Kan. Admin. Regs. § 68-13-3 - Nonsterile preparations
(a) This
regulation shall apply to the following:
(1)
Nonsterile preparations that are compounded in Kansas; and
(2) nonsterile preparations that are shipped
or delivered into Kansas by a pharmacy and are to be administered to a patient
in Kansas.
(b)
"Pharmacy," as used in this regulation, shall mean a pharmacy, nonresident
pharmacy, or outsourcing facility as defined by K.S.A. 2017 Supp.
65-1626,
and amendments thereto.
(c) Any
pharmacist may compound a nonsterile preparation that is commercially available
only if it is different from a product approved by the FDA and there is
sufficient documentation of a specific medical need for an individual
patient.
(d) A pharmacist shall not
compound a nonsterile preparation by any of the following methods:
(1) Using any component withdrawn from the
market by the FDA for safety reasons;
(2) receiving, storing, or using any drug
component that is not guaranteed or otherwise determined to meet the
requirements of an official compendium;
(3) compounding finished drugs from bulk
active ingredients that do not meet the requirements of a monograph listed in
the official compendium; or
(4)
compounding finished drugs from bulk active ingredients that are not components
of FDA-approved drugs.
(e) For the convenience of any patient, any
pharmacist may compound a nonsterile preparation before receiving an order
based on routine, regularly observed prescribing patterns.
(f) Compounding for non-human animals shall
meet the same requirements as those for human prescriptions, except that a
pharmacist shall not compound bulk chemicals for food-producing
animals.
(g) Each nonsterile
preparation sold by a pharmacy to a practitioner for administration to a
patient shall be packaged with a label that includes the following text: "For
Office Use Only - Not for Resale."
(h) Any pharmacy may distribute nonsterile
preparations without a prescription, including providing limited quantities to
a practitioner in the course of professional practice to administer limited
quantities to an individual patient, if the nonsterile preparations are not
intended for resale.
(i) Each
pharmacy selling any prescription nonsterile preparation to a practitioner for
office use shall maintain an invoice documenting the following:
(1) The name and address of the
practitioner;
(2) the drug
compounded, including the lot number and expiration date of each
component;
(3) the quantity sold;
and
(4) the date of the
transaction.
The invoice shall be maintained in the pharmacy and shall be made readily available to the pharmacist-in-charge, the board, and the board's designee.
(j)
Within each pharmacy in which compounding occurs, one area shall be designated
as the principal compounding area, where all nonsterile compounding shall take
place.
(1) Each compounding area shall be
well-lighted and well-ventilated, with clean and sanitary surroundings, and
shall be free of food and beverages.
(2) Each compounding area shall provide the
drugs, chemicals, and devices with necessary protection from deterioration due
to light, heat, and evaporation and shall be arranged to protect all
prescription drugs and devices from theft and any other unauthorized
removal.
(3) All components used in
compounding nonsterile preparations shall be stored in labeled containers in a
clean, dry area and, if required, under proper refrigeration.
(4) Each compounding area shall include a
sink that is equipped with hot and cold running water for hand and equipment
washing.
(k) Each
pharmacist compounding nonsterile preparations shall use purified water if the
formulations indicate the inclusion of water.
(l) Each pharmacist-in-charge shall maintain
a uniform formulation record for each nonsterile preparation, documenting the
following:
(1) The ingredients, quantities,
strength, and dosage form of the nonsterile preparation;
(2) the equipment used to compound the
nonsterile preparation and the mixing instructions;
(3) the container used in
dispensing;
(4) the storage
requirements;
(5) the beyond-use
date to be assigned;
(6) quality
control procedures, which shall include identification of each person
performing or either directly supervising or checking each step in the
compounding process and which may include monitoring the following:
(A) Capsule weight variation;
(B) adequacy of mixing to ensure uniformity
and homogeneity; and
(C) the
clarity, completeness, or pH of solutions;
(7) the source of the formulation, including
the name of the person, entity, or publication; and
(8) the name or initials of the person
creating the formulation record and the date on which the formulation record
was established at the pharmacy.
(m) Each pharmacist-in-charge shall maintain
on the original order or on a separate, uniform record a compounding record for
each nonsterile preparation, documenting the following:
(1) The name and strength of the nonsterile
preparation;
(2) the identifier
used to distinguish the nonsterile preparation's formulation record from other
formulation records;
(3) the name
of the manufacturer or repackager and, if applicable, the lot number and
expiration date of each component;
(4) the total number of dosage units or total
quantity compounded;
(5) the name
of each person who compounded the non-sterile preparation;
(6) the name of the pharmacist, or the
pharmacy student or intern working under the direct supervision and control of
the pharmacist, who verified the accuracy of the nonsterile
preparation;
(7) the date of
compounding;
(8) the assigned
internal identification number, if used;
(9) the prescription number, if
assigned;
(10) the results of
quality control procedures; and
(11) the assigned beyond-use date. In the
absence of valid scientific stability information that is applicable to a
specific drug or nonsterile preparation, the beyond-use date shall not be later
than the expiration date of any component of the formulation and shall be
established in accordance with the following criteria:
(A) For nonaqueous and solid formulations,
either of the following:
(i) If a manufactured
drug product is the source of the active ingredient, six months from the date
of compounding or the time remaining until the manufactured drug product's
expiration date, whichever is earlier; or
(ii) if a substance listed in an official
compendium is the source of an active ingredient, six months from the date of
compounding or the time remaining until the expiration date of any component of
the formulation, whichever is earlier;
(B) for water-containing oral formulations,
not more than 14 days when stored under refrigeration; and
(C) for water-containing non-oral
formulations, not longer than the intended duration of therapy or 30 days,
whichever is earlier.
(n) The compounding record and the
corresponding formulation record specified in subsections (m) and (l),
respectively, shall be retained at the pharmacy for at least five years and
shall be made readily available to the pharmacist-in-charge, the board, and the
board's designee.
(o) If a patient
requests a transfer of the patient's prescription, a copy of the original
prescription shall be transmitted upon the request of the receiving pharmacist.
The transferring pharmacist shall also transfer the following written
information with the prescription:
(1) Active
ingredients;
(2)
concentration;
(3) dosage
form;
(4) route of
delivery;
(5) delivery
mechanism;
(6) dosing duration;
and
(7) details about the
compounding procedure.
(p) The pharmacist-in-charge shall ensure
that all support personnel are trained and successfully demonstrate the
following before performing delegated compounding:
(1) Comprehensive knowledge of the pharmacy's
standard operating procedures with regard to compounding as specified in the
policy and procedure manual; and
(2) familiarity with the compounding
techniques used at the pharmacy.
Notes
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