Withdrawn/Replaced Guidances
No. | Title | Date |
---|---|---|
CPG Sec. 170.100 Turtles - Ban on Interstate and Intrastate Sales and Distribution | Withdrawn 03/03/2015 | |
CPG Sec. 605.100 Use of Statements Regarding NADA Approval by FDA in Labeling and Advertising of New Animal Drugs | Withdrawn 2/20/2020 | |
CPG Sec. 608.300 Lay Use of *Animal Capture and Euthanasia* Drugs | Withdrawn 2/20/2020 | |
CPG Sec. 608.500 Illegal Sales of Veterinary Prescription Drugs Direct Reference Authority for *Warning* Letter Issuance | Withdrawn 2/20/2020 | |
CPG Sec. 625.200 Availability of Bulk Chemicals for Animal Drug Use | Withdrawn 4/14/2022 | |
CPG Sec. 625.300 Unapproved New Animal Drugs - Follow-up Action to Approved Warning Letter - Direct Reference Seizure Authority | Withdrawn 2/20/2020 | |
CPG Sec. 625.400 Reconditioning of New Animal Drugs Seized Under Section 501(a)(5) | Withdrawn 2/20/2020 | |
CPG Sec. 625.500 Failure to Register *and/or Drug List* | Withdrawn 2/20/2020 | |
CPG Sec. 634.100 Drugs Packaged for Infusion or Injection of Food-Producing Animals | Withdrawn 2/20/2020 | |
CPG Sec. 637.100 Plastic Containers for Injectable Animal Drugs | Withdrawn 2/20/2020 | |
CPG Sec. 640.100 Anthelmintics | Withdrawn 2/20/2020 | |
CPG Sec. 641.100 *Products for Control of Fleas and Ticks* Containing a Pesticide | Withdrawn 2/20/2020 | |
CPG Sec. 643.100 Oral Iron Products for Baby Pigs | Withdrawn 2/20/2020 | |
CPG Sec. 645.100 Biological Drugs for Animal Use | Withdrawn 2/20/2020 | |
CPG Sec. 650.100 Animal Drugs for Euthanasia | Withdrawn 5/23/2024 | |
CPG Sec. 654.100 Dimethyl Sulfoxide (DMSO) for Animal Use | Withdrawn 2/20/2020 | |
CPG Sec. 654.300 Chloramphenicol as an Unapproved New Animal Drug - Direct Reference Seizure Authority | Withdrawn 2/20/2020 | |
CPG Sec. 655.200 Adequate Directions for Use - Animal Drugs & Veterinary Devices | Withdrawn 2/20/2020 The agency policy on this subject can be found in CPG Sec. 607.100 - Adequate Directions for Use (Species Designation) - Animal Drugs and Veterinary Devices. | |
CPG Sec. 655.300 Barking Dog Collar | Withdrawn 2/20/2020 | |
CPG Sec. 655.400 The Status of Syringes and Needles for Animal Use | Withdrawn 2/20/2020 | |
CPG Sec. 660.100 Failure to Register | Withdrawn 2/20/2020 | |
CPG Sec. 665.200 Checklist Labeling for Custom Mixed Medicated Feeds | Withdrawn 7/23/2019 | |
CPG Sec. 670.100 Refusals of Formula Information During Inspection of Feed Mills Manufacturing Feeds Requiring Approved Medicated Feed Applications | Withdrawn 6/30/2020 | |
CPG Sec. 670.200 Status of Vitamins and Minerals in Type B and C Medicated Feed and in Non-Medicated Feed | Withdrawn 2/20/2020 | |
CPG Sec. 675.400 Rendered Animal Feed Ingredients | Withdrawn 4/30/2019 | |
CPG Sec. 680.100 Tracers in Animal Feed | Replaced by Guidance 258 - 10/19/2022 | |
CPG Sec. 680.200 CGMP Regulations for Medicated Feeds - Daily Inventory Requirements | Withdrawn 2/20/2020 | |
CPG Sec. 680.500 Unsafe Contamination of Animal Feed from Drug Carryover | Withdrawn 1/30/2023 | |
CPG Sec. 680.600 Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds | Withdrawn 1/30/2023 | |
CPG Sec. 681.100 Order for Post-Approval Record Reviews | Withdrawn 2/20/2020 | |
CPG Sec. 682.100 Use of Drug-Contaminated Products in Animal Feed | Withdrawn 2/20/2020 | |
CPG Sec. 682.200 The Use of Antibiotic Drug Residue By-Products in Animal Feed Feed | Withdrawn 2/20/2020 | |
CPG Sec. 690.100 Nutritional Supplements for Companion Animals | Withdrawn 2/20/2020 | |
CPG Sec. 690.200 Pet Food Labeling | Withdrawn 2/20/2020 | |
CPG Sec. 690.300 Canned Pet Food | Withdrawn 4/30/2019 | |
CPG Sec. 690.400 Water and Gravy in Pet Food | Withdrawn 2/20/2020 | |
CPG Sec. 690.500 Uncooked Meat for Animal Food | Withdrawn 4/30/2019 | |
CPG Sec. 690.600 Rodent Contaminated Pet Foods - *Direct Reference Seizure Authority* | Withdrawn 2/20/2020 | |
Draft Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants | Withdrawn 05/06/2015 | |
1 | Anticoccidial Guidelines | Replaced by Guideline 40 |
2 | Anthelmintics | Withdrawn 12/22/2004 |
4 | Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle | Withdrawn 12/22/2004 |
6 | Submitting NADA's for Generic Drugs Reviewed by NAS/NR | Withdrawn 8/23/2018 |
8 | Guidelines for Toxicological Investigations | Replaced by Guideline 3 |
9 | Preclearance Guidelines for Production Drugs | Withdrawn pending revisions |
10 | Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines | Withdrawn pending revisions |
14 | Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Food Producing Animals | Withdrawn 12/22/2004 |
15 | Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals | Withdrawn 12/22/2004 |
16 | FOI Summary Guideline | Withdrawn 02/24/2005 |
17 | Working Guidelines for Assigning Residue Tolerances | Replaced by Guideline 3 |
18 | Antibacterial Drugs in Animal Feeds: Human Health Safety Criteria | Withdrawn 12/22/2004 |
19 | Antibacterial Drugs in Animal Feeds: Animal Health Safety Criteria | Withdrawn 12/22/2004 |
20 | Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria | Withdrawn 12/22/2004 |
