Lec 3 Adulteration and Misbranding Flashcards
1906: Pure Food and Drug Act (3 things to know)
-recognized the USP and NF as standard drug references
-defined “misbranding” and “adulteration” and assigned penalties to each
-established the Bureau of Chemistry in US dep of agriculture as the responsible party for enforcement, name changed to FDA in 1930
what is “nostrum”? (got this from google)
a medicine, especially one that is not considered effective, prepared by an unqualified person
first federal law regulating medications, it was limited to drugs moving in interstate commerce
a. the Sherley Amendment
b. Federal Food, Drug, and Cosmetic Act
c. Durham-Humphrey Amendment
d. Pure Food and Drug Act
d. Pure Food and Drug Act
the official compendia consists of what 3 publications?
-USP
-NF
-HPUS (homeopathic pharmacopoeia of the US)
which is NOT part of the official compendia?
a. USP
b. HMC
c. NF
d. HPUS
b. HMC
Generally, is the product inside the bottle what it is intended to be! If the answer is no, it is __________
a. misbranded
b. adulterated
b. adulterated
two banned devices
-prosthetic hair fibers
-powdered gloves
not used for supporting human life and/or preventing impairment of human health, and do NOT present a potential unreasonable risk of illness or injury
a. class I devices
b. class II devices
c. class III devices
a. class I devices
moderate risk to use, require special controls to assure safety and effectiveness of devices
a. class I devices
b. class II devices
c. class III devices
b. class II 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
a. class I devices
b. class II devices
c. class III devices
c. class III devices
Generally, is the packaging containing the product (or which must accompany the product) what it is intended to be! If the answer is no, it is _______
a. adulterated
b. misbranded
b. misbranded
established vs proprietary name
established = generic
proprietary = brand
what is the “proprietary name” of the following drug?
Bactrim DS (sulfamethoxazole/trimethoprim)
Bactrim DS
what is the “established name” of the following drug?
Bactrim DS (sulfamethoxazole/trimethoprim)
sulfamethoxazole/trimethoprim
A product is stored outside its recommended temperature, leading its label to fall off due to adhesive failure.
a. misbranding
b. adulteration
c. both
d. neither
c. both
(wrong temp = adulteration; label falling off = misbranding)
An expired drug is counted and put into a prescription bottle and then dispensed to a patient
a. misbranding
b. adulteration
c. both
d. neither
c. both
(expired drug = adulterated; it was still dispensed = misbranded)
T or F: in 1911 the Supreme Court ruled that the Pure Food and Drug Act only prevented false efficacy claims, and not false statements on the drug’s identity
F
(prevented false statements on the drug’s identity, not false or misleading efficacy claims)
prohibits manufacturers from intentionally misleading claims about a drug’s effectiveness
a. the Sherley Amendment
b. Federal Food, Drug, and Cosmetic Act
c. Durham-Humphrey Amendment
d. Pure Food and Drug Act
a. the Sherley Amendment
T or F: the Sherley Amendment was hard to enforce because the onus was on the government to prove intent
T
what event led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act?
the 1937 Elixir Sulfanilamide Tragedy
-required new drug to be shown safe before marketing
-repealed Sherley Amendment requirement to prove intent to defraud
-authorized factory inspections
-required selected dangerous drugs to be administered under direction of a qualified expert
a. Federal Food, Drug, and Cosmetic Act
b. Durham-Humphrey Amendment
c. Pure Food and Drug Act
a. Federal Food, Drug, and Cosmetic Act
T or F: a drug already on the market when the Federal Food, Drug, and Cosmetic act was passed needed to reestablish its safety claims
F (this act only applies for NEW drugs)
4 criteria to be a drug according to Federal Food, Drug, and Cosmetic Act
A. Articles recognized in official compendia
B. Articles intended for use in the diagnosis, cure, mitigation, tx, or prevention of disease in man or other animals
C. Articles (other than food) intended to affect the structure or any function of the body of man or other animals
D. Articles intended for use as a component of any articles specified in (A), (B), or (C)
the Alberty Food Products Co. v. United States case was an example of
a. adulteration
b. misbranding
c. both
d. neither
b. misbranding
(label did not bear adequate directions for use)
3 things highlighted for Durham-Humphrey Amendment
-OTC meds could be labeled with “adequate directions for use”
-Legend meds need a prescription and need statement “Caution: Federal law prohibits dispensing w/o a prescription”
-allows verbal transmission of prescriptions and refills for prescription drugs
which act/amendment allowed refills for rx drugs?
a. the Sherley Amendment
b. Federal Food, Drug, and Cosmetic Act
c. Durham-Humphrey Amendment
d. Pure Food and Drug Act
c. Durham-Humphrey Amendment
if a legend drug does not have the statement, “Caution: Federal law prohibits dispensing w/o a prescription”, it is
a. misbranded
b. adulterated
a. misbranded
