COLOR ADDITIVES FOR DRUGS AND MEDICAL DEVICES.

The Medical Device Amendments of 1976 mandated the control by FDA of color additives in medical devices under specified conditions. Although at this time there are still no specific regulations governing the use of colorants in medical devices, such regulations are certain to be developed. This article presents background information that may be useful in understanding the nature of color additives, the regulatory processes that govern their use, and the effect future regulations could have on the medical device industry. The article includes information on color terminology, chemical structures, color index numbers and physiological areas where they may be used, regulatory history, and activities of the producers and users of color additives in supplying pharmacological and chemical data required for eventual government regulation.