exam 1 lecture 3 Flashcards
what was pharmacy law before 1900?
very little oversight on medications
- no requirement for safety or efficacy
- 1 law passed in 1848 –> custom imspection to prevent adulterated drugs from entering the country
- patent medications used widely w/o federal review
what is patent medication?
“nostrum”
advertised to cure diseases but had no safety/efficacy in ingredients
who was Harvey Washington Wiley?
purdue pharmacy icon
became Chief Chemist of US department of agriculture
brought light to inclusion of contaminants in food and drugs and wanted proper labeling of products
“father of the pure food and drugs act”
what was the Pure Food and Drug Act?
1906 - hallmark law
1st federal law regulating mediations, it was limited to drugs moving in interstate commerce
- recognized US Pharmacopeia and National Formulary as standard drug references
- defined “misbranding” and “adulteration”
- established Bureau of Chemistry in US Department of Agriculture as party for enforcement
what was the Bureau of Chemistry renamed as?
In 1930 it was renamed as the Food and Drug Administration (FDA)
What is the Official Compendia?
US Pharmacopeia (USP)
National Formulary (NF)
Homoeopathic Pharmacopoeia of the US (HPUS)
USP and NF merged in 1975 –> USP-NF
What is adulteration?
The product inside the bottle is not what it is intended to be
What is adulteration of devices?
- device does not conform with performance standards
- certain class 3 devices that do not have appropriate approval for use
- banned devices (prosthetic hair fibers, powered gloves)
- manufacturing, packing, storage, installation of a device not conforming to requirements/conditions
- failure to comply with requirements under which a device was exempted for investigational use
Class 1 device
NOT used for supporting human life and/or preventing impairment of human health, and do NOT present a potential unreasonable risk for illness or injury
Ex: cotton swab, alcohol pads, stethoscopes
Class 2 devices
moderate risk to use, require special controls to assure safety and effectiveness of devices
Ex: MRI, CT scan, syringes, tampons
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 for illness or injury
Ex: HD, pacemaker
What is misbranding?
the package containing the product is not what it is intended to be
Established name
generic name
no smaller than 1/2 brand name
Proprietary name
brand name
Can a drug be bother adulterated and misbranded?
Yes
a product is stored outside recommended temperature, leading to its label falling off due to adhesive failure
a product is stored outside recommended temperature (adulterated)
leading to its label falling off due to adhesive failure (misbranded)
an expired drug is counted put into a prescription bottle and then dispensed to a patient
an expired drug is counted put into a prescription bottle (adulterated)
and then dispensed to a patient (misbranded)
US vs. Johnson
Pure Food and Drug Act Limitations:
only prevented false statements on the drug’s identity, and not false or misleading efficacy claims
congress tried to fix this
Sherley amendment
in response to US vs. Johnson
prohibits manufacturers from INTENTIONALLY misleading claims about a drug’s effectiveness
onus was on the gov to prove intent –> made it difficult to enforce
Elixir Sulfanilamide tragedy
letter to FDR regarding the passing of someone’s daughter
influenced the passing of the federal food, drug, and cosmetic act
Federal Food, Drug, and Cosmetic Act
permitted FDA control over cosmetics and therapuetic devices
required new drugs to be shown safe before marketing
repealed Sherley amendment requirement to prove intent to defraud in drug misbranding cases
FDA safe tolerances be set for unavoidable poisonous substances
authorized factory inspections
required selected dangerous drugs to be administered under the direction of expert (beginning of prescription requirement)
Definition of a drug
A. articles recognized by the official compendia
B. articles inteded for use of diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
C. articles (other than food) intended to affect structure or any function of body of man or animal
D. articles intended for use as a component of any articles specified in A, B, C
Alberty Food Products Co. VS United States
alberty manufactured drugs that were misbranded according to FDA bc they lacked directions for use
The court ruled –> that drugs must be labeled with the purpose and conditions for which the drug was inteded and sufficient info to allow a layman to safely attempt self-medication
Durham-Humphrey Amendment
Separating medications by two classes:
OTC medications could be labeled with “adequate directions for use”
Legend medications must be dispensed under the supervision of a practitioner as a prescription drug with the statement “Caution: Federal law prohibits dispensing without a prescription”
Also allowed verbal transmission for prescriptions and refills
