Page 9 - Reference Guide For Foreign Pharmacy Licensing Exam Theory
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1. Pharmacy Law
PURE FOOD AND DRUG ACT OF 1906
Congress passed this law in 1906 to protect people from unsanitary and poorly labeled food.
FOOD, DRUG AND COSMETIC ACT OF 1938
This law suggests that no new drug can be marketed until proven safe by the FDA for public use.
DURHAM HUMPHREY AMENDMENT OF 1951
This law is also known as “Prescription Drug Amendment”.
It differentiates between prescription and OTC drugs.
It also authorizes oral prescriptions and prescription refills.
It suggests that each drug should be labeled “Caution: Federal law prohibits dispensing without a prescription.”
KEFAUVER HARRIS AMENDMENT OF 1962
It is also known as the “Drug Efficacy Amendment”.
This law indicates that new approved drugs must be safe as well as effective.
It also establishes Good Manufacturing Practice requirements.
MEDICAL DEVICE AMENDMENT OF 1976
This law passed in 1976, and includes:
The classification of medical devices
Safety and efficacy of medical devices
ORPHAN DRUG ACT OF 1983
This law was passed for orphan drugs (drugs for diseases that affect very few people). Congress passed this act
to provide tax relief and other incentives for the pharmaceutical manufacturers to develop and market orphan
drugs.
DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984
This law is also known as Waxman Hatch Amendment.
This law was passed to make generic drugs more readily and easily available to the general public.
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