Source: http://www.law.cornell.edu/cfr/text/21/310/subpart-B
Timestamp: 2013-12-12 22:44:26
Document Index: 165986803

Matched Legal Cases: ['art 310', '§ 310', '§ 310', 'arts 201', '§ 321', '§ 331', '§ 351', '§ 352', '§ 353', '§ 355', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 361', '§ 371', '§ 374', '§ 375', '§ 379', '§ 216', '§ 241', '§ 242', '§ 262', '§ 263', '§ 259']

21 CFR 310, Subpart B - Specific Administrative Rulings and Decisions | Title 21 - Food and Drugs | Code of Federal Regulations | LII / Legal Information Institute
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21 CFR 310, Subpart B - Specific Administrative Rulings and Decisions
There is 1 rule appearing in the Federal Register for 21 CFR 310. Select the tab below to view, or View eCFR (GPOAccess)
§ 310.100 — New drug status opinions; statement of policy.
§ 310.103 — New drug substances intended for hypersensitivity testing.
Title 21 published on 2012-04-01The 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.2012-05-11; vol. 77 # 92 - Friday, May 11, 201277 FR 27591 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates
typeregulations.gov FR Doc.2012-11390 RIN0910-AF43 Docket No.FDA-1978-N-0018 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; delay of compliance dates; request for comments. Effective Date: This final rule is effective June 18, 2012. The final rule published at 76 FR 35620 on June 17, 2011, remains effective June 18, 2012. Comment date: Submit written or electronic comments on the delay of compliance dates by May 21, 2012. Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on June 17, 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, September 3, 2004, are delayed until December 17, 2013, for products with annual sales of less than $25,000, and until December 17, 2012 for all other products subject to the rule. 21 CFR Parts 201 and 310 SummaryThe Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule&apos;s compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule&apos;s requirements for all affected products will require an additional 6 months. This final rule is part of FDA&apos;s ongoing review of OTC drug 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 CodeUSC : Title 21 - FOOD AND DRUGS§ 321 - Definitions; generally§ 331 - Prohibited acts§ 351 - Adulterated drugs and devices§ 352 - Misbranded drugs and devices§ 353 - Exemptions and consideration for certain drugs, devices, and biological products§ 355 - New drugs§ 360b - New animal drugs§ 360c - Classification of devices intended for human use§ 360d - Performance standards§ 360e - Premarket approval21 USC § 360e–1 - Pediatric uses of devices§ 360f - Banned devices§ 360j - General provisions respecting control of devices intended for human use§ 361 - Adulterated cosmetics§ 371 - Regulations and hearings§ 374 - Inspection§ 375 - Publicity§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE§ 216 - Regulations§ 241 - Research and investigations generally§ 242 - Studies and investigations on use and misuse of narcotic drugs and other drugs; annual report to Attorney General; cooperation with States§ 262 - Regulation of biological products§ 263b - Certification of mammography facilities42 USC § 259 to 261a - Repealed. Title 21 published on 2012-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 310 after this date.2012-05-11; vol. 77 # 92 - Friday, May 11, 201277 FR 27591 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates
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