(1) Except when dispensed directly by a practitioner to an ultimate user, no controlled substance listed in Schedule II may be dispensed without the w ritten, facsimile, electronic, or oral prescription of a practitioner. A prescription for a controlled substance listed in Schedule II may be dispensed by a facsimile prescription only as specified in administrative regulations promulgated by the cabinet. A prescription for a controlled substance listed in Schedule II may be dispensed by oral prescription only for immediate administration to a patient enrolled in a hospice program or a resident in a long -term care facility, as defined in KRS 216.535, excluding a family care home, assisted living community as defined in KRS 194A.700, or personal care home, and the practitioner determines that immediate administration is necessary, no appropriate alternative treatment is available, and it is not reasonably pos sible for the prescriber to provide a written prescription. No prescription for a controlled substance in Schedule II shall be valid after sixty (60) days from the date issued. No prescription for a controlled substance in Schedule II shall be refilled. All prescriptions for controlled substances classified in Schedule II shall be maintained in a separate prescription file. (2) Except when dispensed directly by a practitioner to an ultimate user, a controlled substance included in Schedules III, IV, and V, which is a prescription drug, shall not be dispensed without a written, facsimile, electronic, or oral prescription by a practitioner. The prescription shall not be filled or refilled more than six (6) months after the date issued or be refilled more than five (5) times, unless renewed by the practitioner and a new prescription, written, electronic, or oral shall be required. (3) (a) To be valid, a prescription for a controlled substance shall be issued only for a legitimate medical purpose by a practitione r acting in the usual course of his professional practice. Responsibility for the proper dispensing of a controlled substance pursuant to a prescription for a legitimate medical purpose is upon the pharmacist who fills the prescription. (b) A prescription shall not be issued for a practitioner to obtain a controlled substance for the purpose of general dispensing or administering to patients. (4) All written, facsimile, and electronic prescriptions for controlled substances shall be dated and signed by the practitioner on the date issued. A computer -generated prescription that is printed out or faxed by the practitioner shall be manually signed. A prescription may be transmitted by facsimile only as specified in administrative regulations promulgated by the cabinet. Electronic prescriptions shall be created, signed, and transmitted in accordance with the requirements of 21 C.F.R. pt. 1311. (5) All prescriptions for controlled substances shall include the full name and address of the patient, drug name, streng th, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner. (6) All oral prescriptions for controlled substances shall be immediately reduced to writing, dated, and signed by the pharmacist. (7) A pharmacist refilling any prescription shall record on the prescription or other equivalent record the date, the quantity, and the pharmacist's initials. The maintenance of prescription records under the federal controlled substances laws and regulati ons containing substantially the same information as specified in this subsection shall constitute compliance with this subsection. (8) The pharmacist filling a written, facsimile, electronic, or oral prescription for a controlled substance shall affix to the package a label showing the date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner and directions for use and cautionary statements, if any, contained in such prescription or required by law. (9) Any person who violates any provision of this section shall: (a) For the first offense, be guilty of a Class A misdemeanor; and (b) For a second or subsequent offense, be guilty of a Class D felony.
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