Firm Applies to Import Amphetamine and Oxycodone for US Market
Published Date: 4/18/2025
Notice
Summary
Myonex LLC wants to become an official importer of certain controlled drugs like amphetamine and oxycodone. People who make or use these drugs can share their thoughts or ask for a hearing by May 19, 2025. This move could affect companies handling these substances and might shake up the drug import scene soon.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
Application to Import Specific Schedule II Drugs
Myonex LLC applied on January 9, 2025 to be registered as an importer for these Schedule II controlled substances: amphetamine; lisdexamfetamine; methylphenidate; nabilone; oxycodone; hydromorphone; hydrocodone; morphine; oxymorphone; and fentanyl. The company says it plans to import these drugs in dosage form for clinical trials, research, and analytical purposes only.
No Authorization for Commercial Finished Dosage Imports
The registration application explicitly states that authorization will not extend to the import of Food and Drug Administration approved or non‑approved finished dosage forms for commercial sale. Only importation for clinical trials, research, and analytical purposes is stated as planned.
Comment and Hearing Deadline for Stakeholders
Registered bulk manufacturers of the listed substances and other applicants may submit electronic comments or objections, or file a written request for a hearing, on or before May 19, 2025 via regulations.gov or specified DEA addresses. The notice provides the procedure and deadline for participation in the application review.
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