Search results
Results from the WOW.Com Content Network
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
A few volumes of the CFR at a law library (titles 12–26) In the law of the United States, the Code of Federal Regulations (CFR) is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent ...
As codified in 21 U.S.C. chapter 9 of the United States Code from the LII; As codified in 21 U.S.C. chapter 9 of the United States Code from the US House of Representatives; Federal Food, Drug, and Cosmetic Act (PDF/details) as amended in the GPO Statute Compilations collection; Color Additive Status List; Food Ingredients and Colors
Medical foods are regulated by the US Food and Drug Administration under the Food Drug and Cosmetic Act regulations. 21 CFR 101.9(j) (8). [1]The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary ...
Businesses subject to Juice HACCP (21 CFR 120) and Seafood HACCP (21 CFR 123) are exempt. Businesses subject to the Pasteurized Milk Ordinance; Sept 17, 2018. Small businesses, defined as having fewer than 500 full-time equivalent employees; Sept 17, 2017. All other businesses; Sept 17, 2016. [7]
The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". [1] Form FDA 483, [2] "Inspectional Observations", is a form used by the FDA to document and communicate concerns discovered during these inspections.
(e) Except as provided in the first sentence of this Act, compliance with this subpart or any regulations issued thereunder shall not relieve any person from liability at common law or under statutory law. (f) The remedies provided for in this subpart shall be in addition to and not in substitution for any other remedies provided by law.