Here's the law:

https://www.law.cornell.edu/uscode/text/21/360bbb-3

(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—

(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

Here's the law:

https://www.law.cornell.edu/uscode/text/21/360bbb-3