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FDA Compounding Facility Types: 503A Compounding Pharmacies: Traditional compounding pharmacies Compound medications based on individual patient prescriptions Regulated primarily by state pharmacy boards Must be licensed in the state where they operate Can ship to patients in states where they hold licenses Subject to state pharmacy board inspections 503B Outsourcing Facilities: Larger-scale compounding operations Registered directly with the FDA Subject to FDA inspections and current good manufacturing practice (cGMP) requirements Can compound without individual patient prescriptions Must report adverse events to the FDA Generally considered to have more stringent oversight FDA Requirements for Legal Compounding: Drug Shortage Requirement: Semaglutide can only be legally compounded while on the FDA drug shortage list Licensed Prescriber: Must be prescribed by a healthcare provider licensed in your state Individual Patient Prescription: 503A pharmacies must have a patient-specific prescription Proper Ingredients: Must use ingredients from FDA-registered suppliers Quality Standards: Must follow United States Pharmacopeia (USP) guidelines State Licensing: Must be licensed by state pharmacy boards USP Chapter 797 Standards: All sterile compounding (including injectable semaglutide) must follow USP Chapter 797, which requires: Cleanroom Environment: ISO Class 5 or better air quality Sterility Testing: Regular testing to ensure no bacterial contamination Personnel Training: Specialized training for compounding staff Quality Control: Documentation and testing of each batch Beyond-Use Dating: Appropriate expiration dates based on stability testing Environmental Monitoring: Regular testing of compounding area What the FDA Does NOT Regulate: The FDA does not approve compounded medications as finished drug products

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Khan Z, Nisar MA, Hussain SZ, Arshad MN, Rehman A