Pharmaron applies to import controlled drugs: Standard bureaucracy alert
Published Date: 3/26/2025
Notice
Summary
Pharmaron Manufacturing Services (US) LLC wants to become an official importer of certain controlled substances. If you’re a registered manufacturer or interested party, you can share your thoughts or ask for a hearing by April 25, 2025. This move could impact companies dealing with these drugs, but no costs or fees are mentioned yet.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Import registration will not allow finished dosage imports
The notice states that any authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale; only the activities expressly authorized under the registration and 21 U.S.C. 952(a)(2) are permitted.
Applicant seeks to import Dimethyltryptamine (DMT)
Pharmaron Manufacturing Services (US) LLC applied on February 11, 2025 to be registered as an importer of Dimethyltryptamine (controlled substance code 7435, Schedule I). The company says it plans to import DMT for internal analytical use and to support technology transfer, further processing, and subsequent production of Active Pharmaceutical Ingredient (API) for sale to its customers; no other activity for this drug code is authorized.
Deadline to comment or request hearing — April 25, 2025
If you are a registered bulk manufacturer of the affected drug classes or an applicant, you may submit electronic comments or objections, or file a written request for a hearing, on or before April 25, 2025 via https://www.regulations.gov or by mail to the DEA hearing clerk addresses listed in the notice.
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