4 DE Admin. Code 5001. Rules of the Office of the Marijuana Commissioner

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Delaware Administrative Code › Title 4 Alcoholic Beverages and Marijuana › Department of Safety and Homeland Security › 5000 Office of the Marijuana Commissioner › 4 DE Admin. Code 5001

This text was captured on Aug 14, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

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PARAMETER | LIMITS | FREQUENCY

Resistivity | >0.5 megaohms/cm | Monthly

Pb, Cd, Cr, Cu, Ni, Zn | <0.05 mg/L per contaminant, and <0.1 mg/L total | Annually

Total chlorine residual | Non-detectable | Monthly

Heterotrophic plate count | <500 CFU/mL | Monthly

Bacteriological quality of reagent water | Ratio of growth rate: 0.8 to 3.0 (See Standard Methods, Section 9020B. This test is not required if marijuana testing facilities use water that meets the criteria for Types I and II water as defined in Standard Methods Section 1080). | Annually

Matrix Type | Batch Weight | Batch Units | Sample Amount (Portion)

Marijuana Flower | ≤ 5lbs | 3 grams

5.1lbs < w ≤ 10lbs | 11 grams

Marijuana Concentrates | ≤ 1lbs | 1.5 grams

1.1bls < w ≤ 2lbs | 2 grams

2.1bls < w ≤ 3lbs | 3 grams

3.1bls < w ≤ 4lbs | 4 grams

4.1bls < w ≤ 5lbs | 5 grams

Marijuana Products

Up to 500 | 10 units

501-1,000 | 20 units

1001-3,000 | 35 units

3,001-10,000 | 55 units

>10,001 | 80 units

Analytical Component | Methodology

D9-THC, D8-THC, THCA, CBD, CBDA | LC-DAD

CBC, CBCA, CBG, CBGA, CBN, CBNA | LC - MS, LC-MS/MS

GC/ FID

Arsenic-Total mg/L | Digestion followed by ICP/MS

Cadmium-Total mg/L | Digestion followed by ICP/MS

Digestion followed by Flame AA

Digestion followed by Graphite Furnace

Lead-Total, mg/L | Digestion followed by ICP/MS

Digestion followed by Flame AA

Digestion followed by Graphite Furnace

Mercury-Total, mg/L | Digestion followed by ICP/MS

Cold Vapor AA

Pesticides and Plant Growth Regulators - mg/L | QuEChERS, GC-MS, GC-MS/MS

QuEChERS,LC-MS, LC- MS/MS

QuEChERS GC-ECD, GC-NPD, LC-FLD

Water Activity | Humidity Meter, Hygrodynamic Hygrometer

Total Viable Aerobic Bacteria | Culture and enumeration

Total Yeast and Mold | Culture and enumeration

Total Coliforms | Culture and enumeration

Residual Solvents | Headspace GC/FID

METAL | ALL USES* Upper Limit (ppm) | MARIJUANA-INFUSED PRODUCTS ONLY Upper Limit (ppm)

Arsenic (inorganic) | <0.2 | <0.2

Cadmium | <0.2 | <0.2

Lead | <0.5 | <0.5

Mercury | <0.1 | <0.1

* These limits apply to finished marijuana

le Aerobic Bacteria | Culture and enumeration

Total Yeast and Mold | Culture and enumeration

Total Coliforms | Culture and enumeration

Residual Solvents | Headspace GC/FID

METAL | ALL USES* Upper Limit (ppm) | MARIJUANA-INFUSED PRODUCTS ONLY Upper Limit (ppm)

Arsenic (inorganic) | <0.2 | <0.2

Cadmium | <0.2 | <0.2

Lead | <0.5 | <0.5

Mercury | <0.1 | <0.1

* These limits apply to finished marijuana plant material, marijuana resin, and marijuana concentrates intended for ingestion, inhalation, or dermal application. These limits are based on inhalation limits described in USP<232> Elemental Impurities-Limits.

PESTICIDE | CAS # | USE | RESIDUE ANALYTICAL METHODS

Abamectin (Avermectins B1a and B1b) | 71751-41-2 | Insecticide/acaricide | LC-FLD; LC-MS/MS

Acequinocyl | 57960-19-7 | Insecticide/acaricide | LC/MS/MS

Bifenazate | 149877-41-8 | Acaricide | LC; LC-MS/MS

Bifenthrin (synthetic pyrethroid) | 82657-04-3 | Insecticide | GC-ECD; GC-MS/MS LC- MS/MS

Chlormequat chloride | 7003-89-6 | Plant growth regulator | IC, LC-MS/MS

Cyfluthrin (synthetic pyrethroid) | 6859-37-5 | Insecticide | LC; GC-MS/MS; LC-MS/MS

Daminozide (Alar) | 1596-84-5 | Plant growth regulator | LC/UV; LC-MS/MS

Etoxazole | 153233-91-1 | Acaricide | GC-MS(/MS); LC-MS/MS

Fenoxycarb | 72490-01-8 | Insecticide | LCUV; LC-MS/MS

Imazalil | 35554-44-0 | Fungicide | GC-ECD; LC-MS/MS

Imidacloprid | 138261-41-3 | Insecticide | LC-MS/MS

Myclobutanil | 88671-89-0 | Fungicide | GC-ECD; GC-NPD; GSMS/MS; LC-MS/MS

Paclobutrazol | 76738-62-0 | Plant growth regulator; fungicide | LC-MS/MS

Spinosad | 168316-95-8 | Insecticide | LC-MS/MS

Spiromesifen | 283594-90-1 | Insecticide | GC-MS; LC-MS/MS

Spirotetramat | 20313-25-1 | Insecticide | LC/LC-MS/MS

Trifloxystrobin | 141517-21-7 | Fungicide | GC-NPD; GC-MS/MS; LCMS/MS

Acequinocyl | 57960-19-7 | Insecticide/acaricide | LC/MS/MS

Bifenazate | 149877-41-8 | Acaricide | LC; LC-MS/MS

Bifenthrin (synthetic pyrethroid) | 82657-04-3 | Insecticide | GC-ECD; GC-MS/MS LC- MS/MS

Chlormequat chloride | 7003-89-6 | Plant growth regulat

| GC-MS; LC-MS/MS

Spirotetramat | 20313-25-1 | Insecticide | LC/LC-MS/MS

Trifloxystrobin | 141517-21-7 | Fungicide | GC-NPD; GC-MS/MS; LCMS/MS

Acequinocyl | 57960-19-7 | Insecticide/acaricide | LC/MS/MS

Bifenazate | 149877-41-8 | Acaricide | LC; LC-MS/MS

Bifenthrin (synthetic pyrethroid) | 82657-04-3 | Insecticide | GC-ECD; GC-MS/MS LC- MS/MS

Chlormequat chloride | 7003-89-6 | Plant growth regulator | IC, LC-MS/MS

Cyfluthrin (synthetic pyrethroid) | 6859-37-5 | Insecticide | LC; GC-MS/MS; LC-MS/MS

Daminozide (Alar) | 1596-84-5 | Plant growth regulator | LC/UV; LC-MS/MS

Etoxazole | 153233-91-1 | Acaricide | GC-MS(/MS); LC-MS/MS

Fenoxycarb | 72490-01-8 | Insecticide | LC/UV; LC-MS/MS

Imazalil | 35554-44-0 | Fungicide | GC-ECD; LC-MS/MS

Imidacloprid | 138261-41-3 | Insecticide | LC-MS/MS

Myclobutanil | 88671-89-0 | Fungicide | GC-ECD; GC-NPD; GSMS/MS; LC-MS/MS

Paclobutrazol | 76738-62-0 | Plant growth regulator; fungicide | LC-MS/MS

Spinosad | 168316-95-8 | Insecticide | LC-MS/MS

Spiromesifen | 283594-90- | Insecticide | GC-MS; LC-MS/MS

Spirotetramat | 20313-25-1 | Insecticide | LC/LC-MS/MS

Trifloxystrobin | 141517-21-7 | Fungicide | GC-NPD; GC-MS/MS; LCMS/MS

* CFU means colony forming unit.

TARGET CONTAMINANT | UPPER LIMITS

Aspergillus (flavus, fumigatus, niger, terreus) | IF DETECTED

Salmonella spp. | IF DETECTED

Shiga toxin-producing E

A (CFU*/g) | TOTAL YEAST AND MOLD (CFU/g) | TOTAL COLIFORMS AND Escherichia coli (CFU/g) | AFLATOXINS (B1, B2, G1, G2) | OCHRATOXIN A

* CFU means colony forming unit.

TARGET CONTAMINANT | UPPER LIMITS

Aspergillus (flavus, fumigatus, niger, terreus) | IF DETECTED

Salmonella spp. | IF DETECTED

Shiga toxin-producing E. coli (STEC) | IF DETECTED

Pseudomonas aeruginosa | IF DETECTED

Staphylococcus aureus | IF DETECTED

Aflatoxins | < 20 ppb

Ochratoxin | < 20 ppb

Total Yeast & Mold (TYM) | 100,000 CFU/g (Flower) 10,000 CFU/g (Extracts)

Total Viable Aerobic Bacteria | 100,000 CFU/g (Flower) 10,000 CFU/g (Extracts)

Acetone | 67-64-1 | 5000 | Heptane | 142-82-5 | 5000

Acetonitrile | 75-05-8 | 410 | Hexane | 110-54-3 | 290

Benzene ** | 71-43-2 | 2 | Isobutane | 75-28-5 | 5000

Butane | 106-97-8 | 5000 | Isopropyl acetate | 108-21-4 | 5000

1-Butanol | 71-36-3 | 5000 | Methanol | 67-56-1 | 3000

2-Butanol | 78-92-2 | 5000 | Methylbutylketone | 591-78-6 | 50

2-Butanone | 78-93-3 | 5000 | Methylcyclohexane | 108-87-2 | 1180

Carbon tetrachloride** | 56-23-5 | 4 | Methylethylketone | 78-93-3 | 5000

Cumene | 98-82-8 | 70 | Methylisobutylketone | 108-10-1 | 5000

Cyclohexane | 110-82-7 | 3880 | Methylpropane | 75-28-5 | 5000

1,2-Dichlorethane** | 107-06-2 | 5 | 2-Methyl-1- propanol | 78-83-1 | 5000

1,1-Dichloroethene** | 75-35-4 | 8 | 2-Methylbutane | 78-78-4 | 5000

1,2-Dichloroethene | 540-59-0 | 1870 | 2-Methylpentane | 107-83-5 | 290

Dichloromethane | 75-09-2 | 600 | 3-Methylpentane | 96-14-0 | 290

1,2-Dimethoxyethane | 110-71-4 | 100 | N-Methylpyrrolidone | 872-50-4 | 530

1,2-Dimethylbenzene | 95-47-6 | 2170 | Nitromethane | 75-52-5 | 50

1,3-Dimethylbenzene | 108-38-3 | 2170 | Pentane | 109-66-0 | 5000

1,4-Dimethylbenzene | 106-42-3 | 2170 | 1-Pentanol | 71-41-0 | 5000

2,2-Dimethylbutane | 75-83-2 | 290 | 1-Propanol | 71-23-8 | 5000

2,3-Dimethylbutane | 79-29-8 | 290 |

tane | 96-14-0 | 290

1,2-Dimethoxyethane | 110-71-4 | 100 | N-Methylpyrrolidone | 872-50-4 | 530

1,2-Dimethylbenzene | 95-47-6 | 2170 | Nitromethane | 75-52-5 | 50

1,3-Dimethylbenzene | 108-38-3 | 2170 | Pentane | 109-66-0 | 5000

1,4-Dimethylbenzene | 106-42-3 | 2170 | 1-Pentanol | 71-41-0 | 5000

2,2-Dimethylbutane | 75-83-2 | 290 | 1-Propanol | 71-23-8 | 5000

2,3-Dimethylbutane | 79-29-8 | 290 | 2-Propanol | 67-63-0 | 5000

N,N-Dimethylacetamide | 127-19-5 | 1090 | Propane | 74-98-6 | 5000

N,N-Dimethylformamide | 68-12-2 | 880 | Propyl acetate | 109-60-4 | 5000

Dimethyl sulfoxide | 67-68-5 | 5000 | Pyridine | 110-86-1 | 200

1,4-Dioxane | 123-91-1 | 380 | Sulfolane | 126-33-0 | 160

Ethanol | 64-17-5 | 5000 | Tetrahydrofuran | 109-99-9 | 720

2-Ethoxyethanol | 110-80-5 | 160 | Tetralin | 119-64-2 | 100

Ethyl acetate | 141-78-6 | 5000 | Toluene | 108-88-3 | 890

Ethylbenzene | 100-41-4 | 70 | 1,1,1-Trichloroethane** | 71-55-6 | 1500

Ethylene glycol | 107-21-1 | 620 | 1,1,2-Trichloroethylene | 79-01-6 | 80

Ethylene oxide | 75-21-80 | 50 | Xylene | 1330-20-7 | 2170

Ethyl ether | 60-29-7 | 5000 | 1,1,2-Trichloroethylene | 79-01-6 | 80

* See Section 6.0 of this regulation for further information.

** Class 1 solvents provided by USP Chapter <467> shall not be used in the production of any marijuana or marijuana product.

DEPARTMENT OF SAFETY AND HOMELAND SECURITY

Office of the Marijuana Commissioner

5000 Office of the Marijuana Commissioner

5001 Rules of the Office of the Marijuana Commissioner

1.0 General Provisions

1.1 Authority. This regulation is promulgated by the Office of the Marijuana Commissioner pursuant to its authority in the Delaware Marijuana Control Act, 4 Del.C. Chapter 13.

Marijuana Commissioner pursuant to its authority in the Delaware Marijuana Control Act, 4 Del.C. Chapter 13.

1.2 Purpose and Construction. This regulation establishes the standards for issuing marijuana establishment licenses, social equity businesses, and a retail sales tax. They also include a system for inspection, tracking, packaging, and testing marijuana to ensure marijuana products are safe. This regulation shall be liberally construed and applied to promote their underlying purpose of protecting the public's safety, health, and well-being.

1.3 Severability. In the event any particular clause or section of this regulation should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full effect.

1.4 This regulation shall be referred to as the "Regulations of the Office of the Marijuana Commissioner."

2.0 Definitions

The definitions set forth in 4 Del.C. §1302 are hereby adopted and incorporated by reference in this regulation. The following words and terms, when used in this regulation, should have the following meaning:

" Act " means the Delaware Marijuana Control Act, 4 Del.C. Ch. 13.

" Agent " means those persons included in 4 Del.C. §1347 .

" Applicant " means any person applying for a Delaware marijuana business license.

" Branding " means the promotion of a marijuana establishment's brand through the publication of the business name, logo, or other unique design features.

