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