Or. Admin. R. 333-008-1740 - Medical Marijuana Processors: Operation of Registered Processing Site

Current through Register Vol. 61, No. 4, April 1, 2022

(1) Policies and Procedures. In order to be registered and remain registered a processing site must create and maintain written, detailed standard policies and procedures that include but are not limited to:
(a) Instructions for making each medical cannabinoid product, concentrate or extract.
(b) The ingredients and the amount of each ingredient for each process lot.
(c) The process for making each product.
(d) The number of servings in a process lot.
(e) The intended amount of THC per serving and in a unit of sale of the product.
(f) The process for ensuring that the amount of THC is consistently distributed throughout each process lot.
(g) If processing a cannabinoid concentrate or extract:
(A) Conducting necessary safety checks prior to commencing processing; and
(B) Purging any solvent or other unwanted components from a cannabinoid concentrate or extract.
(h) Procedures for cleaning all equipment, counters and surfaces thoroughly.
(i) Proper handling and storage of any solvent, gas or other chemical used in processing or on the processing site premises in accordance with material safety data sheets and any other applicable laws.
(j) Proper disposal of any waste produced during processing in accordance with all applicable local, state and federal laws, rules and regulations.
(k) Quality control procedures designed to, at a minimum, ensure that the amount of THC is consistently distributed throughout each process lot and that potential product contamination is minimized.
(l) Appropriate use of any necessary safety or sanitary equipment.
(m) Emergency procedures to be followed in case of a fire, chemical spill or other emergency.
(n) Security.
(o) Transfers of marijuana items to and from the processing site.
(p) Testing.
(q) Packaging and labeling if the processor intends to or is packaging and labeling marijuana items after transfer to the processing site.
(r) Employee training.
(s) Compliance with these rules, including but not limited to violations and enforcement.
(t) Roles and responsibilities for employees and PRPs in assisting the Authority during inspections or investigations.
(2) Prohibitions. A registered processing site may not process or transfer a marijuana item:
(a) That by its shape, design or flavor is likely to appeal to minors, including but not limited to:
(A) Products that are modeled after non-cannabis products primarily consumed by and marketed to children; or
(B) Products in the shape of an animal, vehicle, person or character.
(b) That is made by applying cannabinoid concentrates or extracts to commercially available candy or snack food items.
(c) That contains dimethyl sulfoxide (DMSO).
(3) Employees. A registered processing site may employ an individual between the ages of 18 and 20 if the individual is a patient. Otherwise, processing site employees must be 21 years of age or older.
(4) Standardized Scales. In order to obtain a registration and to retain registration a processing site registrant must own, maintain on the premises and use a weighing device that is licensed by the Oregon Department of Agriculture. Licensed weighing devices must be used by a processing site whenever marijuana items are:
(a) Transferred to or from the processing site and the transfer is by weight;
(b) Packaged for transfer by weight; or
(c) Weighed for purposes of documenting information required in:
(B) CTS.
(5) Inventory Tracking and Point of Sale System: A registered processing site must have an integrated inventory tracking and point of sale system that can and does, at a minimum:
(a) Produce bar codes or similar unique identification numbers for each lot of usable marijuana transferred to a registered processing site and for each lot of a medical cannabinoid product, concentrate or extract transferred to a registered dispensary;
(b) Capture all information required to be documented in OAR 333-008-1760 and 333-008-1770; and
(c) Generate inventory, transaction, transport and transfer reports requested by the Authority viewable in Excel and PDF format.
(6) Online Verification of Registration Status. A registered processing site must verify an individual's or processing site's registration status with the Authority when receiving a transfer of a marijuana item if the Authority has available an online system for such verification.
(7) Transfers from and to patients or designated primary caregivers.
(a) A registered marijuana processing site may transfer a medical cannabinoid product, concentrate or extract to a patient, or a patient's designated primary caregiver if the patient or the patient's designated primary caregiver provides the marijuana processing site with the marijuana to be processed into the medical cannabinoid product, concentrate or extract and the marijuana processing site receives no compensation for the transfer of the marijuana.
(b) A registered processing site must document each transfer of marijuana by a patient or the patient's designated primary caregiver to the processing site in accordance with OAR 333-008-1760 and 333-008-1770.
(c) A registered processing site must document each transfer of a cannabinoid product, concentrate or extract to a patient or the patient's designated primary caregiver in accordance with OAR 333-008-1760 and 333-008-1770.
(d) A registered processing site may be compensated by the patient or the patient's designated primary caregiver for all costs associated with the processing of marijuana for the patient.
(8) Inventory On-Site. Marijuana items must be kept on-site at the registered processing site. The Authority may take enforcement action against a registered processing site if during an inspection a processing site cannot account for its inventory or if the amount of usable marijuana at the processing site is not within five percent of the documented inventory.
(9) Testing. A registered processing site must comply with the applicable sampling and testing requirements in OAR 333-007-0300 to 333-007-0490 and may not:
(a) Accept a transfer of a marijuana item that has not been tested in accordance with OAR 333-007-0300 to 333-007-0490 or that has failed a test under OAR 333-007-0450 and the product, concentrate or extract cannot be remediated.
(b) Transfer a medical cannabinoid product, concentrate or extract that has not been tested in accordance with OAR 333-007-0300 to 333-007-0490 or that has failed a test under OAR 333-007-0450 and the product, concentrate or extract cannot be remediated.
(10) Packaging and Labeling. A registered processing site must comply with the Commission's labeling and packaging requirements in OAR chapter 845, division 25. A processing site:
(a) Must comply with the Commission's pre-approval process for packaging and labeling in OAR chapter 845, division 25.
(b) Must keep all records related to the pre-approval process for two years from the date of approval and provide those records at the request of the Authority.
(c) May not transfer a marijuana item unless the package and label have been pre-approved by the Commission or pre-approval is not required under the Commission's rules.
(11) Industrial Hemp Products. A processing site may only accept the transfer of and may only transfer a product that contains THC or CBD that is derived from marijuana.
(12) Sampling. A registered processing site may provide a sample of a medical cannabinoid product, concentrate or extract to a dispensary for the purpose of the dispensary determining whether to purchase the product, concentrate or extract but the product, concentrate or extract may not be consumed on the processing site. Any sample provided to a dispensary must be recorded in the database.
(13) For purposes of this rule:
(a) "Lot of usable marijuana" means a quantity of usable marijuana transferred to a registered processing site from the same harvest lot as that term is defined in OAR 333-008-0010; and
(b) "Lot of medical cannabinoid products, concentrates or extracts" means a quantity of a medical cannabinoid product, concentrate or extract transferred to a registered dispensary at one time and that is from the same process lot as that term is defined in OAR 333-008-0010.

Notes

Or. Admin. R. 333-008-1740
PH 9-2016, f. 2-26-16, cert. ef. 3/1/2016; PH 21-2016, f. 6-24-16, cert. ef. 6/28/2016; PH 33-2016, f. & cert. ef. 11/28/2016; PH 29-2017, amend filed 12/22/2017, effective 1/1/2018; PH 174-2018, minor correction filed 04/30/2018, effective 4/30/2018; PH 248-2018, amend filed 08/17/2018, effective 8/17/2018; PH 260-2018, minor correction filed 11/28/2018, effective 11/28/2018; PH 22-2019, amend filed 11/15/2019, effective 1/1/2020; PH 79-2021, amend filed 11/15/2021, effective 1/1/2022

Statutory/Other Authority: ORS 475B.840 & 475B.849

Statutes/Other Implemented: ORS 475B.840 & 475B.849

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