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Topics raised during the meeting included: Sourcing bulk drug substances from appropriately registered establishments and maintaining valid certificates of analysis, along with appropriate testing to establish identity and other relevant quality attributes Maintaining patient-specific prescribing and compounding practices consistent with section 503A and applicable state law Prescribing within an appropriate practitioner-patient relationship as required by applicable law Applying appropriate sterility, bacterial endotoxin, and other quality testing based on the preparation, route of administration, applicable USP standards, and state requirements Strengthening pharmacovigilance and mechanisms for identifying and reporting adverse events Improving product traceability and supply-chain oversight Establishing controls intended to prevent products marketed for “research use only” from being diverted or represented for human use outside appropriate regulatory channels Federal law already requires bulk drug substances used in compounding under section 503A to meet specified conditions, including being accompanied by a valid certificate of analysis and being manufactured by an establishment registered with FDA under section 510 of the FD&C Act
