The Web page,
"This Web page is yet another step we're taking to ensure the safe use of a drug that can provide significant health benefits when used properly, but that can also cause very serious side effects if used without supervision of a health professional," said Steven Galson, M.D.,M.P.H., Director, FDA's Center for Drug Evaluation and Research.
FDA and the manufacturers of isotretinoin have put in place special safeguards to reduce the risks of isotretinoin, including a strict distribution program, called iPLEDGE. The aim of the distribution program is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin. Isotretinoin is available only at a pharmacy that is registered for this distribution program. Additionally, the distribution program is designed to prevent the sale of isotretinoin over the internet. Dispensing must comply with the agency's risk management requirements.
http://www.fda.gov