Controlling and secondary source documents with links to official pages, PDFs, and archives.
FDA's running list of bulk drug substances nominated for use in 503A pharmacy compounding, organized into Category 1 (under evaluation), Category 2 (significant safety risks), and Category 3 (nominated without adequate support).
FDA's running list of bulk drug substances nominated for use by 503B outsourcing facilities. Category 1 substances are under evaluation; Category 2 substances raise significant safety risks; Category 3 substances were nominated without adequate support.
FDA's background package for the Pharmacy Compounding Advisory Committee discussion of BPC-157 free base and BPC-157 acetate. It identifies identity/characterization concerns and safety issues and notes no final determination will be made at the meeting.
FDA approved Egrifta (tesamorelin for injection) to reduce excess abdominal fat in HIV-infected patients with lipodystrophy.
FDA explains that compounded injectable drugs containing GHK-Cu may pose immunogenicity risks due to aggregation and peptide-related impurities.
FDA recommended against placing ipamorelin free base or ipamorelin acetate on the 503A bulk list due to characterization and safety concerns.
FDA warned Melanocorp that Melanotan II was an unapproved new drug that could not be marketed in interstate commerce without an approved application.
FDA approved Mounjaro (tirzepatide) injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FDA approved Ozempic (semaglutide) injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FDA determined that the national shortage of semaglutide injection products (Ozempic and Wegovy) was resolved and provided 60/90-day enforcement-discretion transition periods for compounders.
FDA determined that the national shortage of tirzepatide injection products (Mounjaro and Zepbound) was resolved and provided 60/90-day enforcement-discretion transition periods for compounders.
FDA approved Vyleesi (bremelanotide) subcutaneous injection for acquired, generalized hypoactive sexual desire disorder in premenopausal women.
FDA cited Warrior Labz for marketing BPC-157 and TB-500 products as unapproved new drugs.
FDA approved Wegovy (semaglutide) injection for chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity.
FDA warned Xcel Research that retatrutide, sermorelin, and other peptide products marketed on its website were unapproved new drugs and misbranded. The letter also states that 'research use only' labeling did not overcome the intended-use evidence.
The annual WADA list of substances and methods prohibited at all times (in- and out-of-competition). S0 covers non-approved substances, including examples such as BPC-157.