DEA Notice: Janssen Pharmaceuticals Applies to Import Controlled Substances

Estimated reading time: 2–3 minutes

Date: January 8, 2026

Who applied:

Janssen Pharmaceuticals Inc. applied to be registered as an importer of specific controlled substances.

Address:

1440 Olympic Drive, Buildings 1-5 & 7-14, Athens, Georgia 30601-1645.

Controlled Substances Requested:

  • Ethylphenidate (Drug code: 1727, Schedule I)
  • Methylphenidate (Drug code: 1724, Schedule II)

Purpose:

Janssen plans to import these substances only for analytical purposes. No other activities involving these drug codes are permitted under this registration.

Regulatory Information:

  • The application follows 21 CFR 1301.34(a).
  • Permit approvals will happen only if the business activity fits U.S. law, specifically 21 U.S.C. 952(a)(2).
  • The permission does not allow the import of finished drugs, whether FDA-approved or not, for sale.

Comments and Hearings:

  • Registered bulk manufacturers and applicants can submit electronic comments or objections by February 9, 2026.
  • Requests for a hearing about the application must be submitted by February 9, 2026.
  • Comments must be made at https://www.regulations.gov.
  • Hearing requests must be sent to the DEA at 8701 Morrissette Drive, Springfield, Virginia 22152, to the Attention of the Hearing Clerk/OALJ, DEA Federal Register Representative/DPW, and the Administrator.

Notice Published By:

Thomas Prevoznik, Deputy Assistant Administrator.

Document Number:

2026-00128

Date Filed:

January 7, 2026

For more information, visit the official Federal Register website.


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