What act was designed to prevent the diversion of drugs from normal distribution channels, prohibiting re-importation into the U.S. except by the original manufacturers?

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The Prescription Drug Marketing Act of 1987 was established to safeguard the integrity of the pharmaceutical distribution system. Its primary goal is to prevent the diversion of pharmaceutical drugs from legitimate channels, ensuring that the drugs reaching the public are safe and effective. One significant aspect of this act is the prohibition of the re-importation of prescription drugs into the United States, which can only be performed by the original manufacturers. This provision aims to eliminate the risks associated with counterfeit drugs and to maintain proper handling and storage conditions that can be compromised if drugs are re-imported from unverified sources.

The other acts listed address different issues within drug regulation and safety. For example, the Kefauver-Harris Amendment introduced stronger efficacy requirements for drugs and established stricter controls over the marketing practices of pharmaceuticals. The FDA Modernization Act made various updates to streamline processes within the FDA but does not specifically focus on the distribution and re-importation issues at the heart of the question. The Orphan Drug Act specifically encourages the development of treatments for rare diseases but does not relate directly to the drug distribution channels as addressed in the question.

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