Compounding expert, Eric S. Kastango, BS Pharm, MBA, FASHP, discusses the USP 797 chapter revisions and the new requirements your pharmacy will need to proactively address to ensure compliance.
USP released revised requirements to Chapter <797> on June 1, 2019. Ensuring compliance with these requirements is the responsibility of state and federal regulators, including the FDA. Pharmacies are expected to have adopted the new requirements as of December 1, when the standard becomes official and enforceable.
Discover the following:
- The revisions to the USP <797> chapter requirements and key areas of change
- Standard requirements for master formulation and compounding records.
- Key areas of focus to ensure compliance by the official and enforceable date – December 1, 2019