What must be maintained for recordkeeping compliance under the Prescription Drug Marketing Act?

Maintaining records of drug samples distributed is essential for compliance under the Prescription Drug Marketing Act (PDMA). The PDMA was established to ensure the integrity and safety of the drug supply chain, particularly regarding prescription drugs. A critical component of this act requires that manufacturers and distributors thoroughly account for the distribution of drug samples.

By keeping detailed records of drug samples, facilities can track who received samples, the quantities distributed, and the dates of distribution. This accountability helps prevent misuse and diversion of prescription medications, ensuring that these samples are provided only to authorized healthcare professionals for legitimate medical use. Tracking drug samples also aids in more effective oversight and enforcement of the regulations intended to protect consumers from counterfeit or improperly distributed medications.

Other options relate to general pharmacy practices but are not specifically mandated by the PDMA for compliance regarding drug samples. Sales invoices, patient medication history, and pharmacy inventory reports are important for overall pharmacy operations but do not directly satisfy the specific requirements set forth by the PDMA regarding the management and distribution of drug samples.