4 Del. Admin. Code § 5001-7.0

Current through Reigster Vol. 28, No. 6, December 1, 2024

Section 5001-7.0 - Tracking, Transportation, and Record Keeping

7.1 General tracking requirements

7.1.1 Marijuana establishments must track all marijuana plants, marijuana, and marijuana products from seed to the point of sale, using the seed-to-sale tracking system specified by the Commissioner.

7.1.2 Marijuana establishments must record the following data in the seed-to-sale tracking system:

7.1.2.1 A complete inventory of all seeds, marijuana plants, immature marijuana plants, mother plants and flowering plants, marijuana, and marijuana products in the possession, control, or ownership of the marijuana establishment;

7.1.2.2 When cuttings are propagated, or seeds germinate;

7.1.2.3 Any changes to inventory of any marijuana plants, marijuana, and marijuana products;

7.1.2.4 When marijuana plants are partially or fully harvested or destroyed;

7.1.2.5 When marijuana waste is destroyed;

7.1.2.6 When an authorized transfer occurs;

7.1.2.7 Any unauthorized diversion, irregular movement, or discrepancies in inventory of marijuana plants, marijuana, or marijuana products;

7.1.2.8 All sales records;

7.1.2.9 All testing samples, including samples for research and development, and mandatory compliance test results;

7.1.2.10 The application of any substances for controlling pests, fungi, or other plant health issues; and

7.1.2.11 Any other information required by the seed-to-sale tracking system or specified by the Commissioner.

7.1.3 Any misstatements or omissions shall be a violation of this regulation.

7.1.4 Proper use of the inventory seed-to-sale tracking system does not relieve a marijuana establishment of its responsibility to maintain compliance with all laws, rules, and other requirements.

7.2 Implementation of the seed-to-sale tracking system

7.2.1 Marijuana establishments must have a seed-to-sale tracking system account activated and functional prior to operating or exercising any privileges of a license, unless excused by the Commissioner in writing.

7.2.2 Marijuana establishments may not enter any inventory into the seed-to-sale tracking system until the marijuana establishment receives an active license from the Commissioner.

7.2.3 Marijuana establishments must designate a current onsite employee as the seed-to-sale tracking system administrator. Marijuana establishments must notify the Commissioner when the seed-to-sale tracking system administrator changes and the qualifications of the replacement administrator.

7.2.4 Marijuana establishments must notify the Commissioner of any hiring, termination, or significant change in role of personnel authorized to use the seed-to-sale tracking system within 5 business days.

7.2.5 Marijuana establishments are responsible for all costs associated with the use of the seed-to-sale tracking system.

7.3 Requirements for use of the seed-to-sale tracking system

7.3.1 Marijuana establishments must reconcile all on-premises and in-transit marijuana plants, marijuana, and marijuana product inventories, and sales records, each day in the seed-to-sale tracking system by 11:59 p.m. that same day. If reconciliation is not possible due to external delays, notify the Commissioner the following business day and specify the situation causing the delay.

7.3.2 Marijuana establishments must utilize a standard of weights and measures that is supported by the seed-to-sale tracking system. Any scale used to weigh product prior to entry into the inventory seed-to-sale tracking system must be certified in accordance with Section 6.0 of this regulation.

7.3.3 Marijuana establishments must maintain the security of the seed-to-sale tracking system by adhering to the following:

7.3.3.1 Only employees of the marijuana establishment are authorized to access the seed-to-sale tracking system.

7.3.3.2 Employees must be trained before being given access to the seed-to-sale tracking system.

7.3.3.3 The marijuana establishment is accountable for all actions employees take while logged into the seed-to-sale tracking system.

7.3.3.4 Each individual user is accountable for their actions while logged into the seed-to-sale tracking system.

7.3.3.5 Each individual user shall only log activities in the seed-to-sale tracking system under the user's own unique seed-to-sale tracking system account.

7.3.4 The marijuana establishments using the seed-to-sale tracking system is responsible for the accuracy of all information entered into the seed-to-sale tracking system.

