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The FDA announced the implementation of a stronger distribution program for isotretinoin (Accutane) that is aimed at preventing use of the drug during pregnancy.


The program, iPLEDGE requires healthcare providers and patients to accept specific responsibilities before receiving authorization to prescribe or use the drug. Wholesalers and pharmacies must also comply with the manufacturers' program requirements in order to distribute and dispense isotretinoin. After October 31, 2005, wholesalers and pharmacies will have to register with iPLEDGE in order to obtain isotretinoin from a manufacturer. Starting December 31, 2005, all patients and prescribers must register and comply with requirements for office visits, counseling, birth control, and other responsibilities.


In addition to registering with iPLEDGE, patients must comply with a number of key requirements that include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and women of childbearing age complying with required pregnancy testing.


Providers may register with iPLEDGE via the Internet at or by calling 1-866-495-0654.