Which of the following products are exempt from FDA regulations concerning expiration dating?

Prepare effectively for the FPGEE Management Test. Utilize flashcards and multiple-choice questions with detailed explanations. Ace your upcoming exam!

Dietary supplements are exempt from FDA regulations concerning expiration dating because they are classified differently than medications. The FDA does not require dietary supplements to have expiration dates unless a manufacturer chooses to include them. This exemption stems from the regulatory framework where dietary supplements are treated more like food than traditional pharmaceuticals. As a result, the onus is on manufacturers to ensure the safety and quality of their products, which can include voluntary shelf-life testing, but no mandated expiration dates under federal regulations.

Prescription medications, over-the-counter medications, and controlled substances, on the other hand, do require expiration dating because they must ensure efficacy and safety over time, factors that can significantly impact health outcomes. The expiration date helps consumers and healthcare providers understand until when the product is expected to remain effective and safe for use.

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