Lecture 3 - Adulteration and Misbranding Flashcards
What did the pure food and drug act do?
-Recognized the U.S. Pharmacopeia and the National Formulary as standard drug references
-Defined -misbranding” and “adulteration” and assigned penalties to each practice
-Established the bureau of Chemistry in the U.S. Department of Agriculture as the responsible party for enforcement. Renamed the Food and Drug Administration (FDA) in 1930
Three official drug compendia
-United States Pharmacopoeia (USP)
-National Formulary (NF)
-Homoeopathic Pharmacopoeia of the United States (HPUS)
What is adulteration?
If the product inside the bottle is not what it is intended to be
What are the banned devices?
-Prosthetic hair fibers
-Powdered gloves
What are class 1 devices?
Not used for supporting human life and/pr preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury
What are class 2 devices?
Moderate risk to use, require special controls to assure safety and effectiveness of devices
What are class 3 devices?
High risk to use, support or sustain human life or preventing impairment of human health, and do present a potential unreasonable risk of illness or injury
Definition of misbranding
The packaging does not match the product contained
Can a drug be both adulterated and misbranded?
Yes
What did the Sherley Amendment do to the Pure Food and Drug Act?
-Prohibits manufacturers from intentionally misleading claims about a drugs effectiveness
-The onus was on the government to prove intent, which made this amendment extremely difficult to enforce
-Many medications were allowed to remain on the market for years, even those widely known to have false claims and safety risks
What was the Elixir Sulfanilamide Tragedy?
Sulfanilamide was contaminated with diethylene glycol which is toxic. It killed 100 people
What did the Federal Food, Drug, and Cosmetic Act do?
-Required new drugs to be shown safe before marketing
-Repealed Sherley Amendment requirement to prove intent to defraud in drug misbranding cases
-Authorized factory inspections
-Required selected dangerous drugs to be administered under the direction of a qualified expert (beginning requirement for prescription only medications)
Four criteria for a definition of a drug
-Articles recognized in the official compendia
-Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
-Articles (other than food) intended to affect the structure or any function of the body of man or other animals
-Articles intended for use as a component of any articles specified in A, B, or C
What was the result of Alberty Food Products Co. v. United States?
The court ruled that “In order for the labeling of a drug to bear “adequate directions for use” . . . it must, among other things, state the purpose and conditions for which the drug was intended and sufficient information to enable layman to intelligently and safely attempt self-medication
What is the Durham-Humphrey Amendment?
-Over-the-counter medications could be labeled with “adequate directions for use”
-Legend medications had to be dispensed under the supervision of a health practitioner as a prescription drug and carry the statement “Caution: Federal Law prohibits dispensing without a prescription”
-This amendment also allowed verbal transmission of prescriptions and refills for prescription drugs
