N.Y. Comp. Codes R. & Regs. tit. 10 § 80.46

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

Section 80.46 - Institutional dispensers; additional requirements

(a) Hospitals, veterinary hospitals, mental hospitals, or similar facilities qualified for controlled substances privileges shall first obtain a class 3 license from the department and thereafter, a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(b) Nursing homes and other facilities having the services of a physician, registered nurses and a licensed and registered pharmacist may qualify for a class 3 license for controlled substances privileges. Such facilities shall first obtain a class 3 license from the department and thereafter, a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(c) Institutional dispensers licensed by the department in class 3 may purchase stocks of controlled substances only from authorized distributors or manufacturers licensed by the department.

(d) Institutional dispenser stocks of controlled substances obtained pursuant to a class 3 license are for inpatient and outpatient use through a registered pharmacy dispenser.

(e) Bulk stocks of controlled substances may be distributed within the institution to wards, floor stocks, operating rooms and emergency rooms and carried as substocks of the hospital.

(1) With each substock of a schedule II controlled substance, an administration sheet or other record as the commissioner may approve shall be furnished.

(2) The administration sheet shall list the type of controlled substance, doses and number of doses furnished to the substock and shall indicate:

(i) date and hour of administration;

(ii) name of patient;

(iii) name of prescribing practitioner;

(iv) quantity administered;

(v) balance on hand after each administration; and

(vi) signature of administering nurse.

(f) Administration of all controlled substances shall be authorized only by written order of an authorized practitioner except that:

(1) In an emergency situation, as defined in this subdivision, a practitioner may have a controlled substance administered by oral order provided that immediately thereafter such order is reduced to writing and that a notation be made of the emergency condition which required the administration of the drug. Such oral order shall be signed by the practitioner within 48 hours.

(2) Emergency means that the immediate administration of the drug is necessary for proper treatment, that no alternative treatment is available and it is not possible for the practitioner to provide a written order before the administration of such drug.

(3) As required orders (P.R.N., pro re nata) for controlled substances are not valid beyond 72 hours and must be rewritten at least every 72 hours.

(4) Routine orders or an order in which there is no specific order written by a specific physician or other authorized practitioner are not permissible.

(5) Standing orders or specific controlled substances orders for individual patients to be administered at specified times shall not be valid after seven days and for continuing validity shall be rewritten at least every seven days, except that for a stabilized patient with convulsive disorders or chronic spasticity or minimal brain dysfunction in an institutional setting, and for patients in residential health care facilities, or in prisons, which possess class three controlled substances licenses, such orders shall be valid for 30 days but shall be rewritten at least every 30 days.

(6) Written controlled substances orders for hospitalized patients may, if permissible under the bylaws, rules and regulations of the hospital, be signed by a physician's assistant for patients under the care of the physician or physicians to whom the registered physician's assistant is assigned for supervision, subject to compliance by the registered physician's assistant with any of the foregoing conditions set forth in this section that are applicable to his/her supervising physicians. In every case, such written orders shall be countersigned by the supervising physician within 24 hours if deemed necessary and appropriate by the supervising physician or the hospital. Countersignature by the supervising physician is not required before execution of the order.

(7) Doses of controlled substances shall be withdrawn from the container immediately before administration is to be made to the patient.

(g) Institutional dispensers operating an outpatient department pharmacy shall also obtain a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(1) Such pharmacy shall be registered by the New York State Board of Pharmacy and under the supervision of a licensed and registered pharmacist.

(2) Controlled substances dispensed through outpatient department pharmacy to patients or employees of the institutional dispenser shall be dispensed only pursuant to prescriptions issued by an authorized practitioner.

(h) Independent out-of-hospital health facilities, such as clinics, may qualify to obtain official New York State institutional prescription forms required for prescribing schedule II controlled substances under the New York State Controlled Substances Act by complying with the following:

(1) Obtain an operating certificate from the New York State Department of Health as required under the New York State Hospital Code (Chapter V of this Title) or license by the New York State Department of Mental Hygiene.

(2) Obtain a registration as a clinic from the Drug Enforcement Administration (schedules II, III, IV and V), United States Department of Justice, or its successor agency.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 80.46