E1 Lecture 2 Flashcards
Pharmacy Law before 1900
no requirement for efficacy
no requirement for safety
1 Law: Importation of Drugs in 1848
- US customs inspect to prevent adulterated drugs from entering country
Another Name for Patent Medication
Nostrum
Patent Medications
heavily advertised products purported to cure numerous diseases with no regard to ingredients or safety/efficacy of ingredients
Harvey Washington Wiley
Chief Chemist of US Department of Agriculture
“Father of Pure Food and Drugs Act”
What did Harvey Washington Wiley do?
brought light to the inclusion of contaminants in food and drugs and championed proper labelling of products
Pure Food and Drug Act
1906
Characteristics:
- 1st federal law regulating medications & limited to drugs moving in interstate commerce
- recognized the US Pharmacopeia & National Formulary as standard drug references
- defined misbranding & adulteration
- established the Bureau of Chemistry in the US Department of Agriculture
What was the Bureau of Chemistry renamed as in 1930?
Food and Drug Administration
What does the Official Compendia consist of?
US Pharmacopeia
National Formulary
Homeopathic Pharmacopeia of the US
USP-NF merge in 1975
Adulteration of Medications
product inside the bottle is not what it is intended to be
READ THE LAW
Adulteration of Devices
- devices not in conformity with performance standards
- banned devices (prosthetic hair fibers, powered gloves)
- manufacture, packing, storage, or instillation of device not conforming to requirements/conditions
- failure to comply with requirements under which a device was exempted for investigational use
Class I 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 II Device
moderate risk to use, require special controls to assure safety and effectiveness of devices
Ex) MRI, CT scan
Class III 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, prosthetic mitral valve
Misbranding
the packaging containing the product is not what is intended to be
READ THE LAW
Established Name
generic name
Proprietary Name
brand name
Sizing of Established vs Proprietary Name
1/2 the size of the proprietary name
Can a drug be both adulterated and misbranded?
Yes
A product is stored outside its recommended temperature, leading to is label to fall off due to adhesive failure
Adulterated-Misbranded
An expired drug is counted and put into a prescription bottle and then dispensed to a patient
Adulterated-Misbranded
United States vs Johnson
In 1911, the Supreme Court challenged the Pure Food and Drug Act stating:
- only prevented false statements on the drug’s identity and not false or misleading claims of efficacy
The Sherley Ammendment
1912
prohibits manufacturers from INTENTIONALLY misleading claims about a drugs efficacy
- made the govt. have to prove intent –> difficult
Elixir Sulfanilamide Tragedy
1937
helped push the FDA to overhaul the Pure Food and Drug Act
Federal Food, Drug, and Cosmetic Act
1938
Characteristics:
- allowed FDA control over cosmetics & therapeutic devices
- required new drugs to be shown safe before marketing
- repealed Sherley Amendment requirement to prove intent
- authorized factory inspections
- required selected dangerous drugs to be administered under the direction of a qualified expert (start of Rx-Only medications)
Definition of a Drug
- articles recognized in official compendia
- articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
- articles intended to affect the structure of any function of the body of man or other animals
- articles intended for use as a component of any articles above
MUST MEET ALL 4
Alberty Food Products Co. vs United States
1950
in order for the labeling of a drug to bear adequate directions for use, it must state the purposes and conditions for which the drug was intended and sufficient information to enable a layman to intelligently and safely attempt self-medication
Durham-Humphrey Amendment
1951
written by 2 pharmacists
Characteristics:
- OTC 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”
- allowed verbal transmission of prescriptions and refills for Rx drugs