" Business days " means any day of the week during which normal business operations are conducted, and does not include Saturday and Sunday, or State-recognized holidays.

" Business license " means a license issued by the Department of Finance and required by Title 30 of the Delaware Code to carry on a trade or business.

" Certificate of Analysis " means the report prepared for the marijuana establishment requesting testing regarding the analytical testing performed and results obtained by the marijuana testing facility

day and Sunday, or State-recognized holidays.

" Business license " means a license issued by the Department of Finance and required by Title 30 of the Delaware Code to carry on a trade or business.

" Certificate of Tax Clearance " means a tax certificate issued by Revenue, which certifies that, according to the Revenue's records, as of the date of the certificate, the taxpayer has filed all required State of Delaware tax returns and paid all tax reported thereon, including penalties and interest if applicable, and does not currently owe any tax to the Revenue.

" Commissioner " means the person appointed by the Governor and confirmed by the Senate who serves as the Marijuana Commissioner for the State, as defined in 4 Del.C. §1302(2) .

" Consumer " means an individual 21 years of age or older who purchases marijuana, marijuana products, or marijuana accessories for personal use by the individual or other individuals 21 years of age or older, but not for resale to others.

" Consumer product " means any product not containing marijuana that is marketed and sold to consumers.

" Control " means the decision-making authority over the management, operations, or policies that guide a business, or the authority over the operation of the technical aspects of a business.

" Delaware Taxpayer Portal " means Revenue's website for tax accounting administration and tax return and remittance filing located at https://tax.delaware.gov .

" Deli style dispensing " means marijuana flower sold to consumers that is not pre-packaged prior to sale.

" Department " means the Department of Safety and Homeland Security.

" Division " means the Division of Alcohol and Tobacco Enforcement.

" DNREC " means the Delaware Department of Natural Resources and Environmental Control

ax return and remittance filing located at https://tax.delaware.gov .

" Deli style dispensing " means marijuana flower sold to consumers that is not pre-packaged prior to sale.

" Department " means the Department of Safety and Homeland Security.

" Division " means the Division of Alcohol and Tobacco Enforcement.

" DNREC " means the Delaware Department of Natural Resources and Environmental Control.

" Edible marijuana product " means a marijuana product intended to be consumed orally and swallowed, including gummy candies ("gummies"), baked goods, hard candies, chocolates, or films.

" Employee " means an individual hired directly and paid wages by a marijuana establishment. It does not include volunteers, or contractors or agents who are compensated by other entities.

" Flowering plant " means a marijuana plant from the time it exhibits the first signs of sexual maturity through harvest, which includes budding.

" Inhalable marijuana product " means a marijuana product intended to be consumed through inhalation of smoke or vapor, including marijuana flower and marijuana concentrate.

" Kief " means the sand-like excess plant material and loose trichomes resulting from the grinding and sifting of dried and cured marijuana flower; also referred to as "dry sieve."

" Marijuana " means as defined in 16 Del.C. §4701 .

" Marijuana beverage " means a marijuana product in a liquid form intended to be consumed orally and swallowed. Marijuana beverage includes single-serving marijuana beverages and multi-serving marijuana beverages. Marijuana beverages do not include tinctures.

" Marijuana concentrate " means any product created when marijuana flower is refined into a more potent and purer product. This umbrella term includes any type of hash (water hash, pressed hash), dry sieve (kief), as well as hash oils (CO2 oil, shatter, butter/budder, wax, resin/live resin, and rosin/live rosin) and indicates that these products are a concentrated form of marijuana, carrying a higher potency

concentrate " means any product created when marijuana flower is refined into a more potent and purer product. This umbrella term includes any type of hash (water hash, pressed hash), dry sieve (kief), as well as hash oils (CO2 oil, shatter, butter/budder, wax, resin/live resin, and rosin/live rosin) and indicates that these products are a concentrated form of marijuana, carrying a higher potency.

" Marijuana flower " means the fresh, cured, or dried flower of the marijuana plant as defined in 16 Del.C. §4701 . "Marijuana" as it is defined in this regulation includes marijuana flower.

" Marijuana waste " means any organic waste containing marijuana that is generated through the cultivation, manufacturing, or destruction process of marijuana plants, marijuana, or marijuana products.

" Marketing layer " means the outermost layer of a packaged product for retail sale, which is most predominantly apparent and visible. If the retail package consists of only a single layer, then the outer surface of the container is the marketing layer.

" Medical marijuana program card " means a registry identification card issued pursuant to 16 Del.C. §4909A .

" Mother plant " means a female marijuana plant that is cultivated and used only for the purposes of producing clones, by keeping the plant in a vegetative, non-sexually mature state.

" Multi-serving marijuana beverage " means a marijuana product in a liquid form intended to be consumed orally through multiple servings. Marijuana beverages do not include tinctures.

" Neon colors " means extremely bright versions of primary or secondary colors intended to attract attention.

" Non-consumable product " means any product offered for sale by a marijuana establishment that is not intended for human consumption, including clothing, storage containers, rolling papers, or other marijuana accessories.

" Ownership interest " means a direct or indirect equity interest in a marijuana establishment, including in its shares or stock

secondary colors intended to attract attention.

" Ownership interest " means a direct or indirect equity interest in a marijuana establishment, including in its shares or stock.

" Personnel " means any employee, agent, or volunteer conducting activities on behalf of a marijuana establishment.

" Premises " means the physical facility or property owned and operated by a marijuana establishment.

" Pre-roll " means manufactured marijuana flower that is rolled into a marijuana cigarette by a marijuana product manufacturing facility.

" Qualifying Patient " means an individual who meets the qualifications to receive a medical marijuana program card.

" Responsible person " means each officer or employee, or a member, officer, or employee of a pass-through entity, as defined in §1601 of Title 30 of the Delaware Code, who, as an officer, employee, or member of a marijuana establishment has any control over the marijuana establishment's finances or is responsible for filing the marijuana establishments Retail Marijuana Tax form, or collecting, accounting for, or remitting payment for the marijuana establishment's retail marijuana tax.

" Retail area " means the area of a retail marijuana store where marijuana, marijuana products, and marijuana accessories are offered for sale.

" Retail Marijuana Tax " means the tax imposed by 4 Del.C. §1382(b) .

" Retail Marijuana Tax Form " means the form prescribed by Revenue to calculate the Retail Marijuana Tax due to the State.

" Revenue " means the Delaware Division of Revenue, a division of the Delaware Department of Finance.

" Seed-to-sale tracking system " means the is the software system developed and maintained approved by the Commissioner to track and maintain records across marijuana supply chain activities

ana Tax Form " means the form prescribed by Revenue to calculate the Retail Marijuana Tax due to the State.

" Revenue " means the Delaware Division of Revenue, a division of the Delaware Department of Finance.

" Seed-to-sale tracking system " means the is the software system developed and maintained approved by the Commissioner to track and maintain records across marijuana supply chain activities.

" Shake " means the excess leaf, flower, or stem material removed from marijuana plants during the harvest and manufacturing processes.

" Single-serving marijuana beverage " means a marijuana product in a liquid form intended to be consumed orally through a single serving. Marijuana beverages do not include tinctures.

" Tincture " means a liquid mixture created from a concentrated extract of marijuana.

" Topical marijuana product " means a mixture or extract of marijuana made into a balm, lotion, ointment, or rubbing alcohol solution, that is intended to be consumed in a transcutaneous manner.

" Transdermal marijuana product " means a marijuana product intended to be applied to the skin, whereby the marijuana can be consumed in a transcutaneous manner. Transdermal marijuana products include stick-on patches.

" Transport manifest " means a record, either paper or electronic, required by the Commissioner for the transfer of any marijuana or marijuana product from 1 licensed facility to another licensed facility, including for the purposes of testing.

" Trim " means the same as shake.

" Universal symbol " means the symbol developed by the Commissioner to be placed on every marijuana product intended for sale, for purposes of identifying the product as regulated and product and sold by a licensed marijuana business.

" Waiting area " means the area of a retail marijuana store where customers enter the facility, have their identification and age verified, and where marijuana, marijuana products, and marijuana accessories are not present for sale

r to be placed on every marijuana product intended for sale, for purposes of identifying the product as regulated and product and sold by a licensed marijuana business.

" Water activity " means a measure of the quantity of water in marijuana or a marijuana product that is available, and therefore capable of, supporting bacteria, yeasts, and fungi.

28 DE Reg. 317 (10/01/24)

29 DE Reg. 221 (09/01/25)

29 DE Reg. 787 (03/01/26)

3.0 Licensing

3.1 Open licenses. The Commissioner may issue the following 4 types of open licenses:

3.1.1 Retail marijuana store license pursuant to 4 Del.C. §1332 .

3.1.2 Marijuana testing facility license pursuant to 4 Del.C. §1333 .

3.1.3 Marijuana cultivation facility license pursuant to 4 Del.C. §1334 .

3.1.4 Marijuana product manufacturing license pursuant to 4 Del.C. §1335 .

3.2 Social equity license. The Commissioner may issue the following 4 types of social equity licenses:

3.2.1 Retail marijuana store license pursuant to 4 Del.C. §1343(e)(1) .

3.2.2 Marijuana testing facility license pursuant to 4 Del.C. §1343(e)(2) .

3.2.3 Marijuana cultivation facility license pursuant to 4 Del.C. §1343(c) .

3.2.4 Marijuana product manufacturing license pursuant to 4 Del.C. §1343(d) .

3.2.5 To apply for a social equity license, an individual must meet 1 of the criteria listed in 4 Del.C. §1336 .

3.3 Microbusiness license. The Commissioner may issue the following 2 types of microbusiness licenses:

3.3.1 Marijuana cultivation facility license pursuant to 4 Del.C. §1343(c) .

3.3.2 Marijuana product manufacturing license pursuant to 4 Del.C. §1343(d) .

3.3.3 To hold a microbusiness license, an individual must meet the criteria listed in 4 Del.C. §1340 .

29 DE Reg

ia listed in 4 Del.C. §1336 .

3.3 Microbusiness license. The Commissioner may issue the following 2 types of microbusiness licenses:

3.3.1 Marijuana cultivation facility license pursuant to 4 Del.C. §1343(c) .

3.3.2 Marijuana product manufacturing license pursuant to 4 Del.C. §1343(d) .

3.3.3 To hold a microbusiness license, an individual must meet the criteria listed in 4 Del.C. §1340 .

29 DE Reg. 787 (03/01/26)

4.0 Application Process and Issuance of Licenses

4.1 Application requirements

4.1.1 An applicant must submit an application for a license on the form made available by the Commissioner.

4.1.2 An applicant may not apply for, may not be issued, and may not renew any license that would result in the applicant, or a person with a financial interest in that application or license under Title 4 of the Delaware Code, owning or operating more than 1 marijuana establishment of the same license type in a single county.

4.1.2.1 An applicant is not prohibited from applying for and being issued or renewed more than 1 license in a single county, provided that each license is of a different license type.

4.1.2.2 This section does not apply to converted medical licenses.

4.1.3 The Commissioner does not require an applicant to obtain or own any property or facility to operate a marijuana business prior to conditional licensing.

4.1.4 The Commissioner may verify an applicant's status as a social equity applicant at any time prior to entry into the lottery and require the applicant to submit supporting documentation. Any information an applicant submits in support of their social equity status is considered part of the application and is subject to verification by the Commissioner.

4.2 Minimum qualifications

4.2.1 The Commissioner shall determine whether a submitted application meets the minimum qualifications for the lottery by reviewing the applicant's materials required by 4 Del.C. §1331

ing documentation. Any information an applicant submits in support of their social equity status is considered part of the application and is subject to verification by the Commissioner.

4.2 Minimum qualifications

4.2.1 The Commissioner shall determine whether a submitted application meets the minimum qualifications for the lottery by reviewing the applicant's materials required by 4 Del.C. §1331 . The Commissioner also requires that:

4.2.1.1 Applicants provide a description of their plan to comply with guidance pertaining to marijuana issued by the Financial Crimes Enforcement Network under the Bank Secrecy Act (31 U.S.C. § 5311 et seq.), which may be demonstrated by submitting letters regarding the applicant's banking history from banks or credit unions that certify they are aware of the business activities of the applicant in any state where the applicant has operated a business related to personal use or medical marijuana. An applicant who does not submit the information about a plan of compliance with the Bank Secrecy Act shall not be disqualified from consideration.

4.2.1.2 For marijuana cultivation facility license and marijuana product manufacturing facility license applicants only: quality assurance plan with written policies and procedures for a comprehensive quality assurance program.

4.2.1.3 The Commissioner may require an applicant, or any individual or entity that holds an ownership interest in or control of the applicant, to complete an attestation demonstrating the applicant meets the requirements for the license established in 4 Del.C. §1331 .

4.2.1.4 Additional minimum qualifications may be established by the Commissioner and published on its website at https://omc.delaware.gov .

4.2.2 Applicants must remit a nonrefundable application fee as set forth in 4 Del.C. §§1331 , 1337, and 1341. The Commissioner may adjust the application fees annually for inflation

plicant meets the requirements for the license established in 4 Del.C. §1331 .

4.2.1.4 Additional minimum qualifications may be established by the Commissioner and published on its website at https://omc.delaware.gov .

4.2.2 Applicants must remit a nonrefundable application fee as set forth in 4 Del.C. §§1331 , 1337, and 1341. The Commissioner may adjust the application fees annually for inflation.

4.2.3 The Commissioner may determine that a completed social equity license application may be entered into an open license lottery for the applicable license type without payment of any additional application fees.

4.3 Application review process

4.3.1 The Commissioner will announce the application period at least 10 business days prior to the acceptance of applications. The announcement will include:

4.3.1.1 Types and number of licenses available; and

4.3.1.2 The date the application period begins.

4.3.2 The Commissioner will accept applications for 30 calendar days.

4.3.3 The responsibility for demonstrating the minimum qualifications set forth in Title 4 of the Delaware Code and in this regulation rests on the applicant.

4.3.4 The Commissioner may deny an application for any of the reasons listed in 4 Del.C. §1354 and where the application:

4.3.4.1 Is incomplete in any material detail;

4.3.4.2 Contains a material misstatement, omission, misrepresentation, or untruth;

4.3.4.3 Does not meet the minimum qualifications for the license type;

4.3.4.4 Is not submitted by the established deadline; or

4.3.4.5 Fails to provide additional information requested by the Commissioner.

4.3.5 The Commissioner may award fewer licenses than authorized under law in any licensing round if there are an insufficient number of qualified applicants.

4.3.6 The Commissioner will notify all applicants by email whether they met the minimum qualifications and will be placed in the lottery.

4.4 Lottery

4.4.1 Applicants determined by the Commissioner to meet the minimum qualifications will be entered into a lottery

r may award fewer licenses than authorized under law in any licensing round if there are an insufficient number of qualified applicants.

