National legislation
Financial disclosure by clinical investigators (21 CFR 54.1-54.6).
The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications under the terms of this Regulation. ...
United States of America
2016 (1999)
Regulation of combination products (21 CFR 4.1-4.4).
This Regulation clarifies the application of current good manufacturing practice regulations to combination products, and provides a regulatory framework for designing and implementing the current good manufacturing practice operating system at facilities that manufacture co-packaged or single-entity combination products. ...
United States of America
2013
Organization (21 CFR 5.1100-5.1110).
This Regulation stipulates the official list of the Offices and Commissions under the the Food and Drug Administration. ...
United States of America
2012 (2014)
FDA Food Safety Modernization Act (21 U.S.C. 2201-2252).
The Act furthermore principally provides for measures to strengthen the capacity to respond to food-related risks and threats including food allergy and anaphylaxis management, a food emergency response network, an integrated consortium of laboratory networks, enhancing tracking and tracing of food and recordkeeping, decontamination and surveillance,...
United States of America
2011 (2015)
Food Safety Modernization Act (P.L. 111–353).
This Act amends the Federal Food, Drug, and Cosmetic Act to introduce a major reform to food safety supervision and control by the US Food and Drug Administration (FDA). It requires enhanced regulation of produce from farm to sale and other FDA regulated foods from processing...
United States of America
2011
Production, storage, and transportation of shell eggs (21 CFR 118.1-118.12).
This Regulation also prescribes the issues regarding the: persons covered by the requirements here defined; general terms and definitions; various Salmonella Enteritidis (SE) prevention measures; recordkeeping requirements for the Salmonella Enteritidis; registration requirements for shell egg producers; and additional enforcement and compliance provisions. ...
United States of America
2009 (2010)
Dietary supplements that present a significant or unreasonable risk (21 CFR 119.1).
This Regulation defines that all dietary supplements containing ephedrine alkaloids are to be considered as unreasonably/risky for human health (if not properly labelled and marked). ...
United States of America
2004
Hazard analysis and critical control point (HACCP) systems (21 CFR 120.1-120.25).
This Regulation prescribes concrete rules regarding the: applicability; current good manufacturing practice; sanitation standard operating procedures; hazard analysis; hazard analysis and critical control point (HACCP) plan; legal basis; corrective actions; verification and validation; records and data keeping; training; application of requirements to imported products. ...
United States of America
2001
Shell eggs (21 CFR 115.50).
This Regulation defines that all shell eggs, whether in intrastate or interstate commerce, held for retail distribution shall promptly be placed under refrigeration upon the receipt at a retail establishment, except that, when short delays are unavoidable, the eggs shall be placed under refrigeration, as soon...
United States of America
2000
Dietary supplements (21 CFR 190.6).
This Regulation also prescribes the provisions regarding the new dietary ingredient notifications. ...
United States of America
1997 (2001)
Environmental impact considerations (21 CFR 25.01-25.60).
This Regulation establishes the procedures aimed to grant the correct data exchange principles between State bodies and the Food and Drug Administration regarding the environmentally relevant issues (also public health emergencies, environmental assessment documents and reports, and foods, food additives, and colour additives). ...
United States of America
1997 (2015)
Fish and fishery products (21 CFR 123.3-123.28).
This Regulation also provides issues regarding the: hazard analysis and hazard analysis critical control point (HACCP) plan; corrective actions; verification and inspection; records/data keeping; training; sanitation control procedures; special requirements for imported products; smoked and smoke-flavored fishery products; raw molluscan shellfish; source controls. ...
United States of America
1995
Beverages (21 CFR 165.3-165.110).
This Regulation closely provides the: definitions and general terms; concrete requirements for specific standardized beverages (such as bottled water). ...
United States of America
1995 (2016)
Margarine (21 CFR 166.40-166.110).
This Regulation closely provides the: definitions and general terms; concrete requirements for specific standardized margarine and margarine products. ...
United States of America
1995 (1998)
Civil money penalties hearings (21 CFR 17.1-17.54).
The Regulation further stipulates the official list of maximum penalty amounts. ...
United States of America
1995 (2014)
Cacao products (21 CFR 163.5-163.155).
This Regulation closely provides the rules regarding the: definitions and general terms; methods of analysis; concrete requirements for specific standardized cacao products (such as cacao nibs; chocolate liquor; breakfast cocoa; cocoa; lowfat cocoa; cocoa with dioctyl sodium sulfosuccinate for manufacturing; sweet chocolate; white chocolate; milk chocolate;...
United States of America
1993 (1998)
Product jurisdiction (21 CFR 3.1-3.10).
This Regulation also provides the rules regarding the: assignment of agency component for review of premarket applications (food stuff product pre-market provisions aimed to ensure the adequate review of the safety and effectiveness of any product, or the substantial equivalence of the same in front of...
United States of America
1991 (2010)
Frozen desserts (21 CFR 135.3-135.160).
This Regulation closely defines the following issues: definitions and general terms; composition and specific processing and/or production rules; and requirements for specific standardized frozen desserts (such as ice cream and frozen custard, goat’s milk ice cream, and water ices). ...
United States of America
1990 (1998)
Pesticide Monitoring Improvements Act of 1988 (21 U.S.C. 1401-1403).
Chapter 19 of Title 21 of USC concerns pesticide monitoring and enforcement information data management systems for the Food and Drug Administration. This also concerns pesticide residues in imported meat, poultry products, eggs, and egg products. The Secretary of Health and Human Services shall enter into...
United States of America
1988 (1999)
Current good manufacturing practice in manufacturing, packaging, labelling, or holding operations for dietary supplements (21 CFR 111.1-111.610).
This Regulation also defines issues regarding the personnel; physical plant and grounds; equipment and utensils; requirement to establish a production and process control system; production and process control system: requirements for quality control, requirements for components, packaging, and labels and for product that you receive for...
United States of America
1986 (2008)
Total results:108
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