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 "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, 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 of representatives' activities, while repealing certain provisions related to representative lists. Additionally, it allows licensed veterinarians to authorize individuals to dispense prescription veterinary drugs under specific conditions.
The bill further amends regulations concerning drug manufacturers and wholesalers, requiring them to obtain a certificate of registration from the Commissioner of Consumer Protection, with specific fees based on the number of licensed pharmacists employed. It prohibits the dispensing of drugs for capital punishment and enhances penalties for violations of pharmacy regulations. The bill also introduces new requirements for sterile compounding pharmacies, including compliance with USP standards and reporting obligations for recalls and violations. It streamlines the process for selling nonlegend drugs through vending machines and secure boxes, ensuring public safety and accessibility. Overall, Substitute Bill No. 1355 aims to strengthen the regulatory framework governing pharmaceutical practices while ensuring compliance with both state and federal laws.
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