Each member shall establish and implement written procedures to ensure that:
- A qualified individual shall review and investigate all product complaints to determine whether such complaints involve a possible failure of a cannabis product to meet any of its specifications;
- Quality control personnel shall review and approve decisions determining whether to investigate a product complaint and shall review and approve the findings and follow up action(s) of any investigation performed;
- Pursuant to subdivisions (a) and (b) in this section, any review and/or investigative activities by qualified individuals and quality control personnel shall extend to all relevant batches and records.
- Quality control personnel shall maintain written records for every product complaint and subsequent investigation, if any. The records shall include:
(1) The name and description of the cannabis product;
(2) The batch number or UID of the cannabis product, if available;
(3) The date the complaint was received and the name, address, and/or telephone number of the complainant, if available;
(4) The nature of the complaint including, if known, how the product was used;
(5) The reply to the complainant, if any; and
(6) Any findings of the investigation and/or follow-up action taken when an investigation is performed.
- For purposes of this section, “product complaint” means any communication that contains any allegation, written, electronic, or oral, expressing concern, for any reason, with the quality of a cannabis product that could be related to the manufacturing practices. Examples of product complaints may include but are not limited to: foul odor, off taste, illness or injury, disintegration time, color variation, foreign material in a cannabis product container, improper packaging, mislabeling, cannabis products that contain incorrect concentration of cannabinoids, or cannabis products contain a wrong ingredient, or any form of contaminant.
Each member shall establish and implement written procedures for recalling cannabis products manufactured by the licensee that are determined to be misbranded or adulterated. These procedures shall include:
- Factors which necessitate a recall;
- Personnel responsible for implementing the recall procedures; and
- Notification protocols, including:
(1) A mechanism to notify all customers that have, or could have, obtained the product, including communication and outreach via media, as necessary and appropriate;
(2) A mechanism to notify any licensees that supplied or received the recalled product;
(3) Instructions to the general public and/or other licensees for the return and/or destruction of recalled product.
(4) Procedures for the collection and destruction of any recalled product. Such procedures shall meet the following requirements: 1) All recalled products that are intended to be destroyed shall be quarantined for a minimum of 72 hours. The licensee shall affix to there called products any bills of lading, shipping manifests, or other similar documents with product information and weight, and shall notify the appropriate regulatory agency of the quarantine. The product held in quarantine shall be subject to auditing by the appropriate regulatory agency.
(5) A licensee shall dispose of chemical, dangerous, or hazardous waste in a manner consistent with federal, state, and local laws. This requirement shall include but is not limited to recalled products containing or consisting of pesticide or other agricultural chemicals, certain solvents or other chemicals used in the production of manufactured cannabis batches, and cannabis soaked in a flammable solvent for the purpose of producing manufactured cannabis batches.
(6) A licensee shall not dispose of recalled product in an unsecured area or waste receptacle that is not in the possession and/or control of the licensee.
For recalled cannabis products, the licensee shall enter the following details into the track and trace database: the weight of the product, reason for destruction, and the date the quarantine period will begin.
Failed Product Batches
- Failed product batches shall be destroyed unless remediation or reprocessing is approved by the state agency.
- Remediation or reprocessing of failed product batches or the use of harvest batches that have failed any laboratory test shall comply with any requirements and procedures established by the state appropriate regulatory agency through regulation, in addition to the requirements of this chapter.
- Edible Cannabis Products that fail laboratory testing requirements shall not be re-mediated or reprocessed and shall be destroyed. If any Edible Cannabis Product that has failed laboratory testing is re-mediated, reprocessed, or otherwise mixed with another batch of cannabis product, such action shall render the final cannabis product adulterated, regardless of the defect level of the final cannabis product.
- Not withstanding subsection (e), a cannabis product that is determined through laboratory testing to be labeled with an incorrect amount of THC per package or per serving may be relabeled with the correct information in accordance with a corrective action plan approved by the appropriate regulatory agency.
- Prior to any remediation or reprocessing of a failed product batch or the use of a failed harvest batch, the licensee shall submit a corrective action plan to the appropriate regulatory agency to include, at minimum, a description of how the product or harvest batch will be re-mediated such that the product or any product produced therefrom will meet all laboratory testing and quality assurance requirements. A failed product or harvest batch shall not be re-mediated or reprocessed by a licensee unless the appropriate regulatory agency has approved the licensee’s corrective action plan. Remediation or reprocessing of Edible Cannabis Products shall not be approved.
- Any remediation or reprocessing of a product batch that has failed laboratory testing or quality assurance review or the use of a failed harvest batch by a licensee shall be documented in the manufacturing records. All re-mediated product batches and products produced therefrom shall be tested and undergo quality assurance review in accordance with the requirements established by the appropriate regulatory agency prior to retail sale.