Reporting Prescription Drug Sample Losses, Known Thefts, and Possible Diversion to the FDA in the Aftermath of a Natural Disaster
|This guidance document represents the Food and Drug Administration's (FDA) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.|
FDA is aware that pharmaceutical manufacturers and authorized distributors may by contacted by sales representatives concerning drug sample losses in the wake of natural disasters. Due to the emergency conditions imposed by natural disasters, FDA intends to exercise enforcement discretion by not initiating a regulatory action on the basis of failure to comply with the 5-day, 30-day, or follow-up reporting timeframes described in the Prescription Drug Marketing Act (PDMA) regulations if manufacturers and authorized distributors submit significant loss reports for such samples in a monthly summary report with a cover letter stating that the losses occurred due to damage from a natural disaster, with an attached list of the names of the involved sales representatives.
FDA's exercise of enforcement discretion is limited to the reporting of prescription drug sample losses caused by natural disasters. Reporting of drug sample known thefts and possible/known diversion remain subject to the investigative, reporting, and timeframe requirements of the regulations under 21 CFR 203.37.