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DOJ/DEA | RIN: 1117-AB49 | Publication ID: Spring 2018 |
Title: ●Controlled Substances Manufacturing Quotas: Inventory Allowance; Subcategories for Quotas; Certification of Procurement Quota for Controlled Substances | |
Abstract:
The Drug Enforcement Administration proposes to revise and amend existing regulations to reduce overall inventories held by DEA-registered manufacturers and other registrants; to create use-specific subcategories for procurement quotas; and to clarify the current language and ensure that both manufacturers and distributors are required to obtain certification of a buyer’s quota for the requested schedules I and II controlled substances, as well as list I chemicals. These changes are necessary, in light of the increasingly complex controlled substances manufacturing business practices, to reduce the potential for the diversion of certain controlled substances. Due to this evolution of complexity in the pharmaceutical industry and the inflexible nature of the regulations by which DEA must calculate inventory allowances for manufacturers of controlled substances, the current inventory allowances provide opportunity for the accumulation of controlled substance surpluses to occur. These proposed regulations will rectify a situation where DEA’s ability to strike an appropriate balance between ensuring the availability of controlled substances to industry and the risk to public health and safety has been hindered and resulted in an overproduction of controlled substances inventories available for diversion. |
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Agency: Department of Justice(DOJ) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Other | |
CFR Citation: 21 CFR 1303 21 CFR 1315 | |
Legal Authority: 21 U.S.C. 821 21 U.S.C. 826 21 U.S.C. 871(b) |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
Public Comment URL: www.regulations.gov/ | |
RIN Data Printed in the FR: No | |
Agency Contact: Michael J. Lewis Section Chief Department of Justice Drug Enforcement Administration 8701 Morrissette Drive, Springfield, VA 22152 Phone:202 598-6812 Fax:202 307-9536 |