Pharma Seeks DEA Nod to Import ADHD Drugs: Comments Open
Published Date: 1/8/2026
Notice
Summary
Janssen Pharmaceuticals wants to become an official importer of certain controlled drugs, including ethylphenidate and methylphenidate. People and companies involved with these drugs can share their thoughts or ask for a hearing by February 9, 2026. This move could affect drug supply chains and regulatory oversight but doesn’t mention any direct costs yet.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Finished dosage forms not permitted for commercial import
The notice states that any registration authorization will not extend to the import of Food and Drug Administration (FDA)-approved or non-approved finished dosage forms for commercial sale. That means this importer registration, if granted, would not allow importing finished drug products for commercial sale.
Janssen applied to import two controlled drugs
On November 10, 2025, Janssen Pharmaceuticals Inc. applied to be registered to import ethylphenidate (drug code 1727, Schedule I) and methylphenidate (drug code 1724, Schedule II). The company says it plans to import these substances only for analytical purposes and no other activities for these drug codes are authorized by this registration.
Stakeholders may submit comments or request hearings
Registered bulk manufacturers of the affected basic classes, and other applicants, may submit electronic comments or objections and may file written requests for a hearing on the application on or before February 9, 2026. Comments are to be submitted through https://www.regulations.gov and hearing requests must be mailed to DEA addresses listed in the notice.
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