August 5, 2026
State of California Regulatory Reminder
California Health and Safety Code Sections 119400-119402 requires pharmaceutical companies to implement a robust compliance framework governing interactions with healthcare professionals, establish annual limits on gifts and incentives, and publicly disclose their commitment to compliance each year.
The law applies broadly to companies that “engage in the production, preparation, propagation, compounding, conversion, or processing of dangerous drugs, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis”.
“Dangerous Drugs” means any drug that is unsafe for self-use and includes either of the following:
(1) Any drug that bears the legend “Caution: federal law prohibits dispensing without prescription,” “Rx only,” or words of similar import.
(2) Any drug or device that, pursuant to federal or state law, may be dispensed only by prescription, or that is furnished pursuant to Section 4006 of the Business and Professions Code. “Dangerous drug” does not include labeled veterinary drugs.
“Pharmaceutical company” also means an entity engaged in the packaging, repackaging, labeling, relabeling, or distribution of dangerous drugs.
“Pharmaceutical company” also includes a person who engages in pharmaceutical detailing, promotional activities, or other marketing of a dangerous drug in this state on behalf of a pharmaceutical company.
If a company is marketing “dangerous drugs” in California, it should maintain a compliance program that remains current, transparent, and readily accessible to the public to in order to meet these regulatory requirements.
Key Compliance Requirements:
- Adopt a comprehensive compliance program which aligns with the current U.S. Department of Health and Human Services Office of Inspector General (OIG) guidance for pharmaceutical manufacturers.
- Incorporate industry code requirements which, at minimum, include policies addressing compliance with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on interactions with healthcare professionals.
- Establish a specific internal annual dollar limit on gifts, promotional materials, and other items or activities provided to individual healthcare professionals. Exemptions from the gift limit include drug samples, CME support, educational scholarships, and legitimate professional services.
- Annually certify in writing that the company is operating in accordance with its comprehensive compliance program and all applicable requirements under California Health and Safety Code Chapter 8.
- Publicly disclose on the company’s website a summary of their comprehensive compliance program, and an annual written declaration of compliance.
- Maintain a toll-free telephone number through which members of the public can request copies of the company’s compliance program information, and the company’s annual compliance declaration.
Have questions about California’s requirements? Contact QPharma to learn how our team can help support your compliance program and regulatory objectives.
