The California Cannabis Track-and-Trace System serves to ensure compliant supply chain management within all verticals of the cannabis industry. All three State regulatory agencies reference this system in their regulations. The California Department of Public Health regulates the cannabis manufacturing vertical and strives to protect public health and safety by ensuring commercial cannabis manufacturers operate safe, sanitary workplaces and follow good manufacturing practices to produce products that are free of contaminants, meet product guidelines, and are properly packaged and labeled. Here’s what you need to know about cannabis waste, track-and-trace and CDPH.
CDPH Regulatory Compliance: Track-and-Trace
Cannabis Waste and Track-and-Trace
The destruction and disposal of cannabis goods must be recorded into the California Cannabis Track-and-Trace system. According to the CDPH regulations, waste containing cannabis or cannabis products must be entered into the track-and-trace system within 24 hours of occurrence of the activity (destruction/disposal).
CDPH Track-and-Trace Regulations (included below)
Full Text of CDPH Regulations
40264. Batch Production Record.
(a) The licensee shall prepare a written batch production record every time a batch of a cannabis product is manufactured. The batch production record shall accurately follow the appropriate master manufacturing protocol, and each step of the protocol shall be performed in the production of the batch.
(b) The batch production record shall document complete information relating to the production and control of each batch, including all of the following details:
(1) The UID, and if used, the batch or lot number, of the finished batch of cannabis product and the UIDs of all cannabis products used in the batch.
(2) The identity of equipment and processing lines used in producing the batch;
(3) The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained;
(4) The identification number assigned to each component (or, when applicable, to a cannabis product received from a supplier for packaging or labeling as a cannabis product), packaging, and label used;
(5) The identity and weight or measure of each component used;
(6) A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing;
(7) The actual results obtained during any monitoring operation;
(8) The results of any testing or examination performed during the batch production, or a cross-reference to such results; and
(9) Documentation, at the time of performance, of the manufacture of the batch, including:
(A) The date on which each step of the master manufacturing protocol was performed; and
(B) The initials of the persons performing each step, including:
(i) The initials of the person responsible for weighing or measuring each component used in the batch;
(ii) The initials of the person responsible for verifying the weight or measure of each component used in the batch;
(iii) The initials of the person responsible for adding the component to the batch; and
(iv) The initials of the person responsible for verifying the addition of components to the batch.
(10) Documentation, at the time of performance, of packaging and labeling operations, including:
(A) An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record;
(B) The expected number of packaging and labels to be used, the actual quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; and
(C) The results of any tests or examinations conducted on packaged and labeled cannabis products (including repackaged or relabeled cannabis products), or a cross-reference to the physical location of such results.
(11) Documentation at the time of performance that quality control personnel:
(A) Reviewed the batch production record;
(B) Reviewed all required monitoring operation(s) required by this article;
(C) Reviewed the results of all tests and examinations, including tests and examinations conducted on components, in-process materials, finished batches of
cannabis product, and packaged and labeled cannabis products;
(D) Either approved and released–or rejected–the batch for distribution; and
(E) Either approved and released–or rejected– the finished cannabis product, including any repackaged or relabeled cannabis product.
(12) Documentation at the time of performance of any required material review and disposition decision.
(c) The batch production record shall:
(1) Contain the actual values and observations obtained during monitoring and, as appropriate, during verification activities;
(2) Be accurate, indelible, and legible;
(3) Be created concurrently with performance of the activity documented;
(4) Be as detailed as necessary to provide history of work performed; and:
(A) Include information adequate to identify any associated manufacturing facility (e.g., the name, license number, and when necessary, the location of the facility);
(B) Include the date and, when appropriate, the time of the activity documented;
(C) Include the signature or initials of the person performing the activity; and
(D) Include the identity of the product, the UID, and the lot number or batch identifier, if any.
