Current through Register Vol. 49, No. 6, March 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.
(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.
*Original authority: 338.140, RSMo 1939, amended 1981,
1989, 1997; 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997; and 338.280,
RSMo 1951, amended 1971, 1981 .
