Pharmacology II CVM-5553 Approved and Nonapproved Drugs

1. Pharmacology IICVM-5553 Approved and Nonapproved Drugs Cory Langston, DVM, PhD, Diplomate ACVCP

2. Legal status of veterinary productsApproved products • Approved drugs: have a New Animal Drug Approval (NADA) number • http://www.accessdata.fda.gov/scripts/animaldrugsatfda/ • “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” versus “Sold only through licensed veterinarians.” • Approved biologics have a USDA license number • Approved pesticides have an EPA registration number Rimadyl® Chewable Tablets NADA #141-111, Approved by FDA DOI reporting

3. Legal status of veterinary products Medicated feeds Three categories • OTC – All medicated feed other than VFD • VFD – Veterinary Feed Directive; requires authorization by a veterinarian • Category I – animal drugs which require no withdrawal period. • Category II – animal drugs which require a withdrawal period, and/or have a zero tolerance residue limit. • Type A – is a basic raw medicated article that is used in manufacturing medicated feeds. (premixes) • Type B – is an animal remedy containing an animal feed produced from a Type A drug. (intermediate pre-blend) • Type C – contains an animal drug and may be offered as complete feed, either free-choice or top-dressed on another feed (for example, medicated mineral, or vitamin-enriched crumbles top-dressed on another feed).

4. Legal status of veterinary productsMUMS(major use in minor species OR minor use in major species) • Modifies provisions of the Federal Food, Drug and Cosmetic Act in three ways. • Conditional Approval: Allows to make the drug available before collecting all necessary effectiveness data, but after proving the drug is safe. The drug sponsor can keep the product on the market for up to five years, through annual renewals, while collecting the required effectiveness data. • Indexing: When the potential market for a minor species drug is just too small to ever support the costs of the drug approval process, even under a conditional approval. In such cases, the drug can be “indexed”, which allows it to be a legally marketed unapproved new animal drugs. • Designation: Similar to the “Orphan Drug Act” for humans; provides incentives for approval. Grants to support safety and effectiveness testing will be available. Company given seven years of marketing exclusivity.

5. Legal status of veterinary productsListed Drugs • No FDA approval, but manufactured under Good Manufacturing Procedures (GMP) with FDA inspection e.g., pheynylpropanolamine for hormone-responsive urinary incontinence.

6. Legal status of veterinary productsMedically Necessary Personal Veterinary Import •  Compassionate need import L'interféron vétérinaire e.g., feline recombinant interferon omega for refractory stomatitis

7. Legal status of veterinary drugsCompounded drug • Compounded drug: An extra-label practice whereby, when no formulation exists to meet the demands of the patient, a pharmacist is allowed to create a new formulation from an existing approved drug.

8. Compounding • Extra-label compounding of drugs is permitted under AMDUCA with these provisions: • No approved human or animal drug may exists in a formulation to treat that animal. • Approved animal drugs, if they exist, must be used for compounding over human drugs. • The compounding is performed by a licensed pharmacist or veterinarian within the normal scope of practice. (NOT A MANUFACTURER!)

9. AMDUCA: Compounding • The scale of production is commensurate with the need. (NOT A MANUFACTURER!) • Adequate procedures for safety and efficacy are followed. • All relevant state regulations and other AMDUCA guidelines are followed.

11. Compounding liability • The pharmacist assumes liability for the quality of the product (strength, purity). • The veterinarian assumes liability for safety and efficacy. • Picking a compounding pharmacy • http://www.pcab.org/find-a-pharmacy.shtml

12. Legal status of veterinary drugsNutraceuticals and therapeutic diets • Nutraceutical: A foodstuff (as a fortified food or a dietary supplement) that is held to provide health or medical benefits in addition to its basic nutritional value. • Nutraceuticals and therapeutic diets are regulated by the Food and Drug Administration (FDA). Due to limited resources however the FDA uses “enforcement discretion” and does not approve efficacy or assure safety beyond that of a food stuff. • That is, the company does not have to prove efficacy in order to market the product.

13. Nutraceutical & Diets

14. Nutraceutical & Diets “Prescription Diet® b/d® Canine can improve age-related behavioral changes, learning ability and alertness in older dogs.”

15. Alternative therapies • Acupuncture • Holistic medicine • Herbal remedies • Homeopathy

16. Alternative therapies • Homeopathy • a system of medical practice that treats a disease especially by the administration of minute doses of a remedy that would in healthy persons produce symptoms similar to those of the disease

17. Legal status of veterinary drugsUnapproved and illegally marketed

18. Legal status of veterinary drugs • The veterinarian assumes liability for all extra-label use. The degree of liability will vary depending, in part, on whether the use is “generally accepted practice”.