The various physician, patient, and pharmacy requirements for participation in 
the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) program 
and procedures that institutions may implement in order to comply with these 
requirements are described. In 1998, FDA approved the marketing of thalidomide 
(Thalomid, Celgene). Because of the drug's known teratogenic effects, FDA 
tightly controls the distribution of thalidomide in the United States. To comply 
with FDA requirements, Celgene developed the S.T.E.P.S. oversight program, which 
includes registration of thalidomide prescribers and pharmacies that dispense 
thalidomide, extensive patient education about the risks associated with 
thalidomide, and a registry of all patients receiving thalidomide. The 
S.T.E.P.S. program is considered part of the product label. The pharmacy 
requirements of the program were developed with a focus on a retail pharmacy 
practice model, which does not adequately reflect current hospital practice. The 
pharmacy department of the National Institutes of Health Clinical Center 
developed a model that adapts the S.T.E.P.S. program requirements to inpatient 
and outpatient institutional pharmacy practice. Procedures for registering 
patients and prescribers and dispensing thalidomide in the hospital setting were 
developed; the procedures were designed to meet the needs of both the inpatient 
and outpatient pharmacies and to comply with the requirements of the S.T.E.P.S. 
program.