21 CFR Part 600 - BIOLOGICAL PRODUCTS: GENERAL | Title 21 - Food and Drugs | Code of Federal Regulations

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Authority:

21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371, 374; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25.

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 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.

2013-04-02; vol. 78 # 63 - Tuesday, April 2, 2013

78 FR 19585 - Change of Address; Biologics License Applications; Technical Amendment

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-07578
RIN
Docket No.	FDA-2013-N-0011

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule; technical amendment.

This rule is effective April 2, 2013.

21 CFR Part 600

Summary

The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit biologics license applications (BLAs) and BLA amendments and supplements regulated by the Center for Drug Evaluation and Research (CDER). This action is being taken to ensure accuracy and clarity in the Agency's regulations.

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

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

§ 263 - Preparation of biological products by Service

§ 263a - Certification of laboratories

42 USC § 300aa–25 - Recording and reporting of information

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 600 after this date.

2013-04-02; vol. 78 # 63 - Tuesday, April 2, 2013

78 FR 19585 - Change of Address; Biologics License Applications; Technical Amendment

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-07578
RIN
Docket No.	FDA-2013-N-0011

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule; technical amendment.

This rule is effective April 2, 2013.

21 CFR Part 600

Summary

The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit biologics license applications (BLAs) and BLA amendments and supplements regulated by the Center for Drug Evaluation and Research (CDER). This action is being taken to ensure accuracy and clarity in the Agency's regulations.

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 Part 600 - BIOLOGICAL PRODUCTS: GENERAL

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