Most of the Chapter I regulations are based on the
Federal Food, Drug, and Cosmetic Act. Notable sections: •
11 — electronic records and
electronic signature related • 50 Protection of human subjects in
clinical trials • 54 Financial disclosure by clinical investigators • 56 Institutional review boards that oversee
clinical trials • 58 Good laboratory practices (GLP) for nonclinical studies The 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 values • 106-107 requirements for infant formula • 110
et seq. cGMPs for food products • 111
et seq. cGMPs for dietary supplements • 170 food additives • 190
dietary supplements The 200 and 300 series are regulations pertaining to pharmaceuticals : • 202-203 Drug advertising and marketing • 210
et seq. cGMPs for pharmaceuticals • 310
et seq. Requirements for new drugs • 328
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 drugs • 556 Tolerances for residues of drugs in food animals The 600 series covers biological products (e.g. vaccines, blood): • 601 Licensing under section 351 of the Public Health Service Act • 606
et seq. cGMPs for human blood and blood products The 700 series includes the limited regulations on
cosmetics: • 701 Labeling requirements The 800 series are for medical devices: • 803 Medical device reporting • 814 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 classified The 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
milk • Interstate 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). == Chapter II ==