16 Del. Admin. Code § 4470-18.0
Current through Register Vol. 28, No. 7, January 1, 2025
Section 4470-18.0 - Random Sampling Procedures18.1 Compassion Centers will coordinate with the Office of Medical Marijuana (OMM) for collection of samples by State Regulators, who will supervise randomly chosen samples of each batch for testing by the Testing Center. Sample results will be loaded into the DEC3S system by the testing center allowing Compassion Centers to sell the material or incorporate it into other products.18.2 Sampling 18.2.1 Compassion centers may create any size batch they deem appropriate, but not more than five (5) pounds.18.2.2 The minimum sample size is set at 0.5% of batch weight. A one (1) pound batch would require a two (2) gram sample and a five (5) pound batch would require an 11-gram sample. The minimum sample size for testing is one (1) gram.18.2.3 All medical marijuana products will be tested as directed in subsection 18.3 of these regulations.18.3 Compassion Center's Responsibility:18.3.1 Compassion Centers will coordinate harvest schedules with the Office of Medical Marijuana (OMM) and the Testing Center. 18.3.1.1 After the marijuana has been harvested, dried and cured, the OMM staff will supervise selection of random samples from the curing vessels with the Compassion Center staff.18.3.1.2 Compassion Center staff will prepare additional barcode labels and tamper-proof containers for each batch and develop a transportation manifest, initiating the chain of custody process for the batch of plants being tested.18.3.2 The Compassion Centers will not sell or prepare products from the batch being tested until the testing centers enter the values into the DEC3S program, releasing the material for use or sale.18.3.3 Compassion Centers will be invoiced for payment of testing services directly from the Testing Center.18.3.4 All concentrates or other infused products must be sent to the Testing Center using the process listed above before they are cleared for sale.18.4 Testing Facility Responsibility: 18.4.1 The testing center will receive samples from the Office of Medical Marijuana (OMM) staff and co-sign the sample manifest after verification of sample barcodes. The testing center will enter the samples into the lab portion of DEC3S. The Testing Center will process the samples for the following profile, terpenes and contaminates: 18.4.1.1 Tetrahydrocannabinol (THC).18.4.1.2 Tetrahydrocannabinolic Acid (THCA).18.4.1.3 Cannabidiol (CBD).18.4.1.4 Cannabidiolic Acid (CBDA).18.4.1.5 Cannabigerol (CBG).18.4.1.6 Cannabinol (CBN).18.4.1.7 That the presence of contaminants does not exceed the levels in the most current version of the American Herbal Pharmacopoeia Monograph or the guidance from the Division of Public Health.18.4.2 Contaminants include, but are not limited to, all of the following: 18.4.2.1 Residual solvent or processing chemicals.18.4.2.2 Foreign material, including, but not limited to, hair, insects, or similar or related adulterant.18.4.2.3 Microbiological impurity, including total aerobic microbial count, total yeast mold count, P. aeruginosa, aspergillus spp., s. aureus, aflatoxin B1, B2, G1, G2, or ochratoxin A, E. coli, and coliforms.18.4.2.4 Residual levels of volatile organic compounds shall be below the lesser of either the specifications set by the United States Pharmacopeia (U.S.P. Chapter 467) or those set by the Division of Public Health.18.4.3 Terpenes described in the most current version of the cannabis inflorescence monograph published by the American Herbal Pharmacopoeia. Terpene testing will be done as required by the compassion centers to inform patients of the products formulization.18.4.4 After the sample testing has been completed, 18.4.4.1 Testing Center will update DEC3S with the values associated with the tests. If the samples pass all tests, the barcode is unlocked, and Compassion Centers will able to sell or use the marijuana in making other products or concentrates.18.4.4.2 Testing Center will certify destruction of the sample after DEC3S is updated.18.5 Delaware Consolidated Cannabis Control System (DEC3S) Actions: 18.5.1 The Delaware Consolidated Cannabis Control System (DEC3S) will be used throughout the sample collection, manifest and barcode verification procedures.18.5.2 Batches will be listed as unavailable for sale until the Testing Center completes the sample testing and enters the results into DEC3S, unlocking them for sale.18.5.3 The cannabinoid profile values will be available for the Compassion Centers to list on the packaging of the medical marijuana product.18.5.4 If a sample tested fails one or more of the listed standards, the DEC3S will lockout those barcodes until remediation action is completed and the batch is resubmitted for testing. 18.5.4.1 If remediation is not possible, the compassion center will coordinate with the Office of Medical Marijuana on the batches disposition or the batch must be scheduled for destruction.16 Del. Admin. Code § 4470-18.0
23 DE Reg. 667(2/1/2020)
24 DE Reg. 485( 11/1/2020) (Final)