Catalent CTS, LLC Applies to Import Controlled Substances

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Catalent CTS, LLC has applied to the Drug Enforcement Administration (DEA) to become registered as an importer of certain controlled substances. The notice was published in the Federal Register on August 21, 2025.

Catalent CTS, LLC is located at 10245 Hickman Mills Drive, Kansas City, Missouri 64137-1418. The company sent its application to the DEA on July 17, 2025.

The application covers the following controlled substances:

  • Gamma Hydroxybutyric Acid (Drug code 2010), Schedule I
  • Marihuana Extract (Drug code 7350), Schedule I
  • Marihuana (Drug code 7360), Schedule I
  • Tetrahydrocannabinols (Drug code 7370), Schedule I

Catalent CTS, LLC plans to import these substances either in bulk or as dosage unit products. The imports are intended for clinical trials and distribution.

For Tetrahydrocannabinols, Catalent CTS, LLC plans to import only a synthetic type. The company’s registration does not allow any other activities for these drug codes.

According to the DEA notice, permit approval will only be considered when the activity fits the requirements under 21 U.S.C. 952(a)(2). The registration does not allow import of finished dosage forms for commercial sale, either FDA-approved or not.

Anyone who manufactures these substances or has applied to manufacture them can send comments or objections to the DEA by September 22, 2025. Electronic comments must be sent through the Federal eRulemaking Portal at https://www.regulations.gov.

Written hearing requests must be sent to the DEA at 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearings should also go to the attention of the DEA Administrator at the same address.

The notice was signed by Justin Wood, Acting Deputy Assistant Administrator. The notice reference number is 2025-16004.

For more information, visit the Federal Register or the official DEA website.


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