Food and Drug Administration Update for Pediatric Practitioners

Marcia L. Buck, Pharm.D., FCCP


Pediatr Pharm. 2002;8(1) 

In This Article

New Dispensing Regulations

Over the past year, new prescribing and dispensing regulations for isotretinoin (Accutane®) have been developed by the FDA and the drug's manufacturer, Roche Pharmaceuticals (Pediatric Pharmacotherapy 2001;7(7):1-4). On January 2, 2002, training materials on the SMART program (System to Manage Accutane Teratogenicity) were distributed to health care professionals. This program was developed to reduce the number of pregnancies occurring in women taking isotretinoin. Prescriptions for Accutane® must now have a yellow dated qualification sticker, provided by Roche to the prescriber, attached at the time the prescription is written. This sticker ensures that the patient has provided informed consent, is aware of the risks associated with therapy, and that female patients have had the appropriate negative pregnancy tests. The target date for full implementation of the SMART program is April 10, 2002. After that date, only a 30-day Accutane® supply may be dispensed. Prescriptions for female patients may only be filled within 7 days of the sticker qualification date. An FDA MedGuide must also be given to the patient with each prescription.[1,16]


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