On and Extra Label Drug Use

Question 1

what does the FDA regulate

Answer 1

animal drugs

Question 2

what are FDA major animal species

Answer 2

cattle, swine, chickens/turkeys, horses, dogs, cats

Question 3

what does the EPA regulate

Answer 3

topical treatments (ex. pesticides)

Question 4

what does the USDA regulate

Answer 4

animal vaccines

Question 5

do antimicrobials require FDA approval

Answer 5

yes - must be classified as either production or therapeutic use

Question 6

production use

Answer 6

used to improve the rate of gain and feed efficiency

NOT allowed to be used extra-labelly

Question 7

therapeutic use

Answer 7

used to control, prevent, or treat disease

Question 8

what ways are medicines available

Answer 8

OTC, VFDs, prescription drugs

Question 9

medicated feeds

Answer 9

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

Question 10

AMDUCA

Answer 10

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

Question 11

on label drug use

Answer 11

using a drug as described on the FDA approved label

includes species, dose, concentration, route, dosing interval, indication, etc

Question 12

extra label drug use

Answer 12

using a drug in a way that differs from the FDA approved label

includes species, route, dose, dosing interval, indication, etc

Question 13

AMDUCA ELDU requirements

Answer 13

• 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

Question 14

FDA prohibited drugs

Answer 14

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

Question 15

FDA ELDU prohibited drugs

Answer 15

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

Question 16

what ELDU prohibited drugs are allowed to be used extra label in MINOR SPECIES ONLY

Answer 16

cephalosporins
medicated feeds

Question 17

direct vs indirect human health effects

Answer 17

direct: causes immediate impact to consumers

indirect: impacts occur over a longer period of time (carcinogens, mutagens, repro disorders, AMR)

Question 18

what are 4 general guidelines to prevent antimicrobial resistance

Answer 18

1. ELDU of antimicrobials should be the exception not the rule
2. use a reasonable therapeutic treatment period at therapeutic doses in ill/at-risk animals only
3. use culture and sensitivity to guide selection
4. record all antimicrobial administration to evaluate efficacy and protocols

Question 19

GFI 209

Answer 19

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

Question 20

GFI 152

Answer 20

describes medically important vs unimportant antibiotics

Question 21

what are the non-medically important antimicrobials

Answer 21

coccidiostates
bacitracins
ionophores
bambermycin

Question 22

GFI 213

Answer 22

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

Question 23

veterinary feed directives (VFDs)

Answer 23

OTC medically important antimicrobials meant for feed administration OR used in medicated feeds

Question 24

VFD requirements

Answer 24

• 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

Question 25

prescription drugs

Answer 25

OTC medically important antimicrobials meant for water administration