935 CMR, § 500.130 - Additional Operational Requirements for Marijuana Product Manufacturers

(1) In addition to the general operational requirements for Marijuana Establishments required under 935 CMR 500.105 and security requirements provided in 935 CMR 500.110, Marijuana Product Manufacturers shall comply with additional operational requirements required under 935 CMR 500.130.

(2) Production of Edibles shall take place in compliance with the following:

(a) All Edibles shall be prepared, handled, and stored in compliance with the sanitation requirements in 105 CMR 590.000: State Sanitary Code Chapter X: Minimum Sanitation Standards for Food Establishments, and with the requirements for food handlers specified in 105 CMR 300.000: Reportable Diseases, Surveillance, and Isolation and Quarantine Requirements; and

(b) Any Marijuana Product that is made to resemble a typical food or Beverage product shall be packaged and labelled as required by 935 CMR 500.105(5) and (6).

(3) A Marijuana Product Manufacturer shall meet all applicable environmental laws, regulations, permits and other applicable approvals including, but not limited to, those related to water quality and quantity, wastewater, solid and hazardous waste management and air pollution control, including prevention of odor and noise pursuant to 310 CMR 7:00: Air Pollution Control, and to use additional best management practices as determined by the Commission in consultation with the working group established under St. 2017, c. 55, § 78(b) or applicable departments or divisions of the EOEEA to reduce energy and water usage, engage in energy conservation and mitigate other environmental impacts.

(4) A Marijuana Product Manufacturer selling or otherwise Transferring Marijuana to another Marijuana Establishment shall provide documentation of its compliance, or lack thereof, with the testing requirements of 935 CMR 500.160, and standards established by the Commission for the conditions, including time and temperature controls, necessary to protect Marijuana Products against physical, chemical, and microbial contamination as well as against deterioration of finished products during storage and transportation.

(a) A Product Manufacturer shall retain all records of purchases from any manufacturer or supplier of any ingredient, additive, device, component part or other materials obtained by the Product Manufacturer in relation to the manufacturing of Marijuana Vaporizer Devices and such records shall be made available to the Commission on request.

(b) A Marijuana Product Manufacturer shall maintain records of the name and business address of the manufacturer of any cartridge, battery, atomizer coil, hardware or other component of Marijuana Vaporizer Products manufactured by the Licensee. Further, the Product Manufacturer shall, on request by the Commission, identify the materials used in the device's atomizer coil (e.g., titanium, titanium alloy, quartz, copper, nichrome, kanthal, or other specified material) or state if such information cannot be reasonably ascertained.

(c) A copy of the Certificate of Analysis for each thickening agent, thinning agent or terpene infused or incorporated into a Marijuana Vaporizer Device during production shall be retained by a Product Manufacturer and provided as a part of a wholesale transaction with any Marijuana Retailer, MTC or Delivery Operator.

(d) A Product Manufacturer that wholesales Marijuana Vaporizer Devices to a Marijuana Retailer, MTC or Delivery Operator shall provide the recipient with the information insert required by 935 CMR 500.105(5)(c) or the necessary information to produce such an insert and the appropriate labeling information required by 935 CMR 500.000; provided, however, that White Labeling of Marijuana Vaporizer Devices is explicitly prohibited.

(5) In addition to the written operating policies required under 935 CMR 500.105(1), a Marijuana Product Manufacturer shall maintain written policies and procedures for the production or distribution of Marijuana Products as applicable, which shall include, but not be limited to:

(a) Methods for identifying, recording, and reporting diversion, theft, or loss, and for correcting all errors and inaccuracies in inventories. The policies and procedures, at a minimum, shall comply with 935 CMR 500.105(8);

(b) Policies and procedures for handling voluntary and mandatory recalls of Marijuana Products. Such procedures shall be adequate to deal with recalls due to any action initiated at the request or order of the Commission, and any voluntary action by a Marijuana Establishment to remove defective or potentially defective Marijuana Products from the market, as well as any action undertaken to promote public health and safety;

(c) Policies and procedures for ensuring that any outdated, damaged, deteriorated, mislabeled, or contaminated Marijuana or Marijuana Products are segregated from other Marijuana and destroyed. Such procedures shall provide for written documentation of the disposition of the Marijuana or Marijuana Products. The policies and procedures, at a minimum, shall comply with 935 CMR 500.105(12);

(d) Policies and procedures for transportation. The policies and procedures, at a minimum, shall comply with 935 CMR 500.105(13);

(e) Policies and procedures to reduce energy and water usage, engage in energy conservation and mitigate other environmental impacts. The policies and procedures, at a minimum, shall comply with 935 CMR 500.105(15);

(f) Policies and procedures for the Transfer, acquisition, or sale of Marijuana Products between Marijuana Establishments, and if applicable, MTCs and CMOs;

