most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs
used in emergency situations, such as dispensing nitroglycerin, or if a drug is packaged
in such a small quantity it would not hard a child under 5 years old.
1983 - Orphan Drug Act - ✔️✔️This act enables the FDA to promote the research and
marketing of drugs needed for the treatment of rare diseases.
1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman
Amendment) - ✔️✔️This act streamlines the process for granting approval of generic
drugs. It also give manufacturers incentives to develop new drugs by giving patent
extensions. This act allows generic drug companies the ability to rely on safety and
efficacy findings of an innovator's drug after the expiration of the patent.
2
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