GMP Publications - Code of Federal Regulation Handbooks by the FDA

503B Compounding and Packaging

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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 - January 2013

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Guidance for Industry:

 

cGMPs for 503B Human Drug Compounding Outsourcing Facilities - July 2014

Insanitary Conditions at Compounding Facilities - August 2016

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities - January 2017

 

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