CS/HB 313 Summary

• Defines "stem cell" as an allogenic or autologous cell that is altered or processed to become undifferentiated and capable of differentiating into specialized cell types, excluding cells that are only rinsed, cleaned, or sized.

• Allows licensed physicians under chapters 458 or 459 who advertise, use, or purport to use stem cells or stem cell products to voluntarily register with the Department of Health.

• Requires registering physicians to agree to adhere to current applicable good manufacturing practices under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and 21 C.F.R. § 1271 for collection, removal, processing, implantation, and transfer of stem cells.

• Permits manufacturers and distributors of stem cells or stem cell products that advertise, distribute, or operate in Florida to voluntarily register with the department.

• Directs the Department of Health to establish and maintain an online registry identifying registered physicians, manufacturers, and distributors, documenting physician agreements to follow good manufacturing practices, and updating the registry at least monthly.

• Takes effect July 1, 2020.