21 CFR 1 - GENERAL ENFORCEMENT REGULATIONS | LII / Legal Information Institute

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Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

Title 21 published on 2011-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

2012-02-23; vol. 77 # 36 - Thursday, February 23, 2012

77 FR 10658 - Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-4165
RIN	0910-AG73
Docket No.	FDA-2002-N-0153

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Interim final rule; request for comments.

Effective date: This interim final rule is effective March 1, 2012. Comment date: Interested persons may submit either electronic or written comments on this interim final rule by May 23, 2012.

21 CFR Part 1

Summary

The Food and Drug Administration (FDA) is amending its regulations on establishment, maintenance, and availability of records. FDA is issuing this interim final rule (IFR) to amend FDA's regulation on the record availability requirements to implement the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by the FDA Food Safety Modernization Act (FSMA). The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to records relating to any other article of food that the Secretary of Health and Human Services (the Secretary) reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which the Secretary believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This expanded records access authority will further help improve FDA's ability to respond to, and further contain threats of serious adverse health consequences or death to humans or animals.

77 FR 10662 - Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-4167
RIN
Docket No.	FDA-2011-D-0598

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Notice of guidance availability.

February 23, 2012. Submit either electronic or written comments on Agency guidances at any time.

21 CFR Part 1

Summary

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5).” This guidance provides updated information pertaining to the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety and Modernization Act (FSMA) of January 4, 2011.

2012-02-02; vol. 77 # 22 - Thursday, February 2, 2012

77 FR 5171 - Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-2289
RIN	0910-AG60
Docket No.	FDA-2011-N-0121

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective April 2, 2012.

21 CFR Parts 1, 7, and 16

Summary

The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are subject to the same general requirements that apply to other FDA-regulated products.

2011-05-05; vol. 76 # 87 - Thursday, May 5, 2011

76 FR 25538 - Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-10953
RIN	0910-AG67
Docket No.	FDA-2011-N-0197

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Interim final rule; request for comments.

Effective date: This interim final rule is effective July 3, 2011. Comment date: Interested persons may submit either electronic or written comments on this interim final rule by August 3, 2011.

21 CFR Part 1

Summary

The Food and Drug Administration (FDA) is amending its regulations on administrative detention of food for human or animal consumption. As required by the FDA Food Safety Modernization Act (FSMA), FDA is issuing this interim final rule to change the criteria for ordering administrative detention of human or animal food. Under the new criteria, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This will further help FDA prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the U.S. food supply.

76 FR 25542 - Information Required in Prior Notice of Imported Food

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-10955
RIN	0910-AG65
Docket No.	FDA-2011-N-0179

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Interim final rule; request for comments.

This interim final rule is effective July 3, 2011. Interested persons may submit either electronic or written comments on this interim final rule by August 3, 2011. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by June 6, 2011 (see the “Paperwork Reduction Act of 1995” section of this document (section IV of this document).

21 CFR Part 1

Summary

The Food and Drug Administration (FDA) is amending its regulations on prior notice of imported food. As required by the FDA Food Safety Modernization Act, FDA is issuing this interim final rule to require an additional element of information in a prior notice of imported food. This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. The new information can help FDA make better informed decisions in managing the potential risks of imported food into the United States.

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.

United States Code

15 USC 1453 - Requirements of labeling; placement, form, and contents of statement of quantity; supplemental statement of quantity

15 USC 1454 - Rules and regulations

15 USC 1455 - Procedure for promulgation of regulations

19 USC 1490 - General orders

19 USC 1491 - Unclaimed merchandise; disposition of forfeited distilled spirits, wines and malt liquor

21 USC 321 - Definitions; generally

21 USC 331 - Prohibited acts

21 USC 333 - Penalties

21 USC 334 - Seizure

21 USC 335a - Debarment, temporary denial of approval, and suspension

21 USC 343 - Misbranded food

21 USC 350c - Maintenance and inspection of records

21 USC 350d - Registration of food facilities

21 USC 352 - Misbranded drugs and devices

21 USC 355 - New drugs

21 USC 360b - New animal drugs

21 USC 362 - Misbranded cosmetics

21 USC 371 - Regulations and hearings

21 USC 374 - Inspection

21 USC 381 - Imports and exports

21 USC 382 - Exports of certain unapproved products

21 USC 387 - Definitions

21 USC 393 - Food and Drug Administration

42 USC 216 - Regulations

42 USC 241 - Research and investigations generally

42 USC 243 - General grant of authority for cooperation

42 USC 262 - Regulation of biological products

42 USC 264 - Regulations to control communicable diseases

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 1

2012-02-23; vol. 77 # 36 - Thursday, February 23, 2012

77 FR 10658 - Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-4165
RIN	0910-AG73
Docket No.	FDA-2002-N-0153

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Interim final rule; request for comments.

