Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act.
Notable sections:
11 — electronic records and electronic signature related50 Protection of human subjects in clinical trials54 Financial Disclosure by Clinical Investigators 56 Institutional Review Boards that oversee clinical trials58 Good Laboratory Practices (GLP) for nonclinical studiesThe 100 series are regulations pertaining to food:
101, especially 101.9 — Nutrition facts label related(c)(2)(ii) — Requirement to include trans fat values(c)(8)(iv) — Vitamin and mineral values106-107 requirements for infant formula110 et seq. cGMPs for food products170 food additives190 dietary supplementsThe 200 and 300 series are regulations pertaining to pharmaceuticals :
202-203 Drug advertising and marketing210 et seq. cGMPs for pharmaceuticals310 et seq. Requirements for new drugs328 et seq. Specific requirements for over-the-counter (OTC) drugs.The 500 series are regulations for animal feeds and animal medications:
510 et seq. New animal drugs556 Tolerances for residues of drugs in food animalsThe 600 series covers biological products (e.g. vaccines, blood):
601 Licensing under section 351 of the Public Health Service Act606 et seq. cGMPs for human blood and blood productsThe 700 series includes the limited regulations on cosmetics:
701 Labeling requirementsThe 800 series are for medical devices:
803 Medical Device Reporting814 Premarket Approval of Medical Devices 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) 860 et seq. Listing of specific approved devices and how they are classifiedThe 900 series covers mammography quality requirements enforced by CDRH.
The 1000 series covers radiation-emitting device (e.g. cell phones, lasers, x-ray generators); requirements enforced by the Center for Devices and Radiological Health. It also talks about the FDA citizen petition.
The 1100 series includes updated rules deeming items that statutorily come under the definition of "tobacco product" to be subject to the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. The items affected include E-cigarettes, Hookah tobacco, and pipe tobacco.
The 1200 series consists of rules primarily based in laws other than the Food, Drug, and Cosmetic Act:
1240 Rules promulgated under 361 of the Public Health Service Act on interstate control of communicable disease, such as:Requirements for pasteurization of milkInterstate shipment of turtles as pets.Interstate shipment of African rodents that may carry monkeypox.Sanitation on interstate conveyances (i.e. airplanes and ships)1271 Requirements for human cells, tissues, and cellular and tissue-based products (i.e. the cGTPs).Notable sections:
1308 — Schedules of controlled substances1308.03(a) — Administrative Controlled Substances Code Number1308.11 — List of Schedule I drugs1308.12 — List of Schedule II drugs1308.13 — List of Schedule III drugs1308.14 — List of Schedule IV drugs1308.15 — List of Schedule V drugsNotable sections:
1405 Governmentwide requirements for drug-free workplaces