Thank you for visiting How must a controlled substance be labeled and packaged from the manufacturer A Securely and sealed in plain packaging B Clearly labeled with dosage information. This page is designed to guide you through key points and clear explanations related to the topic at hand. We aim to make your learning experience smooth, insightful, and informative. Dive in and discover the answers you're looking for!
Answer :
Final answer:
Controlled substances must be clearly labeled with dosage information and manufacturer details, according to FDA regulations such as 21 CFR 201.56 and 21 CFR 201.57, ensuring safe and effective use.Option b is the correct answer.
Explanation:
Controlled substances must be clearly labeled with dosage information and manufacturer details. This includes all necessary information for safe and effective use such as the name of the product, the manufacturer's name and contact information, lot number, expiration date, the recommended dose, and for prescriptions, a statement such as 'Rx only.' Furthermore, it must include adequate directions for use and appropriate storage conditions.
All of this is in compliance with regulations such as 21 CFR 201.56 and 21 CFR 201.57, which also apply to professional labeling (e.g., package inserts) and patient labeling (e.g., medication guides).Therefore, the correct answer to the question would be (b) Clearly labeled with dosage information and manufacturer details as required by FDA regulations for the proper packaging and labeling of prescription drugs and controlled substances.
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