The program is the latest of several attempts over recent years to prevent women from taking the drug while pregnant or from becoming pregnant during treatment.
The FDA is pushing ahead with plans to launch the program, known as iPledge, on March 1, despite protests from dermatologists complaining that it is overly burdensome and won't succeed in preventing exposures.
The drug has been sold in the U.S. since 1982 and is intended for patients with severe, scarring acne that does not respond to other treatments.
Isotretinoin has been shown effective against severe acne. But the drug can also cause severe birth defects, mental retardation, premature birth, and spontaneous abortions in the fetuses of women who take it while pregnant.
The program will require all patients taking the drug to register online before receiving a prescription. Doctors must counsel women of childbearing age about the importance of not becoming pregnant while on the drug and women will have to sign a consent form acknowledging the drug's risks. Also, negative pregnancy tests will be needed before starting the drug, every month before receiving a refill prescription, right after the last medication dose, and one month after that last dose.
Women of childbearing age also must have two negative pregnancy tests and commit to using two simultaneous forms of contraception before being given a starting prescription. Doctors, pharmacies, and drug wholesalers must also register with iPledge to be eligible to prescribe and distribute isotretinoin.
"It's a comprehensive program involving all the parties," says Susan Cruzan, an FDA spokeswoman.
The agency said in a statement last week that it had worked with drug makers and others "to maintain a critical balance between access to the drug by patients who need it and ensuring its safe use."
But physician groups asked the FDA to delay the launch of the program because of complaints of long waits on a call-in line and a rule requiring women to receive pregnancy test results no more than a week after meeting with a doctor.