Law Library Articles

Once a product is determined to be a drug for animal use, the next step is to determine whether or not it is a new animal drug. The Act defines a new animal drug (in part) as any drug intended for use for animals other than man, the composition of which is not generally recognized, among experts qualified by scientific training and experience, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. All "new animal drugs," must be approved as safe and effective by FDA before being marketed for use. 21 U.S.C. § 360b. Virtually all drugs intended for animal use are new animal drugs within the FDCA's definition and thus are required to receive FDA's approval prior to marketing. 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 pursuant to 21 U.S.C. § 360ccc or there is an index listing in effect pursuant to 21 USC § 360ccc-1 (21 U.S.C. §§ 331(a) and 360b(a)). New animal drugs are regulated using the new animal drug application (NADA) process for initial new active ingredient and formulation approvals; and also for supplemental changes to already approved animal drugs. A drug lacking such approval is deemed to be adulterated under the FDCA and may not be distributed in interstate commerce. The Green Book, accessible from the CVM Home Page contains a searchable database of all FDA-approved animal drugs.  The FDA Center for Veterinary Medicine has an Overview of the Animal Drug Approval Process.

Approval of an NADA, if granted, pertains only to those particular uses of the drug specified in the application (uses that would typically be confined to particular animals). For instance, a NADA showing safety and effectiveness of a particular formulation for a disease condition in swine does not allow the manufacturer to claim similar effectiveness for the disease condition in cattle. Due to the metabolic differences in species of animals, each new condition must be the subject of an approval. Moreover, FDA can revoke approval if, at a later time, evidence demonstrates that a drug is not safe or effective for the particular uses for which it has been approved. The extensive research, as well as laboratory and field testing, that is necessary to establish safety and efficacy is expensive. Drugs that are claimed to be the same as an approved drug, except for the fact they have been made by a different manufacturer, must still meet the rigorous NADA procedures. This requirement exists because it has been established that drugs, even though they may be of a similar chemical composition, do not necessarily work the same way.  Some animal drugs for Minor Species (not dogs or cats) may be marketed without going through the extensive New Animal Drug Approval (NADA) by having the drug Indexed through the Minor Use Minor Species Animal Health Act (MUMS). Minor species are defined by exclusion, as animals other than cattle, horses, swine, chickens, turkeys, dogs and cats. In that case, while the drug does not go through the full approval process, the FDA will permit the drug to be marketed, after a showing of safety and efficacy.  Once the drug is shown by an expert panel to be safe and efficacious it will go onto a list of “indexed” products and may be marketed with certain disclaimers.  This is a fairly new program, and there are few drugs that are on the Indexed list.  Currently there are numerous drugs being sold for use in minor species that are considered “of low regulatory priority.” When more drugs are included on the Index list, the FDA will begin considering taking enforcement actions against the “low priority drugs” that are not Indexed. See the CVM’s Web page on MUMS.

CVM will use the following categories to determine the regulatory status of a drug:

1. Approved new animal drug - An approved New Animal Drug Application (NADA) exists for this indication. Refer to 21 Code of Federal Regulations (CFR) Part 514. Product is used according to label directions.
2. Investigational New Animal Drug (INAD) - A potential sponsor may request an INAD exemption for collecting data to support a new animal drug approval.
3. Extra-label use drug - Use of an FDA - approved drug under the provisions of Animal Medicinal Drug Use Clarification Act (AMDUCA)
4. Extra-label use of medicated feeds - Provisions for the use of approved medicated feeds for minor species are explained in the Compliance Policy Guide (CPG) for Extra-label Use of Medicated Feeds for Minor Species.  (Compliance Policy Guide, Chapter 6, Section 615.115).
5. Regulatory discretion - Drugs that have been evaluated for regulatory discretion as low priority for enforcement action (INADs/NADAs will not be required).
6. Low Regulatory Priority Drugs - Many animal health supplements are considered “drugs of low regulatory priority”. In addition, the drugs that are marketed to minor non-food species, or that will be authorized for inclusion on the MUMS Index list, such as aquaculture drugs may also be considered drugs of low-regulatory priority, at this point. If drug claims appear on the product label, in product catalogs, or in promotional material, the following conditions must be met, even if the drugs are considered low priority drugs: The product must have been manufactured according to CGMPs (Current Good Manufacturing Practices) as defined in 21 CFR 210 & 211: The product manufacturer must be registered with the FDA: and The product must be drug-listed with FDA. Material deviations in labeling or promotion from the permitted low priority claims might cause a particular product to be removed from the low priority category. Enforcement Priorities for Drug Use in Aquaculture