Table of Contents

Aquaculture
What’s New
Approved Drugs
Publicly Available Data
CVM Updates/FDA News
Guidance/Policy Docs
How to Report an ADE
Additional Information

CVM Guidances for Aquaculture

• Guidance for Industry #150: Concerns Related to the use of Clove Oil as an Anesthetic for Fish | pdf | | htm | (April 24, 2007).

• Guidance for Industry #85: Good Clinical Practices: VICH GL9, Final Guidance (May 9, 2001) 

• Guidance for Industry #61: FDA Approval of New Animal Drugs for Minor Uses and for Minor Species (April 1999) 

  • Part 2E: Aquatic Species

• Guidance for Industry #53: Guideline for the Evaluation of the Utility of Food Additives in Diets Fed to Aquatic Animals (May 1994)

• Guideline #33 - Target Animal Safety Guidelines for New Animal Drugs (June 1989)

• Link to Other CVM Guidance Documents

CVM Program Policy and Procedures Manual Sections on Aquaculture

Hyper-links to sections of the CVM Program Policy and Procedures Manual dealing with Aquaculture. Provides a quick reference to the rules, regulations, and instructions pertinent to CVM's aquaculture program responsibilities, including the review of new animal drug applications, low regulatory priority and extra-label drug use, and other post-market surveillance and compliance activities

• 1240.4200 - Drug Use in Aquaculture Enforcement Priorities

• 1240.4210 - Extra-label Use of Approved Drugs in Aquaculture 

• 1240.4220 - Drug-Pesticide Issues 

• 1240.4230 - Regulation of Fish Identification Products 

• 1240.4260 - Classification of Aquaculture Species/Population as Food or Non- food

• 1240.4270 - Use of Drugs in Outdoor Aquatic Research Facilities

Compliance Policy Guide 615.115: Extralabel Use of Medicated Feeds for Minor Species

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