PHPR1002 Federal Pharmacy Laws
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18 Terms
Law
a body of principles that govern conduct and the observance of which can be enforced in courts, or that which must be obeyed and followed by citizens subject to legal sanctions or consequences, according to Walter Fitzgerald
Statutory Law
enacted by a legislative body at the federal, state, or local level
Case Law
comes from judicial decisions or rulings
Civil Law
governs conduct between individuals
Criminal Law
governs conduct between individuals and society as a whole
Substantive Law
defines and provides for the rights of individuals
Procedural Law
provides the mechanism for enforcing one's rights
Sulfanilimide tragedy of 1937
What led to the 1938 Food Drug and Cosmetic Act?
1938 Food Drug and Cosmetic Act
required that new drugs be proven safe for use and approved by FDA before being allowed on the market
Provided distinction between prescription and non-prescription drugs
What did the Durham-Humphrey amendment do?
Durham-Humphrey Amendment of 1951
determined that the "safe" use of certain drugs could only be achieved under appropriate medical supervision; these particular drugs were exempted from "misbranding" provisions as long as they were sold only by prescription
Schedule I
Most restricted schedule that contains drugs with no currently accepted medical use and high potential for abuse; Lack of accepted safety for use, even when used under medical supervision
Schedule II
Most restricted schedule containing drugs with currently accepted medical use and high potential for abuse and severe dependence
Schedule V
Least restricted schedule that includes drugs with accepted medical use and low potential for abuse; Likely to lead only to limited dependence
Required manufacturers of new drugs to submit proof of effectiveness with safety information
What did the Kefauver-Harris amendment do?
Kefauver-Harris amendment of 1962
Required manufacturers of new drugs to submit proof of effectiveness in addition to safety information; Provided for registration of manufacturers and inspections of their sites
Drug efficacy amendment
another name for the Kefauver-Harris Amendment of 1962
DEA
New name for BNDD?