One third of all cases of the acquired immunodeficiency syndrome (AIDS) in the United States are associated with the injection of illicit drugs. There is mounting evidence for the effectiveness of syringe exchange programs in reducing human immunodeficiency virus (HIV) risk behavior and HIV transmission among injection drug users. Expansion of syringe exchange would require increased public funding and undoubtedly would include government regulation of syringe exchanges. An analogy is drawn with the present system of regulation of methadone maintenance treatment programs and possible regulation of syringe exchange programs. Specific recommendations are offered to reduce the likelihood of repeating the regulatory problems of methadone maintenance treatment in future regulation of syringe exchange programs.