7.4 Requirements for use of third-party software

7.4.1 Marijuana establishments may use separate software applications to collect information to be used by the business, including secondary tracking or point of sale systems.

7.4.2 Marijuana establishments must ensure all relevant seed-to-sale tracking system data is accurately transferred to and from the seed-to-sale tracking system for the purposes of reconciliations with any secondary systems.

7.4.3 The seed-to-sale tracking system data is the primary source of inventory data, and any third-party software application must be compatible with the seed-to-sale tracking system.

7.4.4 Third party software for online product reservation shall integrate properly with inventory seed-to-sale tracking system.

7.5 Seed-to-sale tracking system procedures

7.5.1 A marijuana establishments' seed-to-sale tracking system must accurately accomplish the following:

7.5.1.1 Indicate the creation of a harvest batch or production batch including the assigned harvest batch or production batch number.

7.5.1.2 Identify when inventory is no longer on the premises or is part of a transfer to another marijuana establishment, including samples for mandatory compliance testing.

7.5.1.3 Indicate test results from a licensed testing facility, as applicable.

7.5.1.4 Record all remediation steps taken to remediate any batches of marijuana or marijuana products that fail testing.

7.5.1.5 Indicate the seed-to-sale tracking system item categories for all marijuana and marijuana products.

7.5.1.6 Record the actual wholesale price of all marijuana and marijuana products sold or transferred to another marijuana establishment.

7.5.1.7 Record the actual retail price of all marijuana and marijuana products sold to a consumer.

7.5.2 Each marijuana establishments must maintain a plan in the event the marijuana establishment loses access to the seed-to-sale tracking system. The plan must be available for inspection by the Commissioner or the Division at any time.

7.5.2.1 The plan for continuing operations during temporary seed-to-sale tracking system failures must be operational on the first day the marijuana establishment is open for business and include specific forms or procedures to be used. Marijuana establishments must immediately notify the Commissioner and must keep and maintain comprehensive records detailing all marijuana plants, marijuana, and marijuana product tracking activities that were conducted during the loss of access.

7.5.2.2 Once access is restored, all marijuana plants, marijuana, and marijuana product tracking activities that occurred during the loss of access must be entered into the seed-to-sale tracking system and the Commissioner shall be notified access has been restored. Records maintained during the tracking system outage must be retained for at least 2 years.

7.5.2.3 In the event of a statewide outage of the seed-to-sale tracking system that is expected to last more than 24 hours, the Commissioner shall notify marijuana establishments of any interim tracking procedures or requirements for the duration of the outage.

7.6 General transportation requirements

7.6.1 All marijuana plants, marijuana, and marijuana products, including samples for mandatory compliance testing and research and development, must be transported in accordance with the following requirements:

7.6.1.1 Transportation may only be conducted between marijuana establishments;

7.6.1.2 Transportation may only be conducted with a transport manifest generated by the seed-to-sale tracking system;

7.6.1.3 Transportation may only be conducted while the marijuana plants, marijuana, or marijuana products are contained within an enclosed, locked area in the transport vehicle;

7.6.1.4 Transportation method must maintain the integrity and safety of packaging and products; and

7.6.1.5 All marijuana plants, marijuana, and marijuana products must be shielded from public view.

7.6.2 All marijuana plants, marijuana, and marijuana products, including samples for compliance testing, being transported may not be removed from the vehicle until arrival at the destination or transferred or stored at any unlicensed premises.

7.6.3 Marijuana establishments transporting marijuana plants, marijuana, or marijuana products may not conduct any stops between registered facilities except:

7.6.3.1 To accommodate meals and rest periods required by law.

7.6.3.2 To refuel the transport vehicle.

7.6.3.3 Emergency stops, in which case the marijuana establishments transporting the marijuana plants, marijuana, or marijuana products must promptly notify the Commissioner of the reasons for the stop;

7.6.3.4 The marijuana establishments may make multiple deliveries to other licensed premises; and

7.6.3.5 During any stop while transporting product, personnel with a valid employee identification badge issued by the Commissioner must stay with the vehicle at all times.