(g) Policies and procedures to ensure that all Edibles are prepared, handled, and stored in compliance with the sanitation requirements in 105 CMR 590.000: State Sanitary Code Chapter X: Minimum Sanitation Standards for Food Establishments, and with the requirements for food handlers specified in 105 CMR 300.000: Reportable Diseases, Surveillance, and Isolation and Quarantine Requirements;

(h) Policies and procedures for maintaining a product catalogue identifying all types of Marijuana Products actively manufactured at the facility. The catalog shall include a description of the product, photograph or illustration, packaging design, and dosage amounts, including expected Cannabinoid Profile;

(i) Policies and procedures for ensuring safety in all processing activities and the related uses of extraction equipment in compliance with the standards set forth in 527 CMR 1.00: The Massachusetts Comprehensive Fire Safety Code;

(j) Policies and procedures for developing and providing Vendor Samples to a Marijuana Retailer. Policies and procedures shall include methods by which the Marijuana Product Manufacturer will adequately track, record, and document all Vendor Samples developed on, or provided from, the licensed Premises in satisfaction of 935 CMR 500.130(8);

(k) Policies and procedures for developing and providing Quality Control Samples to employees for the purpose of ensuring product quality and determining whether to make the product available to sell. Policies and procedures shall include methods by which the Marijuana Product Manufacturer will adequately track, record, and document all Quality Control Samples developed on, or provided from, the licensed Premises in satisfaction of 935 CMR 500.130(8). Policies and procedures shall further prohibit consumption of Quality Control Samples on the licensed Premises; and

(l) Policies and procedures for White Labeling on behalf of any Delivery Operator. Marijuana Product Manufacturers shall retain all Wholesale Agreements entered into with Delivery Operators and shall make them available to the Commission upon request.

(6) Product Database. In addition to the requirement to establish policies and procedures for maintaining a product catalogue under 935 CMR 500.130(5)(h), a Marijuana Product Manufacturer, after receiving a Provisional License but prior to receiving a Certificate to Commence Operations, shall provide the following information about the Finished Marijuana Products it intends to produce and make available at wholesale to a Marijuana Retailer or Delivery Operator prior to commencement of operations. This information may be used by the Commission for its Product Database.

(a) The Marijuana Product Manufacturer shall provide the following:

1. Marijuana Product type;

2. Marijuana Product Brand Name;

3. List of direct ingredients;

4. List of indirect ingredients;

5. Serving size, including a description of what constitutes a serving size for a product that is not already a single serving;

6. Potency;

7. A photograph of a Finished Marijuana Product, against a white background, outside of but next to the Marijuana Product's packaging, including any external or internal packaging, provided however that where single servings of a multi-serving product are unable to be easily identified because of its form, a description of what constitutes a single serving shall be provided (e.g. a single serving is a 1" x 1" square), and where an Edible cannot be stamped, for example, due to size or a coating, the photograph of the Edible outside of, but next to, its external and internal packaging, such as the wrapper, and labeling information for the Edible;

8. A photograph of the Marijuana Product, against a white background, inside the packaging; and

9. A list of Marijuana Products to be sold based on anticipated or executed agreements between the Marijuana Product Manufacturer and Marijuana Retailer or Delivery Operator.

(b) Photographs shall be submitted in a form and manner determined by the Commission.

(c) A Marijuana Product Manufacturer shall provide the information required under 935 CMR 500.130(6)(a) for each Marijuana Product that it produces prior to the product being made available for sale through a licensed Marijuana Retailer, MTC or Delivery Operator and shall update the information whenever a substantial change to the product information occurs. Substantial changes, including changes to information listed in 935 CMR 500.130(6)(a)1.through 9., shall be submitted to the Commission for inclusion in the Product Database prior to the transfer of the Marijuana Product.

(7) Notwithstanding a stricter municipal or state regulation, a Marijuana Product Manufacturer shall identify the method of extraction (e.g., Butane, Propane, CO2) on a physical posting at all entrances of the Marijuana Establishment. The Posting shall be a minimum of 12" x 12" and identify the method of extraction in lettering no smaller than one inch in height. A Marijuana Product Manufacturer shall post a copy of a permit to keep, store, handle or otherwise use flammable and combustible at each place of operation within the facility.

(8) Vendor Samples .

(a) A Marijuana Product Manufacturer may provide a Vendor Sample of a Marijuana Product to a Marijuana Retailer, or Delivery Operator, Provision of a Vendor Sample under 935 CMR 500.130(8) shall not be considered a prohibited practice under 935 CMR 500.105(4)(b)20.

(b) Vendor Samples provided under 935 CMR 500.130(8):

1. May not be consumed on any licensed Premises;

2. May not be sold to another licensee or Consumer;

3. Shall be tested in accordance with 935 CMR 500.160; and

4. Shall be transported in accordance with 935 CMR 500.105(13). A Marijuana Product Manufacturer may include Vendor Samples with other Marijuana Products intended for transportation to an individual Marijuana Retailer or Delivery Operator.

