DEA Notice of Proposed Rulemaking on the Disposal of Controlled Substances
Health Law Update 01/02/13 Larry P. Cote, Christopher T. Dang
On December 21, 2012, the United States Drug Enforcement Administration ("DEA") published a notice of proposed rulemaking with new and revised regulations to govern the secure disposal of controlled substances by ultimate users and DEA registrants. The proposed regulations also include revised definitions and procedures for reverse distributors, return and recall, and a new standard for destruction of controlled substances.
If adopted, the regulations would implement the Secure and Responsible Drug Disposal Act of 2010 (Pub. L. 111-273) (the "Disposal Act") and would be largely incorporated into newly created Part 1317.
Ultimate User Disposal
Before the passage of the Disposal Act, the Controlled Substances Act ("CSA") did not address drug disposal by ultimate users. Under FDA guidance, ultimate users are currently directed to mix unwanted drugs with inedible substances such as coffee grounds, place the mixture into a plastic bag, and discard the bag in the garbage. The CSA, however, did not authorize ultimate users to transfer unused and unwanted medications to other persons for disposal.
The limited amount of readily available and safe disposal opportunities meant that ultimate users often accumulated unused and unwanted controlled substances in home medicine cabinets. Many households do not take any appreciable measures to secure such drugs. Easy access to these controlled substances make them a prime target for drug abuse, particularly among children and teens.
To alleviate this problem, the proposed rule allows DEA registrants authorized as "collectors" to operate mail-back programs and collection receptacles to collect controlled substances for disposal. Law enforcement agencies may also operate these programs along with take-back events. Ultimate users and persons lawfully authorized to dispose of a deceased ultimate user's property may dispose of non-controlled and Schedule II through V controlled substances using any of these programs.
Qualifications for Authorized Collectors
Under the proposed rules, registrants must be authorized to act as a "collector" before receiving controlled substances for destruction. Collectors may be DEA registered manufacturers, distributors, reverse distributors, and retail pharmacies. Eligible registrants may obtain collector authorization through a modification to their registration at no additional cost. Currently, the DEA does not intend to authorize hospitals to act as collectors.
Agents and employees of authorized collectors ("authorized employees") with access to or influence over acquired controlled substances would have to meet certain employment standards. These standards would require authorize collectors to employ persons that have never been convicted of any felony related to controlled substances and have never had an application for registration with the DEA denied; have had a license revoked or suspended; or otherwise have surrendered a DEA registration.
Authorized collectors are exempt from ARCOS and order form requirements when collecting controlled substances from ultimate users and other authorized non-registrants. Distributors and reverse distributors are exempt from ARCOS requirements only for those controlled substances that are acquired from law enforcement agencies or authorized collectors and that were originally collected from ultimate users.
Authorized Collector Operated Mail-Back Programs
Under the proposed rule authorized collectors may voluntarily administer mail-back programs so long as the collector maintains and uses an on-site system for the destruction.
Mail-back programs must provide ultimate users or other authorized persons shipping packages that meet DEA standards. Among other requirements, DEA proposes that the packages be postage-paid, pre-addressed, tamper-evident, and bear a unique identification number for tracking. They may be provided at no cost or for a fee, and authorized collectors may partner with third parties for the purpose of funding, disseminating, producing the packages or engaging in other non-collection activity to facilitate the program.
Authorized collectors may only accept packages distributed by the collector or its partners.
Packages may not be not opened, penetrated, or otherwise analyzed and must be promptly destroyed on-site or securely stored until on-site destruction can occur. The term "prompt" is used to describe the time-frame for destruction to allow for some flexibility.
Authorized Collector Collection Receptacles
Under the proposed rules, authorized collectors may install and operate collection receptacles at the same location as their DEA registration. The containers must be lockable, sturdy, securely fixed close to where controlled substances are stored and where an authorized employee is present, and display a sign stating that non-controlled and controlled drugs in Schedule II, III, IV, or V may be accepted. Each container must also feature a removable, tamper-evident, and tear-resistant inner liner bearing a unique identification number.
To dispose of the contents, the liners and their contents should be sealed and destroyed on-site. Alternatively, the liners may be promptly delivered or transferred to a reverse distributor or distributor for destruction.
Long-Term Care Facility ("LTCF") Collection Receptacles
Under the proposed rule, retail pharmacies may administer collection receptacles at LTCFs. LTCFs may use these receptacles to dispose of controlled substances originally possessed by an ultimate user that resides or once resided at the LTCF. The retail pharmacy must submit the physical location of each LTCF where it intends to operate a collection receptacle with its application to become an authorized collector.
