Compounding Pharmacy Applies to Import Morphine: DEA Seeks Comments
Published Date: 8/25/2026
Notice
Summary
Prof Compounding CTS of Ameri wants to become an official importer of controlled substances like morphine. People and companies involved can share their thoughts or ask for a hearing by September 24, 2026. This move could impact how these drugs enter the U.S., so keep an eye on the deadline if you’re involved!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Importer Application: Morphine API
On July 7, 2026, Prof Compounding CTS of Ameri applied to be registered to import Morphine (controlled substance code 9300, Schedule II). The company says it plans to import Morphine Sulfate USP as a narcotic raw material to support the ASPR Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) Program for domestic bulk manufacturing and national preparedness.
No Import of Finished Dosage Forms
The DEA states that any registration and permits will not allow the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. Authorization is limited to the import of the raw material (Morphine Sulfate USP) for bulk manufacturing under the SAPIR program.
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