(c) Vendor Sample limits. A Marijuana Product Manufacturer is limited to providing the following aggregate amounts of Vendor Samples to an individual Marijuana Retailer or Delivery Operator in a calendar month period:

1. Five grams of Marijuana concentrate or extract including, but not limited to, tinctures;

2. Five hundred milligrams of Edibles whereby the serving size of each individual sample does not exceed five milligrams and otherwise satisfies the potency levels set forth in 935 CMR 500.150(4); and

3. Five units of sale per Cannabis product line and no more than six individual Cannabis product lines. For purposes of 935 CMR 500.130(8), a Cannabis product line shall mean items bearing the same Stock Keeping Unit Number.

(d) All Vendor Samples received from a Marijuana Cultivator pursuant to 935 CMR 500.120(13) that are used to manufacture a Marijuana Product shall be assigned a unique, sequential alphanumeric identifier and entered into the Seed-to-sale SOR in a form and manner to be determined by the Commission, and further, shall be designated as "Vendor Sample";

(e) All Vendor Samples provided by a Marijuana Product Manufacturer under 935 CMR 500.130(8) shall be assigned a unique, sequential alphanumeric identifier and entered into the Seed-to-sale SOR in a form and manner to be determined by the Commission and shall further be designated as "Vendor Sample";

(f) Vendor Samples provided under 935 CMR 500.130(8) shall have a legible, firmly Affixed label on which the wording is no less than ¹/₁₆ inch in size containing at minimum the following information:

1. A statement that reads: "VENDOR SAMPLE NOT FOR RESALE";

2. The name and registration number of the Marijuana Product Manufacturer;

3. The quantity, net weight, and type of Marijuana Product contained within the package; and

4. A unique sequential, alphanumeric identifier assigned to the Production Batch associated with the Vendor Sample that is traceable in the Seed-to-sale SOR.

(9) Quality Control Samples.

(a) A Marijuana Product Manufacturer may provide a Quality Control Sample of Marijuana Product to its employees for the purpose of ensuring product quality and determining whether to make the product available to sell. Provision of a Quality Control Sample under 935 CMR 500.130(9) shall not be considered a prohibited practice under 935 CMR 500.105(4)(b)20.

(b) Quality Control Samples provided to employees under 935 CMR 500.130(9):

1. May not be consumed on the licensed Premises;

2. May not be sold to another licensee or Consumer; and

3. Shall be tested in accordance with 935 CMR 500.160.

(c) Quality Control Sample Limits. A Marijuana Product Manufacturer is limited to providing the following aggregate amounts of Quality Control Samples to all employees in a calendar month period:

1. Five grams of Marijuana concentrate or extract including, but not limited to, tinctures;

2. Five hundred milligrams of Edibles whereby the serving size of each individual sample does not exceed five milligrams and otherwise satisfies the potency levels set forth in 935 CMR 500.150(4); and

3. Five units of sale per Cannabis product line and no more than six individual Cannabis product lines. For purposes of 935 CMR 500.130(8), a Cannabis product line shall mean items bearing the same Stock Keeping Unit Number.

(d) All Quality Control Samples provided under 935 CMR 500.130(8) shall be assigned a unique, sequential alphanumeric identifier and entered into the Seed-to-sale SOR in a form and manner to be determined by the Commission, and further, shall be designated as "Quality Control Sample."

(e) Quality Control Samples provided under 935 CMR 500.130(9) shall have a legible, firmly Affixed label on which the wording is no less than ¹/₁₆ inch in size containing at minimum the following information:

1. A statement that reads: "QUALITY CONTROL SAMPLE NOT FOR RESALE";

2. The name and registration number of the Marijuana Product Manufacturer;

3. The quantity, net weight, and type of Marijuana flower contained within the package; and

4. A unique sequential, alphanumeric identifier assigned to the Production Batch associated with the Quality Control Sample that is traceable in the Seed-to-sale SOR.

(f) Upon providing a Quality Control Sample to an Employee, the Marijuana Product Manufacturer shall record:

1. The reduction in quantity of the total weight or item count under the unique alphanumeric identifier associated with the Quality Control Sample;

2. The date and time the Quality Control Sample was provided to the Employee;

3. The agent registration number of the employee receiving the Quality Control Sample; and

4. The name of the Employee as it appears on their agent registration card.

Notes

935 CMR, § 500.130

Adopted by Mass Register Issue 1361, eff. 3/23/2018. Amended by Mass Register Issue 1403, eff. 11/1/2019. Amended by Mass Register Issue 1406, eff. 11/1/2019. Amended by Mass Register Issue 1434, eff. 1/8/2021. Amended by Mass Register Issue 1436, eff. 1/8/2021. Amended by Mass Register Issue 1441, eff. 1/8/2021.