FDA Draft Guidance Documents for Compounding Quality Act Available for Comment

Three draft guidance documents related to the Drug Quality and Security Act have been made available on the FDA Web site for comment.

• Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF) is intended for outsourcing facilities that compound human drugs and focuses on electronic submission of drug reporting information.
• Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF) provides information for outsourcing facilities relating to electronic submission of established registration information.
• Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF) announces FDA’s intentions in enforcing section 503A of the FD&C Act, which was amended by the passage of the new law, and explains how new provisions will be applied pending consultations and rulemaking.