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Answer :
The correct answer is option d. The Anti-Tampering Act of 1982 requires that packaging of OTC medicines must be tamper-proof to protect consumers. This is part of the regulations enforced by the FDA to ensure safety and efficacy in over-the-counter medications.
The Anti-Tampering Act of 1982 requires that d. packaging of OTC medicines are tamper-proof. This law was implemented to enhance the safety of over-the-counter medication and ensure consumer protection against tampered products. The FDA regulates the Good Manufacturing Processes of facilities that manufacture OTC medications, and this includes ensuring that manufacturers conform to standards such as those outlined in 21 CFR 210 and 211, and have tamper-evident packaging as a safeguard against contamination or tampering.
Manufacturing sites must register with the FDA and abide by the regulations. Routine inspections enforce compliance, helping to guarantee the safety of medications distributed to the public. It has been established that strict regulations protect consumers from the dangers of unsafe drugs, though they also may cause delays in bringing new treatments to market, representing a more indirect cost to patients who wait for new therapies.
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