4.3.6 The Commissioner will notify all applicants by email whether they met the minimum qualifications and will be placed in the lottery.

4.4 Lottery

4.4.1 Applicants determined by the Commissioner to meet the minimum qualifications will be entered into a lottery. The lottery will be conducted in an impartial and random manner, with the format of the lottery being determined by the Commissioner.

4.4.2 No more than 10 business days following the lottery, the Commissioner will inform all applicants by email whether they were selected for the lottery.

4.4.3 The Commissioner may request any additional information or supporting documentation from an applicant selected in the lottery necessary to verify aspects of the application, including additional information and supporting documentation related to the ownership and control of the applicant.

4.4.4 The Commissioner may deny issuing a conditional license or an active license to an applicant selected in the lottery if:

4.4.4.1 The applicant fails to provide any additional information or supporting documentation within 10 business days of being notified that a correction needs to be made; or

4.4.4.2 Additional information or supporting documentation submitted by the applicant demonstrates the applicant is not eligible for a conditional or active license.

4.5 Selected applicant and supplemental license application requirements

4.5.1 A selected applicant must complete a supplemental license application in a format prescribed by the Commissioner.

4.5.2 Selected applicants are granted a period of 30 days from the date of notification of selection from the Commissioner to complete a supplemental license application and pay applicable licensing fees.

4.5.3 A selected applicant is required to:

4.5.3.1 Undergo a criminal background check in accordance with 4 Del.C

te a supplemental license application in a format prescribed by the Commissioner.

4.5.3 A selected applicant is required to:

4.5.3.1 Undergo a criminal background check in accordance with 4 Del.C. §1347 ;

4.5.3.1.1 Applicants must follow all criminal history records check guidance provided by the Commissioner, including fingerprinting and state and federal criminal history records checks;

4.5.3.1.2 For applicants that are business entities, fingerprinting and criminal history record checks are required for every owner, officer, director, and employee; and

4.5.3.1.3 The applicant is responsible for all costs associated with fingerprinting and criminal history record checks.

4.5.3.2 Undergo a comprehensive financial background investigation under direction of the Commissioner and authorize the release of financial and background information from all financial institutions, fiduciaries, and other entities, exempting them from any contractual, statutory, or common law confidentiality obligations, to aid in assessing the applicant's capability to operate a marijuana establishment;

4.5.3.3 Submit a Certificate of Tax Clearance for responsible persons;

4.5.3.4 Describe all civil litigation or any settled or closed legal action over the past 3 years to which the applicant, its parent, affiliate, holding, or any subsidiary is or was a party whether in this state or in another jurisdiction.

4.5.3.5 Disclose whether the applicant or any affiliate, intermediary, subsidiarity or holding company ever had any license application, license, permit, or other authorization issued by a government agency in this state or any other jurisdiction denied, suspended, or revoked in the last 10 years

iliate, holding, or any subsidiary is or was a party whether in this state or in another jurisdiction.

4.5.3.6 Execute waiver provided by the Commissioner to permit any governmental authority in any jurisdiction to share with the Commissioner and the Division all data the selected applicant has previously provided to other jurisdictions in connection with a marijuana-related license, as well as any information those jurisdictions have gathered during their investigations of the selected applicant;

4.5.3.7 Submit verification provided by the Commissioner for any information or supporting documentation submitted with the application;

4.5.3.8 Provide the municipality or county within which the selected applicant intends to operate; and

4.5.3.9 Provide any additional information required by the Commissioner.

4.5.4 If a selected applicant fails to meet the requirements in subsection 4.5.3 of this regulation within the 30-day period, the Commissioner may extend this period provided that the applicant demonstrates a good faith effort towards completion. Should the Commissioner deny the extension request, or the selected applicant remains unable to meet the requirements outlined in subsection 4.5.3 of this regulation, the Commissioner is authorized to cancel the application.

4.5.5 The applicable licensing fees are set forth in 4 Del.C. §§1331-1334 , 1337, and 1341, and are payable to the Office of the Marijuana Commissioner biennially.

4.5.6 Upon successful completion and approval of the application and payment of licensing fees, the applicant will be granted a conditional license pursuant to 4 Del.C. §1345

n, the Commissioner is authorized to cancel the application.

4.5.5 The applicable licensing fees are set forth in 4 Del.C. §§1331-1334 , 1337, and 1341, and are payable to the Office of the Marijuana Commissioner biennially.

4.5.6 Upon successful completion and approval of the application and payment of licensing fees, the applicant will be granted a conditional license pursuant to 4 Del.C. §1345 .

4.5.7 Prior to the issuance of a conditional license, the applicant may not:

4.5.7.1 Purchase, possess, cultivate, manufacture, or sell marijuana or marijuana products;

4.5.7.2 Transfer any ownership interest that causes a change in the individual or entity that holds the controlling ownership interest;

4.5.7.3 Transfer control; or

4.5.7.4 Transfer an ownership interest that causes the conditional social equity licensee to no longer meet the social equity applicant definition.

4.6 Issuance of conditional license

4.6.1 Any applicant who receives a conditional license must identify a physical location for the licensed premises and become operational within 18 months from the date the conditional license is granted. The proposed licensed premises must be approved by the Commissioner.

4.6.2 If the applicant is unable to begin operations meeting all criteria established by the Commissioner within 18 months of issuance of the conditional license, the Commissioner may extend the period to become operational if the conditional licensee demonstrates good faith efforts to begin operations. If the Commissioner denies the extension of the conditional license or the licensee is unable to become operational, the Commissioner must rescind the conditional license.

4.7 Termination of a conditional license

onths of issuance of the conditional license, the Commissioner may extend the period to become operational if the conditional licensee demonstrates good faith efforts to begin operations. If the Commissioner denies the extension of the conditional license or the licensee is unable to become operational, the Commissioner must rescind the conditional license.

4.7 Termination of a conditional license. The Commissioner may terminate a conditional license if a conditional licensee or any individual or entity included in the application:

4.7.1 Has been convicted of or pleaded nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have conviction or plea set aside;

4.7.2 Fraudulently or deceptively attempts to obtain a license;

4.7.3 Is ineligible to hold an ownership interest in or control of a business licensed under subsection 4.1.2;

4.7.4 Fails to reveal any material fact pertaining to the temporary licensee's qualification for a license;

4.7.5 Fails to submit a complete supplemental license application;

4.7.6 Fails to convert to an active licensee;

4.7.7 Violates this regulation;

4.7.8 Is not registered or in good standing with the Division of Corporations; or

4.7.9 Has taxes in arrears in any jurisdiction.

4.8 Issuance of an active license. A conditional license will convert to an active license as provided in 4 Del.C. §1346 . The Commissioner also requires:

4.8.1 Submission and subsequent approval of final safety, security, theft or diversion, and operations plans by the Commissioner;

4.8.2 Payment of any fees or costs associated with obtaining a background check;

4.8.3 Submission of an attestation signed by a bona fide labor organization stating that the licensee has entered into a labor peace agreement with the bona fide labor organization;

4.8.4 Submission of a form, provided by the Commissioner, which demonstrates compliance with all local laws including local zoning, fire codes and building codes;

4.8.5 Identifying and demonstrating legal control of

;

4.8.3 Submission of an attestation signed by a bona fide labor organization stating that the licensee has entered into a labor peace agreement with the bona fide labor organization;

4.8.4 Submission of a form, provided by the Commissioner, which demonstrates compliance with all local laws including local zoning, fire codes and building codes;

4.8.5 Identifying and demonstrating legal control of the proposed site, through lease, purchase, or other means, for the marijuana business; and

4.8.6 A completed full inspection of the proposed site premise by the Commissioner and the Division.

4.9 Retention of applications

4.9.1 Upon notification that an applicant was not selected by the lottery, the applicant may request the Commissioner retain the application for subsequent application periods within 1 year.

4.9.2 The Commissioner may contact an applicant with a retained application for any additional information required for subsequent application periods.

4.9.3 Any application retained by the Commissioner that meets the requirements of a subsequent application period within the 1-year retention period shall be automatically entered into a subsequent application period if the applicant has properly updated the application.

4.9.4 The Commissioner may not enter a retained application into a subsequent application period if:

4.9.4.1 Any individual included in the application is in violation of ownership restrictions Title 4 of the Delaware Code or this regulation; or

4.9.4.2 Any individual associated with the application has been found to be in violation of Title 4 of the Delaware Code or this regulation.

4.10 Grounds for refusal of a license

4.10.1 The Commissioner shall consider the convictions listed in 4 Del.C. §1354 as grounds for refusal of a license.

4.10.2 The Commissioner may refuse to license an applicant if a substantial objection is presented pursuant to 4 Del.C. §1354

associated with the application has been found to be in violation of Title 4 of the Delaware Code or this regulation.

4.10 Grounds for refusal of a license

4.10.1 The Commissioner shall consider the convictions listed in 4 Del.C. §1354 as grounds for refusal of a license.

4.10.2 The Commissioner may refuse to license an applicant if a substantial objection is presented pursuant to 4 Del.C. §1354 .

4.10.3 An applicant must meet each of the following requirements, as applicable:

4.10.3.1 Except as otherwise provided in this Section, if the applicant is a business entity, every owner, officer, and director of the business entity who holds more than 10% of the outstanding issued shares must meet each of the requirements of this Section.

4.10.3.2 The applicant must be at least 21 years of age. If the applicant is a business entity, then every owner, officer, and director of the business entity must be at least 21 years of age.

4.10.3.3 The applicant must submit to a criminal history record check in accordance with the requirements in 4 Del.C. §1347 and this regulation.

4.10.3.4 The applicant must fully complete all forms required by the Commissioner and may not knowingly or recklessly make a false statement of material fact to the Commissioner. The Commissioner may cancel a license pursuant to 4 Del.C. §1331 and this regulation if subsequent to the issuance of the license, the Commissioner determines the licensee knowingly or recklessly made a false statement of material fact to the Commissioner.

4.10.4 The Commissioner may refuse to license an applicant that in the Commissioner's discretion, based on any information collected in the criminal background check conducted pursuant to 4 Del.C. §1347 , presents a risk to the health or public safety of Delaware citizens.

29 DE Reg. 221 (09/01/25)

29 DE Reg

ensee knowingly or recklessly made a false statement of material fact to the Commissioner.

29 DE Reg. 221 (09/01/25)

29 DE Reg. 787 (03/01/26)

5.0 License Renewals, Transfers and Change of Information

5.1 License renewal process

5.1.1 All licensees must apply for renewal on or before the first day of the third month preceding the biennial expiration date of a license as provided in 4 Del.C. §1353 . In addition, the following requirements apply:

5.1.1.1 A retail marijuana store licensee seeking renewal must comply with 4 Del.C. §1332 and this regulation.

5.1.1.2 A marijuana testing facility licensee seeking renewal must comply with 4 Del.C. §1333 and this regulation.

5.1.1.3 A marijuana cultivation facility licensee seeking renewal must comply with 4 Del.C. §1334 and this regulation.

5.1.1.4 A marijuana product manufacturing facility licensee seeking renewal must comply with 4 Del.C. §1335 and this regulation.

5.1.1.5 A social equity licensee seeking renewal must comply with 4 Del.C. §1337 and this regulation.

5.1.1.6 A microbusiness licensee seeking renewal must comply with 4 Del.C. §1341 and this regulation.

5.1.2 A marijuana establishment seeking renewal must submit:

5.1.2.1 The renewal application in the form designated by the Commissioner;

5.1.2.2 A criminal background check in accordance with 4 Del.C. §1347 , including:

5.1.2.2.1 Proof of fingerprinting and state and federal criminal history records checks.

5.1.2.2.2 For applicants that are business entities, fingerprinting and criminal history record checks are required for officer, director, employee, and owner with an interest of 10% or more

form designated by the Commissioner;

5.1.2.2 A criminal background check in accordance with 4 Del.C. §1347 , including:

5.1.2.2.1 Proof of fingerprinting and state and federal criminal history records checks.

5.1.2.2.2 For applicants that are business entities, fingerprinting and criminal history record checks are required for officer, director, employee, and owner with an interest of 10% or more.

5.1.2.2.3 Any additional information requested by the Commissioner to verify aspects of the license, including additional information and supporting documentation related to the ownership and control of the license as described in subsection 4.4.3 of this regulation; and

5.1.2.2.4 Payment of the renewal fee determined by the Commissioner.

5.1.3 The Commissioner or the Division may conduct a full inspection of the licensed premise before renewing a license. If a licensee fails the inspection or submits a deficient application for renewal, the licensee may submit a plan to correct the deficiencies with an amended renewal application.

5.1.4 The Commissioner may deny a license renewal if:

5.1.4.1 The plan to correct deficiencies identified in an inspection is insufficient.

5.1.4.2 The amended renewal application is incomplete or deficient.

5.1.4.3 Applicant ownership and operational control violates Title 4 of the Delaware Code or this regulation.

5.1.4.4 The licensee violates Title 4 of the Delaware Code or this regulation during the license period.

5.1.5 A licensee who fails to apply for license renewal or whose license was not renewed by the Commissioner must cease operations at all premises and may not sell or give away marijuana to any entity or individual.

5.1.6 A license may be reinstated upon payment of the reinstatement fee specified by the Commissioner and submission of a reinstatement application approved by the Commissioner.

5.1.7 A microbusiness licensee may not request a license tier increase.

5.1.8 The Commissioner will make a decision on an application for renewal of license as prescribed 4 Del.C. §1353

ijuana to any entity or individual.

5.1.6 A license may be reinstated upon payment of the reinstatement fee specified by the Commissioner and submission of a reinstatement application approved by the Commissioner.

5.1.7 A microbusiness licensee may not request a license tier increase.

5.1.8 The Commissioner will make a decision on an application for renewal of license as prescribed 4 Del.C. §1353 .

5.2 Transfer of license

5.2.1 A transfer of a license must meet the requirements in 4 Del.C. §1366 .

5.2.2 The Commissioner may deny transfer of an interest for any proposed transferee if:

5.2.2.1 The proposed transferee does not meet the requirements of Title 4 of the Delaware Code or this regulation.

5.2.2.2 The proposed transferee has been convicted of or pleaded nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;

5.2.2.3 The payment of taxes due in any jurisdiction is in arrears;

5.2.2.4 The proposed transfer violates state, local or federal law; or

5.2.2.5 Other good cause exists to deny the proposed transfer.

5.2.3 Any individual or entity identified as having ownership or control of a license may not hold an ownership interest that exceeds the limitations set forth in subsection 4.1.2.

5.2.4 If the Commissioner approves a transfer of an ownership interest of a license and subsequently the Commissioner finds that a transfer violates state, local, or federal law or other binding contractual agreements, the Commissioner may:

5.2.4.1 Issue a fine against any parties involved in the transfer;

5.2.4.2 Declare the transfer void; or

5.2.4.3 Cancel the license.

5.3 Change in location of business premise

5.3.1 A marijuana establishment may not change the premises where the license is to be used without approval of the Commissioner.

