Federal Register #DEA-1765

DEA Bulk Manufacturer Registration Application for Controlled Substances by Irvine Labs, Inc.

This opportunity involves the Drug Enforcement Administration (DEA) reviewing an application from Irvine Labs, Inc. to become a bulk manufacturer of Schedule I controlled substances for research purposes. - Government Buyer: - Drug Enforcement Administration (DEA), U.S. Department of Justice - OEM/Vendor: - Irvine Labs, Inc. - Products Requested: - Bulk manufacture of Active Pharmaceutical Ingredients (APIs) for: - Marihuana Extract (drug code 7350) - Marihuana (drug code 7360) - Tetrahydrocannabinols (drug code 7370) - Quantities: - Not specified in the notice - Notable Requirements: - Manufacture is limited to product development and distribution to DEA-registered researchers - No other activities are authorized for these substances under this registration - Public comments and requests for hearings are invited regarding the application - OEMs are highlighted as the primary manufacturer for these controlled substances - The DEA is seeking input from the public and industry stakeholders

Description

Irvine Labs, Inc. has applied to be registered as a bulk manufacturer of basic classes of controlled substances. The company plans to bulk manufacture bulk Active Pharmaceutical Ingredients for product development and distribution to DEA-registered researchers. No other activities for these drug codes are authorized for this registration. Comments on the application can be submitted electronically or requests for a hearing can be filed by November 9, 2026.

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