Do wholesale facilities require a separate location for expired, misbranded, or adulterated medications?

Wholesale facilities are required to maintain a separate location for expired, misbranded, or adulterated medications to ensure safety and compliance with regulations. This practice is essential for several reasons.

First, having a dedicated area for these types of medications helps prevent contamination and inadvertent distribution of products that could pose health risks. For example, expired medications may lose potency and efficacy, while adulterated or misbranded medications can be harmful or misleading to consumers and healthcare providers regarding their intended use.

Additionally, regulatory bodies, including the FDA and state pharmacy boards, mandate that wholesalers have stringent controls over their storage practices. Proper segregation of these items from active inventory mitigates the chance of human error, protecting public health and ensuring that only safe and effective drugs reach the market.

Furthermore, this requirement aligns with good manufacturing practices (GMP) and ensures traceability, which is crucial for recalls and safety monitoring. By managing expired, misbranded, or adulterated medications properly, wholesale facilities can maintain compliance and support the integrity of the pharmaceutical supply chain.