Federal Law Flashcards
The Pure Food and Drug act of 1906
Prohibited foods and drugs that were distrubted through interstate commerce to be adulterated or misbranded (DID NOT require manufacturers to list ingredients or directions for use on the label)
Food and Drug Cosmetic Act of 1938
Required any new drug to be proven safe when used according to directions on label before being marketed
Required adequate directions for use on the label, and warnings about habit-forming drugs w/in the products “grandfathered” drugs, Prescriptions, and refills
Grandfathered Drug
Any drug marketed prior to 1938 that was exempt from labeling and proof of safety standards of Food, Drug and Cosmetic Act
E.g. Digoxin, Nitroglycerin, Levothyroxine, Phenobarbital
Durham Humphrey Amendment of 1951
Amendment to FDCA, Established 2 drug classes: Legend Drugs and OTCs
Legend Drug Classifcation for Durham Humphrey Amendment
Required Medical supervision to be taken safely and not have to list adequate directions for use on label, but require “Caution Federal Law prohibits dispensing without an Rx” on manufacturer label
OTC Drug Classification for Durham Hymphrey Amendment
No requirement for medical supervision, but does require adequate directions on label for use.
Kefauver-Harris Amendment of 1962
Required all new drugs marketed to show Efficacy as well as safety.
Regulates Prescription&OTC drug advertising
Medical Device Amendment of 1976
Classifies Medical devices according to specific function and set performance standards
Demands coformance with GMP and requires adherence to record/reporting requirements
Orphan Drug Act 1983
Provided various tax and licensing incentives to manufacturers that made development of such drugs more appealing.
Rare disease if <200,000 people in USA
Waxman Hatch Amendment of 1984
Drug price competition and patent-term restoration act which streamlined drug approval process for generics and provided incentives to develop new drugs.
Pioneer drug firm has +5 years of exclusiviity to market after drug approved.
