Header:
NORTH DAKOTA ADMINISTRATIVE CODE
TITLE 61. STATE BOARD OF PHARMACY
ARTICLE 2. PHARMACIES
CHAPTER 3. SECURITY STANDARDS FOR PHARMACIES
Date:
08/31/2009
Document:
61-02-03-01. Security standards for pharmacies.
A pharmacy must comply with the following security standards:
1. Pharmacist in charge. Every pharmacy must have a pharmacist designated as the pharmacist-in-charge who shall be responsible to the board for a pharmacy's compliance with the laws and regulations, both state and federal, pertaining to the practice of pharmacy. The pharmacist-in-charge shall see that directives from the board are communicated to, and complied with by, the management, other pharmacists, and interns of the pharmacy.
2. Personnel permitted in prescription area. Personnel permitted in the prescription area are pharmacists, interns, drug inspectors, peace officers when acting in their official capacity, drug salesmen, and supporting personnel of the pharmacy. Interns, drug salesmen, and supporting personnel shall be permitted in the prescription area only when a pharmacist is on duty, except in an extreme emergency. No more than one clerical person shall be permitted in the prescription area per pharmacist.
3. Prescription area and storage shall be kept locked. The prescription area and any additional storage area for drugs restricted to a pharmacist, except in an extreme emergency, shall be kept locked when a pharmacist is not on duty. The pharmacist shall keep each portion of the prescription area secured and locked at all times the pharmacist does not have full vision or control of such portions of the prescription area. The prescription area shall be open for business to the public at all times that the retail establishment is open for business to the public, or for a minimum of eight hours a day should the retail establishment be open longer than eight hours per day. The board of pharmacy recognizes that the hours that the prescription area of a pharmacy is open for business to the public will depend on the type of pharmaceutical services offered, as well as other factors, and therefore, variations in the required hours that a prescription area shall be open for business to the public may be granted by the board of pharmacy.
4. Only pharmacist permitted to unlock prescription area or storage area. The pharmacist shall be the only person permitted to unlock the prescription area or any additional storage area for drugs restricted to a pharmacist, except in an extreme emergency. Only the pharmacist shall maintain possession of the key to the prescription area. The pharmacist shall be responsible for assuring that only authorized personnel have access to the legend and nonproprietary drugs stored in the prescription area or additional storage area.
5. Extreme emergency. An extreme emergency shall be in case of fire, water leak, electrical failure, public disaster, or other catastrophe, whereby the public is better served by overlooking the safety security restrictions on drugs.
6. Receiving and checking area for drugs. The area where prescription drugs are received, opened, and marked shall be under the immediate supervision of a pharmacist, and immediately thereafter the prescription drugs shall be kept or moved into the secured area of the pharmacy.
7. Security of prescription area. In order for the prescription area to be left without a pharmacist on duty when other people are in the store, after business hours, the prescription area shall be enclosed by a permanent barrier or partition from floor to ceiling, with entry doors that can be securely locked. If a prescription area is continually attended by a pharmacist when other people are in the store, the prescription area need not be enclosed by the permanent barrier. The barrier shall be so designed that only a pharmacist with a key, except in an extreme emergency, shall have access to the area where prescription only drugs, dangerous drugs, narcotics, and other drugs and devices restricted to sales by pharmacists are stored, compounded, and dispensed.
8. Types of permanent barrier. The permanent barrier may be constructed of other than a solid material. If constructed of a material other than a solid, the openings or interstices in the material shall not be large enough to permit removal of items in the prescription area by any means. Any material used in the construction of the permanent barrier must be of sufficient strength and thickness that it cannot be readily or easily removed, penetrated, or bent. The plans and specifications of the permanent barrier shall be submitted to the board for approval that it affords adequate security.
9. Additional storage area. When additional storage area is required for drugs that are restricted to pharmacists, the area shall be contained by a permanent barrier from floor to ceiling. All doors or gates to the storage area shall be able to be locked, and only a pharmacist with a key shall be permitted to enter the storage area, except in an extreme emergency.
10. Security standards variations. The board of pharmacy recognizes that the security standards for pharmacies will depend on the type of pharmaceutical services offered, and therefore, variations for required security standards may be granted by the board of pharmacy.
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