N.Y. Comp. Codes R. & Regs. tit. 9 § 114.7

Current through Register Vol. 46, No. 36, September 4, 2024

Section 114.7 - Requirements for Cannabinoid Hemp Processors

(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.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 114.7

Adopted New York State Register November 24, 2021/Volume XLIII, Issue 47, eff. 11/24/2021

Amended New York State Register October 5, 2022/Volume XLIV, Issue 40, eff. 10/5/2022

Amended New York State Register December 13, 2023/Volume XLV, Issue 50, eff. 12/13/2023