Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.600 - Standards of Operation for a Class F: Renal Dialysis Pharmacy

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule is being amended pursuant to
				  Executive Order 17-03 to remove unnecessary/duplicative rule
				  language.
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 self-administration 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
				self-administration 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-in-charge.