Biopharma Wants Bulk Drugs—DEA Says 'Apply Within'
Published Date: 8/25/2026
Notice
Summary
Biopharmaceutical Research Company has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
No Economic Impacts Identified for this Document
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-11526, Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment
Starting July 9, 2026, new rules make it easier for doctors and pharmacies to provide medicine that helps people recover from opioid addiction. These changes affect healthcare providers by expanding who can give medication-assisted treatment and how pharmacies can deliver these medicines. The goal? Faster, safer access to treatment with clear rules that save time and support recovery.
2026-10128, Revision of Applications for Manufacturing and Procurement Quotas
The DEA wants to update how companies apply for permission to make and buy certain controlled drugs and chemicals. These changes will make the rules clearer, help prevent drug shortages, and ensure enough supply for medical and scientific needs. If you’re a manufacturer or involved in this process, get ready to follow new steps and share your thoughts by July 20, 2026.
2025-05007, Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients
Starting December 31, 2025, veterans can get buprenorphine treatment and follow-up care through telemedicine, making it easier to access help for opioid use disorder without leaving home. This change affects veterans using VA health services and aims to improve treatment access while the government reviews feedback and policies. No new costs are mentioned, but the delay gives agencies time to ensure the rules work well.
2025-02793, Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients
The government is giving veterans easier access to buprenorphine treatment through telemedicine, letting them get care remotely. This change affects veterans using VA health services and aims to make treatment smoother and more convenient. The new rules were supposed to start February 18, 2025, but now they’ll kick in on March 21, 2025, while the government gathers public feedback.
2026-20552, Wellwise Pharmacy Inc.; Decision and Order
Wellwise Pharmacy in Texas had its DEA registration suspended and is facing revocation because it kept filling risky prescriptions for controlled drugs without checking warning signs. This affects the pharmacy’s ability to legally handle these medicines, protecting public health and safety. The decision took effect immediately in late 2025, stopping Wellwise from operating under its DEA license and signaling serious legal and financial trouble ahead.
2026-20535, Arenbii Pharmacy LLC; Decision and Order
Arenbii Pharmacy in Texas lost its DEA license because it kept filling risky drug prescriptions without fixing obvious problems. This means they can’t legally handle certain controlled medicines anymore, protecting public safety. The decision is final, and Arenbii didn’t ask for a hearing, so the revocation starts now with no chance to appeal.
Previous / Next Documents
Previous: 2026-17272, Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest
The U.S. International Trade Commission got a complaint about certain wearable breast pumps and their parts, claiming some companies might be breaking import rules. They want the public to share thoughts on how this could affect everyone, especially buyers and sellers. This could lead to changes in what products are allowed in the U.S., so keep an eye out for updates and deadlines!
Next: 2026-17274, Bulk Manufacturer of Controlled Substances Application: Curia New York Inc
Curia New York Inc has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.