21 | Nutritional Ingredients in Animal Drugs and Feeds | Replaced by P&P 1240.3420 9/17/09 |
22 | Guideline Labeling of Arecoline Base Drugs Intended for Animal Use | Withdrawn 7/6/2011 |
25 | Guidelines for the Efficacy Evaluation of Equine Anthelmintics | Replaced by Guidance 109 |
26 | Guidelines 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 Drugs | 04/86 (superceded by Guidance 61) |
27 | New Animal Drug Determinations | Replaced by P&P 1240.3500 9/17/2009 |
28 | Animal Drug Applications Expedited Review Guideline | Replaced by P&P 1240.3135 10/14/2009 |
29 | Guidelines for the Effectiveness Evaluation of Swine Anthelmintics | Replaced by Guidance 110 |
30 | Guidelines for Anti-infective Bovine Mastitis Product Development | Replaced by Guideline 49 |
31 | Guideline for the Evaluation of Bovine Anthelmintics | Replaced by Guideline 95 |
32 | Guideline for Threshold Assessment | Replaced by Guideline 3 |
33 | Target Animal Safety Guidelines for New Animal Drugs | Replaced by #185 4/24/2009 |
34 | Biomass Guideline - Guideline for New Animal Drugs and Food Additives Derived From a Fermentation; Human Food Safety Evaluation | Replaced by Guideline 3 |
36 | Guidelines for Efficacy Evaluation of Canine/Feline Anthelmintics | Replaced by Guidance 111 |
39 | Guideline on the Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug Studies | Replaced by Guidance 85 |
40 | Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drug Combinations in Poultry | Superseded by Guidance for Industry #217 11/20/2012 |
41 | Draft Guideline: Formatting, Assembling, and Submitting New Animal Drug Applications | Withdrawn 03/2002 |
42 | Animal Drug Manufacturing Guidelines- Series of Four Guidelines | Withdrawn 10/30/2019 pending revision |
43 | Draft Guideline for Generic Animal Drug Products Containing Fermentation-Derived Drug Substances | Withdrawn 05/24/2006 |
50 | Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products | Withdrawn 01/30/2024 |
51 | Points to Consider Guideline - Development of a Pharmacokinetic Guideline Enabling Flexible Labeling of Therapeutic Antimicrobials | See Guidance 66 for updated information |
52 | Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora, February 18, 2004 | Replaced by Guidance 159 |
54 | Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds | 06/1994 --See Final Guidance 80 |
58 | Guidance for Industry for Good Target Animal Study Practices: Clinical Investigators and Monitors | Withdrawn 12/22/2004; superseded by guidance 85 |
59 | How to Submit a Notice of Claimed Investigational Exemption in Electronic Format to CVM | Withdrawn 09/30/2011 |
60 | Guidance For Industry: Animal Proteins Prohibited From Animal Feed; Small Entity Compliance Guide | Replaced by Guidance 67, 68, 69, and 70 |
66 | Withdrawal of Guidance Document on Professional Flexible Labeling of Antimicrobial Drugs | Withdrawn 01/30/2002 |
77 | Guidance for Industry: Interpretation of On-Farm Feed Manufacturing and Mixing Operations: DRAFT GUIDANCE | Withdrawn 06/12/2003 |
78 | Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals | Replaced by Guidance 152 |
86 | How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to CVM | Withdrawn 09/30/2011 |
87 | How to Submit a Notice of Intent to Slaughter for Human Food Purpose in Electronic Format to CVM | Withdrawn 09/30/2011 |
88 | How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVM | Withdrawn 09/30/2011 |
102 | Manufacture and Distribution of Unapproved Piperazine Products | Withdrawn 3/4/2020 |
105 | Computerized Systems Used in Clinical Investigations | Withdrawn 10/2/2024. The agency policy on this subject can be found in Guidance for Industry, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers." |
107 | How to Submit a Protocol without Data in Electronic Format to CVM | Withdrawn 09/30/2011 |
121 | Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims | Withdrawn 05/24/2011 |
153 | Draft Guidance for Industry #153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals | Withdrawn 05/06/2015 |
154 | Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records Withdrawn 02/25/03 | Withdrawn 02/25/2003 |
155 | Draft Guidance for Industry: 21 CFR Part 11: Electronic Records; Electronic Signatures; Electronic Copies of Electronic Records | Withdrawn 02/4/2003 |
172 | Guidance for Industry #172 - Use of unapproved hormone implants in veal calves, April 2, 2004 | Withdrawn 07/15/2004 |
174 | Guidance for Industry #174 - Use of Material from BSE-Positive Cattle in Animal Feed | Withdrawn 04/13/2011 |
182 | VICH GL42 - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports | Withdrawn 01/17/2014; harmonized under Guidance 188 |
210 | Guidance for Industry #210 The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species | Withdrawn 07/25/2022 pending revisions |
230 | Draft Guidance for Industry #230 Compounding Animal Drugs from Bulk Drug Substances | Withdrawn 11/7/2017; Replaced by Draft Guidance 256 |
269 | Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak | Withdrawn 02/21/2023 |
270 | Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency | Expired 11/08/2023 |