North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-02 - Pharmacies › Chapter 61-02-03 - Security Standards for Pharmacies › Section 61-02-03-01 - Security standards for pharmacies

Current through Supplement No. 393, July, 2024
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.
General Authority: NDCC 43-15-10(11)
Law Implemented: NDCC
								43-15-10(11)