Section R66-35-3 - Product Registration(1) Each cannabinoid product distributed or available for distribution in Utah shall be officially registered annually with the department.(2) Application for registration shall be made to the department on a form provided by the department including the following information:(a) the name and address of the applicant and the name and address of the person whose name will appear on the label, if other than the applicants;(b) the name of the product;(c) the type and use of the product;(d) a complete copy of the label as it will appear on the product in a legible format; and(e) if the product has been assigned a National Drug Code in accordance with 21 CFR 207.33, the applicant shall provide the National Drug Code number.(3) The application shall include a certificate of analysis from a third-party laboratory for the product in compliance with Section R68-26-4. The certificate of analysis shall show the cannabinoid profile of the product by percentage of mass.(4) A registration fee per product, as set forth in the fee schedule approved by the Legislature, shall be paid to the department with the submission of the application.(5) The department may deny registration for an incomplete application.(6) A new registration is required for any of the following: (a) any change in the cannabinoid product ingredients;(b) any change to the directions for use; and(c) any change of name for the product.(7) Other changes may not require a new registration but the registrant shall submit copies of each label change to the department as soon as they are effective.(8) The registrant is responsible for the accuracy and completeness of information submitted.(9) A registration is good for one calendar year from the date of registration and shall be renewed through payment of an annual renewal fee before expiration.(10) A cannabinoid product that has been discontinued shall continue to be registered in the state until the product is no longer available for distribution.(11) A late fee shall be assessed for a renewal of a cannabinoid product registration submitted after the day of expiration and shall be paid before the registration renewal is issued.(12) The department may not register a cannabinoid product if the product: (a) uses the cannabinoid as a food additive; or(b) is represented for use as a conventional food, with the exception of:(i) a gummy if the gummy is shaped as a gelatinous cube or gelatinous rectangular cuboid or in another basic geometric shape and not in a shape that could be considered appealing to children such as a star shape, fruit, or animal shape; or(ii) a liquid suspension under two ounces.Utah Admin. Code R66-35-3
Adopted by Utah State Bulletin Number 2024-10, effective 5/13/2024