Substitute Bill No. 1355 seeks to enhance the regulation of nonsterile compounded pharmaceutical products and pharmaceutical marketing practices in Connecticut. It introduces new definitions, such as "Component," "Nonsterile compounded pharmaceutical product," and "Nonsterile compounding pharmacy," and mandates the Commissioner of Consumer Protection to adopt regulations ensuring compliance with state laws and United States Pharmacopeia standards. The bill allows the Department of Consumer Protection to import specific drugs to ensure patient access and establishes a framework for the Commissioner to issue policies with the force of law prior to formal regulation adoption. Additionally, it modifies existing regulations for pharmaceutical marketing firms, requiring annual registration and detailed reporting of representatives' activities, while repealing provisions related to posting representative lists online.

The bill also amends regulations concerning drug manufacturers and wholesalers, clarifying that certain pharmacies are not classified as wholesalers under specific circumstances and introducing a tiered fee structure for registration based on the number of licensed pharmacists employed. It prohibits the manufacture or distribution of drugs intended for execution and mandates reporting of suspicious orders of controlled substances. Furthermore, it enhances oversight of sterile compounding pharmacies, requiring compliance with USP standards and establishing new reporting requirements for recalls and violations. The legislation also addresses the distribution of nonlegend drugs and opioid antagonists through vending machines and syringe services programs, emphasizing public safety and accessibility while streamlining regulatory processes. Overall, the bill aims to improve the safety, transparency, and compliance of pharmaceutical practices in Connecticut.

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