Wyoming MPJE (Pharmacy Jurisprudence) Practice Exam

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What is required to be on a manufacturer's label?

IND number and clinical trial reference
Name and address, established name of drug, quantity inside bottle, weight of each active ingredient, Rx only, route of administration, storage directions, lot number and expiration, separate list of inactive ingredients
Production method and export regulations
Warnings about side effects only

The correct answer is: IND number and clinical trial reference

On a manufacturer's label, the IND number (Investigational New Drug number) and clinical trial reference are required for investigational drugs that are still in the clinical trial phase before they are approved for marketing and sale. This information is crucial to ensure traceability and accountability for products under investigation. Therefore, having the IND number and clinical trial reference on a manufacturer's label is vital to comply with regulations and standards related to investigational drugs. Options B, C, and D are incorrect: - Option B lists general requirements for a drug label according to the FDA, but it does not specifically address the requirements for investigational drugs, which must include the IND number and clinical trial reference. - Option C is not relevant to the necessary information on a manufacturer's label for drugs. - Option D is incorrect because warnings about side effects alone do not provide the same level of necessary information as the IND number and clinical trial reference for investigational drugs.