To whom may covered entities make public health disclosures regarding a product regulated by the Food and Drug Administration (FDA) when more than one person is identified on the product label?
Answer:Covered entities may identify persons responsible for an FDA-regulated product by using the product label, the literature that accompanies the product, or other sources of labeling, such as the Physician’s Desk Reference. If multiple persons are named, covered entities may choose any of the persons named by these sources.
See our public health section and frequently asked questions about the public health provision for more information.
Date Created: 12/20/2002
Last Updated: 03/14/2006