FDA Entry Point

Animal & Veterinary Drugs

The FDA’s Center for Veterinary Medicine (CVM) regulates drugs intended for animal use, including prescription veterinary drugs, OTC animal drugs, and medicated feeds. Foreign manufacturers of animal drugs must register with the FDA and comply with the same registration and listing requirements as human drug manufacturers.

Veterinary Drug Establishment Registration

Manufacturers of animal drugs prescription or OTC must register annually with the FDA’s CVM through the DRLS system.

  • Animal drug establishment registration
  • Annual renewal management
  • Foreign facility U.S. Agent required
  • DUNS number coordination

Veterinary Drug Product Listing

All marketed animal drug products must be listed with the FDA’s CVM, with accurate ingredient and labeling information.

  • Animal drug product listing (DRLS)
  • NADA & ANADA product support
  • OTC animal drug listings
  • Medicated feed product listing

Veterinary Drug Label Review

Animal drug labels must comply with FDA CVM labeling regulations under 21 CFR Part 500, Subpart C. We review for compliance before market entry.

  • Prescription animal drug label review
  • OTC animal Drug Facts panel
  • Indication & dosage compliance
  • Withdrawal time statements

Medicated Feed Registration

Manufacturers of animal drugs, prescription or OTC, must register annually with the FDA’s CVM through the DRLS system.

  • Medicated feed mill license support
  • Type A medicated article registration
  • Feed ingredient compliance review
  • CVM regulatory guidance

Ready to Bring Your Animal & Veterinary Drugs to Market?

Animal drug compliance touches CVM registration, listing, labeling, and feed rules at the same time.

Let us manage all of it for you.

Register

Animal & Veterinary Drugs FAQs

Does my animal drug facility need to register with the FDA?

Yes. Manufacturers of prescription or OTC animal drugs, whether domestic or foreign, must register annually with the FDA’s Center for Veterinary Medicine (CVM) and comply with the same establishment registration framework that applies to human drug manufacturers.

What’s the difference between NADA and ANADA?

A New Animal Drug Application (NADA) is for an original approval, while an Abbreviated New Animal Drug Application (ANADA) is for a generic version of an already-approved animal drug. Both require FDA listing once approved.

What labeling rules apply to animal drugs?

Animal drug labeling is governed primarily by 21 CFR Part 500, Subpart C, which sets required content and misbranding standards, along with withdrawal time statements for drugs used in food-producing animals.

Do medicated animal feeds need separate FDA approval?

Yes. Feeds containing a New Animal Drug must comply with FDA’s medicated feed regulations, which can include a medicated feed mill license and Type A medicated article registration depending on how the feed is manufactured.