N.Y. Comp. Codes R. & Regs. tit. 10 § 80.75

Current through Register Vol. 46, No. 45, November 2, 2024

Section 80.75 - Institutional dispensers

(a) Institutional dispensers licensed by the department may cause controlled substances to be administered or dispensed for use on the premises only pursuant to a written order by a practitioner for such medication. A prescription is not required for inpatient use. In an emergency situation in which a physician determines that it is necessary to transfer a critically ill patient from one hospital to an alternative medical facility, an institutional dispenser may cause a single dose of a controlled substance to be dispensed to the medical attendant accompanying the patient if the duration of the transfer may reasonably be expected to exceed three hours.

(b) An institutional dispenser may dispense controlled substances for use off its premises only pursuant to a prescription issued by a practitioner. All such prescriptions for outpatient use shall be filled only in a hospital pharmacy or other registered pharmacy. However, a practitioner in the emergency room of a hospital without a full-time pharmacy and when the services of a registered pharmacy are not available may dispense controlled substances to a patient in an emergency situation. For the purposes of this subdivision, an emergency means that the immediate dispensing of the controlled substance is necessary and no alternative treatment is available. The practitioner may dispense no more than a 24-hour supply in accordance with directions for use and must conform with the applicable labeling requirements of section 80.71 of this Part.

(c) Official New York prescription forms are available for use by institutional dispensers. Institutional dispensers shall register with the department to be issued official prescriptions.

(1) The registration application for an institutional dispenser shall include but not be limited to the requesting institution's name, primary or other practice site address(s), the Federal registration number or exemption certificate, where applicable, a State agency license number, if applicable, and shall be signed by a person authorized by the institution to request such forms.

(2) An institutional dispenser's registration shall be without fee and subject to approval by the department. Such registration shall be valid for a period of two years.

(3) An institutional dispenser registered to be issued official prescription forms shall order such forms in the manner required by the department. The number of prescriptions requested by the institution shall be subject to approval by the department and shall be issued free of charge in the manner and quantity approved by the department.

(4) Official prescription forms shall be sent to the institutional dispenser's primary address. Primary address is the address of a registered institution's Federal Drug Enforcement Administration (DEA) registration or, if such facility is not required to be registered with DEA, an address designated as the primary address in the facility's registration with the department.

(d) Staff practitioners are required to use such forms to prescribe controlled substances for outpatient use, indicating the practitioner's Drug Enforcement Administration registration number on the form. Staff practitioners may create, sign and transmit electronic prescriptions for controlled substances for outpatient use provided the practitioner complies with all other requirements for issuing controlled substance prescriptions in this Part and with Federal requirements for electronic prescribing of controlled substances. A prescription generated on an electronic system that is printed out or transmitted via facsimile is not considered an electronic prescription and shall be manually signed.

(e) Interns or residents are required to use the Drug Enforcement Administration registration number of the institution and the code number assigned by the institution for such purpose. Any practitioner who is an intern, resident or foreign physician may dispense and prescribe controlled substances under the registration of the hospital or other institution which is registered and by whom the physician is employed, provided that:

(1) the dispensing or prescribing is in the usual course of his professional practice;

(2) the practitioner is authorized or permitted to do so by the laws of New York State;

(3) the hospital or institution has determined that the practitioner is permitted to dispense or prescribe drugs in New York State;

(4) the practitioner acts only within the scope of his employment in the hospital or institution; and

(5) the hospital or institution authorizes the intern, resident, or foreign physician to dispense or prescribe under its registration number and assigns a specific code number for each practitioner so authorized.

(f) It is the responsibility of the dispensing institution to obtain all official prescriptions for outpatient use and to assign such prescriptions to staff practitioners and interns and to insure the security of all such official prescriptions. Institutions obtaining official New York State prescriptions shall establish a system of control and security which will include the following:

(1) A record of all such prescriptions received.

(2) A record of all such prescriptions assigned to staff practitioners.

(3) A system requiring that such prescriptions be kept under lock and key when not in use.

(4) A system whereby official prescriptions are surrendered to the institution if the practitioner to whom they were assigned terminates his affiliation with the institution.

(5) A system whereby the Bureau of Narcotic Enforcement, New York State Department of Health, is notified immediately of the loss, destruction or theft of any such official prescriptions assigned to the institution.

(6) A system whereby the institution has a sufficient number of official prescriptions in reserve for use by the institution.

(g) Staff practitioners, interns, residents, or foreign physicians who are authorized to dispense or prescribe controlled substances in a hospital or other institution and use the institution's official New York State prescription forms, other hospital or institutional forms, or the institution's electronic prescribing application must conform to the requirements of sections 80.67, 80.69 and 80.71 of this Part.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 80.75