Substitute Senate Bill No. 1355 seeks to enhance the regulatory framework surrounding prescription drugs, devices, and nonlegend drugs in Connecticut, with a particular focus on nonsterile compounded pharmaceutical products. The bill introduces new definitions, such as "Component," "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. It also allows for the importation of specific drugs, including levonorgestrel, mifepristone, and misoprostol, to improve patient access. Additionally, the bill modifies existing regulations for pharmaceutical marketing firms, requiring annual registration and reporting of representatives while removing the obligation for the department to post representative lists online.

The bill further amends regulations for manufacturers and wholesalers, requiring them to obtain a certificate of registration from the Commissioner of Consumer Protection, with specific exemptions for certain out-of-state manufacturers. It emphasizes the need for compliance with relevant laws and expands the criteria for denying registrations based on criminal history. Notably, the bill prohibits the sale or dispensing of drugs intended for use in executions and mandates that any registered manufacturer or wholesaler ceasing distribution of controlled substances must report this decision. It also introduces new provisions for the distribution of opioid antagonists and modifies the requirements for vending machines selling nonlegend drugs, including waiving fees for those distributing without compensation. Overall, the bill aims to strengthen regulatory oversight, enhance public safety, and ensure ethical practices in drug distribution.

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