5.3.2 A licensee may apply to change the premises where the license is to be used by submitting an application and applicable fee to the Commissioner on a form prescribed by the Commissioner

void; or

5.2.4.3 Cancel the license.

5.3 Change in location of business premise

5.3.1 A marijuana establishment may not change the premises where the license is to be used without approval of the Commissioner.

5.3.2 A licensee may apply to change the premises where the license is to be used by submitting an application and applicable fee to the Commissioner on a form prescribed by the Commissioner.

5.4 All material changes to a license require the express approval of the Commissioner.

29 DE Reg. 221 (09/01/25)

6.0 General Compliance

6.1 Ownership requirements

6.1.1 A social equity license may not be transferred to a person who does not meet the criteria in 4 Del.C. §1336 until at least 3 years have passed since the social equity license was initially awarded.

6.1.2 A change ownership of a license must meet the requirements in 4 Del.C. §1372 and this regulation.

6.2 General facility requirements

6.2.1 Marijuana establishments must ensure that their premises comply with all applicable local laws, regulations, and zoning requirements.

6.2.2 Marijuana establishments that handle or otherwise conduct activities with food, food ingredients, or food products must comply with all applicable requirements in the State of Delaware Food Code.

6.2.3 Marijuana establishments must ensure that their premises complies with all applicable federal workplace safety laws and regulations in accordance with the General Duty Clause of the OSH Act (Public Law 91-956) and 29 C.F.R

that handle or otherwise conduct activities with food, food ingredients, or food products must comply with all applicable requirements in the State of Delaware Food Code.

6.2.3.1 The presence of functioning fire and smoke detection systems, and, where applicable, fire suppression systems;

6.2.3.2 The presence of functioning carbon monoxide detection systems;

6.2.3.3 The prominent display of emergency procedures, including evacuations and shelter-in-place procedures;

6.2.3.4 Personnel access to procedures for the safe handling and operation of any applicable equipment or tools; and

6.2.3.5 Any other applicable federal, state, or local laws and regulations pertaining to workplace safety.

6.2.4 Marijuana establishments must ensure compliance with all applicable rules, regulations, and standards contained in:

6.2.4.1 National Fire Protection Association (NFPA) standards;

6.2.4.2 International Building Code (IBC); and

6.2.4.3 International Fire Code (IFC).

6.3 General security requirements

6.3.1 Marijuana establishments must ensure that all usable marijuana plants, marijuana, and marijuana products are stored in a locked and secured area.

6.3.2 Marijuana establishments must implement appropriate security and safety measures to deter and prevent the unauthorized entrance into areas containing marijuana plants, marijuana, and marijuana products, and the theft or diversion of marijuana plants, marijuana, and marijuana products. Security and safety measures must include the following:

6.3.2.1 Access to the premises

6.3.2.1.1 Access from outside the premises must be closely monitored and limited to primary entry points

es to deter and prevent the unauthorized entrance into areas containing marijuana plants, marijuana, and marijuana products, and the theft or diversion of marijuana plants, marijuana, and marijuana products. Security and safety measures must include the following:

6.3.2.1 Access to the premises

6.3.2.1.1 Access from outside the premises must be closely monitored and limited to primary entry points.

6.3.2.1.2 Entry into any area where marijuana plants, marijuana, or marijuana products are held must be limited to authorized personnel.

6.3.2.1.3 Visitors, repair and maintenance workers must be supervised in restricted areas;

6.3.2.1.4 Commercial grade locks appropriate for facilities requiring high levels of physical security are required on all perimeter entry doors.

6.3.2.1.5 All external entrances to indoor facilities on the premises must be lockable.

6.3.2.1.6 All perimeter windows must be in good condition and lockable.

6.3.2.2 Alarm system

6.3.2.2.1 The alarm system must be fully operational at all premises.

6.3.2.2.2 The alarm system must immediately alert a licensed third-party security company of an unauthorized breach of security.

6.3.2.2.3 The alarm system must include an audible alarm capable of being disabled remotely by the security company.

6.3.2.2.4 The alarm system must immediately send an automatic or electronic notification to local or municipal public safety personnel in the event of a loss of electrical support backup system.

6.3.2.2.5 The alarm system must prevent tampering with computers or electronic records.

6.3.2.2.6 Marijuana establishments must conduct a maintenance inspection and test of the alarm system at intervals no more than 30 days from the previous inspection or test. A marijuana establishment must promptly make all necessary repairs to ensure the proper operation of the alarm system.

6.3.2.3 Lighting

6.3.2.2.5 The alarm system must prevent tampering with computers or electronic records.

6.3.2.3 Lighting. Any perimeter entry point of a marijuana establishment must have lighting sufficient for observers to see, and cameras to record, any activity within 10 feet of the gate or entry to the premises.

6.3.2.4 Video surveillance

6.3.2.4.1 A sufficient number of cameras must be permanently affixed to allow the viewing, in its entirety, of any area where marijuana plants, marijuana, or marijuana products are cultivated, manufactured, stored, or prepared for transfer or sale, or where samples for testing are collected, prepared, and sealed.

6.3.2.4.2 Video surveillance must meet the following requirements:

6.3.2.4.2.1 Minimum camera resolution is 720p;

6.3.2.4.2.2 All cameras must record continuously 24 hours per day or be motion activated and at a minimum of 15 frames per second;

6.3.2.4.2.3 All recorded images must clearly and accurately display the time and date. Time is to be measured in accordance with the U.S. National Institute Standards and Technology standards;

6.3.2.4.2.4 An electronic hard drive or comparable electronic storage device used only for the storage of surveillance system video footage must be secured on the premises, be on a third-party server, or be secured in another manner to protect from tampering or criminal theft; and

6.3.2.4.2.5 Video footage must be digitally recorded and held for 90 days for routine footage or up to 36 months if video contains information of significance.

6.3.2.4.3 A marijuana establishment must provide the Commissioner with access to the video 24 hours a day, 7 days a week through a secure internet connection

, or be secured in another manner to protect from tampering or criminal theft; and

6.3.2.4.2.5 Video footage must be digitally recorded and held for 90 days for routine footage or up to 36 months if video contains information of significance.

6.3.2.4.3 A marijuana establishment must provide the Commissioner with access to the video 24 hours a day, 7 days a week through a secure internet connection.

6.3.2.5 In the event of a failure of an alarm or video surveillance system due to loss of electrical support or mechanical malfunction that is expected to exceed an 8-hour period, marijuana establishments must:

6.3.2.5.1 Notify the Commissioner within 24 hours;

6.3.2.5.2 Provide alternative security measures approved by the Commissioner, or close the authorized physical addresses impacted by the failure or malfunction until the alarm or video surveillance systems have been restored to full operation;

6.3.2.5.3 Maintain documentation for a period of at least 24 months after the event. The documentation must include:

6.3.2.5.3.1 All maintenance inspections and tests conducted on the alarm or video surveillance system;

6.3.2.5.3.2 Any servicing, modification, or upgrade performed on the alarm or video surveillance system;

6.3.2.5.3.3 The date of the action;

6.3.2.5.3.4 A summary of any actions performed; and

6.3.2.5.3.5 The name, signature, and title of the individual who performed the actions.

6.3.2.6 Marijuana establishments must maintain documentation for any alarm activation or other event which requires response by public safety personnel, and any unauthorized breach of security.

6.3.3 Theft and diversion. If a marijuana establishment discovers evidence of theft or diversion, the marijuana establishment must report the theft or diversion to the Commissioner and law enforcement within 1 business day

a establishments must maintain documentation for any alarm activation or other event which requires response by public safety personnel, and any unauthorized breach of security.

6.3.3.1 Complete an investigation;

6.3.3.2 Amend the marijuana establishment's standard operating procedures, if directed by the Commissioner; and

6.3.3.3 Send a report of the investigation to the Commissioner.

6.4 General conduct of marijuana establishments

6.4.1 Marijuana establishments must conduct monthly inventories in accordance with the following:

6.4.1.1 On the date business commences, the marijuana establishment must conduct an initial comprehensive inventory review of all marijuana plants, marijuana, and marijuana products at all premises;

6.4.1.2 Documentation of all inventory reviews shall include, at a minimum, the date of the inventory, a summary of the inventory findings and the name, signature, and title of the individual or individuals who conducted the inventory; and

6.4.1.3 If an inventory review identifies a discrepancy, the marijuana establishment must notify the Commissioner within 24 hours of discovery of the event

ses;

6.4.1.3 If an inventory review identifies a discrepancy, the marijuana establishment must notify the Commissioner within 24 hours of discovery of the event.

6.4.2 Marijuana establishments must maintain a current and accurate copy of an operating manual that includes:

6.4.2.1 Procedures for the oversight of the marijuana establishment, including documentation of the reporting and management structure of the marijuana establishment;

6.4.2.2 Procedures for the safe handling of marijuana plants, marijuana, and marijuana products;

6.4.2.3 Procedures to ensure accurate record keeping, including protocols to ensure that quantities of marijuana and marijuana products purchased do not suggest re-distribution;

6.4.2.4 Personnel security policies;

6.4.2.5 Safety and security procedures, including requirements in accordance with subsection 6.3 of this regulation, and including a disaster plan with procedures to be followed in case of fire or other emergencies;

6.4.2.6 Personal safety and crime prevention techniques;

6.4.2.7 Job descriptions or employment contracts developed for all employees and volunteer agreements for all volunteers which includes duties, responsibilities, authority, qualifications, and supervision;

6.4.2.8 The marijuana establishment's alcohol and drug free workplace policies;

6.4.2.9 Procedures to prevent theft or diversion;

6.4.2.10 A business continuity plan; and

6.4.2.11 Any additional operating manual requirements for the marijuana establishment's respective license type.

.2.10 A business continuity plan; and

6.4.2.11 Any additional operating manual requirements for the marijuana establishment's respective license type.

6.4.3 Personnel training. Marijuana establishments must develop, implement, and maintain on the premises an on-site training curriculum, or enter into contractual arrangements with outside resources capable of meeting personnel training requirements. All personnel must receive training in the following prior to commencing work on behalf of the marijuana establishment:

6.4.3.1 Proper use of security measures and controls that have been adopted by the marijuana establishment; and

6.4.3.2 Specific procedures for responding to an emergency, including accident, robbery, active shooter, or violent incident.

6.4.4 Employment identification badge

6.4.4.1 All personnel must have an employment identification badge issued by the Commissioner that permits the individual to conduct activities on behalf of the marijuana establishment. Employment identification badges must be visible on the individual's person at all times the individual is conducting activities on behalf of the marijuana establishment.

6.4.4.2 Applications for an employment identification badge must be submitted on forms made available by the Commissioner. Every applicant must be fingerprinted and complete a criminal history background check.

6.4.4.3 The Commissioner may deny an employment identification badge to any individual who:

6.4.4.3.1 Has been convicted of an offense listed in 4 Del.C. §1354(b)(4) ;

6.4.4.3.2 Does not provide sufficient documentation that the individual is 21 years of age or older; or

6.4.4.3.3 In the Commissioner's discretion, based on information collected in the criminal background check process, presents a risk to the health or public safety of Delaware citizens

cation badge to any individual who:

6.4.4.3.1 Has been convicted of an offense listed in 4 Del.C. §1354(b)(4) ;

6.4.4.3.2 Does not provide sufficient documentation that the individual is 21 years of age or older; or

6.4.4.3.3 In the Commissioner's discretion, based on information collected in the criminal background check process, presents a risk to the health or public safety of Delaware citizens.

6.4.4.4 Employment identification badges must be renewed every 2 years in accordance with the following:

6.4.4.4.1 An application for renewal of an employment identification badge must be submitted prior to the expiration date, and no earlier than 60 days before the expiration date.

6.4.4.4.2 If an application for renewal of an employment identification badge has been submitted before the expiration date, but has not been processed by the Commissioner, personnel may conduct activities on behalf of the marijuana establishment until the new employment identification badge has been issued.

6.4.4.5 Employment identification badges for which a renewal application has not been received by the Commissioner will expire. Personnel with an expired badge may not conduct any activities on behalf of the marijuana establishment.

6.4.4.6 If an employment identification badge is lost or stolen, the marijuana establishment must notify the Commissioner within 24 hours. After notification, the Commissioner will indicate whether the badge holder may continue to conduct activities on behalf of the marijuana establishment.

6.4.4.7 Marijuana establishments must notify the Commissioner within 48 hours of the termination of the personnel's affiliation with the marijuana establishment. The marijuana establishment must follow instructions from the Commissioner for return of the employment identification badge.

6.4.4.8 The Commissioner may charge a fee for the issuance or replacement of an employment identification badge.

6.4.5 Marijuana establishments must conduct annual financial audits

48 hours of the termination of the personnel's affiliation with the marijuana establishment. The marijuana establishment must follow instructions from the Commissioner for return of the employment identification badge.

6.4.4.8 The Commissioner may charge a fee for the issuance or replacement of an employment identification badge.

6.4.5 Marijuana establishments must conduct annual financial audits. The audit must be conducted by an independent auditing firm and submitted to the Commissioner with the marijuana establishment's annual report. The Commissioner or an auditing firm contracted by the Commissioner must have access to all books and records kept by any marijuana establishment at all times.

6.4.6 Prohibited conduct. Marijuana establishments may not:

6.4.6.1 Purchase marijuana plants, marijuana, or marijuana products from any person or entity other than another marijuana establishment licensed by the State of Delaware;

6.4.6.2 Sell or prepare products from a batch undergoing mandatory compliance testing until the marijuana testing facility has entered the applicable values into the seed-to-sale tracking system; or

6.4.6.3 Operate if an imminent health hazard exists due to an emergency such as fire, flood, extended interruption of electrical or water service, sewage backup, misuse of poisonous or toxic materials, onset of an apparent food-borne illness outbreak, gross unsanitary occurrences or conditions, or other circumstances that may endanger public health.

6.4.7 Visitor logs. Marijuana establishments must document and retain records following the entry of any individual not affiliated with the marijuana establishment into any area of the premises that is not accessible to the public.

6.4.7.1 Visitor logs must include the full legal name and signature of the visitor, the visitor's phone number, the date of the visitation, and a check-in and check-out time

Visitor logs. Marijuana establishments must document and retain records following the entry of any individual not affiliated with the marijuana establishment into any area of the premises that is not accessible to the public.

6.4.7.1 Visitor logs must include the full legal name and signature of the visitor, the visitor's phone number, the date of the visitation, and a check-in and check-out time.

6.4.7.2 If the visitor is a holder of an active employment identification badge under this regulation, the visitor log must include the individual's unique identification number.

