Regulations and Consideration Minor Species Flashcards
What is a pet farm animal?
No such thing, may be loved like pet but must be treated following farm animal rules
What does AMDUCA stand for?
Animal medicinal drug use clarification act
Must be followed by “pet” farm animals
What is the Minor use minor species act cover?
make more medications legally available to vets and owners
*treatment minor animal species, uncommon disease in major species
*overcome financial roadblock of trials
What is FARAD?
Food animal residue avoidance databank
What is Zero tolerance?
If you are using a drug extra label there is no acceptable amount of residue
Zero tolerance
-Lack of data to support safety level
What are some of the AMDUCA limitations?
Valid VPCR - knowledge of diagnosis, available for follow up and recently seen and acquainted with keeping and care
*Must be no other licensed or marked drug that is effective
*Vet drug before human
*Extra label only by vet
*Cant use for nontherapeutic purpose (Repro, growth, feed efficiency)
*Residue risk to public health
*No compounded
What are some prohibited drugs?
Chloramphenicol, clenbuterol, DES, nitroimidazoles, nitrofurans, glycopeptide, phenylbutazone, gentian violet, antiviral
No extra-label - cephalosporin, sulfonamide, fluoroquinolone, medicated feed
What does MUMs stand for?
Minor species minor use
What are some non-food animal species?
Dog, cat, horse,
Pocket pet, rat, mice, ferrets, ornamental fish
What are some major food animal species?
Cattle - beef and dairy
Swine
Poultry - chicken and turkey
What are some minor food animal species?
Sheep and goat, wildlife, gamebird, honeybee, rabbit, lobster, fish
Are Camelids a minor food animal species?
no - withdraw a guess
What is conditional approval?
Proven safe when used on label - legally sold and marketed while getting evidence of efficacy
-1yr conditional approval
What is Indexing?
Index legally marketed unapproved new animal drugs for minor species
-Zoo animals
-Rare
What is designation?
MUMs beofre approval or conditional
-Sponsor eligible for incentive support approval
-7yr exclusive marketing right
Is it legal to use a conditionally approved, indexed or designed drug extra label?
NO
CYA?
Cover your ass - get withdraw
