Lecture 18 4/2/24

Question 1

What was the purpose of the Pure Food and Drugs Act?

Answer 1

set up for the modern FDA

Question 2

What was required under the Pure Food and Drugs Act?

Answer 2

-“truthful” labelling standards
-meet purity and product strength standards

Question 3

What were the shortcomings of the Pure Food and Drugs Act?

Answer 3

-no way to remove dangerous drugs from the market
-required a very high burden of proof for misbranding
-no authority was designated

Question 4

What are the characteristics of Banbar?

Answer 4

-offered as a concoction to treat diabetes
-marketed as an alternative to insulin
-FDA proved it was ineffective, but could not pull from market because they could not improve intent to defraud the consumer

Question 5

What are the characteristics of Marmola?

Answer 5

-composed of thyroid extracts
-labelled for obesity
-led to elevated heart rates and insomnia

Question 6

What are the characteristics of Radithor?

Answer 6

-“radioactive water”
-led to radium poisoning
-could not be removed from market because it was accurately labelled

Question 7

What are the characteristics of lead toys?

Answer 7

-trinkets sold inside candy
-risk of choking death and lead toxicity
-package was accurately labelled, so could not be removed

Question 8

What are the characteristics of Dinitrophenol?

Answer 8

-thermogenic/could increase weight loss
-fatal blood disorders and cataracts possible
-considered a cosmetic and thus beyond the act

Question 9

What are the characteristics of Dr. Hess’s poultry tablets?

Answer 9

-poultry dewormer
-contained nicotine and kamala
-would disrupt egg production for months

Question 10

What are the characteristics of Bowman’s abortion remedy?

Answer 10

-ineffective for Brucellosis
-would lead to more infections in the herd
-FDA won case, but company overcame this by changing label claims and moving them to advertising

Question 11

What are the characteristics of the elixer sulfanilamide disaster of 1937?

Answer 11

-ideal for strep throat treatment, but not water soluble
-pharmacists would dissolve in ethylene glycol (antifreeze)
-over 100 people died across 15 states
-prior to disaster, animal safety studies were not required and ethylene glycol toxicity was not widely known

Question 12

What was the purpose of the Federal Food, Drug, and Cosmetic Act?

Answer 12

-gave FDA authority to regulate medical devices and cosmetics
-allowed FDA to set standards for food
-differentiated between drugs (FDA) and pesticides (EPA)

Question 13

What were the new regulations put in place on drugs and devices?

Answer 13

-provide adequate directions for use
-misbranding is illegal
-misbranding no longer requires intent to defraud
-drugs and devices that endanger health are illegal
-news drugs must be proven safe

Question 14

What are the characteristics of nutritional supplement regulation?

Answer 14

-not covered by the FFDCA
-must have a statement on the packaging stating that the product is not intended for diagnosis, treatment, cure, or prevention of disease

Question 15

What is important about AMDUCA?

Answer 15

permits veterinarians to prescribe extralabel drugs under certain conditions

Question 16

What is extralabel usage?

Answer 16

-use of an approved drug in a manner that is not in accordance with approved label directions
-includes changes in dose, route, indication, and/or species

Question 17

What are the characteristics of a veterinary-client-patient relationship?

Answer 17

-veterinarian has assumed responsibility for making clinical judgements
-client has agreed to follow vet’s instructions
-vet has sufficient knowledge of the patient to initiate at least a general/prelim. diagnosis
-vet is readily available for follow-up eval. or has arranged continuing care/treatment/emergency coverage
-vet provides oversight of treatment, compliance, and outcome
-patient records are maintained

Question 18

What are the limitations to extralabel drug use under AMDUCA?

Answer 18

not permissible if:
-extralabel drug use in an animal of an approved new animal drug or human drug by a lay person
-extralabel use of an approved new animal drug or human drug in/on animal feed
-extralabel use resulting in any residue which may present a risk to public health
-extralabel use resulting in any residue above an established safe level/concentration/tolerance

Question 19

What considerations must be made for ELDU in food animals?

Answer 19

-can only be done when there is no approved food animal drug
-diagnosis and evaluation of condition must be done
-must establish an extended withdrawal period
-institute procedures to assure animal’s identity is maintained
-take appropriate measures to assure withdrawal times are met and no illegal residues occur

Question 20

How must an extralabel drug be labelled?

Answer 20

-name and address of prescribing vet
-established name of drug and active ingredient
-directions for use as specified by vet
-any cautionary statements
-vet’s specific withdrawal/discard times for any products coming from the animal

Question 21

When can the FDA prohibit ELDU?

Answer 21

-when there is a lack of acceptable analytical method for the drug
-when extralabel use of the drug presents a risk to public health
-compounding of animal drugs from active pharmaceutical ingredients

Question 22

What is the AMDUCA group 1 restriction?

Answer 22

drugs with no allowable ELDU in any food-producing animal species

Question 23

What is the AMDUCA group 2 restriction?

Answer 23

drugs with restricted ELDU in food-producing animal species

Question 24

What is the AMDUCA group 3 restriction?

Answer 24

drugs with special restrictions for grade A dairy operations

Question 25

Why must withdrawal times be provided for pet/companion food animals?

Answer 25

legally, these animals are still considered food animals as they could potentially enter the food chain

Question 26

Which drugs fall under the AMDUCA group 1 restriction and why?

Answer 26

-chloramphenicol: aplastic anemia
-clenbuterol: tocolytic
-diethylstilbestrol: repro health
-fluoroquinolones: antimicrobial resistance
-glycopeptides: antimicrobial resistance
-nitroimidazoles: cancer
-nitrofurans: cancer

Question 27

Which drugs fall under the AMDUCA group 2 restriction and why?

Answer 27

-neuraminidase inhibitors: no use in poultry
-cephalosporins: 3rd gen. order of prohibition; antimicrobial stewardship
-gentian violet: no use in feed; cancer causing
-indexed drugs: not fully approved
-phenylbutazone: no use in female dairy cattle older than 20 mo.
-sulfonamides: no use in lactating dairy cattle; milk residues

Question 28

Which drugs fall under the AMDUCA group 3 restriction?

Answer 28

-non-medical grade DMSO
-dipyrone
-colloidal silver

Question 29

Why is Firocoxib not able to be used in horses?

Answer 29

-an approved equine product already exists
-cost and convenience are not part of the AMDUCA ELDU algorithm

Question 29

What are the steps to selecting an ELDU?

Answer 29

-have a VCPR
-be in compliance with AMDUCA
-have a valid reason for selecting the drug over an approved product
-be able to provide withdrawal times if patient is a food animal

Question 30

What are the potential consequences of impermissible ELDU?

Answer 30

-civil penalties
-criminal penalties
-action against license

Question 31

What is the purpose of FARAD?

Answer 31

provide advice on withdrawal times on an individual case basis

Question 32

What is the guideline regarding treatment in which more doses are needed than what is on the drug label?

Answer 32

another course of therapy is allowed IF the animal has been re-examined and the vet determines that another course of therapy is required