6.4.7.3 Visitor logs must be maintained for a period of 1 year following the date of visitation.

6.5 Retail marijuana store general requirements

6.5.1 A retail marijuana store license permits the following activities:

6.5.1.1 Purchasing prepackaged retail units of marijuana from marijuana cultivation facilities;

6.5.1.2 Purchasing prepackaged retail units of marijuana, marijuana concentrates, and marijuana products from marijuana products manufacturing facilities;

6.5.1.3 Selling prepackaged retail units of marijuana, marijuana concentrates, and marijuana products, to consumer 21 years or older or with a valid medical marijuana program card;

6.5.1.4 Providing samples of marijuana and marijuana products to authorized individuals for mandatory compliance testing in accordance with subsection 11.2 at the direction of the Commissioner;

6.5.1.5 Collecting samples of marijuana for research and development testing in accordance with subsection 11.7 and transporting those samples to a marijuana testing facility;

6.5.1.6 Storing prepackaged retail units of marijuana, marijuana concentrates, and marijuana products;

6.5.1.7 Selling marijuana accessories and non-consumable products that are not intended for human consumption, including clothing, storage containers, rolling papers, or other marijuana accessories

in accordance with subsection 11.7 and transporting those samples to a marijuana testing facility;

6.5.1.6 Storing prepackaged retail units of marijuana, marijuana concentrates, and marijuana products;

6.5.1.7 Selling marijuana accessories and non-consumable products that are not intended for human consumption, including clothing, storage containers, rolling papers, or other marijuana accessories.

6.5.1.8 Transporting prepackaged retail units of marijuana, marijuana concentrates, or marijuana products to other marijuana establishments; and

6.5.1.9 Destroying marijuana, marijuana concentrates and marijuana products in accordance with subsection 12.2.

6.5.2 A retail marijuana store is prohibited from:

6.5.2.1 Selling marijuana, marijuana concentrates, and marijuana products to a person under 21 years of age without a valid medical marijuana program card;

6.5.2.2 Selling more marijuana, marijuana concentrates, and marijuana products than is allowed for in 4 Del.C. §1332 and this regulation, during a single transaction to an individual;

6.5.2.3 Giving away marijuana, marijuana concentrates, and marijuana products for no remuneration;

6.5.2.4 Selling any marijuana, marijuana concentrates, and marijuana products which contain synthetic cannabinoids;

6.5.2.5 Selling marijuana, marijuana concentrates, and marijuana products to a person who is visibly intoxicated;

6.5.2.6 Displaying marijuana products in an insecure manner or in a manner that products can be viewed from outside the establishment;

6.5.2.7 Selling or giving away consumable products not containing marijuana, including cigarettes or alcohol, or any edible product that does not contain marijuana, including sodas, candies, or baked goods;

6.5.2.8 Selling retail marijuana or retail marijuana products over the Internet

rijuana products in an insecure manner or in a manner that products can be viewed from outside the establishment;

6.5.2.8 Selling retail marijuana or retail marijuana products over the Internet. This does not preclude online pre-orders for pick-up at the retail location, provided that the sale is not completed until all other requirements have been met, including identity and age verification; and

6.5.2.9 Delivering retail marijuana or retail marijuana products to a person not physically present in the retail marijuana store's licensed premises. Individuals holding a valid medical marijuana program card may receive home delivery.

6.5.3 A retail marijuana store must:

6.5.3.1 Ensure all sales of marijuana and marijuana products take place within the retail area of the retail marijuana store premises;

6.5.3.2 Prohibit the consumption of marijuana or marijuana products on the premises of the retail marijuana store;

6.5.3.3 Comply with all provisions of Delaware and federal law in regard to individuals with disabilities;

6.5.3.4 Prominently display the active retail marijuana store license where it can reasonably be viewed by state and local agencies and the public;

6.5.3.5 In addition to the training requirements described in subsection 6.4.3 of this regulation, ensure all employees are trained in recognizing valid identification cards; and

6.5.3.6 Verify customer age by reviewing the purchaser's government-issued photo identification card showing that the individual is 21 years of age or older or holds a valid medical marijuana program card. A valid, government-issued identification must contain a photo and the date of birth of the individual and be unexpired

e all employees are trained in recognizing valid identification cards; and

6.5.3.6.1 A driver's license issued by any state within the United States, District of Columbia, or U.S. territory;

6.5.3.6.2 An identification card, including a temporary identification card, issued by any state within the United States, District of Columbia, or U.S. territory;

6.5.3.6.3 A United States military identification card or any other identification card issued by the United States government including a permanent resident card, alien registration card, or consular card;

6.5.3.6.4 A passport or passport identification card; or

6.5.3.6.5 A tribal enrollment card issued by the governing authority of a federally recognized Indian tribe.

6.5.4 Retail marijuana store operating plan. Retail marijuana stores must maintain a current and accurate copy of an operating plan that includes:

6.5.4.1 Procedures for recognizing valid identification cards, including the duties and responsibilities of employees when presented with fraudulent identification by an individual under the age of 21;

6.5.4.2 Procedures for the safe handling of marijuana and marijuana products available for sale;

6.5.4.3 Requirements for the record keeping and disposal of marijuana and marijuana products removed from their original packaging for the purposes of displaying products available for sale; and

6.5.4.4 Procedures for the monthly inventory review of all marijuana and marijuana products for sale in accordance with subsection 7.1.2 of this regulation.

6.5.5 Display of marijuana and marijuana products

.5.4.3 Requirements for the record keeping and disposal of marijuana and marijuana products removed from their original packaging for the purposes of displaying products available for sale; and

6.5.4.4 Procedures for the monthly inventory review of all marijuana and marijuana products for sale in accordance with subsection 7.1.2 of this regulation.

6.5.5 Display of marijuana and marijuana products. Marijuana and marijuana products available for sale at a retail marijuana store must be displayed:

6.5.5.1 In a manner that is not visible to the general public from a public right-of-way;

6.5.5.2 In a locked display case or container that can only be accessed with the assistance of an employee of the retail marijuana store.

6.5.5.2.1 A display case containing marijuana or marijuana products must include the potency of the marijuana or marijuana products next to the name of the marijuana or marijuana products using the standards established by Section 9.0 of this regulation.

6.5.5.2.2 If an individual wishes to inspect marijuana or a marijuana product located in a display case, an employee of the retail marijuana store must assist the individual and remain with them at all times while the product is being inspected.

6.5.5.2.3 Marijuana and marijuana products may be removed from their packaging and placed in a display case or container but may not be sold or consumed when the marijuana or marijuana product is no longer being used for display purposes.

6.5.6 A retail marijuana store may petition the Commissioner to allow deli style dispensing of marijuana flower. The Commissioner will consider the petition weighed against the health and public safety of consumers

oved from their packaging and placed in a display case or container but may not be sold or consumed when the marijuana or marijuana product is no longer being used for display purposes.

6.5.6.1 A detailed plan for selling unpackaged marijuana flower safely, without undue exposure to ubiquitous airborne contaminates;

6.5.6.2 A detailed plan for security and inventory control; and

6.5.6.3 A wholesale agreement with a licensed marijuana establishment providing marijuana flower.

6.5.7 Retail marijuana store security requirements

6.5.7.1 Retail area. A retail marijuana store must have a retail area where marijuana, marijuana products, or marijuana accessories are offered for sale. The retail area must:

6.5.7.1.1 Be physically separated from the waiting area; and

6.5.7.1.2 Be locked and accessible to customers only through permission by a retail marijuana store employee. A retail marijuana store employee may provide access by physically or remotely unlocking the entrance to the retail area for purposes of allowing a customer to enter the retail area.

6.5.7.2 Waiting area. A retail marijuana store must have a waiting area where marijuana, marijuana products, and marijuana accessories are not present. The waiting area must:

6.5.7.2.1 Be physically separated from the retail area;

6.5.7.2.2 Be the area first accessed by customers upon entrance into the premises;

6.5.7.2.3 Include a reception area where an employee of the retail marijuana store verifies that the purchaser has a valid government-issued photo identification card showing that the individual is 21 years of age or older; and

6.5.7.2.4 Be attended by a retail marijuana store employee at all times during operating hours

.2.2 Be the area first accessed by customers upon entrance into the premises;

6.5.7.2.4 Be attended by a retail marijuana store employee at all times during operating hours.

6.6 Marijuana testing facilities general requirements

6.6.1 A marijuana testing facility license permits the following activities:

6.6.1.1 Receiving samples of marijuana and marijuana products from individuals authorized by the Commissioner for the purpose of required compliance testing;

6.6.1.2 Receiving samples of marijuana and marijuana products from marijuana cultivation facilities, marijuana product manufacturing facilities, retail marijuana stores, and individuals authorized by the Commissioner for the purpose of research and development;

6.6.1.3 Denying receipt of samples from to marijuana cultivation facilities, marijuana product manufacturing facilities, and retail marijuana stores, for any reason, including samples that do not meet the requirements of subsection 11.9;

6.6.1.4 Performing analysis of samples of marijuana and marijuana products following protocols approved by the Commissioner and in accordance with subsection 11.10;

6.6.1.5 Providing a Certificate of Analysis, for the sample provided to the marijuana testing facility, to marijuana cultivation facilities, marijuana product manufacturing facilities and retail marijuana stores;

6.6.1.6 Storing samples of marijuana and marijuana products;

6.6.1.7 Destroying and disposing of samples, subject to all requirements of subsection 12.2;

6.6.1.8 Reporting of testing results in accordance with subsections 11.5 and 11.10.9; and

6.6.1.9 Receiving samples of marijuana, marijuana concentrates, and marijuana products from individuals holding a valid medical marijuana program card or consumers 21 years or older, for the purpose of testing

oducts;

6.6.1.7 Destroying and disposing of samples, subject to all requirements of subsection 12.2;

6.6.1.8 Reporting of testing results in accordance with subsections 11.5 and 11.10.9; and

6.6.2 A marijuana testing facility must:

6.6.2.1 Operate in accordance with the International Organization for Standardization 17025 (ISO 17025) standards as confirmed by accreditation or by an International Laboratory Accreditation Corporation (ILAC) recognized accreditation body.

6.6.2.2 Meet the requirements specified in Sections 3.0 and 4.0 of this regulation.

6.6.3 Active licenses for marijuana testing facilities:

6.6.3.1 May not be issued prior to a final inspection and correction of any deficiencies in a manner acceptable to the Commissioner;

6.6.3.2 Must be kept posted in a conspicuous place on the premises;

6.6.3.3 Must clearly identify the name of the laboratory, the license number, the name of the marijuana testing facility director, the issue date, and expiration date; and

6.6.3.4 Must include a list of the analytes and methods for each test category for which the marijuana testing facility is approved to conduct testing. Test categories approved for the analysis of marijuana plant materials must be listed separately from those approved for marijuana concentrates.

6.6.4 Marijuana testing facilities may examine samples from other marijuana testing facilities in this state, provided that the marijuana testing facility providing the samples is licensed in this state pursuant to this regulation.

ther marijuana testing facilities in this state, provided that the marijuana testing facility providing the samples is licensed in this state pursuant to this regulation.

6.6.5 Marijuana testing facilities may receive samples from private citizens for examination. The individual or individuals providing samples will be responsible for any cost associated with examination and testing of the samples. Results obtained through examination of samples provided by private citizens are not subject to the reporting requirements in this regulation.

6.6.6 Management. Each marijuana testing facility must have a director who is responsible for the day-to-day management and operation of the marijuana testing facility, and for ensuring the achievement and maintenance of quality standards of practice.

6.6.6.1 The marijuana testing facility director must possess a doctorate degree in the chemical or biological sciences from a college or university accredited by a national or regional certifying authority and a minimum of 2 years of analytical laboratory experience or possess a master's degree in the chemical or biological sciences and a minimum of 4 years of analytical laboratory experience or possess a bachelor's degree in the chemical or biological sciences and a minimum of 5 years of analytical laboratory experience.

6.6.6.2 The marijuana testing facility director's responsibilities include:

6.6.6.2.1 Being present on the premises of the marijuana testing facility during the hours of operation to ensure adequate and appropriate supervision of marijuana testing facility activities;

6.6.6.2.2 Ensuring the accurate performance of all tests in the marijuana testing facility including the submission of appropriate reports on all tests;

6.6.6.2.3 Ensuring the supervision of all personnel in the marijuana testing facility and for hiring adequately trained personnel commensurate with the workload;

6.6.6.2.4 Being available during the hours of operation for personal or telephone consultation with personnel;

6.6.6.2.5 Notifying the Comm

ts in the marijuana testing facility including the submission of appropriate reports on all tests;

6.6.6.2.3 Ensuring the supervision of all personnel in the marijuana testing facility and for hiring adequately trained personnel commensurate with the workload;

6.6.6.2.4 Being available during the hours of operation for personal or telephone consultation with personnel;

6.6.6.2.5 Notifying the Commissioner within 30 days of any change in marijuana testing facility services or supervisory personnel; and

6.6.6.2.6 Establishing and adhering to written policies and procedures for a comprehensive quality assurance program.

6.6.6.3 In the event the director of the marijuana testing facility is absent for a continuous period longer than 1 month in duration, the marijuana testing facility may not operate unless a person who meets the qualifications of subsection 6.6.6.1 of this regulation is in attendance.

6.6.6.4 The marijuana testing facility director must designate a qualified quality assurance management officer who is responsible for the marijuana testing facility's quality assurance management plan and its implementation. This individual may be an outside consultant or the marijuana testing facility director. The quality assurance management officer must:

6.6.6.4.1 Have a bachelor's degree in a chemical or biological science and 2 years of related laboratory experience. The Commissioner may waive these qualifications if the person has previous laboratory quality assurance experience acceptable to the Commissioner in a licensed, certified, or accredited laboratory, or possesses other qualifications acceptable to Commissioner;

6.6.6.4.2 Be responsible for the oversight of quality control data, including establishing acceptance criteria, documenting, and monitoring corrective action;

6.6.6.4.3 Where staffing allows, be independent of the technical areas for which they have quality assurance oversight;

6.6.6.4.4 Have general knowledge of the methodologies for which data review is performed;

6.6.6.4.5 Have oversight of t

;

6.6.6.4.2 Be responsible for the oversight of quality control data, including establishing acceptance criteria, documenting, and monitoring corrective action;

6.6.6.4.3 Where staffing allows, be independent of the technical areas for which they have quality assurance oversight;

6.6.6.4.4 Have general knowledge of the methodologies for which data review is performed;

6.6.6.4.5 Have oversight of the marijuana testing facility's quality assurance system; and

6.6.6.4.6 Conduct or arrange for annual internal audits of the technical operation of the marijuana testing facility, and report findings to the marijuana testing facility director.

