503B Compounding Master Guide

503 B Compounding and Packaging Master Guide Handbook:

Regulations:

• 21 CFR Part 11 Electronic Records; Electronic Signatures
• 21 CFR Part 201 Drug Labeling
• 21 CFR Parts 210/211 (use current title)
• 21 CFR Part 801 Device Labeling
• 21 CFR Part 820 Quality Regulations
• Food, Drug and Cosmetic Act 503B Outsourcing Facilities - 2013

- - - - - - - - - - - - - - - - - -

Guidance for Industry:

• CGMP - Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act - 2020
• Insanitary Conditions at Compounding Facilities - 2020
• Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities - 2017

- - - - - - - - - - - - - - - - - - - - - - - - -

503BMaster-C-251225