South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which act requires effective measures against drug tampering, established in 1982?

1. Prescription Drug Marketing Act

2. Federal Anti-Tampering Act

3. Kefauver-Harris Amendment

4. Orphan Drug Act

The correct answer is: Federal Anti-Tampering Act

The Federal Anti-Tampering Act, established in 1982, was a direct response to concerns about the safety and integrity of food and drug products in the United States. This act was enacted following incidents of tampering, including the case where cyanide-laced Tylenol capsules resulted in multiple fatalities. The act requires food and drug manufacturers to implement effective measures to protect against tampering, thereby ensuring that products are safe for consumer use. The importance of this legislation lies in its role in enhancing public safety by criminalizing the act of intentionally tampering with consumer products. It establishes penalties for individuals who engage in such dangerous behavior, thus serving as a deterrent and promoting greater accountability among manufacturers and distributors. In contrast, the other options listed pertain to different aspects of pharmaceutical regulation. For instance, the Prescription Drug Marketing Act focuses on the regulation of drug samples and the integrity of drug distribution channels. The Kefauver-Harris Amendment addresses drug efficacy and safety through stricter approval processes for new medications. The Orphan Drug Act encourages the development of treatments for rare diseases, providing incentives to manufacturers. None of these acts directly pertains to measures against drug tampering as the Federal Anti-Tampering Act does. This context highlights why the Federal Anti