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Used solely for in vitro experiments and cannot be: Used in clinical trials involving humans Administered to humans as part of an experiment or investigation Supplied to another party for human investigational use Description of CJC-1295+DAC
FDA: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A January 2025 guidance explaining Category 1, the interim enforcement policy, and development of the formal list
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Update 23 , 118 (2016)
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