Current through Register Vol. 46, No. 39, September 25, 2024
(a) All cannabinoid hemp processors shall:
(1) extract hemp extract and/or manufacture
cannabinoid hemp products to GMP standards and if applicable for the type of
processor license, maintain a qualified third-party certification, to the
satisfaction of the office, for the applicable GMP standard(s) for the duration
of the license;
(2) maintain
standard operating procedures and quality control standards to ensure
consistency of hemp extract and/or cannabinoid hemp products, including but not
limited to product purity, strength and composition;
(3) maintain sufficient records to
demonstrate that any hemp or hemp extract used by the licensee was grown,
derived, extracted and transported in accordance with applicable laws and
licensing requirements of the jurisdiction(s) from which such hemp or hemp
extract was sourced. Such records shall include any pesticides used in the
growing of such hemp, date(s) each shipment was received, adequate chain of
custody to demonstrate from whom the licensee purchased such hemp or hemp
extract, and certificates of analysis. For hemp received from an out-of-state
grower, processors shall also maintain records of the out-of-state grower
registration or license number in the respective jurisdiction;
(4) keep all designated extracting and
manufacturing areas safe and sanitary, including but not limited to ensuring
that such areas are adequately lit, cleaned, smoke-free, and no food is
consumed in such areas;
(5) provide
all employees performing extraction or manufacturing with adequate training and
proper safety equipment;
(6)
manufacture cannabinoid hemp products in accordance with section
114.8 of this Part;
(7) test a statistically significant number
of cannabinoid hemp products per lot or batch at a third-party testing
laboratory meeting all the requirements in section
114.10 of this Part, and maintain a
certificate of analysis for all samples tested;
(8) maintain sufficient records pertaining to
the calibration and inspection of instruments used in extraction and
manufacturing of cannabinoid hemp products;
(9) report, in a frequency and manner
prescribed by the office, the total production and sales of the licensee during
such reporting period;
(10) ensure
the security of the licensed premises to prevent unauthorized individuals from
entering the facility and to prevent hemp extract and/or cannabinoid hemp
products from being diverted from the facility;
(11) not use synthetic cannabinoids,
artificially derived cannabinoids, or [DELTA] 8-tetrahydrocannabinol or [DELTA]
10-tetrahydrocannabinol created through isomerization, in the extraction or
manufacturing of any cannabinoid hemp products;
(12) assign a lot or batch number to each lot
of hemp extract or cannabinoid hemp product, extracted or manufactured by a
licensee; and
(13) maintain any and
all records required by this Part for at least three years and immediately
produce such records upon request of the office.
(b) Possession and the intermediate sale of
hemp extract by and between licensed cannabinoid hemp processors, is permitted,
provided when such extract leaves the licensed premises it is accompanied by a
certificate of analysis certifying that the extract is less than five (5)
percent THC and a copy of the cannabinoid hemp processor's license, and further
provided such hemp extract is only transported intra-state.
(c) Licensees shall monitor complaints from
cannabinoid hemp retailers and consumers and have a mechanism in place to
notify the licensee's supply chain to recall products when directed by the
office or as deemed appropriate by the licensee. Licensees shall notify the
office within 24 hours of learning of a serious adverse event.
(d) Licensees shall ensure the proper
disposal, beyond reclamation, of any hemp extract or by-product from the
extraction and manufacture process with a total [DELTA] 9-Tetrahydrocannabinol
concentration greater than three-tenths of a percent (0.3%) and which will not
be used or subject to further processing. Such disposal shall render the hemp
extract or by-product unusable for any intoxicating purpose. Licensees shall
maintain records to document and track any [DELTA] 9-Tetrahydrocannabinol
extracted from hemp or found within hemp extract throughout the extraction and
manufacturing process, including records pertaining to the amount used in
cannabinoid hemp products and the disposal of all hemp extract, [DELTA]
9-Tetrahydrocannabinol or by-product;
(1)
licensees shall dispose of any cannabinoid hemp product that is outdated,
damaged, deteriorated, contaminated or otherwise deemed not appropriate for
sale; and
(2) licensees shall
dispose of liquid, chemical and hazardous waste in accordance with applicable
federal, state and local laws and regulations.
(e) The office may conduct random sampling
and testing of hemp, hemp extract, cannabinoid hemp products, or any solvents,
chemicals, or materials used by the licensee, unannounced, at any time during
normal business hours of the licensee.
(f) If a cannabinoid hemp processor is
authorized to perform extraction, the processor shall:
(1) only extract using methods approved by
the office, on the licensed premises, and using employees and equipment
sufficient to ensure safe extraction; and
(2) use only those solvents that are approved
by the office. Solvent-based extraction must be completed in a commercial,
professional grade, closed-loop system capable of recovering the solvent used
for extraction.
