Which statement best describes expiration-date exemptions?

Which statement best describes expiration-date exemptions?

• A. Lotion and similar products with no dosage limit and stability of 3 years are exempt
• B. All OTC products are exempt
• C. Only prescription products are exempt
• D. Exemption applies to all products regardless of stability

Answer: (A)

Expiration-date exemptions apply to specific OTC topical products when there is no fixed dosage and the product has demonstrated sufficient stability. If a lotion or similar product shows stability of 3 years and has no dosage limit, it can be exempt from requiring an expiration date. This reflects that the product remains safe and effective over that period without a dated label. The other statements aren’t correct because not all OTC products are exempt, exemptions aren’t limited to prescription products, and the exemption depends on stability criteria rather than applying universally to all products regardless of stability.

Expiration-date exemptions apply to specific OTC topical products when there is no fixed dosage and the product has demonstrated sufficient stability. If a lotion or similar product shows stability of 3 years and has no dosage limit, it can be exempt from requiring an expiration date. This reflects that the product remains safe and effective over that period without a dated label. The other statements aren’t correct because not all OTC products are exempt, exemptions aren’t limited to prescription products, and the exemption depends on stability criteria rather than applying universally to all products regardless of stability.