FDA Updates Guidance on Compounded GLP-1 Agonists Amid Shortage Resolution
The FDA has issued updated guidance regarding the compounding of semaglutide and tirzepatide as drug shortage conditions evolve. The agency clarifies the legal framework for 503A and 503B compounding pharmacies and outlines enforcement priorities as branded products become more available...
Read Full StoryRecent Regulatory News
Florida Introduces New Peptide Regulation Bill Targeting Research Chemical Sales
Florida lawmakers have introduced HB 1247, which would establish new requirements for businesses selling research peptides within the state, including registration and labeling requirements...
FDA Issues Warning Letters to Multiple Online Peptide Sellers
The FDA has issued warning letters to several online retailers selling peptides with therapeutic claims, citing violations of the Federal Food, Drug, and Cosmetic Act...
Australia's TGA Announces Review of Peptide Scheduling Classifications
The Therapeutic Goods Administration has announced a comprehensive review of how research peptides are classified under the Poisons Standard, potentially affecting access to several compounds...
Compounding Pharmacy Association Files Lawsuit Challenging FDA Semaglutide Restrictions
A coalition of compounding pharmacies has filed a federal lawsuit challenging the FDA's determination that semaglutide is no longer in shortage, arguing the agency failed to follow proper procedures...
Texas AG Office Clarifies Enforcement Position on Research Peptide Sales
The Texas Attorney General's office has issued guidance clarifying how existing laws apply to the sale of research peptides, providing clearer boundaries for businesses operating in the state...