Rules and regulations
Senate Bill (SB) 22-224: Protections for Donor-conceived Persons and Families Act was passed by the Colorado Legislature in 2022. The law declares that anonymity in gamete donation and a lack of transparency in the related industry causes significant harm to donor-conceived people and their families. SB 22-224 creates state requirements regarding the donation, matching, and use of gametes (unfertilized eggs and sperm) or, in some cases, embryos, in assisted reproduction. It also establishes a state licensing program for gamete agencies, gamete banks, and fertility clinics.
On May 8, 2024, the Colorado Legislature passed Senate Bill 24-223: Licensing for Clinics That Provide Fertility Services, which made changes to certain sections of the 2022 Donor-conceived Persons and Families of Donor-conceived Persons Protection Act.
The Colorado Board of Health approved regulations related to Colorado’s Donor-conceived Persons and Families of Donor-conceived Persons Protection Act on September 18, 2024. A gamete agency, gamete bank, or fertility clinic must not match or provide gametes or embryos to recipients in Colorado without adhering to state regulations and obtaining a license from CDPHE by July 1, 2025.
On May 7, 2025, House Bill 25-1259 In Vitro Fertilization Protection & Gamete Donation Requirements was passed by the Colorado legislature, which makes changes to 25-57-101, et seq, Colorado Revised Statutes (CRS), Donor-conceived Persons and Gamete Agencies, Gamete Banks, and Fertility Clinics.
As a result, the Department is proposing revisions to 5 Colorado Code of Regulations (CCR) 1005-6, Donor-conceived Persons and Gamete Agencies, Gamete Banks, and Fertility Clinics. These rules regulate the donation, matching, and use of gametes (unfertilized eggs and sperm) in assisted reproduction, including the establishment of a state license program for gamete agencies, gamete banks, and fertility clinics.
Feedback submitted is for consideration by CDPHE in drafting the proposed rules and will not be shared directly with the Board of Health.
CDPHE will submit a packet with the proposed rules to the Board of Health to request an official rulemaking hearing on Aug. 20, 2025. If the request is granted, stakeholder engagement and feedback will continue until the rulemaking hearing on Oct. 15, 2025. Refer to the Board of Health webpage for more information about the hearings.
For easy access to specific sections of Rule, download the Rule PDF below and open it with Adobe Acrobat Reader. Then, click on the bookmark icon on the left side of the page in Acrobat to navigate directly to specific sections of Rule. This navigation tool will not function when the PDF is opened in an internet browser.
