The California State Board of Pharmacy (“Board”) has proposed amendments to clarify how central fill operations may operate in California’s pharmacy practice environment. These amendments are intended to increase consumer transparency, ensure patients know when a central fill facility has filled their prescriptions and who to contact with questions, and provide pharmacies with greater flexibility regarding labeling and product verification.
In-State Licensing and Restrictions on Non-Resident Pharmacies
If the proposed amendments to the regulation are passed, the central fill pharmacy must be located in California and licensed by the Board. The Board’s amended statement of reasons explains that the California-location requirement is intended to facilitate inspection of central fill facilities to ensure compliance with California laws and regulations.
Another purpose of the in-state location requirement is to avoid potential delays in therapy and to support timely filling and return of prescription medication to the originating pharmacy for dispensing.
Notably, “central fill pharmacies are permitted to enter into a contract with a non-resident pharmacy” provided the other requirements for central fill are satisfied.
Under the proposed amendments, the role of non-resident pharmacies will be restricted to the processing of prescription medications, and they will be prohibited from physically filling prescription medications.
Non-resident pharmacies that are currently dispensing prescription medications pursuant to a central fill arrangement will need to restructure their models before the regulation becomes effective.
Interestingly, however, the proposed regulation will not affect non-resident pharmacies that fill and mail prescription medications directly to California patients. Rather, the proposed regulation clarifies that non-resident pharmacies are operating outside of the central fill framework.
Key Proposed Changes to California’s Central Fill Framework
- Changing from “Refill” to “Central Fill.” “Central Fill” will be substituted for “Refill” to align with the Board’s intent that the rule should not restrict central fill activity based solely on whether the prescription is new or a refill, as long as the regulatory conditions are otherwise satisfied. The existing regulation was titled “Procedures for Refill Pharmacies” and only explicitly authorized a pharmacy to process “a request for refill of a prescription” received from another pharmacy. Despite appearing to entirely exclude new prescriptions, the Board clarifies in its amended statement of reasons that the regulation was never intended to limit central fill to the refill of prescriptions. The amendment will align with the Board’s intention that a central fill pharmacy prepare and package any prescription medication, regardless of whether it is a new or refill prescription.
- Changes to Final Product Verification Process. The new regulation will allow originating pharmacies to perform final product verification before dispensing and to complete final product verification by viewing images in lieu of performing a physical visual inspection. In addition, the regulation would allow a pharmacist to forego final product verification if the pharmacist performed product verification at the time of stocking the automatic dispensing device, the device is not accessed by pharmacy personnel, and the medication from the automatic dispensing device is dispensed into a labeled container. These changes would allow pharmacies greater flexibility to design efficient central fill workflows while maintaining the accountability framework under which both pharmacies share responsibility for ensuring the order is properly filled.
- Fulfillment of Controlled Substance Prescription Medications through Central Fill. The new regulation will also clarify that central fill pharmacies may process prescription medications for controlled substances. The current regulation is silent on the permissibility of controlled substances, neither authorizing nor prohibiting central fill processing of controlled substance prescription medications. This has led some pharmacies to adopt a cautious and conservative approach to central fill arrangements and to omit the dispensing of controlled substance prescription medications from their workflow.
If these proposed changes to the regulations are finalized, pharmacies seeking to engage in central fill activities in California will need to adhere to these requirements, along with contractual and/or ownership requirements, as well as labeling and record-keeping requirements.
Preparing for Compliance Under California’s Proposed Central Fill Rules
Pharmacies engaging in central fill arrangements should use this rulemaking as a prompt to review and audit their existing central fill arrangements, including contracts, licensure status, site location, labeling practices, patient communications, record retention, final verification workflows, automated dispensing processes, controlled-substance procedures, and the division of responsibilities between central fill and originating pharmacies.
In light of California’s evolving regulatory landscape and the Board’s stated focus on transparency, patient-facing accountability, and increased scrutiny of central fill models for compliance purposes, pharmacies should evaluate whether their current central fill models align with the proposed central fill framework and should seek regulatory counsel where questions remain.
How Frier Levitt Can Help
Frier Levitt’s attorneys are experienced in helping pharmacies structure and implement compliant central fill and shared services arrangements by advising on licensing requirements, contractual relationships, operational workflows, product verification procedures, recordkeeping obligations, and reimbursement considerations. We work with pharmacies to strengthen compliance programs, establish clear lines of responsibility between participating entities, and proactively identify and mitigate legal and regulatory risks before they result in enforcement actions or operational disruptions.
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