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?
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 Physicians Desk Reference. If multiple persons are named, covered entities may choose any of the persons named by these sources. See the fact sheet and frequently asked questions on this web site about the public health provision for more information.
Related Questions
- 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?
- To whom may covered entities make public health disclosures regarding a produce regulated by the Food and Drug Administration (FDA) when more than one person is identified on the product label?
- Does the public health provision of the HIPAA Privacy Rule require covered entities to make public health disclosures?