Under the current proposed rules, a LTCF that does not possess a retail pharmacy administered on-site collection receptacle is not permitted to otherwise deliver or dispose of controlled substances on behalf of the ultimate user.
DEA Registrant Disposal
Registrant disposal is currently governed by 21 C.F.R. § 1307.21 with additional guidance included in the DEA manuals. The DEA proposes to delete the existing rule and replace it with new provisions in Part 1317.
Under the new rules, non-practitioner registrants (e.g. manufacturers, distributors, and reverse distributors) would be authorized to dispose of their controlled substance inventory either by:
- Promptly destroying the drugs on-site in accordance with federal, state, and local law;
- Transferring or delivering the substance to a registered reverse distributor; or
- For the purpose of return or recall, promptly delivering the controlled substance to or arranging pick up by the person from whom the controlled substance was originally obtained or other authorized agent.
Practitioner registrants (e.g. physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person authorized to distribute, dispense, research, administer a controlled substances) would be allowed to dispose of controlled substances either by:
- Promptly destroying the drugs on-site in accordance with federal, state, and local law;
- Transferring the substance to a registered reverse distributor;
- For the purpose of return or recall, promptly delivering to or arranging pick up by the person from whom the controlled substance was originally obtained or other authorized agent; or
- Request assistance from the local DEA Special Agent in Charge.
Again, the term "prompt" is used to allow for some flexibility.
The DEA proposes to consolidate and clarify the current reverse distributor regulations. Notably, once in possession of the controlled substance, a reverse distributor must either:
- Immediately store the controlled substance at or transfer the controlled substance to the reverse distributor's registered location for secure storage until timely destruction or timely return of the controlled substance to the manufacturer;
- Immediately deliver the substance to the manufacturer or manufacturer's agent;
- Timely destroy the controlled substance; or
- Immediately deliver the substance to the place of destruction for timely destruction.
The DEA proposes to use the term "immediately" to emphasize that transfers or deliveries should be done with the goal of continuously moving the shipments toward their ultimate and secure destination. To that end, the DEA proposes that reverse distributors be required to destroy controlled substances acquired for destruction as soon as practicable but no later than 14 calendar days of pick-up or delivery. This 14 calendar day threshold would only apply to reverse distributors.
Return and Recall
Under the proposed rules, existing 21 C.F.R. § 1307.12 would be deleted and new return and recall procedures would be established for registrants and ultimate users.
Registrants in lawful possession of a controlled substance may return that substance for the purpose of return or recall to person from whom the controlled substance was obtained, the manufacturer, or to an agent authorized by the manufacturer to accept returns or recalls. Returning and receiving registrants would be required to document returns and DEA Form 222 must be used for Schedule I or II controlled substances.
Ultimate users may deliver the recalled controlled substance to the manufacturer or other registrant authorized by the manufacturer. DEA registered manufacturers or their agents would not be required to obtain a collector authorization to accept recall returns. Registrants receiving recalled controlled substances from ultimate users would have to maintain a record of the controlled substances received but would not be required to use DEA Form 222 to document such returns. The DEA also proposes that DEA registered manufacturers and their agents report all recall acquisitions.
Methods and Procedure for Destruction
Last, but not least, the DEA proposes a new "non-retrievable" standard of destruction. The destruction method should render the controlled substance to a state where it is no longer susceptible to diversion. However, the DEA is not requiring or recommending any particular method of destruction so long as the desired result is achieved and it complies with all other applicable laws and regulations.
The procedure for destruction requires two authorized employees to handle or supervise the loading and unloading of controlled substances for transfer to another registrant for disposal. If transported by the registrant, two authorized employees must accompany the shipment. Two authorized employees must also handle or observe the handling of controlled substances until the drug is rendered non-retrievable. Lastly, two authorized employees must personally witness and document the destruction.
The proposed rules will dramatically revamp the current regulations and guidance on the disposal of controlled substances. For ultimate users or persons lawfully authorized to dispose of a deceased ultimate user's controlled substances, the regulations ostensibly provide additional opportunities to safely dispose of unused and unwanted controlled substance. LTCFs also gain much needed clarity on what to do with unused or unwanted controlled substances from resident or former residents. However, LTCFs must dispose controlled substances in cooperation with authorized and participating retail pharmacies.
DEA registered manufacturers, distributors, reverse distributors, and retail pharmacies are asked to voluntarily administer mail-back programs and collection receptacles. Industry adoption, however, will largely depend on the economics of a particular program and the burden that an eligible registrant is willing to carry. Similarly, law enforcement adoption will likely depend on available agency funding or grants.
The public comment period provides a valuable opportunity for industry stakeholders to get in another word before the final rules are published, and interested parties should submit their comments on or before February 19, 2013.