Lecture 18 4/2/24 Flashcards
What was the purpose of the Pure Food and Drugs Act?
set up for the modern FDA
What was required under the Pure Food and Drugs Act?
-“truthful” labelling standards
-meet purity and product strength standards
What were the shortcomings of the Pure Food and Drugs Act?
-no way to remove dangerous drugs from the market
-required a very high burden of proof for misbranding
-no authority was designated
What are the characteristics of Banbar?
-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
What are the characteristics of Marmola?
-composed of thyroid extracts
-labelled for obesity
-led to elevated heart rates and insomnia
What are the characteristics of Radithor?
-“radioactive water”
-led to radium poisoning
-could not be removed from market because it was accurately labelled
What are the characteristics of lead toys?
-trinkets sold inside candy
-risk of choking death and lead toxicity
-package was accurately labelled, so could not be removed
What are the characteristics of Dinitrophenol?
-thermogenic/could increase weight loss
-fatal blood disorders and cataracts possible
-considered a cosmetic and thus beyond the act
What are the characteristics of Dr. Hess’s poultry tablets?
-poultry dewormer
-contained nicotine and kamala
-would disrupt egg production for months
What are the characteristics of Bowman’s abortion remedy?
-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
What are the characteristics of the elixer sulfanilamide disaster of 1937?
-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
What was the purpose of the Federal Food, Drug, and Cosmetic Act?
-gave FDA authority to regulate medical devices and cosmetics
-allowed FDA to set standards for food
-differentiated between drugs (FDA) and pesticides (EPA)
What were the new regulations put in place on drugs and devices?
-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
What are the characteristics of nutritional supplement regulation?
-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
What is important about AMDUCA?
permits veterinarians to prescribe extralabel drugs under certain conditions
What is extralabel usage?
-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
What are the characteristics of a veterinary-client-patient relationship?
-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
What are the limitations to extralabel drug use under AMDUCA?
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
What considerations must be made for ELDU in food animals?
-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
How must an extralabel drug be labelled?
-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
When can the FDA prohibit ELDU?
-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
What is the AMDUCA group 1 restriction?
drugs with no allowable ELDU in any food-producing animal species
What is the AMDUCA group 2 restriction?
drugs with restricted ELDU in food-producing animal species
What is the AMDUCA group 3 restriction?
drugs with special restrictions for grade A dairy operations
