Kan. Admin. Regs. § 68-13-2

Current through Register Vol. 43, No. 32, August 8, 2024

Section 68-13-2 - Definitions

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.

(s) "Excursion" means a deviation from the range of temperatures specified by the manufacturer for storage or transport of a pharmaceutical based on stability data.

(t) "Glove fingertip test" means a test in which a gloved fingertip is pressed to and cultured on a microbiological growth media plate. Each successful glove fingertip test shall yield no more than three colony-forming units per contact plate for the annual competency evaluation and shall yield zero colony-forming units at least three times for the initial competency evaluation.

(u) "Hazardous drug" means any drug or compounded drug identified by at least one of the following criteria:

(1) Carcinogenicity;

(2) teratogenicity or developmental toxicity;

(3) reproductive toxicity;

(4) organ toxicity at low doses;

(5) genotoxicity; or

(6) drug product structure or toxicity that mimics that of existing hazardous drugs.

(v) "HEPA" means high-efficiency particulate air.

(w) "ISO class eight environment" means an atmospheric environment containing less than 3,520,000 airborne particles measuring at least 0.5 micron in diameter per cubic meter of air.

(x) "ISO class five environment" means an atmospheric environment containing less than 3,520 airborne particles measuring at least 0.5 micron in diameter per cubic meter of air.

(y) "ISO class seven environment" means an atmospheric environment containing less than 352,000 airborne particles measuring at least 0.5 micron in diameter per cubic meter of air.

(z) "Laminar airflow system" and "LAFS" mean an apparatus designed to provide an ISO class five environment for the compounding of sterile preparations using air circulation in a defined direction that passes through a HEPA filter.

(aa) "Manufacturing" means manufacture as defined in K.S.A. 65-1626, and amendments thereto.

(bb) "Media fill test" means a test in which a microbiological growth medium, which may consist of a soybean-casein digest medium, is substituted for an actual drug product to simulate admixture compounding. The media fill test shall be successful if it produces a sterile preparation without microbial contamination.

(cc) "Moderate nonsterile compounding" means making a nonsterile preparation that requires special calculations or procedures to determine quantities of components per nonsterile preparation or per dosage unit or making a nonsterile preparation for which stability data is not available. Nonsterile preparations made using moderate nonsterile compounding shall include morphine sulfate suppositories, diphenhydramine troches, and a mixture of two or more manufactured creams if stability of the mixture is not known.

(dd) "Multiple-dose container" means a multiple-unit container for any sterile preparation intended only for parenteral administration, usually containing antimicrobial preservatives.

(ee) "Nonsterile preparation" means a pharmaceutical made using simple nonsterile compounding, moderate nonsterile compounding, or complex nonsterile compounding.

(ff) "Official compendium" has the meaning specified in K.S.A. 65-656, and amendments thereto.

(gg) "Order" means either a prescription order as defined in K.S.A. 65-1626, and amendments thereto, or a medication order as defined in K.A.R. 68-5-1.

(hh) "Parenteral," when used to refer to a solution, means that the solution is administered by injection through one or more layers of skin or by other routes of administration that bypass the gastrointestinal tract.

(ii) "Parenteral product" means a sterile preparation administered by injection through one or more layers of skin or by other routes of administration that bypass the gastrointestinal tract.

(jj) "Practitioner-patient-pharmacist relationship" means a relationship that meets all of the following conditions:

(1) The practitioner has assumed the responsibility for making medical judgments regarding the health of the patient and the need for medical treatment.

(2) The practitioner has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition, and the practitioner has examined the patient and is available for follow-up.

(3) The practitioner has communicated the necessary prescriptions to the pharmacist, who is able to provide pharmaceutical care to the patient and, if needed, communicate with the practitioner.

(kk) "Primary engineering control" means a clean room or an apparatus for compounding sterile preparations, including an LAFS, a BSC, a CAI, or a CACI, designed to provide an ISO class five environment for compounding sterile preparations.

(ll) "Purified water" means water that meets the requirements for ionic and organic chemistry purity and protection from microbial contamination specified in section 1231 of the official compendium.

(mm) "Refrigeration" and "controlled cold temperature" mean a temperature maintained thermostatically between 2° and 8°C (36° to 46°F) that allows for excursions between 0° and 15°C (32° to 59°F) that are experienced during storage, shipping, and distribution, such that the allowable calculated mean kinetic temperature is not more than 8°C (46°F).

(nn) "Room temperature" means a temperature maintained thermostatically that meets the following criteria:

(1) Encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F);

(2) results in a mean kinetic temperature calculated to be not more than 25°C (77°F); and

(3) allows for excursions between 15° and 30°C (59° to 86°F) experienced in pharmacies, hospitals, and storage facilities, such that the allowable calculated mean kinetic temperature remains in the allowed range.

(oo) "Segregated compounding area" means a designated, demarcated area or room that is restricted to compounding low-risk sterile preparations, which shall contain a primary engineering control providing unidirectional airflow that maintains an ISO class five environment and shall be void of all activities and materials extraneous to the sterile compounding process.

(pp) "Simple nonsterile compounding" means either of the following:

(1) Making a nonsterile preparation that has a compounding monograph listed in the official compendium or that appears in a peer-reviewed journal containing specifics on component quantities, compounding procedure, equipment, and stability data for the formulation and appropriate beyond-use dates; or

(2) reconstituting or manipulating commercially available products that require the addition of one or more ingredients as directed by the manufacturer.

Nonsterile preparations made using simple nonsterile compounding shall include captopril oral solution, indomethacin topical gel, and potassium bromide oral solution.

(qq) "Single-dose container" means a single-unit container for any sterile preparation intended for parenteral administration that is accessed once for one patient.

(rr) "Specific medical need" means a medical reason why a commercially available drug product cannot be used, excluding cost and convenience.

(ss) "Sterile preparation" means any dosage form of a drug, including parenteral products free of viable microorganisms, made using currently accepted aseptic compounding techniques under acceptable compounding conditions. This term shall include any commercially compounded sterile drug dosage form that has been altered in the compounding process.

(tt) "Sufficient documentation" means either of the following:

(1) A prescription documenting a specific medical need; or

(2) a notation in a pharmacy's or an outsourcing facility's records that verbal or other documentation of the specific medical need was received for each prescription, including the name of the person verifying the specific medical need, the date, and the specific medical need.

Kan. Admin. Regs. § 68-13-2

Authorized by K.S.A. 65-1630 and K.S.A. 2017 Supp. 65- 1637e; implementing K.S.A. 2017 Supp. 65-1626, K.S.A. 2017 Supp. 65-1626a, K.S.A. 65-1634, K.S.A. 2017 Supp. 65-1637c, and K.S.A. 2017 Supp. 65-1642; amended by Kansas Register Volume 37, No. 17; effective 5/11/2018.