North Dakota Administrative Code › Title 33 - State Department of Health › Article 33-44 - Medical Marijuana › Chapter 33-44-01 - Medical Marijuana › Section 33-44-01-55 - Manufacturing facility quality control and quality assurance program

Current through Supplement No. 393, July, 2024
1. A manufacturing facility shall develop and
				follow a written quality control and quality assurance program. The program
				must be established to protect qualifying patient health and implemented in a
				manner to assist in complying with testing required in sections 33-44-01-42,
				33-44-01-43, and 33-44-01-44. A manufacturing facility is not prohibited by
				these rules to test marijuana and usable marijuana as part of a quality control
				and quality assurance program.
2. A
				quality control and quality assurance program must include an assessment of the
				profile of the active ingredients, including expiration date, and the presence
				of inactive ingredients and contaminants. Testing results must be used to
				determine appropriate conditions and expiration dates.
3. A manufacturing facility shall develop and
				follow written procedures for sampling marijuana and usable marijuana.
				Procedures must be developed related to sampling methods, sample collection,
				and documentation of sampling. Test results from random samples must be
				retained for at least three years.
4. The manufacturing facility shall develop
				and follow written procedures for performing stability testing of usable
				marijuana to determine product expiration date. Once an expiration date has
				been determined through testing described in subsection 5, a manufacturing
				facility must perform periodic stability testing to verify expiration
				dates.
5. If stability testing has
				not been completed within one year of production, a manufacturing facility may
				assign a tentative expiration date based on available stability information.
				Stability testing is to include, at a minimum, an assessment of microbiological
				contaminants and mycotoxins, heavy metals, and concentration. When applicable,
				the stability testing must include water activity and moisture content or
				solvents. If an expiration date is one year or less, at a minimum, a stability
				test must be performed once before fifty percent of the period has expired and
				at the end of the expiration date. If an expiration date is more than one year,
				at a minimum, a stability test must be performed at no less than six-month
				intervals and at the end of the expiration date. After the manufacturing
				facility verifies the tentative expiration date, or determines the appropriate
				expiration date, the manufacturing facility shall include the expiration date
				on each batch of marijuana or usable marijuana.
6. A manufacturing facility shall retain a
				uniquely labeled reserve sample representing each harvest lot, process lot of
				cannabinoid concentrate to be packaged in a container for transfer to a
				dispensary, and process lot of medical cannabinoid product for at least one
				year following the expiration date. The reserve sample must be stored in the
				same immediate container-closure system the usable marijuana is packaged in for
				dispensaries, or in one that has similar characteristics. The reserve sample
				must consist of at least twice the quantity necessary to perform all required
				tests.
General Authority:
NDCC 19-24.1-36
Law Implemented:
NDCC 19-24.1-36