounts left over that need to be destroyed, or made “non-retrievable,” to prevent diversion and to protect public health and safety. But establishing protocols for disposal of those drugs can be challenging and the government believes there may be multiple viable alternatives.
While incineration has been the historical go-to destruction method to achieve that end, the U.S. Drug Enforcement Administration (DEA) is seeking input about alternative processes to accomplish the same result that are consistent with state and environmental laws and regulations.
In an Advance Notice of Proposed Rulemaking (ANPRM) published in October 2023, titled Controlled Substance Destruction Alternatives to Incineration, the DEA is seeking comments regarding “methods of destruction . . . other than incineration which may meet the disposal requirements of DEA registrants, and to promote the public exchange of technology and process development information . . .” The comment period ends April 1, 2024.
Those who may choose to provide comment must consider the DEA’s results-oriented definition of non-retrievable. It does not address process:
“Non-retrievable means, for the purpose of destruction, the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes. The process to achieve a non-retrievable condition or state may be unique to a substance's chemical or physical properties. A controlled substance is considered “non-retrievable” when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. The purpose of destruction is to render the controlled substance(s) to a non-retrievable state and thus prevent diversion of any such substance to illicit purposes.”
Ten questions compose the bulk of the DEA’s notice and help shape the issue and potential response. The DEA instructs:
“Please identify destruction methods or technology currently being utilized or developed to render the controlled substances non-retrievable. For each method or technology identified, please include:
1. If known, the potential users of this method or technology.
2. A detailed description of the method of destruction or technical process utilized to achieve the non-retrievable standard. Does this method or technology involve incineration at any point to attain the non-retrievable standard?
3. The controlled substance(s) to which the method of destruction or technology to render the controlled substance(s) non-retrievable may be applicable.
4. If known, list any controlled substances that will not be rendered non-retrievable by this method.
5. The volume or throughput (per hour) required to render the controlled substance non-retrievable.
6. The registrant's anticipated cost to execute, implement, or utilize the method of destruction or technology discussed above.
7. The analytical process utilized to evaluate the effectiveness of the method of destruction or technology. Provide the analytical results validating attainment of the non-retrievable standard.
8. The characteristics or constituents of any by-products or waste generated through the process used to render the controlled substance non-retrievable. Provide the waste profile sheet or similar documentation showing analytical results of the by-products or waste generated.
9. The disposal process of the by-products or waste generated.
10. The Federal, state, or local regulatory requirements associated with the disposal process and/or disposal of the by-products or waste.”
To learn more about the DEA’s call for comments, click the link to the DEA’s ANPRM to include your comments:
https://www.regulations.gov/document/DEA-2023-0148-0001
Should you choose to contribute input, provide detailed information that clearly communicates and supports your comments. Proprietary information can be redacted, if requested.
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