Approved and Unapproved Drug Use Flashcards
What does the FDA regulate?
- food (wholesomeness)
- drugs
- medical devices
- nutraceuticals
- therapeutic diets
What does the USDA regulate?
- patient-side diagnostic tests
- biologics: vaccines, immunomodulators, antiserum, monoclonal antibody treatments
What does the EPA regulate?
- disinfectants
- pesticides: insecticides (topical), rodenticides
VFD
Veterinary feed directive (requires authorization by vet)
- applies to feeds, top-dressings, milk replacers
Medicated feeds that are not VFD
OTC antibiotics that have no human health implication
Category 1
Animal drugs which require no withdrawal period
- made by both licensed and unlicensed feed mills (includes some VFDs)
Category 2
Animal drugs which require a withdrawal period, and/or have a zero tolerance residue limit
- made only by licensed feed mills
Type A
Basic, raw medicated article and carrier that is used in manufacturing medicated feeds
- concentrated premixes
Type B
Animal remedy containing an animal feed produced from a Type A drug
- intermediate pre-blend containing at least 25% animal feed
- used to make other Type B feeds or Type C feed
Type C
Contains an animal drug and may be offered as complete feed, either free-choice or top-dressed on another feed
- ex: medicated mineral, vitamin-enriched crumbles top-dressed on another feed
- complete feed!
implications of the 2015 amendment to the VFD regulations as it relates to over the counter
antimicrobial use.
Eliminates use of medically important antimicrobials for growth promotion and feed efficiency
- brings therapeutic use in feed and water under supervision of vets (disease prevention and control still allowed)
Approved drugs have a ____
New animal drug approval number (NADA)
Approved biologics have a ______
USDA license number
Approved pesticides have an _______
EPA registration number
By what means may an unapproved veterinary drug be legally marketed in the USA?
- nutraceuticals and therapeutic diets
- MUMS, indexed drug
Prior to 2002, only ____ required duration of immunity challenge studies
Rabies
Duration of immunity
Required for new agents
- only done by a few companies
- west nile virus - yes
- canine distemper - no
MUMS
Major use in minor species, or minor use in major species
- modifies provisions of Federal Food, Drug, and Cosmetic Act with conditional approval, designation, and indexing
Conditional approval
Allows company to make the drug available before collecting all necessary effectiveness data, but after proving drug is safe
- can keep drug on market for up to 5 years, with annual renewal while collecting data
Designation
Similar to “Orphan Drug Act” for humans
- provides incentives for approval
- grants to support safety and effectiveness testing available
- company given 7 years of marketing exclusivity
Indexing
When the potential market for a minor species drug is too small to ever support the costs of the drug approval process, even under conditional approval
- indexed drug allows it to be a legally marketed unapproved new animal drugs
Medically necessary veterinary product
Used to treat or prevent a serious animal disease or condition, or is needed to assure the availability of safe food products of animal origin and no other available source of that product or adequate alternative drug substitute exists
- owner inconvenience and non-therapeutic uses are inappropriate reasons for classification as an MNVP
Nutraceutical
Foodstuff (fortified food or a dietary supplement) that is held to provide health or medical benefits in addition to its basic nutritional value
Other things categorized as nutraceuticals
- probiotic: live bacteria intended to colonize the GIT
- prebiotic: food or dietary supplement that modulates the GI microflora
- synbiotic: prebiotic + probiotic
In what area does the FDA use “enforcement discretion” and does not approve efficacy or assure safety?
Nutraceuticals and therapeutic diets
- company does not have to prove efficacy in order to be on market, only have to be wholesome
Therapeutic diets
Do not have to disclose studies that did not work, are safe but there is a question of efficacy
Holistic medicine
Infers treatment of the entire individual
- represents alternatives to traditional medicine
Homeopathy
System of medical practice that treats a disease by the administration of minute doses of a remedy that would in healthy persons produce symptoms similar to those of the disease
- is a form of pseudo-science
