21 CFR 74, Subpart D - Medical Devices | Title 21 - Food and Drugs | Code of Federal Regulations

Title 21 published on 2012-04-01

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.

2012-09-11; vol. 77 # 176 - Tuesday, September 11, 2012

77 FR 55693 - D&C Red No. 6 and D&C Red No. 7; Change in Specification; Confirmation of Effective Date

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-22296
RIN
Docket No.	FDA-2011-C-0050

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule; confirmation of effective date.

Effective Date Confirmed: August 7, 2012.

21 CFR Part 74

Summary

The Food and Drug Administration (FDA) is confirming the effective date of August 7, 2012, for the final rule that published in the Federal Register of July 6, 2012 (77 FR 39921) and that revised the requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol.

2012-07-06; vol. 77 # 130 - Friday, July 6, 2012

77 FR 39921 - D&C Red No. 6 and D&C Red No. 7; Change in Specification

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-16581
RIN
Docket No.	FDA-2011-C-0050

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective August 7, 2012, except as to any provisions that may be stayed by the filing of proper objections. Submit either electronic or written objections and requests for a hearing by August 6, 2012. See section XI of this document for information on the filing of objections.

21 CFR Part 74

Summary

The Food and Drug Administration (FDA or the Agency) is revising its requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol. This action is in response to a petition filed by Sun Chemical Corp.

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

USC : Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 341 - Definitions and standards for food

§ 342 - Adulterated food

§ 343 - Misbranded food

§ 348 - Food additives

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 355 - New drugs

§ 361 - Adulterated cosmetics

§ 362 - Misbranded cosmetics

Title 21 published on 2012-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 74 after this date.

2012-09-11; vol. 77 # 176 - Tuesday, September 11, 2012

77 FR 55693 - D&C Red No. 6 and D&C Red No. 7; Change in Specification; Confirmation of Effective Date

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-22296
RIN
Docket No.	FDA-2011-C-0050

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule; confirmation of effective date.

Effective Date Confirmed: August 7, 2012.

21 CFR Part 74

Summary

The Food and Drug Administration (FDA) is confirming the effective date of August 7, 2012, for the final rule that published in the Federal Register of July 6, 2012 (77 FR 39921) and that revised the requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol.

2012-07-06; vol. 77 # 130 - Friday, July 6, 2012

77 FR 39921 - D&C Red No. 6 and D&C Red No. 7; Change in Specification

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-16581
RIN
Docket No.	FDA-2011-C-0050

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective August 7, 2012, except as to any provisions that may be stayed by the filing of proper objections. Submit either electronic or written objections and requests for a hearing by August 6, 2012. See section XI of this document for information on the filing of objections.

21 CFR Part 74

Summary

The Food and Drug Administration (FDA or the Agency) is revising its requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol. This action is in response to a petition filed by Sun Chemical Corp.

21 CFR 74, Subpart D - Medical Devices

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