Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

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What leads to a drug being labeled as misbranded if determined to deteriorate?

  1. Lack of proper packaging

  2. Expiration date not indicated

  3. Over-the-counter availability

  4. FDA approval missing

The correct answer is: Lack of proper packaging

A drug is labeled as misbranded if it is deemed to deteriorate primarily due to lack of proper packaging. Proper packaging is essential to protect the drug from environmental factors that could cause it to degrade or lose potency. If a drug is not properly packaged, and this inadequacy leads to deterioration, it fails to meet the standards set by regulatory agencies regarding safety and efficacy. In this context, the other options do not directly correlate to misbranding due to deterioration. An expiration date not indicated is related to labeling requirements but does not inherently cause a drug to deteriorate. Over-the-counter availability is more about the drug's classification than its condition. Missing FDA approval pertains to the legal status of a drug’s marketing rather than its physical quality or packaging. Proper packaging is crucial to ensure that the product remains safe and effective until its expiration, thereby playing a pivotal role in preventing misbranding due to deterioration.