Extra-label use of drugs may be considered by food animal veterinarians only when there is no approved new animal drug containing the same active ingredient in the required dosage form and concentration (unless the approved drug has been found to be clinically ineffective). The veterinarian must also make an informed diagnosis, establish an appropriate withdrawal time to avoid illegal drug residues (or keep the animal out of the food supply if no scientific information exists), and institute Labeling of drugs prescribed for extra-label use At a minimum, the following label information is recommended: 1. The name and address of the prescribing veterinarian. 2. The established name of the active ingredient(s). 3. Directions for use specified by the practitioner (including animal identification; dosage, frequency, and route of administration; and duration of therapy). 4. Cautionary statements specified by the veterinarian. 5. Veterinarian’s specified withdrawal/discard time(s) for meat, milk, eggs, or any food that might be derived from the treated animals. Because extra-label use of animal and human drugs in nonfood- producing animals (companion, sporting, exotic, etc.) does not ordinarily pose a threat to the public health, extra-label use of animal and human drugs is permitted in these species within the context of a VCPR, except where the public health is threatened. Limitations to extra-label use provisions of AMDUCA The following specific extra-label uses are prohibited: 1. Extra-label use in an animal of an approved animal or human drug by a lay person (except under the supervision of a licensed veterinarian). 2. Extra-label use of an approved new animal drug or human drug in or on an animal feed. 3. Extra-label use resulting in any residue that may present a risk to the public health. 4. Extra-label use resulting in any residue above an established safe level, safe concentration, or tolerance. FDA may also prohibit the extra-label use of an approved new animal or human drug or class of drugs in animals if FDA determines that: 1. An acceptable analytical method has not been established or cannot be established. Reporting adverse drug reactions Users of new animal drug products are encouraged to notify the product’s manufacturer of any unexpected or adverse reactions resulting from the use of that product. The manufacturer is responsible for reporting rates of injury, toxicity, and sensitivity reactions to the FDA, along with unexpected incidence or severity of side-effects associated with use and failure of the drug to exhibit expected pharmacological action. FDA scientists analyze these data to determine whether modifications are needed in the drug’s labeling, dosage level, and so on to mitigate future adverse reactions. In extreme instances, the Types of FDA regulatory actions The objective of FDA regulatory programs is to ensure compliance with the federal Food, Drug, and Cosmetic Act. Specific enforcement activities include actions to correct and prevent violations, remove violating products or goods from the market, and punish offenders. The range of enforcement activities varies depending on the severity of an infraction. Actions include: ● Warning letter s. Sent to individuals or firms, advising them of violation and requesting a written response outlining corrective actions. ● Seizure . An action brought against an adulterated or misbranded FDA-regulated product to remove specific violating goods from commerce.
procedures to assure that the identity of the treated animal(s) is/are carefully maintained. Extra-label medication use in food animals must always be supported by an appropriate medical rationale and cannot be used to enhance production. The prescribed or dispensed extra-label drug (prescription legend or over-the-counter) must bear labeling information that is adequate to ensure the safe and proper use of the product. 2. The extra-label use of the drug or class of drugs presents a risk to the public health. A prohibition on a drug or drug class may be a general ban or may be limited to a specific species, indication, dosage form, route of administration, or combination of factors. The following drugs are prohibited for extra-label use in all animals: 1. Chloramphenicol. 2. Clenbuterol. 3. Diethylstilbestrol (DES). 7. Furazolidone. 8. Nitrofurazone. 9. Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine). 10. Fluoroquinolones. 11. Glycopeptides. 12. Phenylbutazone in female dairy cattle 20 months of age or older. 13. Cephalosporins in cattle, swine, chicken, or turkeys (except for approved uses/formulations). 14. Adamantane in chickens, turkeys, and ducks. 15. Neuraminidase inhibitors in chickens, turkeys, and ducks. Extra-label use of drugs in treating food-producing animals for improving rate of weight gain, feed efficiency or other production purposes is prohibited under AMDUCA. A drug (including a bulk drug) may not be mixed into feed for any use or at a potency level not specifically permitted by the regulations in 21 CFR Part 558, even if prescribed by a veterinarian. adverse reactions may be so severe as to request withdrawal of approval of the drug. In the case of unapproved drugs and devices, reports should be submitted on Form FDA 1932a, Veterinary Adverse Reaction, Lack of Effectiveness, or Product Defect Report , which is available on the FDA website.12 FDA may occasionally need more detailed information about an incident, and the veterinarian may be called by an FDA staff veterinarian. Adverse reactions may also be reported by telephone by calling 888-FDA-VETS (888-332-8387). 4. Dimetridazole. 5. Ipronidazole. 6. Other nitroimidazoles. ● Injunction . An order by a court that requires an individual or corporation to do or refrain from violating or causing violations of the act. ● Criminal prosecution . May be recommended in appropriate cases for violation of Section 301 of the act. Misdemeanor convictions, which do not require proof of intent to violate the act, can result in fines (up to $500,000) and/ or imprisonment up to 1 year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to 3 years. FDA field offices conduct investigations that may lead to recommendations for enforcement/regulatory action. The action recommended will depend upon the nature of the violation and other factors.
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