21 CFR Part 601 - LICENSING | LII / Legal Information Institute

Authority:

15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).

Source:

38 FR 32052, Nov. 20, 1973, unless otherwise noted.

Cross References:

For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21-12.23. For U.S. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111.

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

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

U.S. Code: Title 15 - COMMERCE AND TRADE

§ 1451 - Congressional declaration of policy

§ 1452 - Unfair and deceptive packaging and labeling; scope of prohibition

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

§ 1454 - Rules and regulations

§ 1455 - Procedure for promulgation of regulations

§ 1456 - Enforcement

§ 1457 - Omitted

§ 1458 - Cooperation with State authorities; transmittal of regulations to States; noninterference with existing programs

§ 1459 - Definitions

§ 1460 - Savings provisions

§ 1461 - Effect upon State law

U.S. Code: Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 355 - New drugs

§ 360 - Registration of producers of drugs or devices

§ 374 - Inspection

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 601 after this date.

2015-02-18; vol. 80 # 32 - Wednesday, February 18, 2015

80 FR 8577 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2015-03211
RIN
Docket No.	FDA-2013-N-0500

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Notice of public meeting; request for comments; reopening of the comment period.

Meeting. The public meeting will be held on March 27, 2015, from 8 a.m. to 5 p.m. Registration to attend the meeting must be received by March 20, 2015. See the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. Comments. The comment period for the proposed rule publilshed November 13, 2013 (78 FR 67985), is reopened. Submit either electronic or written comments regarding proposed alternatives to the proposed rule by April 27, 2015.

21 CFR Parts 314 and 601

Summary

The Food and Drug Administration (FDA) is announcing a 1-day public meeting entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” The purpose of the meeting is to provide a public forum for FDA to listen to comments on the proposed rule on “changes being effected” supplements that was published in the Federal Register of November 13, 2013, and alternatives offered to this proposed rule. FDA is also reopening the comment period for the proposed rule to receive submissions of additional written comments on the proposed rule as well as alternative proposals presented during the public meeting.

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21 CFR Part 601 - LICENSING

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