Source: https://www.law.cornell.edu/cfr/text/21/522.1850
Timestamp: 2017-02-26 10:19:57
Document Index: 147883210

Matched Legal Cases: ['art 522', 'art 522', '§ 522', '§ 510', '§ 360', 'art 522', 'arts 510', 'arts 510', 'arts 510', 'arts 510', 'arts 520', 'arts 510', 'arts 510', 'arts 510']

21 CFR 522.1850 - Polysulfated glycosaminoglycan. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter E › Part 522 › Section 522.1850 21 CFR 522.1850 - Polysulfated glycosaminoglycan.
There are 8 Updates appearing in the Federal Register for 21 CFR Part 522. View below or at eCFR (GPOAccess)
§ 522.1850 Polysulfated glycosaminoglycan.
(1) Each 1-milliliter (mL) ampule of solution contains 250 milligrams (mg) polysulfated glycosaminoglycan.
(2) Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 50-mL vials contains 100 mg polysulfated glycosaminoglycan.
(b)Sponsor. See No. 010797 in § 510.600(c) of this chapter.
(c)Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)Conditions of use - (1)Horses - (i)Indications for use. For the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.
(ii)Amount - (A)Intra-articular use (carpal): 250 mg once a week for 5 weeks.
(B)Intramuscular use (carpal and hock): 500 mg every 4 days for 28 days.
(iii)Limitations. Do not use in horses intended for human consumption.
(2)Dogs - (i)Indications for use. For control of signs associated with noninfectious degenerative and/or traumatic arthritis of canine synovial joints.
(ii)Amount. 2 mg per pound of body weight by intramuscular injection twice weekly for up to 4 weeks (maximum of 8 injections).
[ 72 FR 56896, Oct. 5, 2007, as amended at 74 FR 67816, Dec. 21, 2009] 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§ 360b - New animal drugs
Title 21 published on 2015-12-03The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.2016-09-30; vol. 81 # 190 - Friday, September 30, 201681 FR 67149 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor&apos;s Address
typeregulations.gov FR Doc.2016-23230 RIN Docket No.FDA-2016-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective September 30, 2016. 21 CFR Parts 510, 520, 522, 524, 529, and 558 SummaryThe Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor&apos;s address.
2016-08-29; vol. 81 # 167 - Monday, August 29, 201681 FR 59131 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor&apos;s Name and Address; Change of Sponsor&apos;s Address
typeregulations.gov FR Doc.2016-19914 RIN Docket No.FDA-2016-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective August 29, 2016, except for the amendments to 21 CFR 558.274, 58.355, 58.363, 58.550, 558.625, and 558.630, which are effective September 8, 2016. 21 CFR Parts 510, 520, 522, 524, and 558 SummaryThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications, changes of sponsors&apos; names and addresses, and the voluntary withdrawals of approval of applications.
2016-07-26; vol. 81 # 143 - Tuesday, July 26, 201681 FR 48700 - New Animal Drugs; Change of Sponsor
typeregulations.gov FR Doc.2016-17501 RIN Docket No.FDA-2014-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 26, 2016. 21 CFR Parts 510, 520, 522, 524, and 558 SummaryThe Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.
2016-06-08; vol. 81 # 110 - Wednesday, June 8, 201681 FR 36787 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
typeregulations.gov FR Doc.2016-13517 RIN Docket No.FDA-2016-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective June 8, 2016 except for the amendments to 21 CFR 520.1696b, 520.2325a, 520.2261a, 558.248, and 558.625, which are effective June 20, 2016. 21 CFR Parts 510, 520, 522, 556, and 558 SummaryThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February.
2016-04-18; vol. 81 # 74 - Monday, April 18, 201681 FR 22520 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
typeregulations.gov FR Doc.2016-08827 RIN Docket No.FDA-2016-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective April 18, 2016. 21 CFR Parts 520, 522, 524, 529, 556, and 558 SummaryThe Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in January and February.
2016-04-01; vol. 81 # 63 - Friday, April 1, 201681 FR - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
typeregulations.gov FR Doc.C1-2016-07135 RIN Docket No.FDA-2015-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558 Summary
2016-03-30; vol. 81 # 61 - Wednesday, March 30, 201681 FR 17604 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
typeregulations.gov FR Doc.2016-07135 RIN Docket No.FDA-2015-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective March 30, 2016. 21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558 SummaryThe Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in November and December 2015.
2015-12-09; vol. 80 # 236 - Wednesday, December 9, 201580 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
typeregulations.gov FR Doc.2015-31042 RIN Docket No.FDA-2015-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015. 21 CFR Parts 510, 520, 522, 524, and 558 SummaryThe Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in September and October 2015.
Title 21 published on 2015-12-03.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.2016-09-30; vol. 81 # 190 - Friday, September 30, 201681 FR 67149 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor&apos;s Address