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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
§ 360b - New animal drugs
§ 360c - Classification of devices intended for human use
§ 360d - Performance standards
§ 360e - Premarket approval
§ 360f - Banned devices
§ 360j - General provisions respecting control of devices intended for human use
§ 361 - Adulterated cosmetics
§ 371 - Regulations and hearings
§ 374 - Inspection
§ 375 - Publicity
§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
§ 216 - Regulations
§ 241 - Research and investigations generally
§ 242 - Studies and investigations on use and misuse of narcotic drugs and other drugs; annual report to Attorney General; cooperation with States
§ 262 - Regulation of biological products
§ 263b - Certification of mammography facilities
Title 21 published on 2015-12-03
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 310 after this date.
The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA.
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are generally recognized as safe and generally recognized as effective (GRAS/GRAE). In the 1994 TFM, certain antiseptic active ingredients were proposed as being GRAS for antiseptic rub use by consumers based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments and changes in the use patterns of these products, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use. We also are proposing that all consumer antiseptic rub active ingredients have in vitro data characterizing the ingredient's antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.