Drug Legality Flashcards
Who has the hardest approval standard and is responsible for labeling medications and supplements, and regulating new prescription drugs before they can be sold?
FDA
Which FDA center is responsible for overseeing the animal and veterinary program, and regulates animal drugs, animal feed, and veterinary devices?
Center for Veterinary Medicine (CVM)
Who oversees drugs with potential for human abuse?
DEA
Who oversees animal biologics (vaccines, anti-toxins, diagnostics) and things like x-ray exposure to veterinary professionals?
USDA
Who oversees pesticides and has a pretty easy approval standard?
EPA
T/F: DEA regulation of controlled substances is at the Federal level only.
FALSE
Federal and State regulations. State regulations can be more strict.
Practitioners have to registered with the DEA every 2 years in order to prescribe what kind of drugs?
Controlled substances
How long do records of any controlled substance administration have to be retained?
3 years
As part of their goal to protect human health and the environment, the ___ and FDA work together to decide what will be regulated as a drug vs pesticide.
EPA
What is a major challenge for the athletic commission and AEI in control of doping at athletic events?
Control doping without interfering with legitimate use of veterinary medications
Who regulates how prescriptions must be written?
Each state’s veterinary medical board
If prescription drugs are being sold or used without a prescription, it should be reported to:
State authority and FDA
How long do treatment/dispensing records need to be kept for uncontrolled substances?
2 years
What did the Animal Medicinal Drug Use Clarification Act in 1994 do?
Enabled veterinarians to use human or animal drugs extra-label under certain conditions.
What is the stipulation for using drugs extra-label in food animals?
Must not result in volatile residues
What are some drugs that are prohibited for extra-label use in food animals?
Chloramphenicol
Clenbuterol
DES
T/F: Individual treatment records have to be kept for every animal, including for herd treatment.
FALSE
Individual records are not necessary for herd treatment
What kind of tests are done to see if a new product is safe and effective for people to use?
Clinical trials
What was the purpose of the act for Animal Drugs Intended for Minor Use/Minor Species (MUMS) in 2004?
Provide FDA authorized drugs for less common species and indications
What are the stipulations for a new drug being brought to market?
Safe
Effective
Good quality
Proper labeling
How long does it take to bring a new drug to market?
7-10 years
*and MILLIONS of dollars
Who monitors new drugs after they’ve been brought to market, including reports of adverse events and marketing materials?
FDA
What did the Federal Food, Drug, and Cosmetic Act do?
Provided 5 years of market exclusivity to new animal drugs before generics can be made.
Who should adverse drug reactions be reported to?
Drug manufacturer
FDA
