Patent ID: 7885824

Claim:
A method for delivering a medical therapy by a distributor comprising the distributor: a) receiving prescription data from a physician authorizing distribution of the medical therapy to a specific patient in need of the medical therapy, wherein the medical therapy was characterized as a high-risk medical therapy and the Food and Drug Administration (FDA) required a restricted distribution program, the elements of which distribution program comprised registering in a computer-readable storage medium prior to the distribution of the medical therapy to the patient all of the physician, the patient, and the distributor, and generating a validation code to dispense the medical therapy; b) confirming that the patient is eligible to receive the medical therapy; c) confirming that the patient understands risks associated with the medical therapy; d) distributing the medical therapy to the patient independent of requiring: (i) registration of either the physician, or the patient, or the distributor or a combination thereof, in a computer readable storage medium prior to distribution of the medical therapy; or (ii) a validation code to dispense the medical therapy; wherein, the risk level of the patient or medical therapy was recharacterized and FDA permitted the change to the restricted distribution program.