Standards of Operation for a Class F: Renal Dialysis Pharmacy

PURPOSE: This rule defines minimum standards for a Class F: Renal Dialysis Pharmacy. (1) A Class F pharmacy (renal dialysis) shall be limited in scope to the provision of dialysis products and supplies to persons with chronic kidney failure for self-administration at the person’s home or specified address. Pharmacy services and dialysis supplies and products provided by a Class F pharmacy shall be limited to the distribution and delivery of drugs and devices as provided within this rule. All drugs and devices must be ordered by an authorized prescriber for administration or delivery to a person with chronic kidney failure for selfadministration at the person’s home or specified address. All dialysis supplies and products provided by a Class F pharmacy shall be prepackaged and covered by an approved New Drug Application (NDA) or 510(k) application issued by the Food and Drug Administration (FDA). (2) A Class F pharmacy shall maintain a pharmacist-in-charge on a consultant basis who shall review pharmacy operations at least weekly. Class F pharmacies shall ensure: (A) Use of legend drugs and devices that are provided to a person for the treatment of chronic kidney disease for selfadministration at the person’s home or specified address are under the professional supervision of an appropriate practitioner licensed under Missouri law; (B) Only drugs and devices that have been ordered by an authorized prescriber and are included on the list of approved formulary drugs and devices are provided to patients; (C) No drugs or devices are dispensed to a patient until adequate training in the proper use and administration of such products has been completed; (D) Proper documentation of drug and device distributions and deliveries are maintained by the Class F pharmacy and are made available upon request to practitioners involved in the care of the patient and to board of pharmacy representatives; (E) A policy and procedure manual is maintained that is available for inspection by board of pharmacy personnel. The manual shall include a quality assurance program with which to monitor the qualifications, training and performance of personnel; and (F) The pharmacist-in-charge is responsible for the drug/ device delivery system and for establishing a written protocol for the implementation of the delivery system including methods for supervising drug/device deliveries to patients of the pharmacy. 1. Any written protocols shall be available for inspection by board of pharmacy personnel. 2. Any changes to the policy and procedure manual or to written protocols must be approved by the pharmacist-incharge. (3) A Class F pharmacy may deliver products to a person with chronic kidney failure only upon the receipt of a valid prescription from an authorized prescriber specifying or including: (A) Documents that the intended recipient will require such products for the appropriate treatment of the disease and that the intended recipient has been trained in home dialysis therapy; (B) The duration of the prescriber’s order, not to exceed one (1) year, including all authorized refills; and (C) The name and product code of each product prescribed and the quantity prescribed. (4) Personnel of the pharmacy shall assemble the products to be delivered pursuant to the prescriber’s order(s). In assembling such products for delivery, the pharmacy shall take steps necessary to assure the following: (A) The code numbers and quantities of the products assembled match the code numbers identified in the prescriber’s order(s); (B) Any products bearing an expiration date have a minimum of three (3) full months of shelf-life remaining; (C) A visual inspection is completed of all drugs and devices for compliance with the prescriber’s order(s) and with all labeling requirements as set forth in 338.059, RSMo. Manufacturer sealed case lots shall be labeled with the name of the patient, date, and a control number that serves as a unique patient identifier number; and (D) Products ordered by a prescriber and provided to patients of the pharmacy shall be delivered either by personnel of the pharmacy or by a carrier authorized by the pharmacy. 1. Upon the delivery to patients of any drugs/devices, pharmacy personnel or the approved carrier shall confirm receipt by the patient or the patient’s designee and that the number of units delivered equals the number of units identified by documentation supplied by the pharmacy. (5) Class F pharmacies shall ensure: (A) The license of the pharmacy is displayed in plain view at the pharmacy location; (B) The pharmacy is open such hours as are necessary to safely and effectively dispense and deliver supplies to those persons designated by the applicable prescriber; (C) The pharmacy maintains sufficient space and storage capabilities as necessary to carry out its operations; and (D) All drugs and/or devices shall be properly identified and any outdated, misbranded or adulterated items shall be segregated from the active inventory within a clearly separate and defined area and held separately until the item is destroyed or returned to a licensed drug distributor. AUTHORITY: sections 338.220 and 338.280, RSMo 2016, and section 338.140, RSMo Supp. 2019.* This rule originally filed as 4 CSR 220-2.600. Original rule filed Jan. 20, 1998, effective Aug. 30, 1998. Moved to 20 CSR 220-2.600, effective Aug. 28, 2006. Amended: Filed May 13, 2019, effective Nov. 30, 2019. *Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019; 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997, 1999, 2001, 2004, 2007, 2009, 2011, 2013, 2014; and 338.280, RSMo 1951, amended 1971, 1981.