An OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a tamper-resistant package or that is not properly labeled under this section is adulterated under section 501 of the act or misbranded under section 502 of the act, or both.

1. True
2. False

Question

17-11-2024
Medicine

College

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An OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a tamper-resistant package or that is not properly labeled under this section is adulterated under section 501 of the act or misbranded under section 502 of the act, or both.

1. True
2. False

Answer :

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poonamyadav poonamyadav · Answer 1 · 2025-01-11T17:20:49-05:00

Final answer:

The statement regarding the packaging and labeling of OTC drug products being classified as adulterated or misbranded if not meeting certain standards is true. The FD&C Act outlines the importance of product integrity and consumer safety, which is enforced by the FDA.Correct answer is True.

Explanation:

The statement that an Over-The-Counter (OTC) drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale, which is not packaged in a tamper-resistant package or that is not properly labeled under the provided section, is considered adulterated under section 501 of the act or misbranded under section 502 of the act, or both, is true. It is critical to understand the significance of compliant packaging and labeling in the pharmaceutical industry, as these aspects are protected under the FD&C Act to ensure consumer safety and product integrity.

According to the Food, Drug, and Cosmetic Act (FD&C Act), a product can be deemed misbranded for reasons including but not limited to false or misleading labeling, or failing to provide essential product information. Similarly, a product is classified as adulterated if it fails to meet the quality standards set forth by the manufacturing regulations, contains harmful substances, or if it's packaged under unsanitary conditions.