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Disposal of Controlled Substances; Final Rule

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Disposal of Controlled Substances; Final Rule Vol. 79 Tuesday, No. 174 September 9, 2014 Part II Department of Justice Drug Enforcement Administration 21 CFR Parts 1300, 1301, 1304, et al. Disposal of Controlled Substances; Final Rule VerDate Mar<15>2010 19:16 Sep 08, 2014 Jkt 232001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\09SER2.SGM 09SER2 tkelley on DSK3SPTVN1PROD with RULES2 53520 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations DEPARTMENT OF JUSTICE Outline promulgated by the Attorney General. 21 U.S.C. 822(g), 828(b)(3). This final Drug Enforcement Administration I. Executive Summary rule implements regulations that expand A. Purpose of the Regulatory Action the entities to which ultimate users may 21 CFR Parts 1300, 1301, 1304, 1305, B. Summary of the Major Provisions of the transfer unused, unwanted, or expired 1307, and 1317 Regulatory Action pharmaceutical controlled substances C. Summary of Changes in the Final Rule II. Background and Legal Authority for the purpose of disposal, as well as [Docket No. DEA–316] III. Discussion of Comments the methods by which such A. Support for the Proposed Rule (1 Issue) pharmaceutical controlled substances RIN 1117–AB18 B. Definitions and Terms (12 Issues) may be collected. Specified entities may C. Types of Entities That May Operate a voluntarily administer any of the Disposal of Controlled Substances Collection Program (9 Issues) authorized collection methods in D. Locations Where Authorized Collectors accordance with these regulations. AGENCY: Drug Enforcement May Maintain Collection Receptacles or Administration (DEA), Department of Host Take-Back Events (1 Issue) B. Summary of the Major Provisions of Justice. E. Registration Requirements for the Regulatory Action Authorized Collectors (5 Issues) ACTION: Final rule. The DEA is implementing new F. Law Enforcement (7 Issues) regulations for the disposal of G. Collection Receptacle Design, Inner SUMMARY: This rule governs the secure Liners, Placement, and Security (24 pharmaceutical controlled substances disposal of controlled substances by Issues) by ultimate users in accordance with the registrants and ultimate users. These H. Mail-Back Programs (11 Issues) Disposal Act. In drafting the regulations will implement the Secure I. Take-Back Events (6 Issues) implementing regulations, the DEA and Responsible Drug Disposal Act of J. Prohibition on Handling, Sorting, and considered the public health and safety, 2010 by expanding the options available Inventorying Inner Liner Contents and ease and cost of program to collect controlled substances from Mail-Back Package Contents (8 Issues) implementation, and participation by ultimate users for the purpose of K. Long-Term Care Facilities (LTCFs) (21 various communities. To this end, the disposal, including: Take-back events, Issues) DEA found that in order to properly L. Disposing on Behalf of Ultimate Users address the disposal of controlled mail-back programs, and collection (Other than Residents of LTCFs) (3 receptacle locations. These regulations Issues) substances by ultimate users, it was contain specific language allowing law M. Registrant Return, Recall, and Transfer necessary to conduct a comprehensive enforcement to voluntarily continue to (3 Issues) review of DEA policies and regulations conduct take-back events, administer N. Destruction (19 Issues) related to each element of the disposal mail-back programs, and maintain O. Economic Concerns (18 Issues) process, including the transfer, delivery, collection receptacles. These regulations P. Recordkeeping and Reporting (8 Issues) collection, destruction, return, and will allow authorized manufacturers, Q. Hazardous Materials Transportation and recall of controlled substances, by both distributors, reverse distributors, Hazardous Waste Destruction (3 Issues) registrants and non-registrants (i.e., R. Transporting Collected Substances (3 narcotic treatment programs (NTPs), ultimate users). The reverse distributor Issues) registration category, which is pertinent hospitals/clinics with an on-site S. Miscellaneous Comments (2 Issues) pharmacy, and retail pharmacies to IV. Regulatory Analyses to the process of registrant disposal, was voluntarily administer mail-back included in this comprehensive review. programs and maintain collection I. Executive Summary These regulations are incorporated into receptacles. In addition, this rule A. Purpose of the Regulatory Action a new part 1317 on disposal. Definitions expands the authority of authorized relating to the disposal of controlled hospitals/clinics and retail pharmacies On October 12, 2010, the Secure and substances are added to § 1300.05(b), to voluntarily maintain collection Responsible Drug