FDA Regulations
The following information is collated personally, review any information before official use.
Some information gathered from 2017 document, most gathered from FDA site July 2021
Not all regulations have working links, page is under construction
General Regulations
21 CFR Part
Information and guidance on 21 CFR
21 CFR Part 5 – Organization
Information and guidance on 21 CFR 5
21 CFR Part 11 – Electronic Records; Electronic Signatures
Information and guidance on 21 CFR 11
21 CFR Part 1301 – (71-77) Security, (90-93) Employee Screening
Information and guidance on certain sections of 21 CFR 1301
21 CFR Part 1302 – Labelling and Packaging Requirements for Controlled Substances
Information and guidance on 21 CFR 1302
21 CFR Part 1304 – Records and Reports of Registrants
Information and guidance on 21 CFR 1304
21 CFR Part 1316 – Administrative Functions, Practices, and Procedures
Information and guidance on 21 CFR 1316
21 CFR Part 1317 – Disposal
Information and guidance on 21 CFR 1317
Drug Substances
21 CFR Part 200 – General
Information and guidance on 21 CFR 200
21 CFR Part 201 Labelling
Information and guidance on 21 CFR 201
21 CFR Part 210/211 – Drug cGMPs
Information and guidance on Drug cGMPs
21 CFR Part 216 – Human Drug Compounding
Information and guidance on 21 CFR 216
21 CFR Part 310 – New Drugs
Information and guidance on 21 CFR
21 CFR Part 312 – Investigational New Drug Application
Information and guidance on 21 CFR
21 CFR Part 314 – Applications for FDA Approval to market a new drug
Information and guidance on 21 CFR
21 CFR Part 1305 – Orders for Schedule I and II Controlled Substances
Information and guidance on 21 CFR 1305
21 CFR Part
Information and guidance on 21 CFR
Laboratory
21 CFR Part 58 – Good Laboratory Practices for non-clinical Lab Studies
Information and guidance on 21 CFR 58
21 CFR Part
Information and guidance on 21 CFR
Food and Beverage
21 CFR Part 101 – Food Labelling
Information and guidance on 21 CFR 101
21 CFR Part 104 – Nutritional Guidelines for Foods
Information and guidance on 21 CFR 104
21 CFR Part 110 cGMPs
Information and guidance on 21 CFR
21 CFR Part 111
Information and guidance on 21 CFR
21 CFR Part 130 – Food Standards: General
Information and guidance on 21 CFR
21 CFR Part
Information and guidance on 21 CFR
Cosmetics
21 CFR Part
Information and guidance on 21 CFR
Medical Devices
21 CFR Part
Information and guidance on 21 CFR