Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

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How would you classify a drug that is manufactured without a valid prescription or valid Drug Enforcement Administration (DEA) registration?

  1. Adulterated

  2. Counterfeit

  3. Misbranded

  4. Recalled

The correct answer is: Adulterated

A drug that is manufactured without a valid prescription or a valid Drug Enforcement Administration (DEA) registration falls under the classification of adulterated. Adulteration refers to a product that fails to meet quality standards due to improper manufacturing practices or because it is produced without the necessary legal oversight and documentation. This classification underscores the lack of compliance with federal regulations that ensure drugs are safe, effective, and manufactured in approved facilities. In this context, the absence of a valid prescription or DEA registration indicates that the drug has not been manufactured in accordance with legal standards, thereby compromising its integrity and safety. Therefore, the classification of adulterated effectively conveys the legal and quality implications of such a drug's production.