Wisconsin MPJE (Pharmacy Jurisprudence) Practice Exam

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What was one of the key provisions of the Hatch-Waxman Amendment?

  1. Approval process for biologics

  2. Established the concept of bioequivalence for generic drugs

  3. Defined dietary supplements

  4. Separated prescription from OTC drugs

The correct answer is: Approval process for biologics

One of the key provisions of the Hatch-Waxman Amendment was the establishment of an approval process for generic drugs. This amendment aimed to streamline the process for generic drug approval by allowing manufacturers to rely on the safety and efficacy data of the original brand-name drug, thereby promoting more affordable access to medication for patients. This provision helped pave the way for increased competition in the pharmaceutical market and contributed to cost savings for consumers.

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