; and (B) has been included in a list of drugs published by the Secretary in the Federal Register as presenting a risk of misuse, abuse, addiction, overdose, or drug-drug interactions necessitating inclusion in the Prescription Safety Alert System, so long as the Secretary provided no less than 30 days for public comment before finalizing the inclusion of such drug product in such list. (2) The term dispenser means a person who is licensed in accordance with State law to engage in the practice of pharmacy to dispense covered drug products directly to patients or their caregivers, except such term does not include a closed-system pharmacy. (3) The term closed system pharmacy means any facility, including a nursing home, correctional facility, adult congregate living facility, or other custodial care facility, that is licensed by law to engage in the practice of pharmacy that distributes or dispenses covered drug products utilizing a closed delivery system where prescriptions are individually prepared for a custodial consumer. (4) The term prescription and dispensing history means a patient’s history, dating back a minimum of 12 months, or such period as the Secretary deems appropriate, of receiving, filling, or attempting to receive or fill, prescriptions for covered drug products, including specific data elements, as applicable to any particular patient or prescription, including— (A) a description of the drug dispensed or attempted to be filled; (B) pharmacy national provider identifier (NPI); (C) prescription (Rx) number; (D) fill number; (E) other applicable coverage code; (F) date or dates of service; (G) prescriber identifiers; (H) patient information; (I) third party identifiers; and (J) such other information the Secretary deems appropriate by guidance. (5) The term standard setting organization has the meaning given to such term in section 1171(8) of the Social Security Act. .