Allows a patient to receive, and the practitioner to provide or administer, any unapproved drug or medical device the patient or their legal representative desires, provided certain conditions are met. Sets forth circumstances under which a health care practitioner may recommend, provide, or administer an unapproved drug or medical device.
Requires a practitioner who discovers that an unapproved drug or medical device creates a danger to a patient immediately to cease use and recommendation of such drug or device and provide specified information to its manufacturer and the Director of the Centers for Disease Control and Prevention. Requires the manufacturer that receives such information to: (1) immediately cease sale and distribution of the drug or device; and (2) comply with specified notification and reporting requirements. Sets forth certain investigative and reporting duties that the Director, the Secretary of Health and Human Services, and a practitioner must perform with respect to the dangerousness or effectiveness of unapproved drugs or medical devices.
Sets forth a penalty for violations of this Act.