Importer of Controlled Substances Application: Indivior Manufacturing LLC
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
Indivior Manufacturing LLC has submitted an application to the U.S. Drug Enforcement Administration (DEA) to be registered as an importer of one or more basic classes of controlled substances. This is a standard federal regulatory notice published in the Federal Register, as required under the Controlled Substances Act, to inform the public and allow for comment before a registration decision is made. Indivior is a pharmaceutical company known for manufacturing buprenorphine-based medications used in the treatment of opioid use disorder. The application to import controlled substances is consistent with the company's need to secure raw materials or active pharmaceutical ingredients classified under DEA schedules for use in manufacturing approved medications. The notice does not introduce new regulations or policy changes but fulfills a procedural requirement. Interested parties may submit comments or objections to the DEA regarding this application within the designated comment period. The DEA will evaluate the application based on statutory criteria including the applicant's compliance history, the legitimate need for the substances, and public health considerations.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Indivior Manufacturing LLC has applied to DEA for registration as an importer of controlled substances under the Controlled Substances Act
- Public notice period opened for comments or objections regarding the application
- DEA will evaluate the application based on compliance history, legitimate need, and public health criteria
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Obligations
What this law requires
Obtain DEA registration as an importer of basic class(es) of controlled substance(s) before importing any controlled substances
Submit a complete application to the DEA that includes information about the applicant's compliance history, legitimate need for the substances, and public health considerations
Allow the public and interested parties a designated comment period to submit comments or objections regarding the importer application
Demonstrate compliance history with controlled substance regulations as part of DEA evaluation of the registration application
Establish and document a legitimate need for the imported basic classes of controlled substances in manufacturing approved medications