Iowa Admin. Code r. 657-8.5
Current through Register Vol. 47, No. 11, December 11, 2024
Rule 657-8.5 - Environment and equipment requirementsThere 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).Iowa Admin. Code r. 657-8.5
ARC 8671B, lAB 4/7/10, effective 5/12/10; ARC 0503C, lAB 12/12/12, effective 1/16/2013Amended by IAB April 15, 2015/Volume XXXVII, Number 21, effective 5/20/2015Amended by IAB February 17, 2016/Volume XXXVIII, Number 17, effective 3/23/2016Amended by IAB June 20, 2018/Volume XL, Number 26, effective 7/25/2018Amended by IAB January 30, 2019/Volume XLI, Number 16, effective 3/6/2019Amended by IAB May 22, 2019/Volume XLI, Number 24, effective 6/26/2019