Substitute House Bill No. 6768, Public Act No. 23-52, is a comprehensive piece of legislation that introduces new definitions and regulations in the realm of pharmaceutical practice, effective January 1, 2024. The bill defines terms such as "centralized dispensing practitioner," "dispensing assistant," and "legend drug," and sets forth requirements for group practices that dispense legend drugs or devices, including registration with the Department of Consumer Protection, designating a dispensing practitioner or pharmacist, and adhering to a registration fee. It exempts group practices dispensing less than a seventy-two-hour supply of legend drugs as professional samples from certain reporting requirements, while those dispensing more are required to register for and use the electronic prescription drug monitoring program. The bill also allows pharmacists to prescribe emergency and hormonal contraceptives under certain conditions, and requires pharmacies to provide information on where to obtain drugs for the termination of pregnancy if not available at the pharmacy. It includes legal language insertions and deletions, such as the deletion of a colon in the definition of "flavoring agent" and the insertion of new conditions for the addition of flavoring agents to prescription products.
Additionally, the bill addresses the sale of nonlegend drugs through vending machines, requiring businesses to obtain permits and ensure proper labeling and packaging. It increases the fine for violations related to dispensing legend drugs or devices to a maximum of $1,000 per violation. The bill also sets forth requirements for sterile compounding pharmacies, including compliance with USP chapters and reporting of violations or recalls to the Department of Consumer Protection. It mandates that sterile compounding pharmacies maintain a thirty-day supply of on-site inventory and notify the department of any changes to compounding areas. The bill amends the definition of "Device" and restructures prohibitions in Section 21a-93 of the general statutes, with insertions and deletions to update the legal language. Lastly, it introduces provisions for the distribution and storage of opioid antagonists through vending machines and syringe services programs, including environmental controls and liability protections for prescribing practitioners or pharmacists.
Statutes affected: Raised Bill: 20-579, 20-617a, 20-623, 20-633b
GL Joint Favorable Substitute: 20-579, 20-617a, 20-623, 20-633b
File No. 215: 20-579, 20-617a, 20-623, 20-633b
File No. 835: 20-617a, 20-623, 20-633b
Public Act No. 23-52: 20-617a, 20-623, 20-633b