University Health Care
Hospitals & Clinics
Drug Information Service

Drug Information Service

Alerts
 
 
Accutane and Generic Isotretinoin
- iPLEDGE Risk Management Program Modification
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October 12, 2006

The FDA notified health care professionals about a change in the iPLEDGE program.  Male and female patients of non-child bearing potential no longer have to wait 23 days to fill a new prescription for isotretinoin if they do not fill it within 7 days of the prescription date.  Women of child-bearing potential must still wait 23 days to fill an isotretinoin prescription if they miss the 7-day window.  The iPLEDGE program for Accutane and generic isotretinoin was approved in 2005 to minimize pregnancy exposures.  Wholesalers, prescribers, pharmacies and patients must register with this program in order to distribute, prescribe, dispense, and use isotretinoin.

More information about the iPLEDGE program can be accessed at the following link: