(a) The Commissioner of Health and Environmental Control is hereby directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded, under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.

(b)(1) A drug intended for use by man which (A) is a habit-forming drug to which Section 39-23-40(d) applies; or (B) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or (C) is limited by an effective application under Section 39-23-70 to use under the professional supervision of a practitioner licensed by law to administer such drug, shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

(2) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of Section 39-23-40, except paragraphs (a), (i)(2) and (3), (k), and the packaging requirements of paragraphs (g) and (h), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and if stated in the prescription the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this subsection.

(3) The Commissioner of Health and Environmental Control may by regulation remove drugs subject to Section 39-23-40(d) and Section 39-23-70 from the requirements of paragraph (1) of this subsection when such requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the Federal act by regulations issued thereunder may also by regulations issued by the Commissioner of Health and Environmental Control, be removed from the requirements of paragraph (1) of this subsection.

(4) A drug which is subject to paragraph (1) of this subsection shall be misbranded if at any time prior to dispensing its label fails to bear the statement "Caution: Federal law prohibits dispensing without prescription." A drug to which paragraph (1) of this subsection does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.

(5) Nothing in this subsection shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or which may hereafter be included within the classifications stated in Sections 44-49-10, 44-49-40, 44-49-50 and 44-53-110 to 44-53-580.

HISTORY: 1962 Code Section 32-1510.105; 1972 (57) 3046.