6.6.7 Personnel. Each marijuana testing facility must:

6.6.7.1 Employ enough qualified personnel commensurate with the workload to ensure that services are provided effectively and safely and in accordance with prevailing laboratory standards and practices;

6.6.7.2 Establish a job description for each classification of position, clearly delineating qualifications, duties, and responsibilities inherent in each position;

6.6.7.3 Maintain personnel records for all personnel which include:

6.6.7.3.1 Current background and training documentation pertaining to qualifications;

6.6.7.3.2 Orientation procedures, including an initial demonstration of capability for each method or instrument the personnel will be performing or operating;

6.6.7.3.3 Evidence of periodic evaluation of work performance.

6.6.7.4 Train personnel initially and annually thereafter on the following:

6.6.7.4.1 Professional conduct, ethics, and state laws regarding marijuana;

6.6.7.4.2 The use of the seed-to-sale tracking system used by the marijuana testing facility; and

6.6.7.4.3 Testing methods employed by the marijuana testing facility.

6.6.8 Record keeping

.7.3.3 Evidence of periodic evaluation of work performance.

6.6.7.4 Train personnel initially and annually thereafter on the following:

6.6.7.4.1 Professional conduct, ethics, and state laws regarding marijuana;

6.6.7.4.2 The use of the seed-to-sale tracking system used by the marijuana testing facility; and

6.6.7.4.3 Testing methods employed by the marijuana testing facility.

6.6.8 Record keeping. In addition to the requirements and processes specified in Section 7.0 of this regulation, each marijuana testing facility must:

6.6.8.1 Create, control, and maintain records of raw data, chain-of-custody records, calculations, quality control data, and other essential documentation;

6.6.8.2 Complete all records with signatures, units of measurement, and documentation sufficient for verification of results; and

6.6.8.3 Retain all records in such a manner as to permit prompt retrieval and inspection by the Commissioner.

6.6.9 Quality assurance and quality control programs. Each marijuana testing facility must:

6.6.9.1 Have a quality assurance management plan that details the quality assurance system of quality control requirements in its standard operating procedures, and document that all personnel review the quality assurance management plan annually. The quality assurance/management plan must include:

6.6.9.1.1 Sample handling procedures;

6.6.9.1.2 Emergency sampling and handling plans;

6.6.9.1.3 Laboratory glassware, plastic ware, and equipment washing and sterilizing procedures;

6.6.9.1.4 Instrument calibration procedures;

6.6.9.1.5 A list of detailed analytical procedures or analytical references;

6.6.9.1.6 Data reduction, validation, and reporting procedures including non-compliance action plans;

6.6.9.1.7 Types and frequency of internal audit samples (quality control samples) and external audit samples (proficiency testing samples);

6.6.9.1.8 Internal audit procedures and frequencies;

6.6.9.1.9 Preventative maintenance procedures and schedules;

6.6.9.1.10 Procedures for determining accuracy and precision and met

, validation, and reporting procedures including non-compliance action plans;

6.6.9.1.7 Types and frequency of internal audit samples (quality control samples) and external audit samples (proficiency testing samples);

6.6.9.1.8 Internal audit procedures and frequencies;

6.6.9.1.9 Preventative maintenance procedures and schedules;

6.6.9.1.10 Procedures for determining accuracy and precision and method detection limits of all analytes and specified frequencies;

6.6.9.1.11 Control limits and corrective action policies;

6.6.9.1.12 Marijuana testing facility organization, staff, and responsibilities;

6.6.9.1.13 Procedures for marijuana testing facility and managerial data review;

6.6.9.1.14 Detection limits for cannabinoids and contaminant analytes specified in this regulation. Detection limits must be determined by detection limit studies prior to placing new methods in service and annually thereafter. The resulting detection limits must be less than half of the upper limit concentration criteria specified in this regulation. If the marijuana testing facility cannot meet a detection limit that is less than half of the upper limit for an analyte, a request for a variance must be submitted; and

6.6.9.1.15 The applicable quality control procedures required for methodologies described by the FDA, AOAC, AHP or USP.

6.6.9.2 Follow all applicable quality control activities described in its quality assurance/management plan as approved by the Commissioner;

6.6.9.3 Review their quality assurance management plan annually and provide a copy of the updated quality assurance/management plan to the Commissioner with the annual license renewal application;

6.6.9.4 Have clearly established internal and external quality controls to ensure high standards of performance and reliability of test results

assurance/management plan as approved by the Commissioner;

6.6.9.3 Review their quality assurance management plan annually and provide a copy of the updated quality assurance/management plan to the Commissioner with the annual license renewal application;

6.6.9.4 Have clearly established internal and external quality controls to ensure high standards of performance and reliability of test results. These quality controls must consider factors including preventative maintenance, periodic inspection, testing for proper validation of methods, evaluation of reagents and volumetric equipment, surveillance of results, remedial action taken to correct deficiencies, and quality control failures and other factors as may be deemed necessary by the Commissioner;

6.6.9.5 Perform all analyses using methods that are currently approved by the Commissioner;

6.6.9.6 Make its quality assurance/management plan accessible to all personnel in the marijuana testing facility.

6.6.10 Proficiency testing and demonstration of capability. Each marijuana testing facility must adhere to the following:

6.6.10.1 The marijuana testing facility's quality assurance management plan must include standard procedures for determining the capability of its analysts before they can begin conducting quantitative analysis of marijuana or marijuana products.

6.6.10.2 The Commissioner must be notified when significant changes are made to the standard analytical procedures such as changes to extraction techniques, or the instrumentation used.

6.6.10.3 All personnel are required to perform initial demonstration of capability prior to implementing routine analyses.

lyses.

6.6.10.4 Each marijuana testing facility must participate in a proficiency testing program approved by the Commissioner for each analyte (or group of analytes), matrix, and method for which the marijuana testing facility is allowed to conduct or for which it is requesting allowance. Proficiency testing samples must be procured from a proficiency testing provider approved by the Commissioner. The Commissioner may require that the proficiency testing program include "round robin" proficiency testing whereby samples from the same batch are tested by more than 1 licensed marijuana testing facility for comparison of results.

6.6.10.4.1 If proficiency test samples are not commercially available, marijuana testing facilities must submit a plan to define and develop in-house quality control samples it will use to demonstrate its proficiency for each analyte, matrix, and method of analysis. The plan must include:

6.6.10.4.1.1 The source of the sample;

6.6.10.4.1.2 The matrix type;

6.6.10.4.1.3 Preparation procedures;

6.6.10.4.1.4 Target analytes in the sample;

6.6.10.4.1.5 How the analyte concentration was determined;

6.6.10.4.1.6 Control limits and how they were determined; and

6.6.10.4.1.7 Sample shelf life and expiration testing.

6.6.10.4.2 The laboratory must participate in a proficiency testing program annually for each analyte, matrix, and method and receive an acceptable evaluation for each test category described in this regulation.

6.6.10.4.3 Proficiency test results must be submitted by the accredited provider directly to the Commissioner by October 31 of each year. Marijuana testing facilities must designate the Commissioner as a recipient of the provider's proficiency test results report. Marijuana testing facilities may not communicate or receive proficiency test results to or from other marijuana testing facilities before the accredited provider makes them available

mitted by the accredited provider directly to the Commissioner by October 31 of each year. Marijuana testing facilities must designate the Commissioner as a recipient of the provider's proficiency test results report. Marijuana testing facilities may not communicate or receive proficiency test results to or from other marijuana testing facilities before the accredited provider makes them available.

6.6.10.4.4 When a marijuana testing facility receives an unacceptable evaluation for an analyte in a study, it must determine the cause for the failure, take corrective action, and participate in another proficiency testing study for the failed analyte. Documentation of the investigation and corrective must be maintained, and a copy provided to the Commissioner before the next proficiency testing study.

6.6.10.4.5 Failure to complete proficiency testing studies annually, or failure to obtain an acceptable result in a proficiency testing study will result in loss of approval for the testing of the analyte in question until 2 consecutive proficiency testing studies resulting in acceptable evaluations have been completed. There must be an interval of at least 30 days between the 2 studies.

6.6.10.4.6 All proficiency test samples must be analyzed in the same manner and frequency as real marijuana and marijuana products using the same staff, procedures, and equipment.

6.6.10.4.7 Marijuana testing facilities may not send a proficiency testing sample, or a portion thereof, to another marijuana testing facility for any analysis for which it is approved or seeking approval.

6.6.10.4.8 A marijuana testing facility may not knowingly receive any proficiency testing sample, or a portion thereof, from another marijuana testing facility for any analysis for which the sending marijuana testing facility is approved or seeking approval

ncy testing sample, or a portion thereof, to another marijuana testing facility for any analysis for which it is approved or seeking approval.

6.6.10.4.9 Marijuana testing facility management or personnel may not communicate with any individual at another marijuana testing facility concerning a proficiency testing sample or attempt to obtain the assigned value from their proficiency testing provider.

6.6.10.4.10 All raw data obtained in analyzing proficiency testing samples must be retained and be available for review for a minimum of 5 years.

6.6.11 Procedures manual. Each marijuana testing facility must have available at all times, in the immediate working areas of personnel engaged in conducting analytical laboratory sample receiving, sample accessioning, and testing, a procedures manual which includes a detailed compilation of all automated and manual methods and procedures for chain-of-custody, and analytical testing which is performed by the laboratory and for which it is approved. Procedures manuals must:

6.6.11.1 Be written in a uniformly consistent format;

6.6.11.2 Specify the approved method used;

6.6.11.3 Describe the quality control activities pertinent to the method;

6.6.11.4 Contain information concerning preparation and storage of media, reagents, control and calibration procedures, and pertinent literature references;

6.6.11.5 Describe the marijuana testing facility's technical procedures for the receiving, processing, and examination of samples;

6.6.11.6 For tests which are normally performed on automated test equipment, provide for alternate methods or for storage of test samples, in the event the automated equipment becomes inoperable; and

6.6.11.7 Be approved, signed, and dated by the current marijuana testing facility director and the qua

esting facility's technical procedures for the receiving, processing, and examination of samples;

6.6.11.6 For tests which are normally performed on automated test equipment, provide for alternate methods or for storage of test samples, in the event the automated equipment becomes inoperable; and

6.6.11.7 Be approved, signed, and dated by the current marijuana testing facility director and the quality assurance/management officer. Changes in procedures must be approved, signed, and dated by the current marijuana testing facility director and the quality assurance/management officer.

6.6.12 Waste disposal. In addition to the requirements and processes specified in Section 12.0 of this regulation, each marijuana testing facility must:

6.6.12.1 Manage medical waste per Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management & Disposal of Regulated Medical Waste in Delaware ( 7 DE Admin. Code 1302, Part 262 Standards Applicable to Generators of Hazardous Waste); and

6.6.12.2 Manage hazardous waste per DNREC rules and regulations.

6.6.13 Prohibited conduct. Marijuana testing facilities must adhere to the following requirements:

6.6.13.1 No marijuana testing facility or owner, officer, director, manager, general partner, or employee of a marijuana testing facility may have a direct or indirect financial interest in a marijuana cultivation facility, marijuana product manufacturing facility, or retail marijuana store.

6.6.13.2 A marijuana testing facility may not transfer any marijuana, marijuana products, or samples to any person or entity other than the person or entity who provided the sample, a law enforcement officer authorized to collect the marijuana or marijuana product, or another licensed marijuana testing facility with a valid license to perform the testing requested, or the Commissioner

juana store.

6.6.13.3 No owner, officer, director, manager, general partner, contractor, or employee of a marijuana testing facility may accept any gifts of goods, services, or money from a marijuana cultivation facility, marijuana product manufacturing facility, retail marijuana store, or a person or an organization representing the entities.

6.6.13.4 A marijuana testing facility must maintain the confidentiality of test results and may not report test results with any identifying information to anyone other than the person or entity who submitted the sample, law enforcement officers authorized to collect the information, the CDC, or the Commissioner.

6.6.13.5 No employee of a marijuana testing facility may alter the results of any test. In cases in which a sample was retested in accordance with Section 11.0 of this regulation, both test results must be maintained.

6.6.13.6 No employee of a marijuana testing facility may conceal from the Commissioner the results of any mandatory test for cannabinoid content or contamination.

6.6.13.7 A marijuana testing facility must maintain its accreditation at all times for at least 1 analyte and technology required as part of mandatory compliance testing to remain licensed by the Commissioner.

6.6.14 Marijuana testing facilities security requirements

6.6.14.1 Facility requirements

eal from the Commissioner the results of any mandatory test for cannabinoid content or contamination.

6.6.14 Marijuana testing facilities security requirements

6.6.14.1 Facility requirements. Each marijuana testing facility must adhere to the following:

6.6.14.1.1 Be housed in well-lighted, sanitary, vented quarters equipped with hot and cold running water and bathroom facilities, and contain ample space to process and examine the samples commensurate with the total workload;

6.6.14.1.2 Be in distinct and separate locations from living quarters unless provisions exist for separate entrances, and plumbing fixtures;

6.6.14.1.3 Have ample workbench space, have sufficient water, gas, suction, electrical outlets, and sinks;

6.6.14.1.4 Have adequate and proper storage space for all chemicals including explosive, flammable, corrosive, and caustic materials;

6.6.14.1.5 Have flooring composed of non-porous material in laboratory areas where acids, caustics, and solvents are used;

6.6.14.1.6 Have adequate temperature and humidity controls as may be required for proper performance of tests and operation of instruments affected by environmental conditions;

6.6.14.1.7 Have adequate electrical supply; and

6.6.14.1.8 Have adequate refrigeration for samples, standards, and reagents used in testing.

6.6.14.2 Equipment and supplies. Each marijuana testing facility must adhere to the following:

6.6.14.2.1 Possess on-site all equipment necessary for the testing method.

6.6.14.2.2 Have sufficient glassware and plastic lab-ware necessary for the analyses. Glassware shall be borosilicate glass or other corrosion-resistant glass and free of cracks and chips.

6.6.14.2.3 Markings and etchings shall be legible. Volumetric flasks, pipettes, and other glassware used for volumetric analysis shall be class "A"

Possess on-site all equipment necessary for the testing method.

6.6.14.2.2 Have sufficient glassware and plastic lab-ware necessary for the analyses. Glassware shall be borosilicate glass or other corrosion-resistant glass and free of cracks and chips.

6.6.14.2.3 Markings and etchings shall be legible. Volumetric flasks, pipettes, and other glassware used for volumetric analysis shall be class "A".

6.6.14.2.4 The marijuana testing facility must have sufficient facilities to wash and sterilize glassware, lab-ware, and other containers used in the analyses.

6.6.14.2.5 All precision equipment and instruments (e.g., pipettes, pH meters, conductivity meters) must be calibrated and checked for accuracy at regular intervals as required by the method and the marijuana testing facility's quality assurance policies. Documentation of calibration and accuracy checks must be maintained. Records of service by a qualified instrument service organization shall be maintained.