40277. Weights and Measures.
(a) Weighing devices used by a licensee shall be approved, tested, and sealed in accordance with the requirements in Chapter 5 (commencing with Section 12500) of Division 5 of the Business and Professions Code, and registered with the county sealer consistent with Chapter 2 (commencing with 12240) of Division 5 of the Business and Professions Code. Approved and registered devices shall be used whenever:
(1) Cannabis or cannabis product is bought or sold by weight or count;
(2) Cannabis or cannabis product is packaged for sale by weight or count;
(3) Cannabis or cannabis product is weighed or counted for entry into the track-and-trace system; and
(4) The weighing device is used for commercial purposes as defined in section 12500 of Business and Professions Code.
(b) For the purposes of this chapter, count means the numerical count of the individual cannabis product units.
(c) For bulk shipments of cannabis and cannabis products, a licensee shall be licensed as a weighmaster, and a certificate issued by a licensed weighmaster, shall be consistent with the requirements in Chapter 7 (commencing with section 12700) of Division 5 of Business and Professions Code.
40282. Inventory Control – Cannabis and Cannabis Products.
(a) A licensee shall establish and implement a written inventory control plan capable of tracking the location and disposition of all cannabis and cannabis products at the licensed premises.
(b) A licensee shall reconcile the on-hand inventory of cannabis and cannabis products at the licensed premises with the records in the track-and-trace database least once every thirty (30) calendar days. Reconciliation shall be performed by one person and independently verified by a second person.
(c) If a licensee finds a discrepancy between the inventory and the track-and-trace database, the licensee shall conduct an audit.
(d) The licensee shall notify the Department within 24 hours if an audit reveals a discrepancy that is not within five percent of the documented inventory.
(e) If a licensee finds evidence of suspected theft or diversion, the licensee shall immediately report the suspected theft or diversion to the Department.
40290. Waste Management.
(d) Waste containing cannabis or cannabis products shall be entered into the track-and-trace system as required under Section 40512.
40500. Record Keeping Requirements.
(a) The licensee shall have the following documents available on the premises at all times and shall make the documents available to the Department and any enforcement agency upon request:
(1) The valid state license issued by the Department;
(2) Any other valid license issued by a state cannabis licensing agency;
(3) The valid license, permit, or other approval issued by the local jurisdiction;
(4) The premises diagram;
(5) The current standard operating procedures as defined in Section 40275;
(6) Shipping manifests;
(7) Employee records, including evidence of employee qualifications and training procedures and logs; and
(8) Any other record or documentation required to be kept pursuant to this Chapter or the Act.
b) The records required pursuant to subsection (a) shall be maintained in a manner immediately accessible on the premises to the Department and any enforcement agencies upon request for a period of two (2) years, except that outdated standard operating procedures shall not be accessible to onsite employees. After two (2) years, records may be maintained by the licensee in an alternate manner, provided that the records can be made available to the Department or enforcement agency no later than 48 hours following a request and that the records are retained for a period of 7 years in total.
(c) All documentation shall be maintained in English.
Article 2. Track-and-Trace System
40510. Track-and-Trace System General Requirements
(a) A licensee shall enter all commercial cannabis activities into the track-and-trace system within 24 hours of occurrence.
(b) Within ten (10) calendar days of notification from the department that the annual license application fee has been processed, a licensee shall register for track-and-trace system training provided by the Department of Food and Agriculture or its designee.
(c) If a licensee has not registered for training pursuant to subsection (a), the licensee shall register for training within five (5) business days of notification from the Department that the license has been approved.
(d) A licensee shall designate at least one owner to be the track-and-trace system account manager. The track-and-trace system account manager shall have the following responsibilities:
(1) Designate authorized track-and-trace system users and require designated users to be trained in the proper and lawful use of the track-and-trace system before the designated user can access the system;
(2) Maintain an accurate and complete list of all track-and-trace system account managers and users and update the list immediately upon any change;
(3) Ensure that each track-and-trace account manager and user has a unique logon, consisting of a username and password, which shall not be shared with or used by any other person;
(4) Cancel any track-and-trace system account manager or user from a track-and trace system account if the individual is no longer a licensee representative;
(5) Obtain UID tags from the Department of Food and Agriculture, or its designee, and ensure that a sufficient supply of UIDs is available at all times;
(6) Ensure that all inventory is tagged and entered in the track-and-trace system as required by Section 40512 or track-and-trace system requirements.
