September 2nd, 2025 – Proactive Alert: California Compliance Requirements for Transparency Programs

As part of QPharma’s ongoing commitment to supporting life sciences, we are providing this important regulatory reminder regarding California Safety & Health Code § 119402, which impacts pharmaceutical manufacturers’ transparency programs and compliance obligations.

Key Compliance Requirements – Applicable to 2024 Activities

Under California law, manufacturers of “dangerous drugs”, defined as prescription drugs or medical devices, must:

• Adopt a Corporate Compliance Program in accordance with the HHS OIG’s 2003 Compliance Program Guidance.
• Maintain a Code of Conduct that aligns, at a minimum, with the current PhRMA Code.
• Establish and adhere to self-imposed annual dollar limits on gifts, promotional items, and other marketing incentives provided to medical and health professionals.

Website Posting Requirements

Manufacturers must post the following on their company website:

• An annual written declaration confirming compliance with their Corporate Compliance Program and California law.

Note: This declaration should reflect activities conducted in 2024 and must indicate that it was posted in 2024.

• A toll-free number or hyperlink providing public access to the Corporate Compliance Program and Code of Conduct.

Action Required

Attached are expenses associated with California HCPs for your review. These should be considered as part of your compliance declaration and annual website update.

Additional Information

This alert is for informational purposes only. For questions regarding California’s requirements, please contact a member of the QPharma Transparency Team at 1-888-742-7620 or Click Here