Effective date: This interim final rule is effective March 1, 2012. Comment date: Interested persons may submit either electronic or written comments on this interim final rule by May 23, 2012.

21 CFR Part 1

Summary

The Food and Drug Administration (FDA) is amending its regulations on establishment, maintenance, and availability of records. FDA is issuing this interim final rule (IFR) to amend FDA's regulation on the record availability requirements to implement the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by the FDA Food Safety Modernization Act (FSMA). The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to records relating to any other article of food that the Secretary of Health and Human Services (the Secretary) reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which the Secretary believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This expanded records access authority will further help improve FDA's ability to respond to, and further contain threats of serious adverse health consequences or death to humans or animals.

77 FR 10662 - Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-4167
RIN
Docket No.	FDA-2011-D-0598

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Notice of guidance availability.

February 23, 2012. Submit either electronic or written comments on Agency guidances at any time.

21 CFR Part 1

Summary

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5).” This guidance provides updated information pertaining to the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety and Modernization Act (FSMA) of January 4, 2011.

2012-02-02; vol. 77 # 22 - Thursday, February 2, 2012

77 FR 5171 - Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-2289
RIN	0910-AG60
Docket No.	FDA-2011-N-0121

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective April 2, 2012.

21 CFR Parts 1, 7, and 16

Summary

The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are subject to the same general requirements that apply to other FDA-regulated products.

2011-05-05; vol. 76 # 87 - Thursday, May 5, 2011

76 FR 25538 - Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-10953
RIN	0910-AG67
Docket No.	FDA-2011-N-0197

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Interim final rule; request for comments.

Effective date: This interim final rule is effective July 3, 2011. Comment date: Interested persons may submit either electronic or written comments on this interim final rule by August 3, 2011.

21 CFR Part 1

Summary

The Food and Drug Administration (FDA) is amending its regulations on administrative detention of food for human or animal consumption. As required by the FDA Food Safety Modernization Act (FSMA), FDA is issuing this interim final rule to change the criteria for ordering administrative detention of human or animal food. Under the new criteria, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This will further help FDA prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the U.S. food supply.

76 FR 25542 - Information Required in Prior Notice of Imported Food

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-10955
RIN	0910-AG65
Docket No.	FDA-2011-N-0179

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Interim final rule; request for comments.

This interim final rule is effective July 3, 2011. Interested persons may submit either electronic or written comments on this interim final rule by August 3, 2011. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by June 6, 2011 (see the “Paperwork Reduction Act of 1995” section of this document (section IV of this document).

21 CFR Part 1

Summary

The Food and Drug Administration (FDA) is amending its regulations on prior notice of imported food. As required by the FDA Food Safety Modernization Act, FDA is issuing this interim final rule to require an additional element of information in a prior notice of imported food. This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. The new information can help FDA make better informed decisions in managing the potential risks of imported food into the United States.

2011-04-14; vol. 76 # 72 - Thursday, April 14, 2011

76 FR 20901 - Further Amendments to General Regulations of the Food and Drug Administration To Incorporate Tobacco Products

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-9044
RIN	0910-AG60
Docket No.	FDA-2011-N-0121

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed rule.

Submit either electronic or written comments on the proposed rule by June 13, 2011. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by May 16, 2011, (see the “Paperwork Reduction Act of 1995” section of this document).

21 CFR Parts 1, 7, and 16

Summary

The Food and Drug Administration (FDA) is proposing to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products.

2011-03-08; vol. 76 # 45 - Tuesday, March 8, 2011

76 FR 12563 - Amendments to General Regulations of the Food and Drug Administration; Confirmation of Effective Date

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-5147
RIN	0910-AG55
Docket No.	FDA-2010-N-0560

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Direct final rule; confirmation of effective date.

Effective date confirmed: April 14, 2011.

21 CFR Parts 1, 14, and 17

Summary

The Food and Drug Administration (FDA) is confirming the effective date of April 14, 2011, for the final rule that appeared in the Federal Register of November 30, 2010 (75 FR 73951). The direct final rule amends certain general regulations of FDA to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act, by revising the Agency's regulations to require tobacco products to be subject to the same general requirements that apply to other FDA-regulated products. This document confirms the effective date of the direct final rule.

21 CFR 1 - GENERAL ENFORCEMENT REGULATIONS

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