Final Exam - All Lecture Sets Flashcards
Which event most directly led to the passing of the 1938 Federal Food, Drug and Cosmetic Act?
The Elixir Sulfanilamide Tragedy
Which events caused widespread public outcry and legislative pressure but did not immediately result in legislation?
The publication of ‘the jungle’
The American chamber of horrors exhibit
Patent medication scandals
What the 1906 Pure Food and Drug Act did?
-first federal law regulating meds
-recognized USP and NF as standard drug references
-defined ‘misbranding’ and ‘adulteration’ and assigned their penalties
-established the party responsible for the above penalties as the bureau of Chemistry in the US department of agriculture. Was renamed to the FDA in 1930
3 official compendia
-USP
-NF
-HPUS (homeopathic)
Adulteration and Misbranding -
is the product in the bottle what it is intended to be? If the answer is no, it is ____
adulterated
class I devices
NOT used for supporting human life and/or preventing impairment of human health, do NOT present a potential unreasonable risk of illness of injury
class II devices
moderate risk to use, require special controls to assure safety and effectiveness of devices
class III devices
high risk to use, DO support or sustain human life or preventing impairment of human health, and DO present a potential unreasonable risk of illness or injury
Adulteration and Misbranding -
is the packaging containing the product (or which must accompany the product) what it is intended to be? If the answer is no, then it is _______
misbranded
misbranded if:
- label is false or misleading
- label does not contain manufacturer, packer, or distributor
- accurate quantity of contents
- required info is NOT PROMINENTLY displayed or clearly stated
- established name (generic name) not included (at least half as large as proprietary (brand) name)
- directions for use
- warnings
proprietary name = ?
brand name
established name = ?
generic name
examples of how a drug can be both ADULTERATED and misbranded
- A PRODUCT IS STORED OUTSIDE ITS RECOMMENDED TEMPERATURE, leading its label to fall off due to adhesive failure.
- AN EXPIRED DRUG IS COUNTED AND PUT INTO A PRESCRIPTION BOTTLE and then dispensed to a patient.
importance of US v Johnson
claim was that PF&DA only prevented false statements of a drugs identity and not false or misleading efficacy claims
1912 Shirley Amendment did what?
-amended the PF&DA because of US v Johnson
-prohibited manufacturers from INTENTIONALLY misleading claims about drug effectiveness
-did not address drugs already on market, especially those with known risk and false claims
1938 Food, Drug and Cosmetic Act
-required new drugs be proven SAFE before marketing
-REPEALED Shirley amendment
-authorized factory inspections
-this is when Rx ONLY medications came about, required selected dangerous drugs to be administered under direct supervision of a qualified expert
definition of a drug as defined by the Federal Food, Drug and Cosmetic Act
- articles recognized in official compendia
- articles intended for the diagnosis, cure, mitigation, treatment, or prevention of disease (in humans or animals)
- articles (other than food) intended to affect the structure or any function of the body
- articles intended for use as a component of any articles specified in 123
1950 Alberty Food Products Co. v US
in order for the drug to bear ‘adequate directions for use’ it must, among other things, state the purposes and conditions for which the drug was intended and sufficient information to enable a layman to intelligibly and safely attempt self medication
1951 Durham-Humphrey Amendment
-OTC meds could be labeled with ‘adequate directions for use’
-legend drugs had to be dispendsed under supervision of a health practitioner as a prescription drug and carry the statement “caution: federal law prohibits dispensing without a prescription.”
-also allowed verbal transmission of prescriptions and refills for prescriptions
