Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.5 - Environment and Equipment Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
There shall be adequate space, equipment, and supplies for the
				professional and administrative functions of the pharmacy pursuant to rule
				657-8.3(155A). Space and equipment shall be available in an amount and type to
				provide secure, environmentally controlled storage of drugs.
(1)
Refrigeration.
The
			 pharmacy shall maintain one or more refrigeration units, unless the pharmacy
			 does not stock refrigerated items. The pharmacy shall document verification
			 that the temperature of the refrigerator is maintained within a range
			 compatible with the proper storage of drugs requiring refrigeration. If the
			 temperature is manually or visually verified, a record of minimum daily
			 verification shall be maintained.
(2)
Sink.
The pharmacy shall
			 have a sink with hot and cold running water located within the pharmacy
			 department and available to all pharmacy personnel; the sink shall be
			 maintained in a sanitary condition.
(3)
Secure barrier.
A
			 pharmacy department shall be closed and secured in the absence of the
			 pharmacist except as provided in rule
			 657-6.7 (124,155A) or
			 657-7.5 (124,155A). To ensure
			 that secure closure, the pharmacy department shall be surrounded by a physical
			 barrier capable of being securely locked to prevent entry when the department
			 is closed. A secure barrier may be constructed of other than a solid material
			 with a continuous surface if the openings in the material are not large enough
			 to permit removal of items from the pharmacy department by any means. Any
			 material used in the construction of the barrier shall be of sufficient
			 strength and thickness that it cannot be readily or easily removed, penetrated,
			 or bent.
(4)
Remodel or
			 relocation
-
inspection. A
pharmacy planning to
			 remodel or relocate a licensed pharmacy department on or within the premises
			 currently occupied by the pharmacy department, or a pharmacy intending to
			 remodel or install a sterile compounding facility or equipment, shall provide
			 written notification to the board at least 30 days prior to commencement of the
			 remodel, pharmacy relocation, or sterile compounding installation. The board
			 may require on-site inspection of the facility, equipment, or pharmacy
			 department prior to or during the pharmacy's remodel, relocation, or opening.
			 The board may also require on-site inspection of a temporary pharmacy location
			 intended to be utilized during the remodel, construction, or relocation of the
			 pharmacy department.
(5)
Orderly and clean.
The pharmacy shall be arranged in an
			 orderly fashion and kept clean. All required equipment shall be in good
			 operating condition and maintained in a sanitary manner. Animals shall not be
			 allowed within a licensed pharmacy unless that pharmacy is exclusively
			 providing services for the treatment of animals or unless the animal is a
			 service dog or assistive animal as defined in Iowa Code subsection
			 216C.11(1).
(6)
Light, ventilation, temperature,
			 and humidity.
The pharmacy shall be properly lighted and ventilated.
			 The temperature and humidity of the pharmacy shall be maintained within a range
			 compatible with the proper storage of drugs.
(7)
Other equipment.
The
			 pharmacist in charge and the pharmacy, by and through its owner or license
			 holder, shall share the responsibility for ensuring the availability of any
			 other equipment necessary for the particular practice of pharmacy and to meet
			 the needs of the patients served by the pharmacy.
(8)
Bulk counting machines.
Unless bar-code scanning is required and utilized to verify the identity of
			 each stock container of drugs utilized to restock a counting machine cell or
			 bin, a pharmacist shall verify the accuracy of the drugs to be restocked prior
			 to filling the counting machine cell or bin. A record identifying the
			 individual who verified the drugs to be restocked, the individual who restocked
			 the counting machine cell or bin, and the date shall be maintained. Established
			 policies and procedures shall include a method to calibrate and verify the
			 accuracy of the counting device. The pharmacy shall, at least quarterly, verify
			 the accuracy of the device and maintain a dated record identifying the
			 individual who performed the quarterly verification.
(9)
Authorized collection
			 program.
A pharmacy that is registered with the DEA to administer an
			 authorized collection program shall provide adequate space, equipment, and
			 supplies for such collection program pursuant to 657-Chapter 10 and federal
			 regulations for authorized collection programs, which can be found at
www.deadiversion.usdoj.gov/drug_disposal/
.
(10)
Health of personnel.
The pharmacist in charge or supervising pharmacist shall ensure that pharmacy
			 personnel experiencing any health condition that may have an adverse effect on
			 drug products or may pose a health or safety risk to others be prohibited from
			 working in the pharmacy until such health condition is sufficiently resolved.
			 All personnel who normally assist the pharmacist shall report to the pharmacist
			 any health conditions that may have an adverse effect on drug products or may
			 pose a health or safety risk to others.
(11)
Hazardous drugs.
The
			 pharmacy shall ensure pharmacy personnel and patients are adequately protected
			 from unnecessary exposure to hazardous drugs. As of December 1, 2019, the
			 pharmacy shall be in compliance with United States Pharmacopeia (USP) General
			 Chapter 800 for handling hazardous drugs. A pharmacy engaged in compounding of
			 hazardous drugs may request delayed compliance for specific requirements in USP
			 General Chapter 800 pertaining to compounding, in accordance with rule
			 657-20.5 (126,155A).