The Drug Enforcement Administration (DEA) final rule, published 9/9/2014 and effective 10/9/2014, will establish more options for the secure disposal of controlled substances by practitioners and their clients. This will benefit veterinarians, animal owners, and the environment alike by expanding options and reducing complications and confusion. Additionally, there should be fewer instances of controlled substances toxicoses in humans and animals, and there should be a reduction in the amount of these products entering our nation’s waters.
The current process for disposal of controlled substance by registrants
- Under 21 CFR 1307.21, which will be deleted and incorporated into the new 21 CFR 1317 when the final rule goes into effect 10/9/2014.
- Three copies of DEA form 41
- Involves making a request for assistance from your local DEA Special Agent in Charge (SAC), who then provides authorization and instructions for you to do one of the following.
- Transfer the substance to another DEA registered person authorized to possess it
- Give the substance to a DEA agent
- Destroy the substance in the presence of a DEA agent or other authorized person
- Dispose of it by other means as the SAC may determine to assure that the substance does not become available to unauthorized persons.
- The SAC may authorize a registrant regularly needing to dispose of controlled substances to do so as instructed by the SAC without getting prior approval in each instance, on the condition that the registrant keeps records and file reports as specified by the SAC.
Starting October 9, 2014
- The final rule goes into effect.
- Client education on pharmaceutical disposal should be updated to include the new disposal options (authorized take-back events, mail-back programs, and collection receptacle locations) available to your clients and other ultimate users. These options are not available to registrants for disposal of their controlled substance inventory or stock.
- Only one copy of DEA form 41 is needed when required [21 CFR 1317.05(a)(4)(i)]. It is important to note that the final rule specifies [21 CFR 1304.21(e)] that a DEA form 41 is not needed for destruction of a controlled 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). Instead, this destruction needs to be recorded per 21 CFR 1304.22(c).
- Specific wording added to the regulations, clarifying that the SAC may instruct a registrant to dispose of a controlled substance by transferring it to a registrant authorized to transport or destroy the substance.
- Expanded disposal options for registered practitioners (21 CFR 1317.05).
On-site destruction – sufficient to render the controlled substance(s) non-retrievable and in compliance with applicable Federal, State, Tribal, and local laws and regulations.
“Non-retrievable” for the purpose of destruction is defined in the final rule as “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.”
A particular method for destruction is not required, so long as the desired result is achieved. The standard of destruction is intended to allow development a variety of destruction methods that are secure, convenient, and responsible, consistent with preventing the diversion of such substances. The DEA clarified in the 2012 proposed rule that “flushing and mixing controlled substances with coffee grounds or kitty litter are examples of existing methods of destruction that do not meet the non-retrievable standard.”
Reverse distribution – using common or contract carrier pick-up or by reverse distributor pick-up at the registrant’s registered location.
Returns or recalls – using common or contract carrier pick-up or pick-up by other registrants at the registrant’s registered location and sending 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. Procedures and recordkeeping are also discussed under 1304.22 and 1317.10.
Record retention is addressed under 21 CFR 1304.04. With few exceptions, DEA inventory, disposal, and other records must be kept by the registrant and be available, for at least 2 years for inspection and copying by authorized employees of the DEA.
Interested in becoming an authorized collector? The DEA is authorizing, among others, certain registrants (manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies) to be ‘‘collectors,’’ with authorization to conduct mail-back programs. 21 CFR 1317.40, 1317.70, and 1317.75 will help you determine if you might qualify. The DEA clarifies in 21 CFR 1317.05 and 1317.75 that registrants cannot use collection receptacles to dispose of controlled substances from their inventory or stock.
As mentioned in an earlier blog, the AVMA is updating its online information to reflect the regulatory changes made by DEA. Key resources include:
- The AVMA microsite on Waste Disposal by Veterinary Practices: What Goes Where?, a members-only resource that has pages on topics such as Drug and Chemical Disposal and Federal Regulation of Waste Disposal.
- www.avma.org/unwantedmeds, which is accessible by the public and provides readers with general information regarding pharmaceutical disposal and will soon have information for owners specifically on the new regulations pertaining to disposal of unwanted or expired controlled substances.