Section 80.50 - Minimum security standards for institutional dispensers, institutional dispensers limited, treatment programs, license holders engaging in research, instructional activities and chemical analysis

80.50 Minimum security standards for institutional dispensers, institutional dispensers limited, treatment programs, license holders engaging in research, instructional activities and chemical analysis.

(a) Reserve or main stocks of controlled substances shall be securely kept as follows:

(1) Schedule I and II controlled substances shall be kept in one of the following secure storage areas:

(i) A GSA class 5 rated steel cabinet or equivalent safe approved by the Bureau of Narcotic Enforcement of the Department of Health. Any cabinet or safe weighing less than 750 pounds shall he bolted or cemented to the floor or wall in such a way that it cannot be removed. The door of the cabinet or safe shall contain a multiple position combination lock, a relocking device or the equivalent, and steel plate having a thickness of at least one-half inch.

(ii) A vault, constructed of substantial masonry and having a multiple position combination lock, a relocking device or the equivalent, and a door having a thickness of steel plate of at least one-half inch. For new construction, floor, walls and ceiling shall not be less than eight inches of reinforced concrete, but less may be accepted where there are compensating extra safeguards.

(2) Schedule III, IV and V controlled substances shall be stored in a securely locked cabinet of substantial construction.

(b) Working stocks of controlled substances of a registered pharmacy may be dispersed throughout the stocks of noncontrolled substances in such a manner as to obstruct theft or diversion provided the conditions of section 80.6 of this Part are met and the pharmacy is locked when not in operation. If not dispersed, controlled substances in Schedules II, III and IV shall be kept in a stationary, securely locked cabinet of substantial construction.

(c) Working stocks of controlled substances for institutional dispensers without a registered pharmacy, treatment programs, license holders engaging in research, instructional activities, and chemical analysis shall be securely kept as follows:

(1) Schedule I, II, III and IV controlled substances shall be kept in stationary, locked double cabinets. Both cabinets, inner and outer, shall have key-locked doors with separate keys; spring locks or combination dial locks are not acceptable. For new construction, cabinets shall be made of steel or other approved metal.

(2) Schedule V controlled substances shall be stored in a stationary, securely locked cabinet of substantial construction.

(3) Limited supplies of controlled substances for use in emergency situations may be stocked in sealed emergency medication kits.

(d) Patient care units of institutional dispensers or institutional dispensers limited shall safeguard substances as follows:

(1) Controlled substances kept as floor stocks on patient care units for general patient use and quantities prescribed or ordered for a specific patient which would exceed a 72-hour supply shall be stored as specified in subdivision (c) of this section.

(2) Controlled substances prescribed or ordered for a specific patient in quantities which would not exceed a 72-hour supply may be stored with the patient's other medications at the patient care unit, provided that they are kept in a securely locked medication cart or other storage unit approved by the department.

(3) Medication carts. Schedule II controlled substances may not be stocked in medication carts.

(i) Medication carts may be utilized to stock Schedule III, IV and V controlled substances as provided in paragraph (2) of this subdivision, provided they are equipped with the following:

(a) double-keyed locks;

(b) when not in use, anchored to a floor or wall device or maintained in another secure location;

(c) locked drawer system; and

(d) independent locking device.

(ii) Access to medication carts shall be limited to an identified individual at all times. Such carts are to be used only in conjunction with a pharmacymaintained patient profile summary.

(4) Records. The following records shall be maintained of controlled substances stocked, dispensed or administered in medication carts:

(i) An order, signed by a person authorized to prescribe under the provisions of this Part, specifying the controlled substances medication for an indicated person or animal.

(ii) A separate record, at the main point of supply for controlled substances, showing the type and strength of each drug, in the form of a running inventory indicating the dates and amounts of such drugs compounded by them or received from other persons and their distribution or use.

(iii) A record of authorized requisitions for such drugs and the distribution to substations or wards should be maintained. Such records shall show delivery to substation or ward by the authorized signature of dispensing personnel. (iv) A record in the patient's chart indicating administration of the controlled substance, including the name of the administering attendant and the date and hour of administration.

(e) Except as provided in paragraph (1) of this subdivision, institutional dispensers limited may only possess controlled substances prescribed for individual patient use, pursuant to prescriptions filled in a registered pharmacy. These controlled substances shall be safeguarded as provided in subdivision (d) of this section.
(1) Except for adult care facilities subject to the provisions of Title 18 NYCRR Parts 487, 488 and 490, institutional dispensers limited may possess limited supplies of controlled substances in sealed emergency medication kits for use as provided in section 80.49(d) of this Part. Each kit may contain up to a 24-hour supply of a maximum of ten different controlled substances in unit dose packaging, no more than three of which may be in an injectable form. Each kit shall be secured in a stationary, double-locked system or other secure method approved by the Department.
(f) Only controlled substances shall be stored within the storage facilities described in this section, except in an automated dispensing system and as noted in subdivisions (b) and (d)(2) of this section.

Effective Date: 
Wednesday, November 26, 2008
Doc Status: 
Complete