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United States Pharmacopeia (USP) Standards USP sets quality standards for pharmaceutical compounding: USP Chapter : Covers sterile compounding Sets standards for facilities, personnel, procedures Defines contamination risk levels Specifies environmental monitoring Requires competency testing for personnel USP Chapter : Covers hazardous drug handling May apply to some compounding situations USP Chapter : Covers non-sterile compounding Less relevant for injectable semaglutide What USP compliance means: Facility meets environmental standards Personnel are trained and competency-tested Procedures follow established protocols Quality systems are in place Current Good Manufacturing Practice (cGMP) What cGMP means: FDAs quality standards for pharmaceutical manufacturing Required for 503B outsourcing facilities Covers all aspects of production and quality Key cGMP requirements: Qualified personnel with defined responsibilities Adequate facilities and equipment Written procedures for all operations Quality control testing Documentation of everything Complaint handling and adverse event reporting Investigations of quality problems Why cGMP matters: More comprehensive than basic compounding standards Similar to requirements for pharmaceutical manufacturers Provides greater quality assurance Required FDA inspections verify compliance State Pharmacy Board Standards Role of state boards: License pharmacies in their states Set state-specific compounding requirements Conduct inspections Handle complaints and enforcement Variation between states: Some states have stricter requirements than others Testing requirements vary Inspection frequency varies This creates quality variation among 503A pharmacies FDA Oversight of Compounding Understanding FDAs role clarifies how compounding is regulated

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