Definitions Flashcards
7 Edible Animal Tissues
- Muscle
- Liver
- Kidney
- Skin/fat
- Milk
- Eggs
- Honey
Withdrawal Time
The amount of time until the drug and its metabolites are completely eliminated from the animal tissue/product. Any residue detected w/o a tolerance is considered a violative residue.
Tolerance
Legally allowed concentration of a drug residue in a tissue that will NOT cause an effect to the body when consumed by a human over a lifetime. If there is no established tolerance for that tissue in an animal species it is considered zero tolerance.
Violative Residue
Means the substance is ABOVE the tolerance level established by FDA and causes a violation.
Non-Violative Residue
Means the substance is still in the body but BELOW the tolerance level established by FDA. A legally acceptable residue of drugs in edible tissues at slaughter/harvest.
Target Test Level in Milk
A residue above the tolerance but FDA may chose not to prosecute. A guide whether or not to prosecute but NOT a tolerance value.
Veterinary Feed Directive
A prescription for antibiotics to be added to any feed source for food animal consumption. You must keep a VFD for two years.
AMDUCA
American Medicinal Drug Clarification Act of 1994
AMDUCA
Recognizes situations and allows only veterinarians to use and prescribe drugs in an extra-label manner. Applies to ALL animals.
AMDUCA Requirement Administration
Parentally, intramammary, topically, or in water. Adding a medically important drug to a feed MUST be at the approved label directions.
Extra Label Drug Use (ELDU)
Drug deviates from the label directions and what is specified by the label. The time the drug persists in the tissues can increase risk of residues.
7 Ways to Alter A Drug For ELDU
- Species
- Dose
- Volume
- Route
- Interval/frequency
- Duration
- Indication
Reasons for ELDU ONLY if there is NOT a labeled drug that:
- Has the clinically effective drug
- Has the needed ingredient
- is the proper dosage form
- Is labeled for indication/disease
What are the first and second step in the process of selecting a drug for ELDU?
First step: If that is NOT possible: use a food-animal labeled drug that can be used extra-label.
Second step: If NO food animal approved drug exists than use a human or companion animal approved drug ELDU.
What are the 5 reasons that are NOT permitted for ELDU?
- Less expensive
- Convenience
- Production benefits
- No valid VCPR in place
- Cannot be used with a prohibited drug