Interaction with the Food and Drug Administration The Food and Drug Administration is most effective in carrying out its mission under a policy of openness and free communication. Everyone is best served when there is clear understanding of FDA regulations and policies, as well as their administration. The FDA seeks to create confidence in programs that are intended to promote and protect the health and well- being of all. The FDA encourages anyone to contact the agency for assistance, to supply information, or to report a problem with a product. To help direct requests to the proper location for a rapid response, it offers the following guidance: References Title 21, Code of Federal Regulations. https://www.fda.gov/medical-devices/medical-device-databases/code- federal-regulations-title-21-food-and-drugs Pesticides. EPA. http://www.epa.gov/pesticides/ Adverse Event Reporting. APHIS, USDA. https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary- biologics/adverse-event-reporting/ct_vb_adverse_event FDA’s Regulation of Pet Food. https://www.fda.gov/animal-veterinary/animal-health-literacy/fdas-regulation-pet- food Animal Drugs @ FDA. https://animaldrugsatfda.fda.gov/adafda/views/#/search The veterinarian-client-patient relationship (VCPR). AVMA. https://www.avma.org/resources-tools/pet-owners/ petcare/veterinarian-client-patient-relationship-vcpr The Federal Register serves as a legal newspaper for making available to the public regulations and legal notices issued by federal agencies. It is published Monday through Friday by the Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408. Distributed by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. It is available at https://www.federalregister.gov
For information on approved drugs, regulations, policies, copies of guidelines, or CVM publications, consult the CVM website.13 For information by mail or to submit suggestions or comments, address a letter to: Center for Veterinary Medicine HFV-1 7519 Standish Place Rockville, MD 20855 CVM can also be contacted via telephone at 240-402-7002 or via email at AskCVM@fda.hhs.gov. Copies of Compliance Policy Guides 7125.37 Proper Drug Use and Residue Avoidance by Non-Veterinarians (7/09/93), and 7125.05 Responsibility for Illegal Drug Residues in Meat, Milk and Eggs (7/01/82) are available from Communications Staff, HFV-12, Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855. CPGs are also available on the FDA website (https://www.fda.gov/inspections-compliance-enforcement-and- criminal-investigations/compliance-manuals/manual-compliance-policy-guides) Food Animal Residue Avoidance Databank. http://www.farad.org/ List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. FDA.: https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-office- stock-drugs-use-nonfood-producing-animals Q&A: GFI #256—Compounding Animal Drugs from Bulk Drug Substances. https://www.fda.gov/animal- veterinary/animal-drug-compounding/qa-gfi-256-compounding-animal-drugs-bulk-drug-substances How to Report Animal Drug and Device Side Effects and Product Problems. Re: https://www.fda.gov/animal- veterinary/report-problem/how-report-animal-drug-and-device-side-effects-and-product-problems Center for Veterinary Medicine. FDA. https://www.fda.gov/about-fda/fda-organization/center-veterinary-medicine 7. Which of the following statements is true about stocking compounded drugs in a practice’s pharmacy for use in that practice’s patients? a. Any compounded drug can be stored in your clinic for use within the context of a valid VCPR. b. Compounded drugs on the FDA’s List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals can be stocked in a veterinary practice. c. No compounded drugs can be used in companion animals, regardless of the circumstances. d. Compounded drugs can only be prepared with an individual patient prescription. 8. Which of the following may be an appropriate scenario for the extra-label use of an animal drug? a. A groomer decides to administer a drug in an extra- label manner to a pet in his care. b. A human drug is added to cattle feed in an extra-label manner. c. Chloramphenicol is prescribed in an extra-label manner to treat a canine infection. d. A veterinarian prescribes an extra-label drug within the context of a VCPR. 9. Under what circumstances can a veterinarian prescribe extra-label drugs to a food animal patient within the context of a VCPR? a. There is no other available treatment option for a diagnosed disease that threatens the animal’s health. b. There is no available test to assess for the presence of drug residues in the animal’s tissue. c. The producer wants to increase weight gain and feed efficiency in his animals. d. The producer would like to add the drugs to his animals’ feed. 10. An FDA-approved animal drug is used in an approved manner, and an adverse drug reaction occurs. Who should
DISPENSING VETERINARY PRESCRIPTION DRUGS: AN OVERVIEW Final Examination Questions Select the best answer for each question and mark your answers on the Final Examination Answer Sheet found on page 68, or complete your test online at EliteLearning.com/Book 1. Which of the following agencies regulates topically-applied flea preventatives?
a. Food and Drug Administration. b. Environmental Protection Agency. c. Center for Veterinary Biologics. d. Animal and Plant Health Inspection Service.
2. Which of the following agencies issues regulations that apply to canned pet foods?
a. Food and Drug Administration. b. Environmental Protection Agency. c. Center for Veterinary Biologics. d. Animal and Plant Health Inspection Service.
3. Which of the following items would be subject to FDA regulation? a. A vaccine for canine parvovirus. b. A screening test kit for drug residues. c. A topical flea preventative. d. A non-therapeutic grooming aid for dogs. 4. In order for a drug to be approved for use in food animals, testing must be performed to ensure that drug residues are safe for human consumption. Who performs this testing? a. Food and Drug Administration. b. Center for Veterinary Biologics. c. Animal and Plant Health Inspection Service. d. The drug’s manufacturer. 5. According to federal requirements, which of the following pieces of information must be included on a veterinary prescription drug label? a. Client address.
b. Veterinarian’s name. c. Drug manufacturer. d. Generic name of the medication.
6. Medicated animal feed regulations dictate which of the following characteristics of the feed? a. Uses and duration of therapy. b. Uses and potency levels. c. Duration of therapy and potency levels. d. Duration of therapy and client characteristics.
the veterinarian contact? a. Drug manufacturer.
b. Food and Drug Administration. c. Center for Veterinary Biologics. d. Environmental Protection Agency.
Course Code: VFL01VP
Page 5
Book Code: VFL1524
EliteLearning.com/Veterinarian
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