The iPLEDGE program is a program by the U.S. Food and Drug Administration (FDA) for managing the risk of isotretinoin (also known as Accutane), a prescription medication used for the treatment of acne. Patients, their doctors and their pharmacists are required by the FDA to register and use the iPLEDGE web site in order to receive, prescribe or dispense isotretinoin. Isotretinoin carries a high risk of causing severe birth defects if taken during pregnancy (see Teratogenicity of isoretinoin) and the goals of the iPLEDGE REMS (risk evaluation and mitigation strategy) program are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin's serious risks and safe-use conditions. The program was designed by the Isotretinoin Product Manufacturers Group (IPMG) and its chosen vendor, Covance, under the direction of the FDA and went live on March 1, 2006. The program has not significantly reduced exposure of pregnant people to the drug in comparison to the previous SMART program, and has been criticized for being overly complicated and difficult for prescribers, pharmacists and patients to navigate successfully. Process Once a doctor decides a patient is a candidate for isotretinoin, they will counsel the patient to ensure they understand the drug and the potential side effects. Once the patient signs the necessary paperwork, their doctor will give them a patient ID number, ID card, and program educational materials. After a patient has been registered in iPLEDGE by their doctor, they receive their password in the mail within 5–10 business days. iPLEDGE originally classified patients as females of child-bearing potential (FCBPs), females not of child-bearing potential (FnCBPs), or males. Effective December 13, 2021 iPLEDGE switched to gender neutral categories: patients who can get pregnant and patients who cannot get pregnant. Patients who can get pregnant are required to pick and use two birth control methods (abstinence included), and must take doctor-administered pregnancy tests in two consecutive months. After the second (confirmatory) negative pregnancy test, the patient must also take an online comprehension test to ensure they understand the requirements of the Program. Once those two items are complete, the patient is authorized to receive drug at an authorized pharmacy. From the date of the second (confirmatory) negative pregnancy test, a patient who can get pregnant has seven days to pick up their prescription. They must see their doctor and take a pregnancy test in each subsequent month in order to