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                Guidance for Industry

Guidance for Industry

                        Guidance by Number
          Guidances Under Development for 2023
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          Guidance for Industry
          Withdrawn/Replaced GuidancesGuidance for Industry Withdrawn/Replaced Guidances
  
  	
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			Title
			DateCPG Sec. 170.100 Turtles - Ban on Interstate and Intrastate Sales and Distribution
			Withdrawn 03/03/2015CPG Sec. 605.100 Use of Statements Regarding NADA Approval by FDA in Labeling and Advertising of New Animal Drugs
			Withdrawn 2/20/2020CPG Sec. 608.300 Lay Use of *Animal Capture and Euthanasia* Drugs
			Withdrawn 2/20/2020CPG Sec. 608.500 Illegal Sales of Veterinary Prescription Drugs Direct Reference Authority for *Warning* Letter Issuance
			Withdrawn 2/20/2020CPG Sec. 625.200 Availability of Bulk Chemicals for Animal Drug Use
			Withdrawn 4/14/2022CPG Sec. 625.300 Unapproved New Animal Drugs - Follow-up Action to Approved Warning Letter - Direct Reference Seizure Authority
			Withdrawn 2/20/2020CPG Sec. 625.400 Reconditioning of New Animal Drugs Seized Under Section 501(a)(5)
			Withdrawn 2/20/2020CPG Sec. 625.500 Failure to Register *and/or Drug List*
			Withdrawn 2/20/2020CPG Sec. 634.100 Drugs Packaged for Infusion or Injection of Food-Producing Animals
			Withdrawn 2/20/2020CPG Sec. 637.100 Plastic Containers for Injectable Animal Drugs
			Withdrawn 2/20/2020CPG Sec. 640.100 Anthelmintics
			Withdrawn 2/20/2020CPG Sec. 641.100 *Products for Control of Fleas and Ticks* Containing a Pesticide
			Withdrawn 2/20/2020CPG Sec. 643.100 Oral Iron Products for Baby Pigs
			Withdrawn 2/20/2020CPG Sec. 645.100 Biological Drugs for Animal Use
			Withdrawn 2/20/2020CPG Sec. 654.100 Dimethyl Sulfoxide (DMSO) for Animal Use
			Withdrawn 2/20/2020CPG Sec. 654.300 Chloramphenicol as an Unapproved New Animal Drug - Direct Reference Seizure Authority
			Withdrawn 2/20/2020CPG Sec. 655.200 Adequate Directions for Use - Animal Drugs & Veterinary Devices
			Withdrawn 2/20/2020 The agency policy on this subject can be found in CPG Sec. 607.100 - Adequate Directions for Use (Species Designation) - Animal Drugs and Veterinary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			Withdrawn 2/20/2020CPG Sec. 655.400 The Status of Syringes and Needles for Animal Use
			Withdrawn 2/20/2020CPG Sec. 660.100 Failure to Register
			Withdrawn 2/20/2020CPG Sec. 665.200 Checklist Labeling for Custom Mixed Medicated Feeds
			Withdrawn 7/23/2019CPG Sec. 670.100 Refusals of Formula Information During Inspection of Feed Mills Manufacturing Feeds Requiring Approved Medicated Feed Applications
			Withdrawn 6/30/2020CPG Sec. 670.200 Status of Vitamins and Minerals in Type B and C Medicated Feed and in Non-Medicated Feed
			Withdrawn 2/20/2020CPG Sec. 675.400 Rendered Animal Feed Ingredients
			Withdrawn 4/30/2019CPG Sec. 680.100 Tracers in Animal Feed
			Replaced by Guidance 258 - 10/19/2022CPG Sec. 680.200 CGMP Regulations for Medicated Feeds - Daily Inventory Requirements
			Withdrawn 2/20/2020CPG Sec. 680.500 Unsafe Contamination of Animal Feed from Drug Carryover
			Withdrawn 1/30/2023CPG Sec. 680.600 Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds
			Withdrawn 1/30/2023CPG Sec. 681.100 Order for Post-Approval Record Reviews
			Withdrawn 2/20/2020CPG Sec. 682.100 Use of Drug-Contaminated Products in Animal Feed
			Withdrawn 2/20/2020CPG Sec. 682.200 The Use of Antibiotic Drug Residue By-Products in Animal Feed Feed
			Withdrawn 2/20/2020CPG Sec. 690.100 Nutritional Supplements for Companion Animals
			Withdrawn 2/20/2020CPG Sec. 690.200 Pet Food Labeling
			Withdrawn 2/20/2020CPG Sec. 690.300  Canned Pet Food
			Withdrawn 4/30/2019CPG Sec. 690.400 Water and Gravy in Pet Food
			Withdrawn 2/20/2020CPG Sec. 690.500  Uncooked Meat for Animal Food
			Withdrawn 4/30/2019CPG Sec. 690.600 Rodent Contaminated Pet Foods - *Direct Reference Seizure Authority*
			Withdrawn 2/20/2020Draft Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants
			Withdrawn 05/06/20151
			Anticoccidial Guidelines
			Replaced by Guideline 402
			Anthelmintics
			Withdrawn 12/22/20044
			Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle
			Withdrawn 12/22/20046
			Submitting NADA's for Generic Drugs Reviewed by NAS/NR
			Withdrawn 8/23/20188
			Guidelines for Toxicological Investigations
			Replaced by Guideline 39
			Preclearance Guidelines for Production Drugs
			Withdrawn pending revisions10
			Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines
			Withdrawn pending revisions14
			Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Food Producing Animals
			Withdrawn 12/22/200415
			Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals
			Withdrawn 12/22/200416
			FOI Summary Guideline
			Withdrawn  02/24/200517
			Working Guidelines for Assigning Residue Tolerances
			Replaced by Guideline 318
			Antibacterial Drugs in Animal Feeds: *Human* Health Safety Criteria
			Withdrawn 12/22/200419
			Antibacterial Drugs in Animal Feeds: *Animal* Health Safety Criteria
