Regulation of Animal Drugs, Pt.2 Flashcards
What 4 criteria of certain chemicals make them considered drugs?
- recognized in one of the official compendia
- intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in people or animals
- intended to affect the structure or any function of the body
- intended to be used as a component of an item falling into one of the 3 categories above
What are the 5 marketing statuses of drug classification? What agency is responsible for determining this?
- controlled substances
- legend (prescription) drugs
- OTC (non-prescription) drugs
- veterinary feed directive drugs
- compounded drugs
FDA
What are veterinary feed directive drugs? How is its use limited?
new category of medicated feeds created under the Animal Drug Availability Act of 1996 that allows the approval and use of new animal drugs in or on animal feed
under the professional supervision of licensed veterinarians (NOT a prescription)
What is the main use of veterinary feed directive drugs? What is a major con?
oral dosing of drugs in large numbers of animals
this approach does not ensure that a specific dose of drug reaches each animal —> drug dosage is a function of food consumption
Why are veterinary feed directive drugs good for producers? How are antibiotics used in feed? What is the lone exception?
allows them to acquire medicated feeds through traditional manufacturers without the involvement of pharmacist or state pharmacy laws
all approved feed-grade antibiotics used in food animal production require VFD approval and extralabel use is prohibited
ionophores
What are 3 requirements for veterinarians administering VFD drugs? How are veterinarians able to give these drugs to producers?
- medical judgement based on health and need for medical treatment with client agreement to follow instructions
- sufficient knowledge of the animal(s) based on a recent physical exam, preliminary diagnoses, and acquaintance
- availability - follow up in cases of adverse reactions
once an initial diagnosis is made, the vet can issue a signed VFD on a preprinted, multipart form and give to producers so they can get products from feed supplier
What is required for distributing VFD feed to producers?
veterinarian signed VFD form
- person/firm supplying VFD to a producer must receive and retain a copy of the form
- licensed manufacturers must receive a copy of acknowledgment stating that the VFD feed will de distributed only in accordance with FDA
- all distributors and retailers who do not hold a feed mill license must notify the FDA within 30 days of VFD feed shipment
How long do VFD forms need to be retained? By whom?
minimum of 2 years for availability to the FDA
all three parties involved - veterinarian, producer, feedmill
What 6 forms of identification need to be present of VFD forms?
- client information
- species, location, number of animals treated
- date(s) of treatment
- drug name, concentration, and amount of feed manufactured
- directions for mixing and feeding, durations, withdrawal times, and expiration date
- veterinarian information
What are OTC drugs? When does the FDA approve veterinary OTCs?
products found for animals in the same retail outlets as for humans as well as pet and feed stores
- for target species
- for approved indications
- at approved doses by approved route
- for approved duration
How should OTC products be used? How do pharmacists factor into this?
precisely as labeled
must make no recommendations for use of human OTC drugs in humans, unless directed by veterinarians
What are controlled substances?
drugs under the jurisdiction of federal Controlled Substances Act and enforcement by the Enforcement Administration (DEA)
- control by federal and state law where individual states are allowed to have more strict requirements that the federal DEA scheduling
What are the 5 schedules of controlled substances?
- SCHEDULE I: no current accepted medical use in the US and have high abuse potential (heroin, methamphetamine)
- SCHEDULE II: high abuse potential and an accepted medical use in the US (morphine, fentanyl)
- SCHEDULE III: accepted medical use and less abuse potential (ketamine, buprenorphine)
- SCHEDULE IV: lower potential for abuse (butorphanol, diazepam, phenobarbital)
- SCHEDULE V: lowest abuse potential (codeine preparations)
Who is able to prescribe controlled substances?
veterinarian registered with the Drug Enforcement Authority (DEA) with separate registrations for every practice site
What is required for recordkeeping of controlled substances?
- documentation in the patient’s medical record stored for 3 years
- schedule II records must be kept separated
- copies of records documenting return or disposal of controlled substances supported by the regional DEA or state BOP
