Patent ID: 7885827

Claim:
A method for providing restricted access to a generic drug that has been approved by the Food and Drug Administration (FDA) as substitutable for a branded restricted distribution drug to a patient to whom the branded restricted distribution drug was prescribed by a physician, wherein the branded restricted distribution drug is a drug that requires compliance with an FDA-approved risk management program comprising a generic drug manufacturer: authorizing fulfillment of the generic drug to the patient only after determining the patient's eligibility has been determined in accordance with an FDA-approved risk management program for the generic drug and, if necessary, after approval is obtained from a prescribing physician to substitute the generic drug for the branded restricted distribution drug, wherein the fulfillment is provided by one of: a pharmacy, the prescribing physician, the generic drug manufacturer, or a distributor, or a combination thereof; and wherein the distribution of the generic drug is not authorized if the patient is determined to be ineligible; provided that authorizing the fulfillment of the generic drug to the patient does not comprise the generic drug manufacturer or distributor: generating a validation code to dispense the generic drug prior to fulfillment of the prescription; or requiring the patient, the pharmacy, or the prescribing physician to be registered with the generic drug manufacturer or distributor prior to the fulfillment of the prescription; and wherein, after authorizing the fulfillment of the generic drug to the patient, data about the eligibility determination of patient for the generic drug, the physician information, the patient information, and the generic drug delivered are recorded in a computer-readable medium.