21 CFR 610, Subpart C - Standard Preparations and Limits of Potency | 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.

2012-05-24; vol. 77 # 101 - Thursday, May 24, 2012

77 FR 30887 - Amendments to Sterility Test Requirements for Biological Products; Correction

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-12594
RIN	0910-AG16
Docket No.	FDA-2011-N-0080

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule, correction.

Effective June 4, 2012.

21 CFR Parts 600, 610, and 680

Summary

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.

2012-05-03; vol. 77 # 86 - Thursday, May 3, 2012

77 FR 26162 - Amendments to Sterility Test Requirements for Biological Products

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-10649
RIN
Docket No.	FDA-2011-N-0080

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective June 4, 2012.

21 CFR Parts 600, 610, and 680

Summary

The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.

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

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 371 - Regulations and hearings

§ 372 - Examinations and investigations

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 263 - Preparation of biological products by Service

§ 263a - Certification of laboratories

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 610 after this date.

2012-05-24; vol. 77 # 101 - Thursday, May 24, 2012

77 FR 30887 - Amendments to Sterility Test Requirements for Biological Products; Correction

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-12594
RIN	0910-AG16
Docket No.	FDA-2011-N-0080

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule, correction.

Effective June 4, 2012.

21 CFR Parts 600, 610, and 680

Summary

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.

2012-05-03; vol. 77 # 86 - Thursday, May 3, 2012

77 FR 26162 - Amendments to Sterility Test Requirements for Biological Products

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-10649
RIN
Docket No.	FDA-2011-N-0080

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective June 4, 2012.

21 CFR Parts 600, 610, and 680

Summary

The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.

21 CFR 610, Subpart C - Standard Preparations and Limits of Potency

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