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U.S. FDA Animal Drug Establishment Registration & Listing Requirements

A new animal drug is defined, in part, as any drug intended for use in animals other than man, including any drug intended for use in animal feed but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggest in the labeling of the drug.

As mandated by the Federal Food, Drug, and Cosmetic Act (Act), a new animal drug may not be sold into interstate commerce unless it is the subject of an approved new animal drug application (NADA), abbreviated NADA (ANADA), or there is a conditional approval (CNADA) in effect, or there is an index listing in effect. Under section 512(j) of the Act, unapproved investigational new animal drugs may be exempt from the approval requirements of the act. An investigational new animal drug may be shipped in interstate commerce for use by experts, qualified by scientific training and experience, to investigate their safety and effectiveness, if the requirements for the exemption set forth in 21 CFR part 511 are met.

Animal drugs intended for use in the United States are considered drugs by the U.S. FDA. As such, establishments that manufacturer or process Animal Drugs are considered drug manufacturers. Therefore, Animal Drug Establishments are subject to U.S. FDA drug registration and listing requirements.

Registrar Corp assists companies with the following Animal Drug requirements:
Drug Certificates Issued By Registrar Corp
  • U.S. FDA Animal Drug Establishment Registration
  • U.S. FDA Animal Drug Listing and Label Submissions
  • Obtaining a DUNS Number
  • U.S. Agent Requirements
  • Registrant Contact Requirements


If you do not have an Establishment Registration Number and a Listing for your Animal Drug with U.S. FDA

New U.S. FDA Animal Drug Registration and Listings  ››

If you already have an Establishment Registration Number and a Listing for your Animal Drug with U.S. FDA

  
Option 1:  Update your existing Animal Drug Registration and Listing information
Click the Update button below for any of the following:
  • Update your Animal Drug Establishment Registration
  • Update an existing Animal Drug Listing with U.S. FDA
  • List another Animal Drug with U.S. FDA
  • Change U.S. Agent or Registrant Contact
Update Animal Drug Registration and Listing Information  ››

  
Option 2:   Order a Certificate of Registration issued by Registrar Corp
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their registration and listings. A Certificate of Registration issued by Registrar Corp serves to verify your compliance with Animal Drug Registration and Listing requirements.

Order Your Animal Drug Certificate  ››





 
U.S. FDA Regulations:

U.S. FDA Regulation: 21 C.F.R. Part 207


































Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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