Disposal Act of 2010 including definitions for ‘‘employee,’’ receptacles at long-term care facilities. (Disposal Act) was enacted (Pub. L. ‘‘law enforcement officer,’’ ‘‘non- This rule also reorganizes and 111–273, 124 Stat. 2858). Before the retrievable,’’ and ‘‘on-site’’ and consolidates previously existing Disposal Act, ultimate users who definitions relating to controlled regulations on disposal, including the wanted to dispose of unused, unwanted, substances generally are revised or role of reverse distributors. or expired pharmaceutical controlled added to § 1300.01. substances had limited disposal options. The goal of this new part on disposal, DATES: Effective Date: This rule is The Controlled Substances Act (CSA) consistent with Congress’s goal in the effective October 9, 2014. only permitted ultimate users to destroy Disposal Act, is to set parameters for Compliance Date: All Memoranda of those substances themselves (e.g., by controlled substance diversion Agreement (MOAs) and Memoranda of flushing or discarding), surrender them prevention that will encourage public Understanding (MOUs) issued pursuant to law enforcement, or seek assistance and private entities to develop a variety to current 21 CFR 1307.21 will not be from the United States Drug of methods for collecting and destroying effective after October 9, 2014. Enforcement Administration (DEA). pharmaceutical controlled substances in Registrants may consult § 1317.05(a)(5) These restrictions resulted in the a secure, convenient, and responsible for information on requesting new accumulation of pharmaceutical manner. Also, consistent with the MOAs and MOUs for disposal of controlled substances in household Disposal Act’s goal to decrease the controlled substances. medicine cabinets that were available amount of pharmaceutical controlled FOR FURTHER INFORMATION CONTACT: for abuse, misuse, diversion, and substances introduced into the Imelda L. Paredes, Office of Diversion accidental ingestion. environment, particularly into the Control, Drug Enforcement The Disposal Act amended the CSA to water, these regulations provide Administration; Mailing Address: 8701 authorize ultimate users to deliver their individuals with various additional Morrissette Drive, Springfield, Virginia pharmaceutical controlled substances to options to dispose of their unwanted or 22152; Telephone: (202) 598–6812. another person for the purpose of unused pharmaceutical controlled SUPPLEMENTARY INFORMATION: disposal in accordance with regulations substances beyond discarding or VerDate Mar<15>2010 18:15 Sep 08, 2014 Jkt 232001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\09SER2.SGM 09SER2 tkelley on DSK3SPTVN1PROD with RULES2 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 53521 flushing the substances. As a result of These DEA regulations authorize authorized registrants that choose to these regulations, the DEA hopes that collectors to maintain collection administer mail-back programs may the supply of unused pharmaceutical receptacles at their registered location. gain from the opportunity to distribute controlled substances in the home will 21 CFR 1317.40. Thus, ultimate users to consumers promotional, educational, decrease, thereby reducing the risk of will be able to carry their unwanted or other informational materials with diversion or harm. pharmaceutical controlled substances to the mail-back packages. an authorized retail pharmacy or other Ultimate User Disposal DEA Registrant Disposal authorized collector location and An ultimate user is defined by the deposit those controlled substances in a The DEA has deleted the existing rule CSA as a ‘‘person who has lawfully secure container for disposal. Hospitals/ related to registrant disposal, 21 CFR obtained, and who possesses, a clinics and retail pharmacies that are 1307.21, and incorporated similar controlled substance for his own use or authorized to be collectors may also requirements on proper disposal for the use of a member of his maintain collection receptacles at long- procedure and security in a new part household or for an animal owned by term care facilities (LTCFs). 21 CFR 1317 on disposal. These changes him or by a member of his household.’’ 1317.40. LTCFs may dispose of provide consistent disposal procedures 21 U.S.C. 802(27). This rule provides pharmaceutical controlled substances for each registrant category, regardless three voluntary options for ultimate user on behalf of an ultimate user who of geographic location. In addition, the disposal: (1) Take-back events, (2) mail- resides, or has resided, at that LTCF, 21 DEA has modified DEA Form 41 and is back programs, and (3) collection CFR 1317.80, through a collection explicitly requiring that form to be used receptacles. Individuals lawfully receptacle that is maintained by an to
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