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Questions and Answers
What is a key consideration for cGMP compliance in OTC labeling?
What is a key consideration for cGMP compliance in OTC labeling?
- Listing inactive ingredients to inform consumers of the complete formulation
- Ensuring each package is labeled with a batch number and an expiration date (correct)
- Incorporating features to indicate if the packaging has been tampered with
- Including clear instructions on how to use the product
What information should be clearly listed for OTC medications to comply with cGMP?
What information should be clearly listed for OTC medications to comply with cGMP?
- Purpose of the product
- Standardized for
- Batch numbers and expiry dates (correct)
- Inactive ingredients only
Why is it important to clearly state the intended use or purpose of the OTC medication?
Why is it important to clearly state the intended use or purpose of the OTC medication?
- To provide accurate information on active ingredients and dosages
- To ensure safety and efficacy of the product (correct)
- To maintain product integrity
- To inform consumers of the complete formulation
What is the purpose of incorporating tamper-evident features in OTC medication packaging?
What is the purpose of incorporating tamper-evident features in OTC medication packaging?
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What does compliance with cGMP in OTC labeling require regarding active ingredients and dosages?
What does compliance with cGMP in OTC labeling require regarding active ingredients and dosages?
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