Federal Register #DEA-1739

DEA Notice: AMPAC Fine Chemicals LLC Application for Bulk Manufacturer Registration of Controlled Substances

This opportunity concerns the Drug Enforcement Administration (DEA) notice regarding AMPAC Fine Chemicals LLC's application for registration as a bulk manufacturer of controlled substances. - Government Buyer: - U.S. Department of Justice, Drug Enforcement Administration (DEA) - OEM/Vendor: - AMPAC Fine Chemicals LLC - Controlled Substances Requested for Bulk Manufacturing: - Tapentadol (drug code 9780, Schedule II) - Norlevorphanol (9634, Schedule I) - Amphetamine (1100, Schedule II) - Lisdexamfetamine (1205, Schedule II) - Methylphenidate (1724, Schedule II) - Levomethorphan (9210, Schedule II) - Levorphanol (9220, Schedule II) - Thebaine (9333, Schedule II) - Remifentanil (9739, Schedule II) - Purpose and Requirements: - Substances will be manufactured for use as intermediates, impurity testing, and distribution to customers - No other activities for these drug codes are authorized under this registration - The DEA is soliciting comments and objections from other registered bulk manufacturers and applicants - No specific purchase quantities, part numbers, or procurement of products/services are included, as this is a registration application, not a product solicitation

Description

AMPAC Fine Chemicals LLC has applied to be registered as a bulk manufacturer of basic classes of controlled substances. The company plans to bulk manufacture the listed controlled substances for use as intermediates, impurity testing, and distribution to its customers. Comments and objections to the proposed registration can be submitted electronically until September 14, 2026. A written request for a hearing can also be filed by the same date. The application is docketed under DEA-1739 and published in the Federal Register, volume 91, page 43668.

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