Thank you for visiting OTC drugs must be sold in tamper resistant packaging except for the following A Effervescent tablets packaged in a tube with a sealed metal foil. 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:
Effervescent tablets in a tube sealed with a metal foil cap are exempt from the requirement of tamper-resistant packaging for OTC drugs. The FDA ensures all OTC drugs are safely labeled and manufacturing sites comply with regulations.
Explanation:
OTC drugs must be sold in tamper-resistant packaging to ensure consumer safety; however, there are exceptions to this packaging requirement. The option that does not need to be sold in tamper-resistant packaging is a. Effervescent tablets packaged in a tube with a sealed metal foil cap. Over-the-counter (OTC) drugs like aspirin and ibuprofen are commonly used by consumers and the FDA ensures that they are appropriately labeled for safe use. While many OTC products undergo the OTC Monograph process, drugs that are considered new, especially those that change from prescription to OTC, must go through the New Drug Application (OTC NDA) review process. In addition, manufacturing sites must register with the FDA and be subject to routine inspections to ensure compliance with regulatory requirements and Current Good Manufacturing Practices (cGMP).
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