South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What does the Federal Anti-Tampering Act require for OTC products?

1. Color coding for different products

2. Tamper-resistant packaging

3. Multi-language instructions

4. Extended shelf life

The correct answer is: Tamper-resistant packaging

The Federal Anti-Tampering Act is specifically designed to enhance the safety and integrity of over-the-counter (OTC) products by requiring manufacturers to use tamper-resistant packaging. This regulation was established in response to incidents of tampering with food and drugs, which posed significant health risks to consumers. By mandating tamper-resistant features, the Act aims to prevent unauthorized access to product contents, thereby ensuring that consumers can trust the safety and efficacy of the products they use. Tamper-resistant packaging typically includes features such as sealed containers, shrink bands, or breakable caps that indicate whether the product has been tampered with. These measures help assure consumers that the items they are purchasing have not been altered or contaminated, which is crucial for maintaining public health and safety. While color coding, multi-language instructions, and extended shelf life may be relevant in other regulatory contexts, they do not specifically address the core intent of the Federal Anti-Tampering Act, which focuses solely on preventing tampering through enhanced packaging standards.