NDAC 61-02-03-01
standards for pharmacies
Cite as N.D. Admin. Code ยง 61-02-03-01
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.