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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 of the influx of
calls to pharmaceutical manufacturers and authorized distributors
from sales representatives concerning drug sample losses in the wake of natural disasters. Due to
the emergency conditions imposed by the 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. Prior public participation in
development of this guidance is not feasible given the urgent need
for its implementation to respond to the emergency conditions
imposed by the hurricane.
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.
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Date created: September 16, 2005; Last updated: October 24, 2007 |
