Substitute Bill No. 1355 seeks to enhance the regulation of nonsterile compounded pharmaceutical products and the practices of pharmaceutical marketing firms in Connecticut. It introduces new definitions, such as "nonsterile compounded pharmaceutical product" and "nonsterile compounding pharmacy," and mandates the Commissioner of Consumer Protection, in consultation with the Commission of Pharmacy, to adopt regulations ensuring compliance with state laws and United States Pharmacopeia standards. The bill allows for the importation of specific drugs, including levonorgestrel, mifepristone, and misoprostol, to improve patient access. It also modifies existing regulations for pharmaceutical marketing firms by requiring annual registration and detailed reporting on representatives' activities, while repealing certain provisions related to representative lists. Additionally, it allows licensed veterinarians to authorize individuals to dispense prescription veterinary drugs under their supervision.

The bill further amends regulations concerning drug manufacturers and wholesalers, establishing a tiered fee structure for registration based on the number of licensed pharmacists or qualified chemists employed. It prohibits manufacturers from knowingly selling drugs intended for use in executions and requires applicants to affirm they will not manufacture or sell such drugs. The bill also introduces new reporting requirements for manufacturers and wholesalers regarding the distribution of controlled substances, clarifies the sale and dispensing of controlled drugs, and enhances regulations for sterile compounding pharmacies. Notably, it streamlines the process for selling nonlegend drugs through vending machines and secure boxes, particularly for naloxone distribution, while providing immunity from liability for practitioners involved in these efforts. Overall, the bill aims to improve regulatory oversight, enhance patient safety, and ensure compliance with ethical standards in pharmaceutical practices.

Statutes affected:
Raised Bill:
GL Joint Favorable Substitute: 20-613a, 20-623, 20-624
File No. 608: 20-613a, 20-623, 20-624
JUD Joint Favorable: 20-613a, 20-623, 20-624