Regulatory Recap of New State & Federal Regulations
In the dynamic landscape of pharmaceutical regulation, staying informed about the latest state and federal changes is crucial. Here is a brief recap of state and federal regulations introduced within the last couple of weeks that I thought were important.
FL International Price Reporting for Manufacturers
Florida introduced today SB1750 if passed would require starting October 1, 2025, each prescription drug manufacturer permit holder and nonresident prescription drug manufacturer permit holder to annually report international drug price data to the Agency for Health Care Administration which applies to prescription drug coverage in the Medicaid program and the state group insurance. To read the introduced bill: https://www.flsenate.gov/Session/Bill/2024/1750/BillText/Filed/HTML
I’ve also written more about this and additional Florida pricing regulations in an article titled, Third Florida Development Paints a Clear Target on Pharma Pricing.
California Drug Price Transparency Rule Updates Effective 4/1/2024
The Department of Health Care Access and Information has adopted and amended regulations regarding reporting prescription drug pricing data which will be effective 4/1/2024. The section changes are mostly updating wording to reference the Department to mean the Department of Health Care Access and Information; along with, minor updates or clarifications to the portal link, WAC reporting on December 31st of each calendar year with three years prior WAC, added Number of units total volume of gross sales and estimated annual number of total patients.
Louisiana BOP Special Note (24-01-765) Official Notification
Within the January Louisiana Board of Pharmacy Newsletter, the BOP provided a Special Note (24-01-765): “The Louisiana Board of Pharmacy Newsletter is considered an official method of notification to pharmacies, pharmacists, pharmacy interns, pharmacy technicians, and pharmacy technician candidates credentialed by the Board. These Newsletters will be used in administrative hearings as proof of notification. Please read them carefully. Electronic copies dating back to 1998 are posted on the Board’s website.”
FDA Launches New Webpage for Searching Pharmaceutical Quality Documents
FDA launched a new search function on FDA’s Office of Pharmaceutical Quality webpage to improve access to drug quality resources and web content. The new search webpage scans existing FDA guidance documents, manuals of policies and procedures (MAPPs), and compliance programs to provide users with relevant and up-to-date resources and information. The launch of this new search webpage is one more step FDA is taking to ensure Americans are confident in their next dose of medication and drug products marketed in the U.S. are safe, effective, and of high quality. You use the new search functionality here, https://www.fda.gov/drugs/pharmaceutical-quality-resources/search-pharmaceutical-quality-documents.
Staying Up to Date with 2024 Regulatory Changes:
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