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2012-01-06
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New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition
Rules and Regulations
D09002ee1bdcc3723
D09002ee1bdcc3774
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA, the Agency) is issuing an order prohibiting certain extralabel uses of cephalosporin antimicrobial drugs in certain food-producing animals. We are issuing this order based on evidence that certain extralabel uses of these drugs in these animals will likely cause an adverse event in humans and, therefore, present a risk to the public health.
77 FR 735
https://www.govinfo.gov/app/details/FR-2012-01-06/2012-35
2012-35
fr06ja12-3
4160-01-P
Docket No. FDA-2008-N-0326
https://www.govinfo.gov/app/details/FR-2012-01-06/2012-35
https://www.govinfo.gov/content/pkg/FR-2012-01-06/html/2012-35.htm
https://www.govinfo.gov/content/pkg/FR-2012-01-06/pdf/2012-35.pdf
Administrative Practice and Procedure
Advertising
Animal Drugs
Labeling
Reporting and Recordkeeping Requirements
11 p.
735
745
77 FR 735
Code of Federal Regulations
Title 21 Part 530
21 CFR Part 530
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition; Federal Register Vol. 77, Issue
RULE
2012-35
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2012-04-05
2012-03-06
Docket No. FDA-2008-N-0326
4160-01-P
2012-35
Final rule.
The Food and Drug Administration (FDA, the Agency) is issuing an order prohibiting certain extralabel uses of cephalosporin antimicrobial drugs in certain food-producing animals. We are issuing this order based on evidence that certain extralabel uses of these drugs in these animals will likely cause an adverse event in humans and, therefore, present a risk to the public health.
This rule becomes effective April 5, 2012. Submit either electronic or written comments on this document by March 6, 2012.
Eric Nelson, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, (240) 276-9201, email: eric.nelson@fda.hhs.gov.
Administrative Practice and Procedure
Advertising
Animal Drugs
Labeling
Reporting and Recordkeeping Requirements
New Animal Drugs; Orders of Prohibition:
Cephalosporin Drugs; Extralabel Animal Drug Use
,
eric.nelson@fda.hhs.gov
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050679s028lbl.pdf
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm126971.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2004/ucm146544.htm
http://www.regulations.gov
Federal Register
Vol. 77, no. 4
Office of the Federal Register, National Archives and Records Administration
2012-01-06
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2012-01-06
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0042-1219
0364-1406
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f:fr06ja12
https://www.govinfo.gov/app/details/FR-2012-01-06
https://www.govinfo.gov/content/pkg/FR-2012-01-06/pdf/FR-2012-01-06.pdf
https://www.govinfo.gov/content/pkg/FR-2012-01-06/xml/FR-2012-01-06.xml
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2012-01-06
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