3333. Dispensing upon official New York state prescription or electronic prescription. 1. A licensed pharmacist may, in good faith and in the course of his or her professional practice, sell and dispense to an ultimate user controlled substances only upon the delivery of an official New York state prescription or the receipt of an electronic prescription to such pharmacist, within thirty days of the date such prescription was signed by an authorized practitioner; provided, however, a pharmacist may dispense a part or portion of such prescription in accordance with regulations of the commissioner in consultation with the commissioner of education. No pharmacy or pharmacist may sell or dispense greater than a thirty day supply of a controlled substance to an ultimate user unless and until the ultimate user has exhausted all but a seven day supply of the controlled substance provided pursuant to any previously issued prescription, except that a pharmacy or pharmacist may sell or dispense up to a three month supply of a controlled substance if there appears, on the official New York state prescription or electronic prescription, a statement that the controlled substance has been prescribed to treat one of the conditions that have been enumerated by the regulations of the commissioner as warranting the prescribing of greater than a thirty day supply of a controlled substance. A pharmacy or pharmacist may sell or dispense up to a six month supply of any substance listed in subdivision (h) of Schedule II of section thirty-three hundred six of this article if there appears, on the official New York state prescription or on an electronic prescription, a statement that the substance has been prescribed to treat one of the conditions that have been enumerated by the regulations of the commissioner as warranting the prescribing of a specified greater supply.
2. No controlled substance may be so dispensed or sold unless it is enclosed within a suitable container, and:
(a) Affixed to such container is a label upon which is indelibly typed, printed, or otherwise legibly written the following:
(i) the name and address of the ultimate user for whom the substance is intended, or if intended for use upon an animal, the species of such animal and the name and address of the owner or person in custody of such animal;
(ii) the name, address, and telephone number of the pharmacy from which such substance is dispensed;
(iii) specific directions for use as stated on the prescription;
(iv) the name of the prescribing practitioner;
(v) the legend, prominently marked or printed in either boldface or upper case lettering: "CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED";
(vi) the number of the prescription under which it is recorded in the pharmacist's prescription file;
(vii) such code number assigned by the department for the particular substance pursuant to section thirty-three hundred eighteen of this article, or when requested by the practitioner, the name of such substance;
(b) Such container shall be identified as a controlled substance by either:
(i) an orange label;
(ii) a label of another color over which is superimposed an orange transparent adhesive tape; or
(iii) an auxiliary orange label affixed to the front of such container and bearing the legend, prominently marked or printed "Controlled Substance, Dangerous Unless Used As Directed";
(c) Any label, transparency, or auxiliary label shall be applied in a manner which would inhibit its removal.
3. The pharmacist filling the controlled substance prescription shall endorse upon the original official New York state prescription the date of delivery and his or her signature or, if an electronic prescription, his or her electronic signature.
4. The endorsed original prescription shall be retained by the proprietor of the pharmacy for a period of five years. The proprietor of the pharmacy shall file or cause to be filed such prescription information with the department by electronic means on a real time basis as the commissioner in consultation with the commissioner of education shall, by regulation, require; provided, however, that the commissioner may, pursuant to a process established in regulation, grant a waiver allowing a pharmacy to make such filings within a longer period of time if and to the extent that the commissioner finds it warranted, in his or her discretion, due to economic hardship, technological limitations that are not reasonably within the control of the pharmacy, or other exceptional circumstance demonstrated by the pharmacy; and provided, further, however, that such regulations shall specify the manner in which such requirements shall apply to the delivery of controlled substances to individuals in this state by means of mail or licensed express delivery services.
5. When filing prescription information electronically pursuant to subdivision four of this section, the proprietor of the pharmacy shall dispose of any electronically recorded prescription information in such manner as the commissioner shall by regulation require.
Last modified: February 3, 2019