(7) Correct any information that is entered into the track-and-trace system in error within three (3) business days of discovery of the error;
(8) Monitor all notifications from the track-and-trace system and resolve all issues identified in the notification. The notification shall not be dismissed by an account manager until the issue(s) identified in the notification has been resolved.
(e) No person shall intentionally misrepresent or falsify information entered into the track-and-trace system. The track-and-trace system shall be the system of record. The licensee is responsible for the accuracy and completeness of all data and information entered into the track-and-trace system. Information entered into the track-and-trace system shall be assumed to be accurate and may be used to take enforcement action against the licensee if not corrected.
(f) The licensee is responsible for all actions that a track-and-trace system account manager or user acting as a licensee representative takes while logged into the track-and-trace system or otherwise conducting commercial cannabis activities.
40512. Track-and-Trace System Reporting Requirements.
(a) A system account manager or user shall record all of the following activities in the track-and-trace system within 24 hours of the activity:
(1) Receipt of cannabis material.
(2) The transfer to or receipt of cannabis products for further manufacturing from another licensed manufacturer.
(3) All changes in the disposition of cannabis or cannabis products. A change in disposition includes, but is not limited to:
(A) Processing of the cannabis or further processing of the cannabis product;
(B) Packaging cannabis products.
(4) Transfer of cannabis products to a distributor.
(5) Any other activity required by the track-and-trace system to be captured.
(b) The following information shall be recorded for each activity entered into the track-and-trace system:
(1) The licensed entity from which the cannabis material or product is received, including that entity’s license number, and the licensed entity to which the cannabis product is transferred, including that entity’s license number.
(2) The name and license number of the distributor that transported the cannabis material or cannabis product.
(3) The type of cannabis material or cannabis product received, processed, manufactured, or transferred.
(4) The weight or count of the cannabis material or cannabis product received, processed, packaged, or transferred.
(5) The date of receipt, processing, packaging, or transfer.
(6) The unique identifier assigned to the cannabis material or cannabis product.
(7) Any other information required by other applicable licensing authorities.
40513. Track-and-Trace System – Loss of Access
(a) If a licensee loses access to the track-and-trace system for any reason, the licensee shall prepare and maintain comprehensive records detailing all required inventory tracking activities conducted during the loss of access.
(b) Upon restoration of access to the track-and-trace system, all inventory tracking activities that occurred during the loss of access shall be entered into the track-and trace system within three (3) business days.
(c) A licensee shall document the date and time when access to the track-and-trace system was lost and when it was restored and the cause for each loss of access.
(d) A licensee shall not transfer cannabis products to a distributor until such time as access to the system is restored and all information is recorded into the track-and-trace system.
40515. Track-and-Trace System – Temporary Licenses
(a) A licensee operating under a temporary license issued pursuant to Section 40126 is not required to record commercial cannabis activity in the track-and-trace system as otherwise required by this article. Temporary licensees shall track all commercial cannabis activities on a paper sales receipt or invoice that includes the following information:
(1) Name, address, and license number of the seller;
(2) Name, address, and license number of the purchaser,
(3) Date of sale or transfer;
(4) Description or type of cannabis or cannabis product;
(5) Weight or quantity of cannabis or cannabis product sold or transferred;
(6) Cost to the purchaser of the cannabis or cannabis product.
(b) After issuance of an annual license, the licensee may continue to conduct commercial cannabis activities with temporary licensees in accordance with subsection
(a). Any commercial cannabis activity conducted between annual license holders shall be recorded in the track-and-trace system.
40517. Track-and-Trace System – UID Tag Order
(a) A licensee shall order UID tags within five (5) business days of receiving access to the track-and-trace system. The receipt of the UID tags by the licensee shall be recorded with the track-and-trace system within three (3) business days of receipt.
(b) Any licensee in operation at the time access to the track-and-trace system is granted shall input all inventory into the track-and-trace system no later than 30 days after receipt of the UID tags.
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