Component Receipt and Evaluation Including Reporting (Sterile Compounding)

This SOP establishes the requirements for receiving and evaluating compounding components—including quarantine on receipt, visual inspection for tampering, review of transaction data, verification of invoices, lot numbers, expiration dates, and Certificates of Analysis (COAs), handling of APIs, OTCs, growth media, and reporting of suspect or illegitimate products to the FDA and trading partners—to ensure product integrity, patient safety, and compliance with USP <797>, DSCSA, and FDA regulations.

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