Benuvia Operations, LLC Applies to Manufacture Controlled Substances
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The Drug Enforcement Administration (DEA) announced that Benuvia Operations, LLC has applied to be a bulk manufacturer of certain controlled substances. The company is located at 3950 North Mays Street, Round Rock, Texas 78665.
Benuvia Operations, LLC applied on October 27, 2025. The application is for the following drugs:
- Lysergic Acid Diethylamide (Drug code: 7315) – Schedule I
- Codeine (Drug code: 9050) – Schedule II
- Hydromorphone (Drug code: 9150) – Schedule II
- Sufentanil (Drug code: 9740) – Schedule II
The company wants to make these drugs in bulk. The purpose is for internal research and for making new dosage forms. No other activities are allowed for these drugs under this registration.
If other manufacturers or applicants are affected by this notice, they can comment on the application. They must submit their comments electronically by January 30, 2026. Comments must be sent through the Federal eRulemaking Portal at https://www.regulations.gov.
Anyone who wants a hearing on this application must also submit a written request by January 30, 2026.
Thomas Prevoznik, the Deputy Assistant Administrator, signed this notice.
This notice was published in the Federal Register, Volume 90, Number 228, on Monday, December 1, 2025. The document number is 2025-21720.
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