935 Mass. Reg. 501.130

Current through Register 1519, April 12, 2024

Section 501.130 - Additional Operational Requirements for Handling and Testing Marijuana and for Production of MIPs

(1) In addition to the general operational requirements for MTCs required under 935 CMR 501.105 and security requirements provided in 935 CMR 501.110, MTCs shall comply with additional operational requirements required under 935 CMR 501.130.

(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 in 105 CMR 500.000: Good Manufacturing Practices for Food, and with the requirements for food handlers specified in 105 CMR 300.000: Reportable Diseases, Surveillance, and Isolation and Quarantine Requirements; and

(b) Any Edible that is made to resemble a typical food or beverage product shall be packaged in an opaque package and labeled as required by 935 CMR 501.105(5)(c).

(3) An MTC engaged in product manufacturing operations 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) An MTC selling or otherwise Transferring Marijuana to another MTC or Marijuana Establishment shall provide documentation of its compliance, or lack thereof, with the testing requirements of 935 CMR 501.160, 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) An MTC shall retain all records of purchases from any manufacturer or supplier of any ingredient, additive, device, component part or other materials obtained by the MTC in relation to the manufacturing of Marijuana Vaporizer Devices and such records shall be made available to the Commission on request.

(b) An MTC 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 MTC 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 an MTC and provided as a part of a wholesale transaction with any MTC or Marijuana Retailer.

(d) An MTC that wholesales Marijuana Vaporizer Devices to an MTC or Marijuana Retailer shall provide the recipient with the information insert required by 935 CMR 501.105(5)(c) or the necessary information to produce such an insert and the appropriate labeling information required by 935 CMR 501.000.

(5) Written policies and procedures for the production and distribution of Marijuana, 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 501.105(8);

(b) A procedure for handling voluntary and mandatory recalls of Marijuana. Such procedure 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 an MTC to remove defective or potentially defective Marijuana from the market, as well as any action undertaken to promote public health and safety;

(c) A procedure 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 501.105(12);

(d) Policies and procedures for transportation and Patient or Personal Caregiver home delivery;

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

(f) Policies and procedures to ensure that all Edibles are prepared, handled, and stored in compliance with the sanitation requirements in 105 CMR 500.000: Good Manufacturing Practices for Food, and with the requirements for food handlers specified in 105 CMR 300.000: Reportable Diseases, Surveillance, and Isolation and Quarantine Requirements; and

(g) 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: Massachusetts Comprehensive Fire Code.

(6)Product Database. An MTC engaged in product manufacturing operations, 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 prior to commencement of operations. This information may be used by the Commission for its Product Database.

(a) The MTC 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 MTC and another MTC or Marijuana Establishment.

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

(c) An MTC shall provide the information required under 935 CMR 501.130(6)(a) for each Marijuana Product that it produces prior to the product being made available for sale and shall update the information whenever a substantial change to the product information occurs. Substantial changes, including changes to information listed in 935 CMR 501.130(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, an MTC shall identify the method of extraction (e.g., Butane, Propane, CO₂) on a physical posting at all entrances of the MTC. 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. An MTC shall post a copy of a permit to keep, store, handle or otherwise use flammable and combustible material at each place of operation within the facility.

(8) Except for a Registered Qualifying Patient or Personal Caregiver, who are not subject to 935 CMR 501.105, only a licensed MTC is permitted to produce MIPs. Unless otherwise authorized by the Commission, an MIP production facility of an MTC may produce MIPs for only that MTC, and up to two additional MTCs under an entity.