			Withdrawn 12/22/200420
			Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria
			Withdrawn 12/22/200421
			Nutritional Ingredients in Animal Drugs and Feeds
			Replaced by P&P 1240.3420 9/17/0922
			Guideline Labeling of Arecoline Base Drugs Intended for Animal Use
			Withdrawn 7/6/201125
			Guidelines for the Efficacy Evaluation of Equine Anthelmintics
			Replaced by Guidance 10926
			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 9/17/200928
			Animal Drug Applications Expedited Review Guideline
			Replaced by P&P 1240.3135 10/14/200929
			Guidelines for the Effectiveness Evaluation of Swine Anthelmintics
			Replaced by Guidance 11030
			Guidelines for Anti-infective Bovine Mastitis Product Development
			Replaced by Guideline 4931
			Guideline for the Evaluation of Bovine Anthelmintics
			Replaced by Guideline 9532
			Guideline for Threshold Assessment
			Replaced by Guideline  333
			Target Animal Safety Guidelines for New Animal Drugs
			Replaced by #185 4/24/200934
			Biomass Guideline - Guideline for New Animal Drugs and Food Additives Derived From a Fermentation; Human Food Safety Evaluation
			Replaced by Guideline 336
			Guidelines for Efficacy Evaluation of Canine/Feline Anthelmintics
			Replaced by Guidance 11139
			Guideline on the Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug Studies
			Replaced by Guidance 8540
			Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drug Combinations in Poultry
			Superseded by Guidance for Industry #217 11/20/201241
			Draft Guideline:  Formatting, Assembling, and Submitting New Animal Drug Applications
			Withdrawn 03/200242
			Animal Drug Manufacturing Guidelines- Series of Four Guidelines
			Withdrawn 10/30/2019 pending revision43
			Draft Guideline for Generic Animal Drug Products Containing Fermentation-Derived Drug Substances
			Withdrawn 05/24/200650
			Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products
			Withdrawn 01/30/202451
			Points to Consider Guideline - Development of a Pharmacokinetic Guideline Enabling Flexible Labeling of Therapeutic Antimicrobials
			See Guidance 66 for updated information52
			Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora, February 18, 2004
			Replaced by Guidance 15954
			Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds
			06/1994 --See Final Guidance 8058
			Guidance for Industry for Good Target Animal Study Practices: Clinical Investigators and Monitors
			Withdrawn 12/22/2004; superseded by guidance 8559
			How to Submit a Notice of Claimed Investigational  Exemption in Electronic Format to CVM
			Withdrawn 09/30/201160
			Guidance For Industry: Animal Proteins Prohibited From Animal Feed; Small Entity Compliance Guide
			Replaced by Guidance 67, 68, 69, and 7066
			Withdrawal of Guidance Document on Professional Flexible Labeling of Antimicrobial Drugs
			Withdrawn 01/30/200277
			Guidance for Industry: Interpretation of On-Farm Feed Manufacturing and Mixing Operations: DRAFT GUIDANCE
			Withdrawn 06/12/200378
			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 15286
			How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to CVM
			Withdrawn 09/30/201187
			How to Submit a Notice of Intent to Slaughter for Human Food Purpose in Electronic Format to CVM
			Withdrawn 09/30/201188
			How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVM
			Withdrawn 09/30/2011102
			Manufacture and Distribution of Unapproved Piperazine Products
			Withdrawn 3/4/2020107
			How to Submit a Protocol without Data in Electronic Format to CVM
			Withdrawn 09/30/2011121
			Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims
			Withdrawn 05/24/2011153
			Draft Guidance for Industry #153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals
			Withdrawn 05/06/2015154
			Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records Withdrawn 02/25/03
			Withdrawn 02/25/2003155
			Draft Guidance for Industry: 21 CFR Part 11: Electronic Records; Electronic Signatures; Electronic Copies of Electronic Records
			Withdrawn 02/4/2003172
			Guidance for Industry #172 - Use of unapproved hormone implants in veal calves, April 2, 2004
			Withdrawn 07/15/2004174
			Guidance for Industry #174 - Use of Material from BSE-Positive Cattle in Animal Feed
			Withdrawn 04/13/2011182
			VICH GL42 - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports
			Withdrawn 01/17/2014; harmonized under Guidance 188210
			Guidance for Industry #210 The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
			Withdrawn 07/25/2022 pending revisions230
			Draft Guidance for Industry #230 Compounding Animal Drugs from Bulk Drug Substances
			Withdrawn 11/7/2017; Replaced by Draft Guidance 256269
			Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak
			Withdrawn 02/21/2023270
			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

                                                                                  Content current as of:
      01/30/2024Guidance for Industry

          
                        Guidance by Number
          Guidances Under Development for 2023
          Newly Added Guidances
          Withdrawn/Replaced Guidances
 
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