Peptide Newsfeed
Tracking FDA actions, policy changes, industry developments, and legal updates affecting therapeutic peptides.
2025-03-05
Senate HELP Committee Holds Hearing on Compounding Pharmacy Oversight
The Senate Health, Education, Labor, and Pensions Committee convened a hearing examining the regulatory framework for compounding pharmacies, particularly in the context of GLP-1 medications. Testimony included perspectives from FDA officials, compounding industry representatives, and patient advocates.
2025-02-10
Multiple State Pharmacy Boards Increase Scrutiny of Peptide Compounding
Pharmacy boards in Texas, Florida, and California have initiated increased oversight of compounding pharmacies dispensing peptides, including unannounced inspections and requests for documentation of prescribing relationships. Several pharmacies have received citations for inadequate quality controls.
2025-01-20
New HHS Leadership Signals Potential Shift in Peptide Regulatory Approach
Recent statements from HHS leadership suggest a potential reevaluation of the regulatory framework for compounded peptides, including possible expanded access pathways. Industry observers note this could significantly impact the availability of compounds like BPC-157 and growth hormone secretagogues.
2024-12-05
Novo Nordisk Files Lawsuits Against Compounding Pharmacies Over Semaglutide
Novo Nordisk has initiated legal action against multiple compounding pharmacies, alleging trademark infringement and unauthorized use of semaglutide. The lawsuits claim compounders are trading on the Ozempic and Wegovy brand names and producing products that are not bioequivalent.
2024-11-15
RICO Class Action Filed Against Major Telehealth and Compounding Operations
A federal RICO class action lawsuit has been filed alleging coordinated fraud between certain telehealth platforms and compounding pharmacies in the peptide and GLP-1 space. The suit claims a pattern of unnecessary prescriptions, inflated pricing, and misleading marketing.
2024-10-02
FDA Declares End to Semaglutide Shortage, Threatening Compounded Access
The FDA has officially removed semaglutide from the drug shortage list, which may end the legal basis for pharmacies to compound the blockbuster GLP-1 medication. Compounding pharmacies had been permitted to produce semaglutide under a shortage exemption since 2022.
2024-09-20
FDA Begins Review of BPC-157 Bulk Drug Substance Category
The FDA Pharmacy Compounding Advisory Committee has placed BPC-157 under review for potential reclassification under the bulk drug substance categories. A Category 2 designation would restrict its use in compounding, while Category 1 would preserve current access.
2024-08-15
FDA Issues Warning Letters to Multiple Online Peptide Vendors
The FDA sent warning letters to several companies selling peptides marketed as "research chemicals" that the agency determined were being sold for human use without approval. The letters cite violations of the Federal Food, Drug, and Cosmetic Act.