7.6.4 Vehicles used for transporting marijuana plants, marijuana, and marijuana products must:

7.6.4.1 Be insured at or above the legal requirements in Delaware;

7.6.4.2 Be equipped with a functional alarm system;

7.6.4.3 Allow only personnel with valid employee identification badge issued by the Commissioner pursuant to subsection 6.4.4 in transport vehicles while transporting marijuana plants, marijuana, or marijuana products;

7.6.4.4 Be equipped with a GPS tracking device; and

7.6.4.5 If requested by the Commissioner, pass an inspection by the Commissioner or the Division before transporting marijuana plants, marijuana, and marijuana products.

7.6.5 Marijuana establishments receiving marijuana plants, marijuana, or marijuana products must:

7.6.5.1 Verify the condition and quantity of marijuana plants, marijuana, or marijuana products included in the transport manifest;

7.6.5.2 Record in the seed-to-sale tracking system and any other relevant business records any refused marijuana plants, marijuana, or marijuana products, or other discrepancies found between the marijuana plants, marijuana, or marijuana products delivered and the marijuana plants, marijuana, or marijuana products on the transport manifest;

7.6.5.3 Enter the received marijuana plants, marijuana, or marijuana products in the seed-to-sale tracking system in accordance with subsection 7.1.2 of this regulation; and

7.6.5.4 Provide an authorized signature of the personnel receiving the marijuana plants, marijuana, or marijuana products on the transport manifest belonging to the party transporting the marijuana plants, marijuana, or marijuana products.

7.6.6 Marijuana establishments transporting the marijuana plants, marijuana, or marijuana products must retain a copy of the transport manifest for their records.

7.6.7 Marijuana product manufacturing facility personnel receiving delivery must:

7.6.7.1 Log into the electronic manifest.

7.6.7.2 Take custody of a shipment of products containing marijuana.

7.6.7.3 Confirm that:

7.6.7.3.1 The transportation personnel is carrying appropriate identification.

7.6.7.3.2 The packaging is secure, undamaged, and appropriately labeled.

7.6.7.3.3 Each package in the shipment is labeled as described in the electronic manifest; and

7.6.7.3.4 The contents of the shipment are as described in the electronic manifest.

7.6.7.4 Record the confirmations in the electronic manifest.

7.6.7.5 Obtain in the electronic manifest the signature or identification number of the transportation personnel who delivers the shipment.

7.6.7.6 Record in the electronic manifest the date and time the receiving personnel takes custody of the shipment.

7.6.7.7 Enter the products containing marijuana into the inventory control system.

7.6.7.8 Segregate the items in the shipment from the inventory until the item can be inspected.

7.6.7.9 Inspect each item to ensure that the packaging of each item is undamaged, accurate and complete.

7.6.7.10 Upon determining the item passes inspection, release the item into the stock.

7.6.8 Transportation personnel must provide a copy of the electronic manifest for the shipment to the marijuana product manufacturing facility receiving delivery.

7.6.9 The transportation must provide the completed electronic manifest to the marijuana establishments conducting shipping.

7.6.10 The marijuana establishments conducting shipping must retain the electronic manifest for the shipment for a period of 5 years.

7.6.11 Discrepancies in shipments

7.6.11.1 A discrepancy between the electronic manifest and the shipment, must be reported to a supervisor.

7.6.11.2 If a discrepancy can be immediately rectified, the accepting manufacturer supervisor must record the rectification in the electronic manifest.

7.6.11.3 A discrepancy that cannot be immediately rectified must be reported to the Commissioner by the marijuana product manufacturing facility receiving delivery within 24 hours of the observation of the discrepancy. The marijuana establishment conducting the shipping must immediately investigate the discrepancy. The marijuana establishment conducting shipping must provide a preliminary report to the Commissioner within 7 business days of observation of the discrepancy, and a final report within 30 days.

7.6.12 Refusal of Shipment. In the event the marijuana establishment receiving delivery of a shipment refuses to take the delivery, it must immediately return the product to the source.

4 Del. Admin. Code § 5001-7.0

28 DE Reg. 226 (9/1/2024) (Final)