On and Extra Label Drug Use Flashcards
what does the FDA regulate
animal drugs
what are FDA major animal species
cattle, swine, chickens/turkeys, horses, dogs, cats
what does the EPA regulate
topical treatments (ex. pesticides)
what does the USDA regulate
animal vaccines
do antimicrobials require FDA approval
yes - must be classified as either production or therapeutic use
production use
used to improve the rate of gain and feed efficiency
NOT allowed to be used extra-labelly
therapeutic use
used to control, prevent, or treat disease
what ways are medicines available
OTC, VFDs, prescription drugs
medicated feeds
the addition of one or more drugs to an animal feed
- type A: highly concentrated; used to make types B and C
- type B: dilute drug pre-mixes; still require further dilution
- type C: medicated feed in its final form
AMDUCA
animal medicinal drug use clarification act of 1994
legalized ELDU under the conditions:
- requires valid VPCR
- only applies to FDA approved drugs
- includes OTC and prescription medications
- prohibits ELDU of feeds in major species
- ELDU can only be for THERAPEUTIC use not production use
on label drug use
using a drug as described on the FDA approved label
includes species, dose, concentration, route, dosing interval, indication, etc
extra label drug use
using a drug in a way that differs from the FDA approved label
includes species, route, dose, dosing interval, indication, etc
AMDUCA ELDU requirements
- treated animals must be IDed the entire time
- cannot use convenience or economics as a basis for ELDU
- must establish an extended withdrawal period in food animals (no residues)
- must keep records
FDA prohibited drugs
can not use these drugs under any circumstance in food animals due to human health risks
- chloramphenicol: aplastic anemia
- clenbuterol: resp. distress
- carcinogenic: genitian violet, DES, nitroimidazoles, nitrofurans
FDA ELDU prohibited drugs
can only use these drugs as described on FDA approved label in approved species
- sulfonamides in lactating dairy cattle
- fluoroquinolones
- antiviral agents
- EPA registered products
- cephalosporins
- medicated feeds
what ELDU prohibited drugs are allowed to be used extra label in MINOR SPECIES ONLY
cephalosporins
medicated feeds
direct vs indirect human health effects
direct: causes immediate impact to consumers
indirect: impacts occur over a longer period of time (carcinogens, mutagens, repro disorders, AMR)
what are 4 general guidelines to prevent antimicrobial resistance
- ELDU of antimicrobials should be the exception not the rule
- use a reasonable therapeutic treatment period at therapeutic doses in ill/at-risk animals only
- use culture and sensitivity to guide selection
- record all antimicrobial administration to evaluate efficacy and protocols
GFI 209
guidance for industry
antimicrobials that are important for therapeutic use in humans should be limited only to treatment necessary for assuring animal health in food producing animals
- NOT for production purposes
- requires veterinary oversight for use of any important antimicrobials
GFI 152
describes medically important vs unimportant antibiotics
what are the non-medically important antimicrobials
coccidiostates
bacitracins
ionophores
bambermycin
GFI 213
removed any marketed feed or water antibiotics that are labeled for production purposes
reclassified any OTC medicated feed or water treatments that contain medically important antimicrobials as VFDs or prescription drugs
veterinary feed directives (VFDs)
OTC medically important antimicrobials meant for feed administration OR used in medicated feeds
VFD requirements
- requires veterinary supervision (VPCR)
- does NOT have prescription drug status
- regulated by CDFA
- ELDU not allowed in major species (minor species only)
medicated milk replacers are considered VFDs
