Pharmacy Law Fast Facts

Bioequivalence and the Orange Book
	Pharmacists are often required or permitted to substitute a generic product for a prescribed trade name product. When substitution is done, pharmacists should assure that the prescribed and substituted products are bioequivalent.
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Experimentation With Human Subjects
	How the IRB and other sources of authority protect human beings from abuse by scientists.
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Off-Label Uses of Approved Drugs
	Standards for using drugs in ways that do not reflect information in the package insert.
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Patient Counseling Responsibilities
	A description of what and how pharmacists are required to tell patients information about drugs.
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ADR Detection and Reporting
	Guidelines for informing the FDA after the discovery of problems with drug use.
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