N.Y. Comp. Codes R. & Regs. tit. 10 § 80.64

Current through Register Vol. 46, No. 51, December 18, 2024

Section 80.64 - Who may issue

(a) A prescription for a controlled substance may be issued only by a practitioner who is:

(1) authorized to prescribe controlled substances pursuant to his licensed professional practice; and

(2) either registered under the Federal Controlled Substances Act and in possession of a registration number from the Drug Enforcement Administration, United States Department of Justice, or its successor agency, or exempted from such registration as an exempt official.

(b) A practitioner issuing an electronic prescription for a controlled substance, in addition to meeting the provisions as noted in subdivision (a) of this section, shall also:

(1) use an electronic prescribing application that is consistent with Federal requirements; and

(2) register the certified electronic prescribing application with the New York State Department of Health, Bureau of Narcotic Enforcement.

(c) Prescriptions excepted from any electronic prescribing requirement set forth in article 2-a of the Public Health Law include prescriptions:

(1) issued by veterinarians;

(2) issued in circumstances where electronic prescribing is not available due to temporary technological or electrical failure. For the purposes of this Part, temporary technological or electrical failure shall be defined as: any failure of a computer system, application, or device, or the loss of electrical power to that system, application, or device, or any other service interruption to a computer system, application, or device in such a manner that is reasonably prevents a practitioner from utilizing his or her certified electronic prescribing application to transmit an electronic prescription for a controlled substance in accordance with this section and Federal requirements. In the instance of a temporary technological or electrical failure, a practitioner shall, without undue delay, seek to correct any cause for the failure that is reasonably within his or her control;

(3) issued by practitioners to whom the commissioner has granted a waiver, or a renewal thereof, from the requirement to use electronic prescribing. A waiver may be issued by the commissioner based upon a showing of a practitioner that his or her ability to issue an electronic prescription in accordance with this section is unduly burdened by:

(i) economic hardship;

(ii) technological limitations that are not reasonably within the control of the practitioner; or

(iii) other exceptional circumstance demonstrated by the practitioner.

The practitioner's showing shall include a sworn statement of facts detailing the circumstances in support of a waiver, and should be accompanied by any and all other information which would be relevant to the commissioner's determination. The practitioner shall also provide any information which would tend to negate the need for a waiver. A waiver shall be granted by the commissioner for a specified period of time, but in no event for more than one year. A practitioner may apply for a renewal of a previously granted waiver. Any application for the renewal of a previously granted waiver shall include an updated statement of facts detailing the continuing circumstances in support of the renewal, along with any facts reasonably known to the practitioner which tend to weigh against the granting of a renewal. Any renewal granted shall be subject to the same requirements as the original waiver;

(4) issued by a practitioner under circumstances where such practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient's medical condition, provided that if such prescription is for a controlled substance, the quantity of controlled substances does not exceed a five day supply if the controlled substance were used in accordance with the directions for use; or

(5) issued by a practitioner to be dispensed by a pharmacy located outside the state.

(d) A practitioner who issues a prescription pursuant to paragraph (c)(2) of this section shall file information about the issuance of such prescription with the department as soon as practicable, but in no instance more than 72 hours following the end of the technological or electrical failure that prevented the issuance of an electronic prescription.

(e) A practitioner who issues a prescription pursuant to paragraph (c)(4) or (5) of this section shall file information about the issuance of such prescription with the department within 48 hours of the date of issue.

(f) A practitioner who has been granted a waiver pursuant to paragraph (c)(3) of this section shall notify the department in writing within five business days upon gaining the capability to issue an electronic prescription. Without regard to the original expiration date, the waiver granted to the practitioner shall terminate within a reasonable period of time as determined by the department, allowing for the practitioner to make accommodations to begin issuing electronic prescriptions.

(g) Any prescription issued pursuant to subdivision (c) of this section shall be issued as an official New York State prescription or an oral prescription in accordance with sections 80.63, 80.67, 80.68, 80.69 and 80.70 of this Part.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 80.64