Rule 42.39.320 - PACKAGING AND LABELING APPLICATIONS, FEES AND DEPARTMENT APPROVAL PROCESSES; EXIT PACKAGE APPROVAL; INITIAL REQUIREMENTS APPLICABLE TO ALL LICENSEES(1) For purposes of this rule, "marijuana product categories" mean any of the marijuana and marijuana products described in ARM 42.39.315 through 42.39.318 that are subject to the packaging and labeling requirements of 16-12-208, MCA.(2) For purposes of this rule, a "unique marijuana product package" means a custom package that contains variations in graphic or design elements including logos. For example, boxes used for pre-rolls with a graphic for "Grape Ape" and a different graphic for "Cherry Pie" are unique marijuana product packages. (3) A unique marijuana product package does not mean a package with variations in language, such as product information or instructions, or a package that depicts flavor variation without an accompanying change in graphic or design, or a different size, shape, or color. For example, mylar bags used for marijuana flower with different colors for indica, sativa, or hybrid used in various sizes are not unique marijuana product packages. (4) For purposes of this rule "generic package" or "generic packaging" means packaging without any graphic or design elements, including logo, whether preprinted on the package or affixed later with an adhesive, sticker, or by other means. (5) All applicants, whether as an initial license applicant or existing licensee, must apply to the department for approval of the labeling of each marijuana product category intended for sale to customers. (6) An applicant must submit a separate application for each label - up to a maximum of nine total label applications - based on the applicant's sale of some or all of the following marijuana or marijuana product categories: (d) adult-use ingestible marijuana-infused products; (e) medical ingestible marijuana-infused products; (f) adult-use non-ingestible marijuana-infused products; (g) medical non-ingestible marijuana-infused products; (h) adult-use marijuana concentrates and extracts; and (i) medical marijuana concentrates and extracts. (7) An applicant will be given the following labeling options for the product categories listed in (6): (a) selecting and affirming its use of a pre-approved template label available for download from the department, at no cost to the applicant, as provided in (16); or (b) use of a custom label design and pay the custom label application fee, as provided in (16).(8) An applicant that elects to use its custom (i.e., non-department template) label design must submit only one template label for each marijuana product category. (9) Except as provided in (10), a new label application is not required when the marijuana facts panel information changes for disclosures such as levels of total potential psychoactive THC, THC, THCa, CBD, or CBDa, date of harvest, strain name, or ingredients. (10) An applicant that sells marijuana products to registered cardholders with THC levels in excess of the limits set in 16-12-224, MCA, must submit a separate application and label template for each of the marijuana product categories sold.(11) All applicants, whether as an initial license applicant or existing licensee, must submit an application to the department for approval for the packaging of each marijuana product category intended for sale to customers.(12) An applicant will be given the following packaging options for the product categories listed in (6): (a) selecting and affirming its use of generic packaging. The applicant shall identify on the application which marijuana or marijuana products will be placed in generic packaging; or (b) use of custom packaging with graphic or design elements, including logo, whether preprinted on the package or affixed with an adhesive, a sticker, or by other means. In this case, the applicant must provide a picture or accurate, detailed rendering of the packaging. Further, the applicant shall identify on the application which marijuana or marijuana products will be placed in each unique marijuana product package. (13) All applicants, whether as an initial license applicant or existing licensee, must submit an application to the department for approval for each exit package type it will use. If the applicant intends to use the same exit package type in multiple sizes, it may submit each size under one application. (a) Exit packaging must comply with ARM 42.39.319(2). (b) Exit packaging must comply with federal child-resistant packaging standards pursuant to 16-12-208(6), MCA. (14) All applications and required attachments, such as photographs and renderings shall be submitted electronically to the department via its online portal. (15) Licensees do not need to apply for package and label approvals for products purchased wholesale that have been previously approved by the department. (16) Except as provided in (17), an applicant must submit the following fees to the department: (a) no charge ($0.00) for label applications described in (7)(a) or packaging applications in (12)(a); (b) $25 per label application described in (7)(b) for custom label design; (c) $10 per package application described in (12)(b); and(d) $10 per exit package application. (17) Wholesale label applicants must submit the following fees to the department: (a) no charge ($0.00) for label applications described in (7)(a) or packaging applications in (12)(a); (b) $25 per label application described in (7)(b) for custom label design; and (c) $10 per package application described in (12)(b). (18) The department shall review each application and shall notify an applicant, in writing, whether the packaging, label, or exit package has been approved or rejected. (19) Whenever the department returns any application for correction, it shall notify an applicant, in writing, of the deficiencies or issues with the application or submitted materials. (20) An applicant will receive an invoice for all application fees upon the department's approval of the application(s). The applicant shall pay all invoiced application fees to the department within ten days of receipt. An applicant's failure to pay all invoiced application fees may result in the reversal of application approval and denial of the application. (21) An applicant whose application is denied under (5) or (11) must reapply. (22) A licensee shall be subject to disciplinary proceedings when: (a) it affirms to the department that it is using a pre-approved department template label but then uses any other label without submitting an application, applicable fees, and receiving department approval; or (b) it affirms to the department that it is using generic packaging, but then uses any other product packaging, with graphic or design elements, including logo, whether preprinted on the package or affixed later with an adhesive, sticker, or by other means, without submitting an application, applicable fees, and receiving department approval.Mont. Admin. r. 42.39.320
NEW, 2022 MAR p. 924, Eff. 6/11/2022; AMD, 2024 MAR p. 631, Eff. 3/23/2024AUTH: 16-12-112, MCA; IMP: 16-12-112, 16-12-208, 16-12-215, 16-12-224, MCA