Regulatory Affairs Certification (RAC) Practice Exam

Distribution records for drug products must reference or contain:

1. Expiration date of the product.

2. Name and address of the consignee.

3. Batch number of the product.

4. Manufacturer's license number.

The correct answer is: Name and address of the consignee.

Distribution records for drug products are crucial for ensuring traceability and accountability throughout the supply chain. The choice that correctly identifies a key component of these records is the name and address of the consignee. Including the name and address of the consignee is essential in regulatory frameworks as it allows for the identification of who received the product. This aspect is critical for product recalls, adverse event reporting, and ensuring compliance with safety and quality standards. Having this information readily available helps authorities track the distribution path of drug products, facilitating quicker responses in case of issues related to safety or regulatory compliance. While other elements, such as the expiration date, batch number, and manufacturer's license number, also play important roles in the overall integrity and compliance of drug products, they do not hold the same significance in the specific context of distribution records as the consignee's information. This emphasis on tracking the responsible parties in the distribution chain indicates a focus on accountability and safety in the distribution of pharmaceuticals.