CT SB01006

Repeals and replaces Section 20-633b effective January 1, 2020, establishing comprehensive regulations for sterile pharmaceutical compounding in pharmacies, including requirements for addendum applications, Department of Consumer Protection inspections, and compliance with USP chapters 797, 800, and 825.

Requires new and existing pharmacies, as well as nonresident pharmacies, to file addendums and obtain department approval before compounding sterile pharmaceuticals, with inspections by the Department of Consumer Protection and Commission of Pharmacy.

Mandates sterile compounding pharmacies report environmental sampling violations within one business day, product recalls within 24 hours (patient-specific) or by next business day (non-patient-specific), and any administrative or legal actions within five business days.

Requires each pharmacy providing sterile pharmaceuticals to designate a pharmacist responsible for overseeing sterile compounding operations who must complete a commissioner-approved competency program and notify the department immediately upon ceasing that designation.

Removes the 240-day time limitation for drugs federally designated as controlled substances to be considered controlled at the state level, and requires the Commissioner to adopt state schedules for FDA-approved marijuana products based on DEA classifications.