Animal & Veterinary

Withdrawn /Replaced Guidances

 CPG Sec. 170.100 Turtles - Ban on Interstate and Intrastate Sales and DistributionWithdrawn 03/03/2015
 Draft Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants
Withdrawn 05/06/2015; For questions, contact Division of Animal Feeds, Office of Surveillance and Compliance, Center for Veterinary Medicine at (240) 402-7077.
1Anticoccidial GuidelinesReplaced by Guideline 40
2AnthelminticsWithdrawn 12/22/2004
4Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for CattleWithdrawn 12/22/2004
8Guidelines for Toxicological InvestigationsReplaced by Guideline 3
9Preclearance Guidelines for Production DrugsWithdrawn pending revisions
10Amendment of Section II(G)(1)(b)(4) of the Preclearance GuidelinesWithdrawn pending revisions
14Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Food Producing AnimalsWithdrawn 12/22/2004
15Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing AnimalsWithdrawn 12/22/2004
16FOI Summary GuidelineWithdrawn  02/24/2005
17Working Guidelines for Assigning Residue TolerancesReplaced by Guideline 3
18Antibacterial Drugs in Animal Feeds: Human Health Safety CriteriaWithdrawn 12/22/2004
19Antibacterial Drugs in Animal Feeds: Animal Health Safety CriteriaWithdrawn 12/22/2004
20Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness CriteriaWithdrawn 12/22/2004
21Nutritional Ingredients in Animal Drugs and FeedsReplaced by P&P 1240.3420 9/17/09
22Guideline Labeling of Arecoline Base Drugs Intended for Animal UseWithdrawn 7/6/2011
25Guidelines for the Efficacy Evaluation of Equine AnthelminticsReplaced by Guidance 109
26Guidelines for the Preparation of Data to Satisfy the Requirements of Section 512 of the Act Regarding Animal Safety, Effectiveness, Human Food Safety and Environmental Considerations for Minor Use of New Animal Drugs04/86 (superceded by Guidance 61)
27New Animal Drug DeterminationsReplaced by P&P 1240.3500 9/17/2009
28Animal Drug Applications Expedited Review GuidelineReplaced by P&P 1240.3135 10/14/2009
29Guidelines for the Effectiveness Evaluation of Swine AnthelminticsReplaced by Guidance 110
30Guidelines for Anti-infective Bovine Mastitis Product DevelopmentReplaced by Guideline 49
31Guideline for the Evaluation of Bovine AnthelminticsReplaced by Guideline 95
32Guideline for Threshold AssessmentReplaced by Guideline  3
33Target Animal Safety Guidelines for New Animal DrugsReplaced by #185 4/24/2009
34Biomass Guideline - Guideline for New Animal Drugs and Food Additives Derived From a Fermentation; Human Food Safety EvaluationReplaced by Guideline 3
36Guidelines for Efficacy Evaluation of Canine/Feline Anthelmintics  Replaced by Guidance 111
39Guideline on the Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug StudiesReplaced by Guidance 85
40Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drug Combinations in PoultrySuperseded by Guidance for Industry #217 11/20/2012
41Draft Guideline:  Formatting, Assembling, and Submitting New Animal Drug ApplicationsWithdrawn 03/2002
43Draft Guideline for Generic Animal Drug Products Containing Fermentation-Derived Drug SubstancesWithdrawn 05/24/2006
51Points to Consider Guideline - Development of a Pharmacokinetic Guideline Enabling Flexible Labeling of Therapeutic AntimicrobialsSee Guidance 66 for updated information
52Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora, February 18, 2004Replaced by Guidance 159
54Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds06/1994 --See Final Guidance 80
58Guidance for Industry for Good Target Animal Study Practices: Clinical Investigators and MonitorsWithdrawn 12/22/2004; superseded by guidance 85
59How to Submit a Notice of Claimed Investigational  Exemption in Electronic Format to CVMWithdrawn 09/30/2011
60Guidance For Industry: Animal Proteins Prohibited From Animal Feed; Small Entity Compliance GuideReplaced by Guidance 67, 68, 69, and 70
66Withdrawal of Guidance Document on Professional Flexible Labeling of Antimicrobial Drugs Withdrawn 01/30/2002
77Guidance for Industry: Interpretation of On-Farm Feed Manufacturing and Mixing Operations: DRAFT GUIDANCEWithdrawn 06/12/2003
78Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing AnimalsReplaced by Guidance 152
86How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to CVMWithdrawn 09/30/2011
87How to Submit a Notice of Intent to Slaughter for Human Food Purpose in Electronic Format to CVMWithdrawn 09/30/2011
88How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVMWithdrawn 09/30/2011
107How to Submit a Protocol without Data in Electronic Format to CVMWithdrawn 09/30/2011
121Expedited Review for New Animal Drug Applications for Human Pathogen Reduction ClaimsWithdrawn 05/24/2011
153Draft Guidance for Industry #153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and AnimalsWithdrawn 05/06/2015
154Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records Withdrawn 02/25/03Withdrawn 02/25/2003
155Draft Guidance for Industry: 21 CFR Part 11: Electronic Records; Electronic Signatures; Electronic Copies of Electronic RecordsWithdrawn 02/4/2003
171CVM GFI #171 Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated ArticlesWithdrawn pending revisions 3/17/2017
172Guidance for Industry #172 - Use of unapproved hormone implants in veal calves, April 2, 2004Withdrawn 07/15/2004
174Guidance for Industry #174 - Use of Material from BSE-Positive Cattle in Animal FeedWithdrawn 04/13/2011
182VICH GL42 - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event ReportsWithdrawn 01/17/2014; harmonized under Guidance 188
230Draft GFI #230 – Compounding Animal Drugs from Bulk Drug SubstancesWithdrawn 11/7/2017


Page Last Updated: 11/13/2017
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