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US-ANIMAL-DRUGS


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.

MEDERA Consulting assists companies with the following Animal Drug requirements:

  • 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

Contact us to find out more about our regulatory consulting services or to receive a free copy of our white paper on marketing a healthcare product in U.S., click here.