NJ Adverse Events Procedure

New Jersey Cannabis Adverse Event Procedures

Do you need an Adverse Event Procedure for your NJ Cannabis Business? You’ve come to the right place. We offer this top quality NJ Cannabis Adverse Event SOP for all license types. Adverse events are negative health reactions that consumers might have to an ingested cannabis product. The CRC requires a formal process for handling cannabis Adverse Events, and their requirement for this procedure to be submitted is for the sake of ensuring that each business knows how to implement the Adverse Events process, should it ever be needed.

5 pages for all 12 processes and procedures described in § 17:30-9.16 CANNABIS BUSINESS COMPLAINT PROCESS

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From the CRC Regulations published on August 19th, 2021, page 99:


(a) A cannabis business shall establish standard operating procedures for receiving and recording complaints associated with usable cannabis or cannabis products that it has cultivated, manufactured, sold or distributed which shall include: 1. A process for submission of a complaint to the cannabis business; 2. A procedure for notifying all cannabis businesses that participated in the supply chain of the product identified in the complaint; 3. A procedure for reviewing the complaint; 4. A procedure for investigating the complaint; 5. A procedure for the review and approval of the findings by cannabis business personnel that are responsible for quality control; and 6. A procedure for follow-up action of any investigation performed and a response to the complainant.

(b) Based on the procedures established in (a) of this subchapter, a cannabis business shall make a determination as to whether the complaint may be evidence of an adverse event.

(c) A cannabis business shall establish procedures for complaints involving adverse events, which shall include: 1. Collecting data necessary to investigate the adverse event, including but not limited to: i. Noting the identifiable consumer who is reported to have experienced the adverse event; ii. Noting the initial reporter of the adverse event, or identifying that the initial reporter requests to remain anonymous; iii. Noting the identity of the specific usable cannabis or cannabis product used, if known, including batch or lot number, and the name of the cannabis business that sold the product to the identifiable consumer; and iv. A description of the adverse event based on information received from the identifiable consumer in (i), above, and the initial reporter in (ii), above. 2. Reporting the adverse event to the Commission within 7 days of becoming aware of the adverse event, including all information and data collected pursuant to this subchapter. 3. Reporting the adverse event to all cannabis businesses who participated in the supply chain of the product involved in the adverse event or the products batch or lot. 4. Investigating the adverse event to determine: i. If there was a deviation from the standard operating procedure in the cultivation of the batch or the manufacturing of the lot, which shall be done by reviewing cultivation or manufacturing logs; and ii. If the batch or lot meets specifications, which shall be done by submitting parts of the retention samples of the batch or lot to a testing laboratory for testing. 5. Determining if an adverse event requires a product recall; 6. A procedure for communicating the adverse event standard operating procedure to: i. Cannabis business staff members; ii. Consumers of the cannabis business; and 101 iii. Other cannabis businesses that purchase cannabis items from or provide cannabis items to the cannabis business.

(d) Adverse events shall be reported to the Commission within 48 hours.

(e) The review and investigation of a complaint or adverse event, and the findings and follow-up action of any investigation performed, must extend to all related batches or lots and relevant records and to all cannabis businesses involved in the supply chain of the product identified in the complaint. 1. Related batches or lots may include, but are not limited to, batches or lots of the same product, other batches or lots processed on the same equipment or during the same time period, or other batches or lots produced using the same components or packaging components.

(f) The cannabis business must keep a written record for four years of the complaint or adverse event and its investigation, including: 1. Identification and batch or lot number of the product; 2. Date the complaint was received and the name, address, or telephone number of the complainant, if available; i. Anonymous complaints shall be logged even when no name, address or telephone number is provided. 3. Nature of the complaint including, if known, how the product was used; 4. All notifications provided to the Commission, other cannabis businesses, consumers, and to the public; 5. Names of all personnel involved in the complaint process and their roles; 6. Findings of the investigation and follow-up action taken when an investigation is performed; and 7. Response to the complainant, if applicable.

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New Jersey Cannabis License