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California Pharmacy Law Updates for 2024 and 2025

Staying up to date with the latest California pharmacy laws is critical in ensuring compliance of your pharmacy with state and federal regulations. As these laws update frequently, it is of the utmost importance to consult a lawyer specializing in the nuances of California pharmacy laws. Having a lawyer retained will help protect from legal issues that may arise from misinformation on the latest best practices.

As of January 1, 2024, several new California pharmacy laws have gone into effect with more to begin in 2025. Below, we will highlight the Business and Professions Code changes we found most noteworthy. To view the full list of changes, click here.

Pharmacist-in-Charge – 4113

Existing law requires every pharmacy to appoint a “pharmacist-in-charge” approved by the California Board of Pharmacy. This head pharmacist is responsible for keeping up with all state and federal pharmacy laws and regulations. Starting in 2024, the head pharmacist (or the pharmacist on duty if the head one is not there) is expected to:

• Make staffing decisions and adjustments to prevent fatigue and distractions that could affect the pharmacists’ ability to work safely.
• Notify the store management as soon as possible of any hazardous conditions that may pose a severe risk to patients, personnel, or staff. Management is required to take immediate action to address the situation.

Chain Community Pharmacy Staffing – Section 4113.6

This section of California pharmacy law outlines the staffing requirements for chain community pharmacies. Pharmacies must have at least one staff member focused on pharmacy-related tasks at all times unless:

• The pharmacist on duty decides workload demands do not require this.
• The pharmacy operates outside normal business hours (before 8 a.m. or after 7 p.m.).

Automated Patient Dispensing System – Section 4119.11

An automated patient dispensing system (APDS) is a machine that holds and dispenses medications to patients once the pharmacist has given their approval. The details to be aware of in Section 4119.11 regarding ADPS, a type of automated drug delivery system (ADDS) include the following:

• Drugs stored in the APDS belong to the pharmacy, and when dispensed, it is as if they were dispensed by the pharmacy itself.
• The pharmacy must keep separate records for the acquisition and distribution of hazardous drugs stored in the APDS, distinct from other pharmacy records.
• The pharmacy is responsible for the security, operation, and maintenance of the APDS and must train personnel on how to operate it.
• A licensed pharmacist is in charge of overseeing the APDS, whether they are physically present on-site or monitoring it electronically.
• The board can issue a license for an APDS to operate at an address where it has already issued another site license.
• The board is required to inspect the proposed location of the APDS within 30 days of receiving the license application. Relocating it requires a new application for licensure, and replacing it must be reported to the board within 30 days.
• If the pharmacy’s main license is not current, valid, or active, then the APDS license will be canceled automatically. A new application for an APDS license can be submitted to the board once the main license is renewed.
• Licensed pharmacies must notify the board in writing within 30 days if they stop using an APDS.

Opioid Antagonist – 1799.113

According to the most recent changes made by the California State Board of Pharmacy, opioid antagonist refers to naloxone hydrochloride or other drugs approved by the FDA that reverse or neutralize an opioid overdose. Previously, only naloxone hydrochloride was stated.

Section 1799.113 states that a person who, in good faith and not for pay, administers or provides an opioid antagonist to someone who has or is suspected to have overdosed from opioids will not be held liable for civil damages related to the situation. However, if the help provided during the emergency is deemed negligent or intentional, this protection does not apply and they can, in fact, be sued for any harm caused by their actions.

Naloxone Hydrochloride – 11871

Section 11870 was added to mandate that public spaces like stadiums, concert venues, and amusement parks maintain unexpired doses of naloxone hydrochloride or another FDA-approved opioid antagonist on-site for potential opioid overdose situations. At least two employees must know where the opioid antagonist is stored within the premises.

Speak to a Leading Pharmaceutical lawyer

Each year, the updates to the California pharmacy laws are extensive and complex. While we have outlined some of the most significant changes in this article, there are several more to be aware of — each with specific legal outlines, context, and limitations. Reach out to an experienced pharmaceutical lawyer for a more comprehensive understanding of the 2024-2025 law updates and how they might affect you or your practice.

Fenton Jurkowitz Law Group has a team of seasoned pharmaceutical lawyers who can help you through the healthcare business dispute process. Our legal advice allows for the resolution of problems quickly and effectively, ensuring the integrity and longevity of your healthcare practice. We recognize the importance of preserving your reputation, maintaining operational continuity, and complying with healthcare regulations. Fill out our contact form on our website today to connect with a healthcare practice attorney at our pharmaceutical law firm.