What program, sponsored by the FDA, regulates the dispensing of isotretinoin (Accutane)?

The iPledge program is a risk management system required for the dispensing of isotretinoin, a medication used primarily to treat severe acne. This program was established by the FDA to ensure that patients, prescribers, and pharmacies comply with specific guidelines to minimize the risks associated with isotretinoin, particularly its teratogenic effects, which can cause severe birth defects if taken during pregnancy.

Under the iPledge program, patients are required to enroll and meet certain criteria, which includes undergoing regular pregnancy testing and using effective birth control methods. Prescribers must also register and be certified, and only registered pharmacies are allowed to dispense isotretinoin to patients who follow the program guidelines. This comprehensive approach helps to ensure safer use of isotretinoin and reduces the likelihood of serious side effects.

The other options do not pertain specifically to isotretinoin regulation. The Risperdal Program is related to a different medication used for treating mental health conditions. The Accutane Safety Program is a non-specific term and is generally outdated since Accutane is a brand name that is no longer commonly prescribed, having been replaced with generic isotretinoin. The Safe Use Program is also not specifically tied to isotretinoin and does not