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The lot number on the label of a drug should be capable of yielding the complete manufacturing history of the package. An incorrect lot number may be regarded as causing the article to be misbranded.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 321 - Definitions; generally
§ 331 - Prohibited acts
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 353 - Exemptions and consideration for certain drugs, devices, and biological products
§ 355 - New drugs
§ 358 - Authority to designate official names
§ 360 - Registration of producers of drugs or devices
§ 360b - New animal drugs
§ 360ss - State standards
§ 371 - Regulations and hearings
§ 374 - Inspection
§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
§ 216 - Regulations
§ 241 - Research and investigations generally
§ 262 - Regulation of biological products
§ 264 - Regulations to control communicable diseases
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 201 after this date.
The Food and Drug Administration (FDA) is reopening the comment period for the notice of proposed rulemaking (NPRM) that appeared in the Federal Register of September 25, 2015. In the NPRM, FDA requested comments on the proposed regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
The Food and Drug Administration (FDA) is proposing regulations to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver Spring, MD, as well as make other related technical revisions. These changes are being made to ensure the accuracy of the Agency's regulations.