Effective January 1, 2023, California has enacted several state laws impacting the practice of pharmacy. While these newly enacted laws are specific to California, pharmacy stakeholders in other jurisdictions should be mindful of these changes, as their home states may endeavor to implement the same or similar rules. You can view the full list of changes to California’s Business and Professions Code here.
Below is an overview of updates to the law which are most relevant to pharmacy providers in California and elsewhere:
Electronic Prescriptions
Last year, the California legislature mandated prescribers to have the capability to send prescriptions electronically to a pharmacy chosen by the patient and for the pharmacy provider to have the capability to receive such electronic prescriptions. Effective January 1, 2023, pharmacy providers are prohibited from refusing to dispense an electronic prescription “solely because the prescription was not submitted via, or is not compatible with, the proprietary software of the pharmacy.” Yet, the statute does provide criteria for when a pharmacy provider may decline to dispense against an electronic prescription. This includes the prescriptions failure to:
- Adhere to standards set forth by the National Council for Prescription Drug Programs (“NCPDP”);
- Comply with the content requirements of Bus. & Prof. Code § 4040;
- For a controlled substance prescription, comply with Parts 1300, 1304, 1306, and 1311 of Title 21 of the Code of Federal Regulations, as amended from time to time; or
- Comply with the federal Health Insurance Portability and Accountability Act (“HIPAA”), the California Confidentiality of Medical Information Act, or the security and confidentiality requirements prescribed to by the pharmacy, pharmacist, or practitioner authorized pursuant to Cal. Bus. & Prof. Code § 4040.
Though not a new addition or revision, pharmacy providers should also remain cognizant of circumstances in which healthcare practitioners are exempt from California’s e-prescription requirement.
Opioid Antagonists
Previously, pharmacy providers in California were statutorily permitted to furnish patients with naloxone hydrochloride in accordance with standardized procedures or protocols developed and approved by both the Board of Pharmacy and the Medical Board of California, in consultation with the California Society of Addiction Medicine, the California Pharmacists Association, and other appropriate entities. Effective January 1, 2023, however, the relevant statutory provisions have been broadened, replacing “naloxone hydrochloride” with “federal Food and Drug Administration-approved opioid antagonist[s].” This amendment will have the effect of allowing pharmacy providers to furnish other opioid antagonists such as Naltrexone, which is available in both oral and long-acting injectable formulations and is FDA-approved to treat opioid and/or alcohol maintenance treatment.
Mobile Dispensing
Under the newly added Section 4110.5, a county, city and county, or special hospital authority may operate a mobile unit to provide prescription medication within its jurisdiction to individuals without fixed addresses and individuals living in county-owned or city-and-county-owned housing facilities. This will include patients enrolled in Medi-Cal plans operated by the county or respective city and county. The law goes on to enumerate several requirements for mobile unit dispensing and further prohibits the carrying and dispensing of controlled substances.
Cultural Competency
Lastly, under newly added Section 4231, the Board of Pharmacy will not renew a pharmacist license unless the applicant submits proof that the applicant has successfully completed thirty (30) hours of approved courses of continuing pharmacy education, including at least one hour (1) of participation in cultural competency. Failure to complete course hours, including those in cultural competency, will result in issuance of an inactive license and subsequently require payment of a renewal fee following completion of the requisite coursework.
In sum, while these changes are not all inclusive of those made to the to the California Health and Safety Code, Business and Professional Code, and Penal Code taking effect in 2023, keeping abreast of the latest revisions to any laws impacting the practice of pharmacy is critical for providers.
How Frier Levitt Can Help
Frier Levitt regularly counsels pharmacies through the development and implementation of comprehensive compliance plans particularly related to navigating legislative and administrative updates. Contact us to speak with an attorney.
