Animal grooming aids The act defines a cosmetic as pertaining only to human use, so products intended for cleansing or promoting attractiveness in animals are not subject to FDA control. However, if such products are intended for a therapeutic purpose, they are subject to regulation as new animal drugs. Drug approval process The term “drug” means articles recognized in the official U.S. Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary; articles intended to diagnose, mitigate, treat, cure, or prevent disease; and non-food items intended to affect the structure or function of the body. A new animal drug is defined (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. ” There are, for all practical purposes, no animal drugs that are not also new animal drugs. The Green Book, accessible from the CVM home page, contains a searchable database of all FDA-approved animal drugs. 5 Unapproved new animal drugs may be distributed if the drug will be used for research, that is, for the collection of data intended to be submitted in support of approval. Investigational New Animal Drug (INAD) regulations provide that such drugs may be distributed for use only by experts, qualified by scientific training and expertise, to investigate the safety and effectiveness of animal drugs. Before a new animal drug receives FDA approval, the sponsor must establish that the new animal drug is safe and effective: ● Safe includes safety to the animal, safety of food products derived from the animal, safety to persons administering the drug or otherwise associated with the animal, and safety in terms of the drug’s environmental impacts. ● Effective means that the product will consistently and uniformly do what the labeling claims it will do. Drug sponsors submit a new animal drug application (NADA) along with supporting data, including all adverse effects associated with the drug’s use. The FDA performs a detailed and comprehensive review, determining whether data were developed in accordance best practices and evaluating the data for safety and efficacy. For drugs used in food animals, the drug producer must also demonstrate that drug residues are safe for human consumption and provide acceptable analytical methods capable of detecting the drug and its metabolites in animal tissue. Prescription products must bear the legend: “ Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” The same drug substances can be marketed in different forms, intended for use by different routes of administration and in different species of animals. Thus, these drug products may be labeled prescription in some cases and over-the counter (OTC) in others.
Pet foods Although pet food products do not require premarket approval by FDA, they are subject to requirements of the act. Pet foods may not be adulterated or misbranded, and they may not contain poisonous or harmful substances beyond established tolerances. They cannot be stored in harmful packaging materials and may not contain unsafe additives. Pet food labeling may not be false or misleading, and damage or inferiority may not be concealed. FDA regulations applying to pet foods are published in Title 21 of the Code of Federal Regulations. Specific regulations address additives, colorings, supplements, or other substances that are approved or generally recognized as safe for an intended use. 4 Animal medical devices A medical device, as defined in the act, is: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part, or accessory, which is … intended for use in the diagnosis of disease, or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. Articles such as screening test kits for drug residues are regulated as animal medical devices. Animal medical devices do not require premarket FDA approval, but they are subject to provisions of the act related to misbranding and adulteration. For example, an animal medical device is misbranded if the labeling is false or misleading, if it does not have adequate directions for use by a layperson, or if it is dangerous to animal or human health when used as directed. The FDA relies on veterinarians and other users to report unsafe animal medical devices. If adequate directions cannot be written for lay use, the animal medical device is deemed unsafe for use except under the supervision of a licensed veterinarian. Therefore, its label must bear the statement: “Caution: Federal law restricts this device to sale by or on the order of a licensed veterinarian.” Examples of animal medical devices required to bear the prescription legend include transcutaneous electronic nerve stimulators, pulse magnetic field devices, and lasers. it is possible to prepare “adequate directions for use” that would allow a layperson to use the drugs safely and effectively. Safe use includes safety to the animal, safety of food products derived from the animal, safety to the persons associated with the animal, and safety in terms of the drug’s impact on the environment. Effective use assumes that an accurate diagnosis can be made with a reasonable degree of certainty, the drug can be properly administered, and the course of the disease can be followed to assess treatment success.
Classifying prescription and over-the-counter animal drugs The FDA determines the marketing status (prescription, over-the-counter, or VFD) of animal drugs based on whether
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