6.6.14.2.6 Analytical balance range and sensitivity must be appropriate for the application for which it is used. Balances must be kept clean and free of corrosion and spillage and shall be checked daily with weights meeting ASTM Type I, Class 1 or 2 specifications with values that bracket the laboratory's weighing needs. Records must be maintained that include acceptance criteria for the checks. ASTM weights shall be recalibrated every 5 years or immediately if nicked or corroded. Non-reference weights may be used but must be calibrated every 6 months against ASTM type 1, 2 or 3 weights.

6.6.14.2.7 All balances must be calibrated annually by a professional balance service. Certificates of calibration must be maintained at the marijuana testing facility.

4.2.7 All balances must be calibrated annually by a professional balance service. Certificates of calibration must be maintained at the marijuana testing facility.

6.6.14.2.8 All incubators, refrigerators, ovens, autoclave or sterilizers, and water baths must contain calibrated thermometers. The marijuana testing facility must maintain copies of the certificates of calibration for each thermometer. Thermometer range and graduation increments must be appropriate for the application for which it is used. Glass thermometers must be checked for accuracy annually, and other types of thermometers quarterly, by comparing with a NIST traceable thermometer at the temperatures of interest. Thermometers must be tagged with the initials of person who conducted the check, the date of accuracy check, and the correction factor (may be 0). There may be no separation in the liquid column of glass thermometers. Calibrated thermometers may be substituted for automated temperature recording systems. If this substitution is made, the marijuana testing facility must maintain copies of the certificates of calibration for the equipment. The automated temperature recording system must be checked for accuracy annually.

6.6.14.2.9 Use analytical reagent grade chemicals unless otherwise allowed or specified by the analytical method.

6.6.14.2.10 Date bottles of dehydrated microbiology media when received and opened. Marijuana testing facilities may not use media beyond the manufacturer's expiration date or beyond 1 year from opening, whichever is sooner. Media must be discarded immediately if caked or otherwise deteriorated. Prepared or prepackaged media are permitted.

6.6.14.2.11 Use plastic lab-ware for microbiology that is clear and non-toxic.

discarded immediately if caked or otherwise deteriorated. Prepared or prepackaged media are permitted.

6.6.14.2.11 Use plastic lab-ware for microbiology that is clear and non-toxic.

6.6.14.2.12 Reagent water for chemical analyses and for general use must be distilled or deionized and have a resistivity value greater than 0.5 megaohms/cm or a conductivity value of less than 2 microhmos/cm at 25° C. Quality checks shall be made according to specified analytical method requirements, but at least monthly, with a conductivity meter. All quality checks must be recorded.

6.6.14.2.13 For microbiological analyses, reagent water must meet all the following criteria:

6.6.14.2.14 Label all reagents and solutions to indicate identity, concentration, storage requirements, expiration dates and any other pertinent information.

6.6.14.2.15 Date all reagents and solutions when received and opened. Marijuana testing facilities may not use materials beyond their expiration dates.

6.6.14.2.16 All marijuana testing facility prepared reagents and solutions must be labeled with preparation and expiration dates. No laboratory prepared materials may be used beyond their expiration dates.

6.6.14.3 Safety and security. Marijuana testing facilities must:

6.6.14.3.1 Include safety instructions in a laboratory safety manual for the protection of personnel from physical, chemical, and biological hazards. The laboratory safety manual must include applicable programs for the protection of employees as outlined in the Code of Federal Regulations (29 C.F.R. Part 1910), including the Occupational Safety and Health Administration standards for hazard communication, and occupational exposure to hazardous chemicals in laboratories;

6.6.14.3.2 Keep samples, standards, reagents, solvents, acids, chemicals, and data in restricted access areas;

6.6.14.3.3 Implement the general security requirements required in subsection 6.3 of this regulation

ons (29 C.F.R. Part 1910), including the Occupational Safety and Health Administration standards for hazard communication, and occupational exposure to hazardous chemicals in laboratories;

6.6.14.3.2 Keep samples, standards, reagents, solvents, acids, chemicals, and data in restricted access areas;

6.6.14.3.3 Implement the general security requirements required in subsection 6.3 of this regulation.

6.7 Marijuana cultivation facility general requirements

6.7.1 Marijuana cultivation facilities are permitted to:

6.7.1.1 Plant and cultivate marijuana plants, subject to the limits associated with each tier of license;

6.7.1.2 Harvest, trim, dry, and cure marijuana plants;

6.7.1.3 Store harvested marijuana, including kief and marijuana trim;

6.7.1.4 Sell and distribute marijuana, including kief and marijuana trim to marijuana cultivation facilities, marijuana product manufacturing facilities, and retail marijuana stores;

6.7.1.5 Provide samples of marijuana and marijuana products to the Division for mandatory compliance testing in accordance with Section 11.0 of this regulation at the direction of the Commissioner;

6.7.1.6 Collect samples of marijuana and marijuana products for research and development testing and transport those samples to a marijuana testing facility;

6.7.1.7 Prepare, package, and label marijuana into individual retail units for wholesale to a retail marijuana store;

6.7.1.8 Transport marijuana to marijuana products manufacturing facilities and retail marijuana stores; and

6.7.1.9 Destroy marijuana plants and marijuana in accordance with Section 12.0 of this regulation.

6.7.2 Marijuana cultivation facilities may not:

6.7.2.1 Produce marijuana concentrates, tinctures, extracts, or other marijuana products;

6.7.2.2 Sell marijuana or marijuana products directly to consumers; and

6.7.2.3 Permit marijuana or marijuana products to be consumed on the premises of the marijuana cultivation facility.

6.7.3 Standard operating procedures

with Section 12.0 of this regulation.

6.7.2 Marijuana cultivation facilities may not:

6.7.2.1 Produce marijuana concentrates, tinctures, extracts, or other marijuana products;

6.7.2.2 Sell marijuana or marijuana products directly to consumers; and

6.7.2.3 Permit marijuana or marijuana products to be consumed on the premises of the marijuana cultivation facility.

6.7.3 Standard operating procedures. A marijuana cultivation facility must establish standard operating procedures in accordance with subsection 6.4.2 of this regulation for all aspects of the planting, cultivating, harvesting, trimming, drying, curing, storing, selling, distributing, sampling, preparing, packaging, labeling, transporting, tracking, and destroying of marijuana plants. The standard operating procedures must include:

6.7.3.1 The creation and timely entry of accurate data into an inventory control system that identifies and tracks the marijuana cultivation facility's inventory of marijuana from the seed or immature plant to the time they are sold or transferred to another marijuana establishment;

6.7.3.2 The safe and sanitary storage of marijuana and marijuana products, including maintaining the cleanliness of any building or equipment used to store or display marijuana or marijuana products;

6.7.3.3 The procedure for providing a sample of its marijuana to the Division for testing and research purposes as required by Section 11.0 of this regulation;

6.7.3.4 The creation and maintenance of a record of samples provided to the Division for the purposes of mandatory compliance testing, the identity of the marijuana testing facility that tested the samples, and the results of the mandatory compliance testing;

6.7.3.5 The proper packaging and labeling of marijuana to be sold to retail marijuana stores, as required by Section 9.0 of this regulation;

6.7.3.6 The selling or transferring of marijuana, including seeds, immature plants, mature plants, and packaged and labeled marijuana, to retail marijuana stores, marijuana product manufacturing facilit

es, and the results of the mandatory compliance testing;

6.7.3.5 The proper packaging and labeling of marijuana to be sold to retail marijuana stores, as required by Section 9.0 of this regulation;

6.7.3.7 The proper disposal and segregated storage of marijuana that is outdated, damaged, deteriorated, misbranded, or adulterated;

6.7.3.8 The training of all personnel in the standard operating procedures and retention of attendance records; and

6.7.3.9 A copy of the standard operating procedures must be readily available on-site for inspection by the Commissioner.

6.7.4 A marijuana cultivation facility must have an environmental and sustainability plan that includes efforts the facility will take to minimize the environmental impact of its operations and plans to minimize water usage.

6.7.5 Batch size. Marijuana cultivation facilities may not package marijuana in batches larger than 10 pounds.

6.7.6 Marijuana cultivation facility security requirements

6.7.6.1 Marijuana cultivation facilities must comply with the following facility protocols:

6.7.6.1.1 Ensure all activities related to the cultivation of marijuana plants take place within a fully enclosed secure indoor facility or within a secured fenced area;

6.7.6.1.2 Have sufficient gas, suction, electrical outlets, sinks, hot and cold running water, and bathroom facilities;

6.7.6.1.3 Have adequate temperature and humidity controls;

6.7.6.1.4 Prominently display a list of all trained personnel inside or immediately outside of the extraction area; and

6.7.6.1.5 Process only marijuana that has been harvested in areas designated for processing

ced area;

6.7.6.1.2 Have sufficient gas, suction, electrical outlets, sinks, hot and cold running water, and bathroom facilities;

6.7.6.1.3 Have adequate temperature and humidity controls;

6.7.6.1.4 Prominently display a list of all trained personnel inside or immediately outside of the extraction area; and

6.7.6.1.5 Process only marijuana that has been harvested in areas designated for processing.

6.7.6.2 Marijuana cultivation facilities must comply with the following safety and security protocols:

6.7.6.2.1 Update their safety, security, and prevention and diversion plan upon requesting a 1-tier increase in size each renewal period; and

6.7.6.2.2 Implement the general security requirements required in subsection 6.3 of this regulation.

6.8 Marijuana product manufacturing facility general requirements

6.8.1 Standard operating procedures. A marijuana product manufacturing facility must establish standard operating procedures in accordance with subsection 6.4.2 of this regulation for all aspects of the receipt, processing, storage, packaging, labeling, handling, tracking, and shipping of products containing marijuana and marijuana waste. The standard operating procedures must be readily available for on-site inspection by the Commissioner and include:

6.8.1.1 The creation and timely entry of accurate data into an inventory control system that identifies and tracks the marijuana product manufacturing facility's stock of marijuana and marijuana products from the time they are delivered or produced to the time they are delivered to another marijuana establishment;

6.8.1.2 The creation and maintenance of a record of samples provided to a licensed marijuana testing facility, the identity of the marijuana testing facility, and the results of the mandatory compliance testing;

6.8.1.3 The sanitary storage of marijuana and marijuana products, including maintaining the cleanliness of any building or equipment used to store or display marijuana or marijuana products; and

6.8.1.4 The training of all personnel in the standard

rovided to a licensed marijuana testing facility, the identity of the marijuana testing facility, and the results of the mandatory compliance testing;

6.8.1.3 The sanitary storage of marijuana and marijuana products, including maintaining the cleanliness of any building or equipment used to store or display marijuana or marijuana products; and

6.8.1.4 The training of all personnel in the standard operating procedures and retention of attendance records.

6.8.2 A marijuana product manufacturing facility must have a standard operating procedure to:

6.8.2.1 Maintain the marijuana and marijuana products free from contamination;

6.8.2.2 Meet the sanitary standards for food preparation as described in 4 Del.C. §1335(f) .

6.8.2.3 Report any personal health condition that might compromise the cleanliness or quality of the marijuana or marijuana products.

6.8.3 A marijuana product manufacturing facility's standard operating procedure must provide for disposal and segregated storage of any marijuana or marijuana product:

6.8.3.1 That is outdated, damaged, deteriorated, misbranded, or adulterated; or

6.8.3.2 Whose containers or packages have been improperly or accidentally opened.

6.8.4 Equipment sanitation, accuracy, and maintenance logs. A marijuana product manufacturing facility's standard operating procedure must provide for maintaining the sanitation of equipment that comes in contact with marijuana or marijuana products. The marijuana product manufacturing facility must ensure that:

6.8.4.1 Automatic, mechanical, or electronic equipment is routinely calibrated and periodically checked to ensure proper performance; and

6.8.4.2 Any scale, balance, or other measurement device is routinely calibrated and periodically checked to ensure accuracy.

6.8.5 The marijuana product manufacturing facility must maintain an accurate log recording the cleaning and calibration of equipment. Weighing or measuring devices must be certified and calibrated in accordance with applicable requirements of the Delaware Department of Agriculture

2 Any scale, balance, or other measurement device is routinely calibrated and periodically checked to ensure accuracy.

6.8.6 A marijuana product manufacturing facility may acquire hemp from a person licensed to produce hemp by the Delaware Department of Agriculture or the Secretary of the U.S. Department of Agriculture. Any product derived from hemp must comply with the testing requirements established in Section 11.0 of this regulation prior to distribution to a retail marijuana store.

6.8.7 A marijuana product manufacturing facility may not:

6.8.7.1 Add any marijuana to a food product where the manufacturer of the food product holds a trademark to the food product's name; except that a manufacturer may use a trademarked food product if the manufacturer uses the product as a component or as part of a recipe and where the marijuana product manufacturer does not state or advertise to the consumer that the final retail marijuana product contains a trademarked food product;

6.8.7.2 Intentionally or knowingly label or package a retail marijuana product in a manner that would cause a reasonable consumer confusion as to whether the retail marijuana product was a trademarked food product; or

6.8.7.3 Label or package a product in a manner that violates any federal trademark law or regulation.

package a product in a manner that violates any federal trademark law or regulation.

6.8.8 Retail marijuana products must be prepared in a marijuana product manufacturing facility that is used exclusively for the manufacture and preparation of retail marijuana or retail marijuana products and using equipment that is used exclusively for the manufacture and preparation of retail marijuana products. Marijuana establishments must obtain approval of the Commissioner to co-locate multiple marijuana establishment license types on a single premises. The Commissioner may approve such application if the following conditions are met:

6.8.8.1 The co-located facilities are clearly delineated from each other in all plans;

6.8.8.2 Any shared space complies with all regulations applicable to each of the co-located license types;

6.8.8.3 The co-located facilities are physically separated by a permanent physical barrier or wall; and

6.8.8.4 The co-located facilities are connected by a single, lockable door.

6.8.9 Marijuana or marijuana products may not be consumed on the premises of a marijuana product manufacturing facility.

6.8.10 Permissible extractions. Except as provided in subsection 6.8.11 of this regulation, marijuana extraction shall only be conducted using the following methods:

6.8.10.1 Mechanical extraction, such as dry screens, sieves, or presses, potable water and ice made from potable water, cryogenic or subzero manufacturing not involving a solvent, or pressure and temperature.

6.8.10.2 Chemical extraction using a nonvolatile solvent such as a non-hydrocarbon-based or other solvent such as water, vegetable glycerin, vegetable oils, animal fats, or food-grade glycerin, (non-hydrocarbon-based solvents shall be food grade).

6.8.10.3 Chemical extraction using a division approved closed loop extraction system

manufacturing not involving a solvent, or pressure and temperature.

