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Tracy Hampton, PhD

JAMA. 2005;294:1481.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The Food and Drug Administration (FDA) has approved a strengthened distribution program aimed at preventing use of isotretinoin by pregnant women. Taken to treat severe nodular acne, isotretinoin carries a significant risk of birth defects if taken during pregnancy.

Under the manufacturers’ new program, called iPLEDGE, physicians and patients must register and agree to accept specific responsibilities before receiving authorization to prescribe or use the drug. For example, patients must complete an informed consent form and obtain counseling about the risks and safe use of the drug, and women of childbearing age must comply with required pregnancy testing. Wholesalers and pharmacies must also comply with specific program requirements to distribute and dispense the product.

The FDA has issued a public health advisory and revised the Patient and Health Care Provider Information sheets that detail the restrictions under iPLEDGE. Individuals can obtain program information and register at https://www.ipledgeprogram.com/. . . [Full Text of this Article]