GLP-1
The semaglutide shortage is over and the rules have changed. Here's what patients and prescribers need to know about compounded semaglutide's legal status in 2026 under 503A and 503B.
GLP-1
Wegovy HD (semaglutide 7.2 mg) launched in the U.S. this week after FDA approval in just 54 days. The STEP UP trial showed 20.7% mean weight loss — with 1 in 3 patients losing 25% or more of body weight.
compounded semaglutide
The Rise and Regulation of Compounded Semaglutide Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist approved by the FDA for diabetes management and weight loss, became the subject of intense regulatory scrutiny between 2022 and 2024. During a critical window when shortages of FDA-approved formulations created access barriers, compounded versions flourished
FDA
Understanding FDA Peptide Enforcement Actions The regulatory landscape for peptides in the United States has undergone significant shifts over the past several years, driven by safety concerns, manufacturing inconsistencies, and the broader challenge of controlling compounded medications. The FDA's enforcement actions against various peptide products reflect an ongoing
503A
Understanding the 503A and 503B Pharmacy Framework The distinction between 503A and 503B pharmacies represents a critical regulatory divide in the pharmaceutical landscape, with significant implications for peptide access and safety. Both categories fall under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act, yet they operate