(a)Except as provided in subsections (b), (c), and (d) of this section, a drug or device that is sold or offered for sale by prescription, including those transported or mailed into this State for use in this State although purchased elsewhere, is misbranded:
(1)if its labeling is false or misleading in any particular; or
(2)unless it is labeled with the following:
(A)the name of the patient or if the patient is an animal the name of its owner and the species of the animal;
(B)the expiration date of the drug where the date is required by law or has been determined by the manufacturer, Department, or any agency of the State or U.S. government, if this date is less than one year from date of dispensing;
(C)the name or place of business of the dispenser;
(D)the serial number and the da
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(a) Except as provided in subsections (b), (c), and (d) of this section, a drug or device that is sold or offered for sale by prescription, including those transported or mailed into this State for use in this State although purchased elsewhere, is misbranded:
(1) if its labeling is false or misleading in any particular; or
(2) unless it is labeled with the following:
(A) the name of the patient or if the patient is an animal the name of its owner and the species of the animal;
(B) the expiration date of the drug where the date is required by law or has been determined by the manufacturer, Department, or any agency of the State or U.S. government, if this date is less than one year from date of dispensing;
(C) the name or place of business of the dispenser;
(D) the serial number and the date the prescription was filled;
(E) directions for use as may be stated in the prescription and the name of the medical, dental, osteopathic, or veterinary professional prescribing the drug or device;
(F) the name and strength of the drug or its generic equivalent, if any, according to the latest official U.S. Pharmacopoeia, latest official Homeopathic Pharmacopoeia of the United States, or latest official national formulary, or any supplement to any of them;
(G) the name of the drug shall be the same as written by the prescriber, unless the prescription has been filled with a generic equivalent approved by the prescriber and the purchaser has been informed of the change.
(b) The labeling requirements of subdivisions (a)(2)(F) and (G) of this section shall not apply to a drug or device if the prescribing physician explicitly requests for medical reasons that such information shall be omitted.
(c) The labeling requirements of subsection (a) of this section shall not apply to a drug or device administered under the supervision of a licensed physician to patients within a hospital or nursing home.
(d) Nothing in this section shall be construed to limit the ability of a licensed physician to give, administer, or dispense any drug or device to a patient under his or her care. (Added 1971, No. 182 (Adj. Sess.), eff. July 1, 1972; amended 2007, No. 163 (Adj. Sess.), § 4; 2023, No. 6, § 144, eff. July 1, 2023; 2023, No. 53, § 94, eff. June 8, 2023.)