LAC 49:I.507 – Safety and Efficacy [Formerly 49:2.2130]

A. Products containing new ingredients cannot be registered unless the application for registration is supported by full reports of investigations which have been made to show whether or not such product is safe for use and, if a drug or device, is effective in use. Such information will not be required; however, if the product has been approved by the U.S. Food and Drug Administration and the application for registration is supported by a copy of that approval.

AUTHORITY NOTE: Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as amended.

HISTORICAL NOTE: Adopted by the Department of Health and Human Resources, Office of Preventive and Public Health Services, September 1968.