Category: Compliance

Federal law mandates that pharmacies maintain accurate and complete records for a minimum of two years, though some state laws require longer retention periods. For healthcare providers and pharmacists, understanding precisely which records must be maintained by a pharmacy is critical for ensuring compliance, preventing drug diversion, and protecting patient safety.

According to the DEA, all practitioners who prescribe, administer, or dispense controlled substances must have a valid DEA registration. Understanding what drugs do you need a DEA number for is a critical first step for compliance and safety in healthcare.

According to Good Manufacturing Practices (GMP), every batch of a drug product must have a comprehensive record. This critical document, known as the **Batch Production and Control Record (BPCR)**, ensures product quality, safety, and regulatory compliance throughout the manufacturing process.

According to the FDA, data integrity violations are consistently among the top reasons for regulatory actions such as warning letters and product recalls. For this reason, the global benchmark for data integrity is the framework known as ALCOA+, a set of principles that ensures trustworthy and reliable data throughout the life sciences and pharmaceutical sectors.