The Natural Medicine Health Act, a law adopted by Colorado voters in November of 2022 is scheduled to go into effect in the near future. This law will enable the use of certain psychedelic medicines including psilocybin and psilocin for the purpose of treating various mental illnesses.
As a necessary part of the implementation of this law, certain rules will have to be promulgated to establish proper licensing and distribution for these medications. Colorado’s Department of Regulatory Agencies (DORA) will be responsible for creating and implementing the foundational rules for this Act.
As part of this Act, DORA will establish the Natural Medicine Access Program and shall regulate the manufacture, cultivation, testing, storage, transfer, transport, delivery, sale, and purchase of natural medicines covered under this Act.
Further, by January 1, 2024, DORA shall be responsible for adopting rules to establish the qualifications, educational, and training requirements that facilitators and health care facilities covered by the Act must meet prior to providing natural medicine services, and in addition, shall approve any required training programs. By September 30, 2024, DORA shall adopt the rules necessary to implement the Regulated Natural Medicine Access Program and shall begin accepting applications for licensure.
Under this Act, DORA will be required to adopt rules including, but not limited to the following:
- Holding and verifying the completion of a preparation session, administration session, and integration session
- Providing health and safety warnings to participants prior to the beginning of natural medicine services
- Providing educational materials to participants prior to the beginning of natural medicine services
- Creating forms for natural medicine facilitators, participants, and authorized representatives of healing centers to sign before providing or receiving natural medicine services
- Establishing guidelines for proper supervision during the administration and transportation of patients during and after receiving natural medicine services
- Creating provisions for the group administration of natural medicine services to multiple participants
- Establishing requirements for the testing for concentration and contaminants within covered natural medicines
- Establishing requirements for the licensure of entities permitted to engage in the testing of natural medicines
- Establishing rules for the advertising and marketing of natural medicines and natural medicine services
This is a non-exhaustive list of rules required to be adopted by DORA regarding the distribution of administration of medicines. DORA will also be required to establish further rules regarding the specific requirements for licensing of distributors and natural medicine health care centers. As the law is still in its early stages, most such rules have yet to be established.