North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-02 - Pharmacies › Chapter 61-02-01 - Pharmacy Permits › Section 61-02-01-03 - Pharmaceutical compounding standards

Current through Supplement No. 393, July, 2024
The minimum standards and technical equipment to be
				  considered as adequate shall include:
1. Definitions.
a. "Active chemical or ingredient" refers to
				chemicals, substances, or other components of articles intended for use in the
				diagnostics, cure, mitigation, treatment, or prevention of diseases.
b. "Aseptic processing" is the method of
				preparing pharmaceutical and medical products that involves the separate
				sterilization of the product and of the package, the transfer of the product
				into the container and closure of the container under ISO class 5 or superior
				conditions, and using procedures designed to preclude contamination of drugs,
				packaging, equipment, or supplies by micro-organisms during the
				process.
c. "Beyond-use date"
				refers to the date placed on preparation label that is intended to indicate to
				the patient or caregiver a time beyond which the contents of the preparation
				are not recommended to be used. The beyond-use date is determined from the date
				and time compounding of the preparation is completed.
d. "Component" is any ingredient used in the
				compounding of a drug product, including any that are used in its preparation,
				but may not appear on the labeling of such a product.
e. "Compounded sterile preparation" (CSP)
				will include all of the following:
(1)
				Preparations prepared according to the manufacturer's labeled instructions and
				other manipulations when manufacturing sterile products that expose the
				original contents to potential contamination.
(2) Preparations containing nonsterile
				ingredients or employing nonsterile components or devices that must be
				sterilized before administration.
(3) Biologics, diagnostics, drugs, nutrients,
				and radiopharmaceuticals that possess either of the above two characteristics,
				and which include baths and soaks for live organs and tissues, implants,
				inhalations, injections, powders for injection, irrigations, metered sprays,
				and ophthalmic preparations.
f. "Compounder or compounding personnel" is
				the pharmacist or other licensed or registered health care professional
				responsible for preparing the compounded preparations.
g. "Compounding" is the preparation, mixing,
				assembling, packaging, and labeling of a drug or device in accordance to a
				licensed practitioner's prescription or medication order. Compounding does not
				include tablet splitting, reconstitution of oral or topical products as
				intended by the manufacturer, or repackaging of nonsterile dosage forms for
				redistribution, dispensing, or administration. Compounding includes:
(1) Preparation of drugs or devices in
				anticipation of prescription drug orders based on routine, regularly observed
				prescribing patterns.
(2) The
				addition of one or more ingredients to a commercial product as a result of a
				licensed practitioner's prescription drug order.
(3) Preparation of drugs or devices for the
				purposes of, or as an incident to, research, teaching, or chemical
				analysis.
(4) Categories of
				compounding.
(a) Nonsterile simple. Should be
				conducted according to USP chapter 795.
(b) Sterile compounds. Risk levels of
				compounded sterile preparations. Risk levels are assigned according to the
				corresponding probability of contaminating a preparation with microbial
				organisms, spores, and endotoxins, or chemical and physical contamination such
				as foreign chemicals and physical matter. Preparations should be compounded
				according to USP chapter 797 based on the appropriate risk level.
(c) Radiopharmaceuticals. See  article 61-05.
(d) Veterinary
				pharmaceuticals. Standards for veterinary pharmaceuticals are consistent with
				all parts of section 61-02-01-03.
h. "Compounding supervisor" is a person who
				supervises and is responsible for the compounding and dispensing of a
				nonsterile or sterile preparation. This may be the pharmacist on duty or the
				pharmacist-in-charge.
i. "Critical
				site" is a location that includes any component or fluid pathway surfaces (such
				as injection ports) or openings (such as opened ampules or needle hubs) exposed
				and at risk of direct contact with air, moisture, or touch
				contamination.
j. "Direct and
				contiguous compounding area" refers to the specific area where a compound is
				prepared.
k. "Disinfection" is the
				process by which the total number of micro-organisms is reduced to a safe level
				or eliminated by applying an agent to inanimate objects that destroys
				disease-causing pathogens or other harmful micro-organisms but may not kill
				bacterial and fungal spores.
l.
				"Hazardous drug" is one of those which studies in animals or humans indicate
				that exposures to them have a potential for causing cancer, development, or
				reproductive toxicity or harm to organs.
m. "ISO class" is a description of an
				atmospheric environment characterized by the number of particles of 0.5 microns
				or larger, within a cubic foot of air. "ISO class 5" atmospheric environment
				contains less than 100 particles, 0.5 microns or larger in diameter, per cubic
				foot of air.
n. "Media fill test"
				refers to tests used to validate aseptic techniques of compounding personnel
				and of processes that ensure the personnel and processes used are able to
				produce sterile products without microbial contamination. Testing uses a
				microbiological growth medium to substitute for actual drug product to simulate
				admixture compounding in determining the quality of a person's
				technique.
o. "NDC number" is the
				national drug code given to each drug separately and specifically approved by
				the food and drug administration for identification and reporting.
p. "Preparation" is a drug dosage form,
				dietary supplement, or a finished device. It contains one or more substances
				formulated for use on or for the patient or consumer.
q. "Primary engineering control (PEC)" refers
				to a device or room that provides an ISO class 5 or superior environment during
				the compounding process, including laminar airflow workbenches (LAFWs),
				biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), and
				compounding aseptic containment isolators (CACIs).
r. "Product" is a commercially manufactured
				drug or nutrient that has been evaluated for safety and efficacy by the food
				and drug administration, accompanied by full prescribing information.
s. "Repackaging" is the transfer of an
				ingredient from one container to another.
t. "Risk levels" of CSPs determine the level
				assigned that represent the probability that it will be contaminated with
				microbial organisms, spores, endotoxins, foreign chemicals, or other physical
				matter.
u. "Seventy percent sterile
				isopropyl" or IPA is an antimicrobial used to clean surfaces used in sterile
				preparations.
v. "Stability" means
				the extent to which a preparation retains, with specified limits, and
				throughout its period of storage and use, the same properties and
				characteristics it possessed at the time of compounding.
w. "US pharmacopeia (USP)" is the book of
				official compendia of standards for the United States.