Important Laws in History Flashcards
Pure Food and Drug Act (1906)
Prohibited the interstate commerce of adulterated food and drug
Shirley Amendments (1911)
Prohibited false and misleading claims for drug products
Federal Food, Drug, and Cosmetic Act (1938)
Must have scientific proof of safety before a drug can be marketed (thalidomide disaster)
Harris-Kefauver Amendments (1962)
Must have scientific proof of efficacy
Orphan Drug Act (1983)
Gave economic and tax incentives for pharmaceutical manufactures to develop drugs for rare diseases (Diseases with <200,000 pts in the US or >200,000 pts in which the cost of development will never be recouped)
Drug Price Competition and Patent Restoration Act (1984)
Created the ANDA for generic drugs (must prove bioequivalence) and restored some of patent life for the time a drug sat at the FDA waiting approval
Prescription Drug Marketing Act (1984)
Regulated samples, regulated who hospitals can sell to, and made it so drugs cannot be re-imported from other countries
Dietary Supplement Health and Education Act (1994)
Made herbals officially dietary supplements and added the disclaimer “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Drug Supply Chain Security Act
Pharmacies must receive transaction information and transaction history from the previous owner (wholesale or manufacturer) and maintain it on file for 6 years
If it is sold to somewhere else, the same info must be provided to the purchaser
A summary of where the product has been in its lifetime
Patient Package Inserts
Package inserts must be provided for every new and refilled Rx, estrogens, and oral contraceptives (including in a hospital setting on initiation and then every 30 days for a drug)
Poison Prevention Act (1970)
Childproof caps required for all Rx drugs except topicals and nitroglycerin
Pts and MDs can request non-childproof caps
Legally must ask each time you dispense a prescription
