Please see: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf

Semaglutide is currently approved for compounding due to Ozempic and Wegovy both being on the FDA Drug Shortage list. These compounds per se are not FDA approved. The FDA does not verify the safety or effectiveness of compounded drugs. Thin4Fun only obtains its medicines from pharmacies that are LegitScrip approved, and all their manufacturing is done under strict FDA and US Pharmacopeia regulations.  

Compliance: 503A, 503B and the USP

The FDA and USP both have strict guidelines as to how 503A and 503B pharmacies may operate. Compliance is key since millions of doctors and patients use these pharmacies every year. Here are just a few of the different regulations and rules pharmacies must comply with under the FDA and the US Pharmacopeia, or USP.

503A Compliance

503A pharmacies have a variety of regulations they must adhere to and be in compliance with. These standards and regulations are important in protecting the health of patients who use pharmacies every day.

To be in compliance, 503A pharmacies must:

• Comply with USP <795> and <797> along with state board of pharmacy regulations
• Perform environmental monitoring every six months
• Assign beyond use dating (BUD) when necessary based on internal or external scientific literature showing stability

503B Compliance

503B compounding pharmacies that provide patient-specific medications are held to much higher regulatory standards than 503A pharmacies. These facilities are required to maintain full compliance with CGMP.

To ensure standards, 503B pharmacies must:

• Comply with USP <795> and <797> along with state board of pharmacy regulations and 21 CFR Part 210 and 211 (CGMP)
• Develop and perform an environmental monitoring program at a minimum, per production shift in the ISO 5 primary compounding areas and weekly in the secondary compounding areas (ISO 7 and ISO 8)
• Maintain their own quality department as an independent entity of operations and sales with complete autonomy for investigations and releasing products
• Register with each state board of pharmacy, DEA (if applicable) and FDA and report their product list to FDA biannually