iPLEDGE is Coming
December 10th, 2005
The FDA has approved a new program that will soon be in effect that will require more strict guidelines be followed when prescribing and taking isotretinoin (Accutane, Sotret, Amnesteem, Clarivis). New requirements will include more thorough counseling by physicians, mandatory enrollment by all patients wishing to take isotretinoin, and closer monitoring of patients during therapy.
In addition, only those physicians that are enrolled may prescribe the medication, only patients registered by prescribers in iPLEDGE can receive isotretinoin and only pharmacies registered with and activated in the iPLEDGE program can dispense isotretinoin.
Pharmacies and wholesalers must be registered to receive isotretinoin by December 30, 2005 and by March 1, 2006, only prescribers enrolled in iPLEDGE will be able to prescribe isotretinoin.
To learn more, visit the iPLEDGE website
Entry Filed under: General Acne News
1 Comment Add your own
1. Everything Acne.com Blog &hellip | December 18th, 2005 at 2:00 pm
[...] This was the title of an editorial in the most recent edition of Cutis magazine. The author touched on many of the key features of the upcoming program that have been discussed in a prior post. Among the key features stressed were the fact that female patients of childbearing potential must enter into a system monthly lab results indicating a negative pregnancy test as well as listing two forms of contraception that are being used. [...]
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