<b>[from www.medscape.com]

"Because thalidomide is a known human teratogen and can cause severe, life-threatening birth defects or fetal death if given during pregnancy, the drug was approved by the FDA for marketing in the US in 1998 only under a special restricted distribution program, the System for Thalidomide Education and Prescribing Safety (STEPS), designed to help ensure the safe and effective prescribing, dispensing, and use of commercially available thalidomide." 

"In the US, the STEPS distribution program restricts access to commercially available thalidomide to prescribing clinicians, pharmacies, and patients who are registered in the program and mandates compliance with registration, education, and safety requirements of the program."         

"The STEPS program minimizes, but may not completely eliminate, the risk that thalidomide may inadvertently be given to a pregnant woman. Thalidomide also is available in the US for use in clinical trials under protocol conditions. The risks versus benefits of thalidomide must be addressed each time use of the drug is being considered." </b>


To receive commercially available thalidomide, a patient must be registered in the STEPS program and agree to comply with all requirements of the program, including mandatory contraceptive measures, and extensive and comprehensive educational counseling, and ongoing monitoring, including regular pregnancy tests if female and of childbearing potential, as outlined in the STEPS informed consent.
       
Compliance is monitored through patient surveys that must be completed by doctors and patients when each prescription of thalidomide is written. A quality assurance committee composed of Celgene employees, agents, and consultants also monitors the STEPS program. In addition, all aspects of the STEPS program are subject to FDA audits. The FDA states that if there is even one fetal exposure to thalidomide, the entire distribution system will be reevaluated, and steps taken to correct deficiencies.  

The STEPS program is not designed to restrict prescribing and dispensing of commercially available thalidomide to only the FDA-labeled use of the drug.  It is designed to try to keep the environment and water supply free of thalidomide, however.  

<b>You MUST return any unused thalidomide to your doctor.</b>