6.8.10.3 Chemical extraction using a division approved closed loop extraction system.

6.8.11 To request authorization from the Commissioner to conduct marijuana extraction using a method other than those specified in subsection 6.8.10 of this regulation, the marijuana establishment must submit a detailed description of the extraction method, including any documentation that validates the method and any safety procedures to be utilized to mitigate any risk to public or worker health and safety.

6.8.12 Extraction equipment shall be used and operated in accordance with its intended manufacturer use and design.

6.8.13 Current safety data sheets shall be kept on the premises for all chemicals used in the extraction process.

6.8.14 Any form of alkane or petroleum hydrocarbon extraction is unauthorized in Delaware.

6.8.15 Volatile solvent extractions. Chemical extractions using volatile solvents are subject to the following minimum requirements:

6.8.15.1 Hydrocarbon-based solvents must be at least 99.5% purity with a Certificate of Analysis from the manufacturer to confirm purity.

6.8.15.2 Ethyl alcohol must be food grade, and non-denatured in composition.

6.8.15.3 Solvents must be free of odorants, bitterants, or other additives and stored, handled, and disposed of in accordance with local, state, and federal regulations.

6.8.15.4 All extractions may be performed in a closed loop extraction system, unless approved by the Commissioner in accordance with subsection 6.8.11 of this regulation

lcohol must be food grade, and non-denatured in composition.

6.8.15.3 Solvents must be free of odorants, bitterants, or other additives and stored, handled, and disposed of in accordance with local, state, and federal regulations.

6.8.15.4 All extractions may be performed in a closed loop extraction system, unless approved by the Commissioner in accordance with subsection 6.8.11 of this regulation.

6.8.15.5 Marijuana product manufacturing facilities may not use ignition sources including heat guns or any open flame source next to extraction equipment that utilizes volatile solvents, including in rooms designated solely for extraction or in areas that contain or uses flammable liquids and gasses.

6.8.16 Closed-loop extraction system requirements. Closed loop systems, other equipment used, the extraction operation, and facilities must be approved for use by the local fire code official and meet any required fire, safety, and building code requirements specified in:

6.8.16.1 National Fire Protection Association (NFPA) standards;

6.8.16.2 International Building Code (IBC);

6.8.16.3 International Fire Code (IFC); and

6.8.16.4 Other applicable standards including all applicable fire, safety, and building codes related to the processing, handling and storage of the applicable solvent or gas.

6.8.17 The Commissioner must be notified when significant changes are made to the standard analytical procedure such as changes to extraction technique, or the instrumentation used.

6.8.18 Marijuana product manufacturing facility security requirements

6.8.18.1 Facility requirements

le fire, safety, and building codes related to the processing, handling and storage of the applicable solvent or gas.

6.8.17 The Commissioner must be notified when significant changes are made to the standard analytical procedure such as changes to extraction technique, or the instrumentation used.

6.8.18 Marijuana product manufacturing facility security requirements

6.8.18.1 Facility requirements. Each marijuana product manufacturing facility must adhere to the following:

6.8.18.1.1 Be housed in well-lighted, sanitary, vented quarters equipped with hot and cold running water and bathroom facilities, and contain ample space to process and examine the samples commensurate with the total workload;

6.8.18.1.2 Be in distinct and separate locations from living quarters unless provisions exist for separate entrances, and plumbing fixtures;

6.8.18.1.3 Have ample workbench space, have sufficient water, gas, suction, electrical outlets, and sinks;

6.8.18.1.4 Have adequate and proper storage space for all chemicals including explosive, flammable, corrosive, and caustic materials;

6.8.18.1.5 Have flooring composed of non-porous material in laboratory areas where acids, caustics, and solvents are used;

6.8.18.1.6 Have adequate temperature and humidity controls as may be required for proper operation of instruments affected by environmental conditions;

6.8.18.1.7 Prominently display a list of all trained personnel inside or immediately outside of the extraction area: and

6.8.18.1.8 Have adequate electrical supply.

6.8.18.2 Safety and security

ry areas where acids, caustics, and solvents are used;

6.8.18.1.6 Have adequate temperature and humidity controls as may be required for proper operation of instruments affected by environmental conditions;

6.8.18.1.7 Prominently display a list of all trained personnel inside or immediately outside of the extraction area: and

6.8.18.1.8 Have adequate electrical supply.

6.8.18.2 Safety and security. Marijuana product manufacturing facilities must:

6.8.18.2.1 Establish and maintain adequate safety and security precautions;

6.8.18.2.2 Include safety instructions for the protection of personnel from physical, chemical, and biological hazards;

6.8.18.2.3 Provide each member of management and personnel a safety orientation and annually review policies and procedures in the safety manual including the proper use of security measures and procedures that have been adopted specific to responding to an emergency, including robbery, violence, or accident;

6.8.18.2.4 Keep samples, standards, reagents, solvents, acids, chemicals, and data in restricted access areas;

6.8.18.2.5 Supervise visitors, repair worker, and maintenance workers in restricted areas; and

6.8.18.2.6 Implement the minimum-security requirements required in subsection 6.3 of this regulation.

6.9 Marijuana micro-businesses are required to adhere the requirements in 4 Del.C. §§1340 and 1343 and this regulation.

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

.9 Marijuana micro-businesses are required to adhere the requirements in 4 Del.C. §§1340 and 1343 and this regulation.

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

alth 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

acking system

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

unt.

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

es 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

ner shall be notified access has been restored. Records maintained during the tracking system outage must be retained for at least 2 years.

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

eing 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

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

nsport 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

blishments 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.

8.0 Marijuana and Marijuana Product Health Standards

8.1 Allowable and prohibited products

8.1.1 Allowable marijuana and marijuana products include:

8.1.1.1 Smokable marijuana, including shake, trim, pre-rolled marijuana, and infused pre-rolled marijuana;

8.1.1.2 Marijuana concentrates, including any type of hash (water hash, pressed hash), dry sieve (kief), and hash oils (extract oil, shatter, wax, resin, and rosin);

8.1.1.3 Non-smokable marijuana products intended for oral consumption, including edible marijuana products, multi-serving marijuana beverages, single-serving marijuana beverages, and tinctures;

8.1.1.4 Topical marijuana products, including balms, lotions, ointments, and rubbing alcohol solutions; and

8.1.1.5 Transdermal marijuana products, including patches.

8.1.2 Marijuana products not listed under subsection 8.1.1 of this regulation must be approved by the Commissioner

uding edible marijuana products, multi-serving marijuana beverages, single-serving marijuana beverages, and tinctures;

8.1.1.4 Topical marijuana products, including balms, lotions, ointments, and rubbing alcohol solutions; and

8.1.1.5 Transdermal marijuana products, including patches.

8.1.2 Marijuana products not listed under subsection 8.1.1 of this regulation must be approved by the Commissioner.

8.1.3 Marijuana and marijuana products may not:

8.1.3.1 Contain nicotine;

8.1.3.2 Contain alcohol if the sale of the alcohol would require a license under 4 Del.C. Ch. 5;

8.1.3.3 Contain any non-cannabinoid additive that would increase potency, toxicity, or addictive potential;

8.1.3.4 Require refrigeration to prevent spoilage;

8.1.3.5 Contain compounds such as fruit filling, cream filling, or meat;

8.1.3.6 Take a shape, color, or character that is identical or substantially similar to commercially available candy or ice cream or a real or fictional person, animal, or fruit, including a caricature, cartoon, or artistic rendering; or

8.1.3.7 Be designed or packaged in a way that is likely to appeal to children, such as using bright, cartoon-like colors, shapes associated with children's products, or characters from children's media.

8.1.4 Equipment or accessories used for vaporizing marijuana concentrates must be coilless ceramic atomizers or similar products where the oil or concentrate does not touch metal coils.

8.1.5 Products developed for inhalation or vaping may not contain: medium-chain triglycerides (MCT), Polyethylene glycol (PEG), Propylene glycol (PG), Vegetable glycerin (VG), Vitamin E acetate, Diacetyl, or Squalene. Any diluent must be 100% naturally occurring plant-derived terpene oil.

8.2 Marijuana product serving size

8.2.1 For edible marijuana products, a standardized single serving of a marijuana product must contain no greater than 10 milligrams of THC.

8.2.2 For multi-serving marijuana beverages, contain no greater than 10 milligrams of THC

table glycerin (VG), Vitamin E acetate, Diacetyl, or Squalene. Any diluent must be 100% naturally occurring plant-derived terpene oil.

8.2 Marijuana product serving size

8.2.1 For edible marijuana products, a standardized single serving of a marijuana product must contain no greater than 10 milligrams of THC.

8.2.2 For multi-serving marijuana beverages, contain no greater than 10 milligrams of THC.

8.2.3 For marijuana tinctures using a calibrated dropper or similar measuring device, contain no greater than 10 milligrams of THC per individual serving, as indicated on the calibrated dropper or similar measuring device.

8.2.4 A marijuana product manufacturer must:

8.2.4.1 Determine the total number of standardized servings for each marijuana product, which must not exceed 10 milligrams of THC per serving.

8.2.4.2 Ensure that each standardized serving of an edible marijuana product be physically demarcated or packaged in a manner that a person could reasonably and clearly determine how much of the product constitutes a single serving.

8.2.4.3 Ensure that each standardized serving is easily separable with minimal effort.

8.2.4.4 Comply with the requirements in Section 9.0 for multi-serving liquid edible marijuana products, which must not exceed 10 milligrams of THC per serving; and

8.2.4.5 For products containing multiple servings, ensure that each serving contains the same amount of THC.

8.3 Marijuana product package size

8.3.1 A standardized package of a marijuana product must:

8.3.1.1 For edible marijuana products, contain no greater than 5 standardized servings per package;

8.3.1.2 For multi-serving marijuana beverages, contain no greater than 60 milligrams of THC per package; and

8.3.1.3 For marijuana tinctures, contain no greater than 300 milligrams of THC per package.

8.3.2 Edible marijuana products formulated with less than 5 standardized servings may package multiple products together to reach the 5 serving maximum per package

standardized servings per package;

8.3.1.2 For multi-serving marijuana beverages, contain no greater than 60 milligrams of THC per package; and

8.3.1.3 For marijuana tinctures, contain no greater than 300 milligrams of THC per package.

8.3.2 Edible marijuana products formulated with less than 5 standardized servings may package multiple products together to reach the 5 serving maximum per package. Small individual products must comply with appearance standards in accordance with Section 9.0 of this regulation.

8.3.3 In accordance with Section 9.0 of this regulation, if a marijuana product package contains multiple servings, the package must be a child-resistant container that is resealable.

29 DE Reg. 221 (09/01/25)

9.0 Packaging and Labeling Requirements for Marijuana and Marijuana Products

9.1 General packaging requirements. All marijuana and marijuana products for retail sale must be packaged as follows:

9.1.1 If the packaging is soft sided, the opening must be sealed in a manner which would indicate if the container has been tampered with or opened. The tamper-evident feature shall not be resealable and shall remain clear that the package has been previously opened.

9.1.2 If the packaging is rigid, the opening shall contain a tamper-evident seal that, once opened, shall remain clear that the package has been previously opened.

9.1.3 The packaging must be child-resistant in accordance with 16 CFR 1700.15.

9.1.4 If the packaging is soft-sided, it must be 4 millimeters or greater in thickness.

9.1.5 If the packaging is rigid, it must have a lid or closure that can be placed tightly and securely.

9.1.6 If the marijuana product contains multiple servings, the packaging must be a child-resistant container that is resealable and must comply with subsection 9.3 if an edible marijuana product or beverage.

9.1.7 The marijuana product must be food-grade in quality and meet the food safety requirements in 16 Del.C. Ch. 33

igid, it must have a lid or closure that can be placed tightly and securely.

9.1.7 The marijuana product must be food-grade in quality and meet the food safety requirements in 16 Del.C. Ch. 33.

9.2 General labeling requirements

9.2.1 All marijuana and marijuana products for retail sale must be labeled in accordance with this regulation. All information on the label may not mislead consumers. All marijuana and marijuana product labels must:

9.2.1.1 Be printed directly on, or on a label or sticker affixed directly to, the marketing layer;

9.2.1.2 Include text no smaller than size 6 font or ½ inch;

9.2.1.3 Be legible, unobstructed, conspicuous, and contrast sufficiently with the background;

9.2.1.4 Be printed in the English language, but may also include translations in additional languages; and

9.2.1.5 Contain required information on a peel-back accordion-style, expandable, extendable, or layered label.

9.2.2 All marijuana and marijuana product labels must include the following product information:

9.2.2.1 The net weight of the marijuana or marijuana product in accordance with subsections 9.3, 9.4, and 9.5 of this regulation;

9.2.2.2 The finished product batch number;

9.2.2.3 If marijuana flower, the name of the marijuana establishment that cultivated, harvested, and packaged the marijuana flower;

9.2.2.4 If a marijuana product, the name of the marijuana establishment that manufactured and packaged the marijuana product;

9.2.2.5 The name of the marijuana establishment that sold the product;

9.2.2.6 An itemization, including weight, of the major cannabinoids and terpenes contained in the marijuana or marijuana product

tablishment that cultivated, harvested, and packaged the marijuana flower;

9.2.2.4 If a marijuana product, the name of the marijuana establishment that manufactured and packaged the marijuana product;

9.2.2.5 The name of the marijuana establishment that sold the product;

9.2.2.6 An itemization, including weight, of the major cannabinoids and terpenes contained in the marijuana or marijuana product. Cannabinoids existing in concentrations of less than 1% shall be printed with a leading zero before the decimal point;

9.2.2.7 If a marijuana product, a list of all major allergens contained in and used in the manufacturing process in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004, 21 U.S.C. §343, specifically including milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans;

9.2.2.8 A list of any solvents used in the manufacturing process;

9.2.2.9 The production date, which for flowers will be the date the marijuana was harvested and for product will be the date the product was produced; and

9.2.2.10 The Delaware Poison Control Center telephone number.

9.2.3 All marijuana and marijuana product labels must include the following warning statements:

9.2.3.1 "For use by adults 21+. KEEP OUT OF REACH OF CHILDREN!"

9.2.3.2 "Marijuana ingestion by children can cause severe illness and hospitalization. KEEP IN LOCKED STORAGE CONTAINERS."

9.2.3.3 "There may be health risks associated with the use of this product, and additional risks for women who are pregnant or breastfeeding or individuals 25 years of age and younger. Do not operate a motor vehicle or heavy machinery while using this product. The use of this product may result in adverse reactions with prescription medication, consult with your doctor or pharmacist."

9.2.4 All marijuana and marijuana product labels must include a universal symbol made available by the Commissioner

men who are pregnant or breastfeeding or individuals 25 years of age and younger. Do not operate a motor vehicle or heavy machinery while using this product. The use of this product may result in adverse reactions with prescription medication, cons

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