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North Carolina News: Item 2114 - Dispensing Isotretinoin
Reprinted from the April 2006 North Carolina Board of Pharmacy Newsletter.
Thanks to Joyce Altsman, state news editor of the Alabama State Board of Pharmacy Newsletter for allowing us to reprint this article from their February 2006 Newsletter.
Pharmacies must register to continue dispensing isotretinoin products. United States Food and Drug Administration (FDA) has approved iPLEDGETM, an enhanced risk man¬agement program designed to minimize fetal exposure to isotretinoin. iPLEDGE will require mandatory registration of prescribers, patients, wholesalers, and pharmacies to further the public health goal to eliminate fetal exposure to isotretinoin. Starting December 30, 2005, unregistered and activated pharmacies were no longer able to dispense Ac¬cutane® (isotretinoin), Amnesteem®, ClaravisTM, or Sotret® to people with severe acne without enrolling in FDA’s new iPLEDGE program through a physician who is enrolled.
Pharmacies have two steps in preparing their pharma¬cies to dispense isotretinoin prescriptions under iPLEDGE: “registration” and “activation.” (After a pharmacy registers for iPLEDGE on www.ipledgeprogram.com or by calling 1-866/495-0654, the “Responsible Site Pharmacist” is sent a follow-up mailing, which contains instructions on how to activate their pharmacy.)
Pharmacies that have not registered and activated by December 30, 2005, will not be eligible to order isotretinoin from their wholesaler and must return all unused products to the manufacturer.
Patient registration began December 30, 2005. Patients currently being treated with isotretinoin may register in the iPLEDGE program or continue in their current program until February 28, 2006.
Starting March 1, 2006, all patients taking isotreti¬noin must be registered in the iPLEDGE program.
Wholesalers that did not register by December 30, 2005, are not eligible to order isotretinoin from manufacturers and must return all unused product to the manufacturer.
Prescribers who have not registered and activated by March 1, 2006, [are] not eligible to prescribe isotretinoin for patients.
Be sure to let dermatologists in your area know that your pharmacy is authorized to dispense isotretinoin.
To register and activate your pharmacy, visit www.ipledgeprogram.com or call 1-866/495-0654.
