GXP

FDA, USP, and the 503B Outsourcing Facilities | IVT

Manufacture large batches of compound sterile preparations (CSP) without:  Pre-registration (e.g., New Drug Application/Abbreviated New Drug Application) Clinical studies Specific prescriptions for individual patients. Ship across state lines. Table I: 503B Registrations (3.) Firm Name Date of Registration Last FDA Inspection Related to Compounding Was a Form FDA-483 Issued? Other FDA Action

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