Source: https://www.law.cornell.edu/cfr/text/21/part-680?qt-cfr_tabs=0
Timestamp: 2016-02-10 15:28:26
Document Index: 637511351

Matched Legal Cases: ['art 680', 'art 680', 'art 680', 'art 680', '§ 680', '§ 680', '§ 680', 'arts 124', 'art 111', 'arts 601', '§ 321', '§ 351', '§ 352', '§ 353', '§ 355', '§ 360', '§ 371', '§ 216', '§ 262', 'art 680']

21 CFR Part 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter F › Part 680 21 CFR Part 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
There are 2 Updates appearing in the Federal Register for 21 CFR Part 680. View below or at eCFR (GPOAccess)
§ 680.1 — Allergenic Products.
§ 680.2 — Manufacture of Allergenic Products.
§ 680.3 — Tests.
21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.
38 FR 32100, Nov. 20, 1973, unless otherwise noted.
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 2015-04-01.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.2015-07-02; vol. 80 # 127 - Thursday, July 2, 201580 FR 37971 - Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications
typeregulations.gov FR Doc.2015-16366 RIN Docket No.FDA-2014-N-1110 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 3, 2015. 21 CFR Parts 601, 610, and 680 SummaryThe Food and Drug Administration (FDA) is amending the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is finalizing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics license applications (BLAs), or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to the Executive order.
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 CodeU.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§ 371 - Regulations and hearings
U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE§ 216 - Regulations§ 262 - Regulation of biological products
Title 21 published on 2015-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 680 after this date.2015-07-02; vol. 80 # 127 - Thursday, July 2, 201580 FR 37971 - Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications