Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 13 - PARENTERAL PRODUCTS › Section 68-13-2 - Definitions

Current through Register Vol. 43, No. 28, July 11, 2024
As used in this article of the board's regulations, each of the
				following terms shall have the meaning specified in this regulation:
(a) "Active ingredients" means chemicals,
			 substances, or other components intended for use in the diagnosis, cure,
			 mitigation, treatment, or prevention of diseases in humans or for use as
			 nutritional supplements.
(b) "Added
			 substances" and "inactive ingredients" mean the ingredients necessary to
			 compound a sterile preparation or nonsterile preparation and not intended or
			 expected to cause a human pharmacologic response if administered alone in the
			 amount or concentration contained in a single dose of the drug
			 product.
(c) "Antearea" means an
			 area, separate from the buffer area, that meets the requirements of an ISO
			 class eight environment and in which personal hygiene and garbing procedures,
			 staging of components, order entry, and labeling are performed.
(d) "Batch" means multiple sterile dosage
			 units in a quantity greater than 25 that are compounded in a discrete process
			 by the same individual or individuals during one limited period.
(e) "Beyond-use date" means a date placed on
			 a prescription label at the time of dispensing, repackaging, or prepackaging
			 that is intended to indicate to the patient or caregiver a time beyond which
			 the contents of the prescription are not recommended to be used.
(f) "Biological safety cabinet" and "BSC"
			 mean a ventilated cabinet for sterile preparations and hazardous drugs to
			 protect personnel, products, and the environment that has an open front with
			 inward airflow for protection of personnel, downward-airflow LAFS for product
			 protection, and HEPA-filtered exhausted air for environmental
			 protection.
(g) "Buffer area" means
			 an area that meets the requirements for an ISO class seven environment and in
			 which the primary engineering control is located.
(h) "Clean room" means a room that meets the
			 requirements for an ISO class five environment.
(i) "Complex nonsterile compounding" means
			 making a nonsterile preparation that requires special training, environment,
			 facilities, equipment, and procedures to ensure appropriate therapeutic
			 outcomes. Nonsterile preparations made using complex nonsterile compounding
			 shall include transdermal dosage forms, modified-release forms, and
			 suppositories for systemic effects.
(j) "Component" means any active ingredient
			 or added substance intended for use in the compounding of a drug product,
			 including any ingredient that does not appear in the drug product.
(k) "Compounding" has the meaning specified
			 in K.S.A. 2017 Supp.
			 65-1626,
			 and amendments thereto.
(l)
			 "Compounding area" means any area in a pharmacy or outsourcing facility where
			 compounding is performed.
(m)
			 "Compounding aseptic containment isolator" and "CACI" mean a compounding
			 aseptic isolator designed to provide worker protection from exposure to
			 undesirable levels of airborne drugs throughout the compounding and material
			 transfer process and to provide an aseptic environment for compounding sterile
			 preparations. Air exchange with the surrounding environment shall not occur
			 unless the air is first passed through a HEPA filter capable of containing
			 airborne concentrations of the physical size and state of the drug being
			 compounded. whenever volatile hazardous drugs are compounded, the exhaust air
			 from the CACI shall be removed by the building's ventilation system.
(n) "Compounding aseptic isolator" and "CAI"
			 mean a type of isolator specifically designed for compounding sterile
			 preparations or nonsterile preparations and designed to maintain an aseptic
			 compounding environment within the isolator throughout the compounding and
			 material transfer process. Air exchange into the CAI from the surrounding
			 environment shall not occur unless the air has first passed through a HEPA
			 filter and an ISO class five environment is maintained.
(o) "Cytotoxic," when used to describe a
			 pharmaceutical, means that the pharmaceutical is capable of killing living
			 cells. This term is also used to describe components classified as cancer
			 chemotherapeutic, carcinogenic, mutagenic, or antineoplastic.
(p) "Dosage unit" means the amount of a
			 sterile preparation that would be administered to or taken by one patient at a
			 time.
(q) "Endotoxin" means a
			 potentially toxic, natural compound that is a structural component of bacterial
			 cell walls and that is released mainly when bacteria undergo destruction or
			 decomposition.
(r) "Essentially a
			 copy" means any sterile preparation or nonsterile preparation that is
			 comparable in active ingredients to a commercially available drug product,
			 unless either of the following conditions is met:
(1) There is a change made for an identified
			 individual patient that produces a clinically significant difference for the
			 patient, as determined by the prescribing practitioner, between the comparable
			 commercially available drug product and either the sterile preparation or the
			 nonsterile preparation.
(2) The
			 drug appears on the drug shortage list in section 506E of the federal food,
			 drug, and cosmetic act,
			 21 U.S.C.
			 356e, at the time of compounding,
			 distribution, and dispensing.