Mylan Technologies Applies to Import Controlled Substances for Testing

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Mylan Technologies Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of controlled substances. The application was officially filed on October 7, 2025.

Mylan Technologies is located at 110 Lake Street, Saint Albans, Vermont 05478-2266. The company seeks to import two specific controlled substances. These are:

  • Methylphenidate (Drug code 1724, Schedule II)
  • Fentanyl (Drug code 9801, Schedule II)

Mylan plans to import these substances in finished dosage form (FDF) from foreign sources. The imports will be used for analytical testing and clinical trials. In these trials, the foreign FDF will be compared to the company’s own FDF made in the United States for foreign markets.

The registration does not authorize other activities for these drug codes. The permit is only for testing and trials. It does not allow the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

The DEA will grant approval only if the registrant’s activities match what is allowed under U.S. law. Other uses are not permitted.

People who make these substances or want to make them may submit comments or objections. Comments must be sent electronically by February 9, 2026. Written requests for a hearing on the application must also be sent by this date.

Comments must be submitted through the Federal eRulemaking Portal at regulations.gov. Written hearing requests must be sent to:

1. Drug Enforcement Administration, Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152
2. Drug Enforcement Administration, DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152
3. Drug Enforcement Administration, Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152

This notice follows 21 CFR 1301.34(a), which governs the importation of controlled substances.

The announcement was issued by Thomas Prevoznik, Deputy Assistant Administrator of the DEA.


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