With less than two weeks before the Connecticut reporting deadline for pharmaceutical companies to report representative interactions and payments to nurse practitioners, the Connecticut Department of Consumer Protection (DCP) released a comprehensive FAQ Document to aid compliance. Here are the key points from the FAQ document:
Definition of a “Gift”
A gift is anything of monetary value obtained for less than market value, including tangible items (pens, t-shirts, meals) and services (transportation, travel, lodging). If unsure, assume it qualifies as a gift or seek legal advice.
Reporting Gift Values
The “Gift Value ($) (No samples drugs)” field represents the total value of gifts provided by the sales representative over the reporting period.
Reporting Requirements
Only drug samples need to be reported in the “Fill Drug Sample Info” worksheet. Non-sample items like gifts are reported in the “Name of all Sales Reps” worksheet.
Annual Registration for Pharmaceutical Manufacturers
All pharmaceutical manufacturers, whether operating within Connecticut or not, must register if they use representatives to market legend drugs to prescribing practitioners.
Marketing Firm Registration
Manufacturers who outsource their sales force must still obtain a Pharmaceutical Marketing Firm Registration. This includes both contracted and outsourced sales forces.
Virtual Manufacturer Registration
Non-resident virtual manufacturers must obtain registration if they market or provide information about legend drugs to practitioners in Connecticut.
Scope of the Regulation
The regulation applies only to legend drugs and does not include over-the-counter (OTC) drugs or devices. It includes virtual manufacturers and those with sales representatives working in Connecticut.
Fees and Record Keeping
There is a $150 fee for both the application and renewal of pharmaceutical manufacturer registration. Updating contact information incurs no fee. Manufacturers must comply with state and federal record-keeping laws.
Application Process and Contact Information
The approval time for registration applications varies. To expedite, submit complete applications with all required information and fees. For questions, email DCP.DrugManufacturers@ct.gov.
The full text of the Public Act 23-171 can be found here. For more information, visit the Connecticut General Assembly website.
For further details, including specific requirements and instructions for updating information, consult the Connecticut General Statutes and the eLicense online system.
Though lately distributed pharmaceutical companies and their representatives should review the FAQ’s to ensure compliance with the new reporting and registration requirements. As the deadline approaches, companies should review these guidelines carefully to avoid potential penalties.