Drug Regulations

Question 1

Who approves prescription and OTC drugs?

Answer 1

FDA

Question 2

Who approves chemicals used as pesticides?

Answer 2

EPA

Question 3

T/F: EPA products can be used off label

Answer 3

False

Question 4

ELDU of FDA approved products is permitted based on ____________ guidelines

Answer 4

AMDUA

Question 5

When is ELDU not allowed?

Answer 5

For EPA approved products

For production reasons (eg oxytocin for milk production)

With fluoroquinolones or sulfonamides

Products labeled for production purposes (eg lutalyse)

Cephalosporins (few exceptions)

For cost/convenience (eg banamine IM vs IV)

Products not FDA approved

For non-medical use of sedatives not labeled for food animals (eg acepromazine)

Question 6

What are the main reasons for residue testing?

Answer 6

Public health concerns

Question 7

What are target tissues for residue testing?

Answer 7

Liver
Kidney
Muscle
Pelvic fat

Question 8

What drugs are a zero tolerance?

Answer 8

ANY detectable level of a drug is a violation

• aminoglycosides
• ELDU
• approved drug used in a different production class than labeled

Question 9

A carcass with voilative residues is condemned by ___________

Answer 9

FSIS

Question 10

What is the ONLY way you can administer flunixin? What happens if you give it by alternative routes?

Answer 10

IV

If given IM or SQ -> tissue necrosis OUCH
VIOLATIVE residents

Question 11

What is the 3 tier method of residue testing?

Answer 11

First tier — will evaluate approx 800sample PER chemical compound class for each of the production classes chosen to be tested in tier 1

Second tier — focuses on tissues at establishment level (kidney inspection swab, positive —> multi-analytic screening)

Third tier — target hers and flocks, if one animal from a facility tests positive, others are likely to also be positive

Question 12

What are the restrictions for using cephalosporins in food animals?

Answer 12

NO human labelled cephalosporins

No ELDU outside labelled production class

Must be given with labeled dose, route of admin, frequency, duration

CAN use extra-label on indication WITHIN approved production class

CAN use extra-label in sheep and goats

CAN use cephaprin ELDU

Question 13

What 12 drugs are prohibited for ELDU?

Answer 13

Chloramphenicol

Clenbuterol

Diethylstilbestrol

Dimetridazole

Ipronidazole

Other nitroimidazoles

Furizolidone

Nitrofurazone

Sulfonamides drugs in lactating dairy cattle

Fluoroquinolones

Glycopeptides

Phenylbutazone in female dairy cattle 20months of age or older

Question 14

_________ contains the recommendations for withdrawal times for legal ELDU

Answer 14

Food animal residue avoidance databank (FARAD)

Question 15

What is the Veterinary feed directive (VFD)?

Answer 15

All food animals must have a perscription to add anti-infective into feed (except for ionophores)

This is for all food animals even if they are not raised for food production

This includes OTC products

• CTC
• OTC
• tylosin

Question 16

Who enforces the Veterinary feed directive?

Answer 16

FDA

Copies are sent to..
Vet
Feed mill/distributor
Producer

Question 17

What are the terms of use for the veterinary feed directive ?

Answer 17

Must document a need (Dx)

Must have a VCPR (check with FDA or state for requirements)

Drug must be approved for species and production class

Dose, duration, route, and indication

ELDU and MUMS not allowed