Pharmaceutical Compounding

Quality standards for different scales

Pharmaceutical Compounding: Quality Standards for Different Scales

This fact sheet was updated in March 2018 to improve clarity.

Overview

Different types of drug compounding carry different risks, which can be mitigated by applying appropriate quality standards—requirements for how drugs are made and stored to prevent dangerous contamination or other problems.

For traditional pharmacies that dispense drugs one prescription at a time, the United States Pharmacopeia (USP) developed standards to minimize risks. Its standards for sterile compounding are called USP <797>, and most states require traditional pharmacies to follow them.

For outsourcing facilities that compound stock supplies of drugs, which pose a greater safety risk because of their typically longer shelf life and larger batch sizes, the Food and Drug Administration requires quality standards similar to the Current Good Manufacturing Practices (CGMP) that apply to drug manufacturers.

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