Title 21 is the portion of theCode of Federal Regulations that governs food and drugs within theUnited States for theFood and Drug Administration (FDA), theDrug Enforcement Administration (DEA), and theOffice of National Drug Control Policy (ONDCP).[1]
It is divided into three chapters:
Most of the Chapter I regulations are based on theFederal Food, Drug, and Cosmetic Act.
Notable sections:
The 100 series are regulations pertaining to food:
The 200 and 300 series are regulations pertaining to pharmaceuticals :
The 500 series are regulations for animal feeds and animal medications:
The 600 series covers biological products (e.g. vaccines, blood):
The 700 series includes the limited regulations oncosmetics:
The 800 series are for medical devices:
The 900 series covers mammography quality requirements enforced byCDRH.
The 1000 series covers radiation-emitting device (e.g.cell phones,lasers,x-ray generators); requirements enforced by theCenter for Devices and Radiological Health. It also talks about theFDA 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.[5]
The 1200 series consists of rules primarily based in laws other than the Food, Drug, and Cosmetic Act:
Notable sections:
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| Public Health Service |
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