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Committee backs 90‑day notice for outsourcing facilities that cease operations in California
Summary
The California State Board of Pharmacy licensing committee recommended the full board pursue rulemaking to require registered outsourcing facilities to provide 90 days' advanced notice before ceasing operations in California, to help preserve continuity of care; staff will also explore whether product discontinuances should be covered.
The California State Board of Pharmacy licensing committee on June 11 recommended that the full board initiate rulemaking to require registered outsourcing facilities to provide 90 days' advanced notice before discontinuing business operations in California.
Chair S. Oo framed the proposal as a step to protect patients and downstream health‑care providers who rely on outsourced sterile and compounded products. Committee members and staff discussed whether the regulation should also address closures that occur as a result of disciplinary action and whether notice should cover discontinuance of a specific product in addition to business closure.
Public commenters and technical experts urged a longer or at least federally consistent notice period. One commenter pointed to FDA and manufacturer precedents and recommended the rule also cover product discontinuations, saying: "I strongly recommend that you change this regulation to say not only when they're going out of business, but when they're going to discontinue a product." (Stephen, public commenter)
Committee member Claudia Marcato and others pressed staff on how much time downstream customers need to pivot to alternative suppliers. After discussion, the committee signaled agreement to recommend a 90‑day notice period as the working proposal and asked staff to refine the draft regulatory language and return it to the full board for initiation of formal rulemaking. Chair S. Oo said staff will also evaluate whether and how product discontinuances could be incorporated into future drafts.
Staff and counsel noted disciplinary closures raise separate issues because disciplinary orders often contain continuity‑of‑care provisions; the committee asked staff to review model disciplinary language and identify any statutory or regulatory gaps. The committee did not adopt final regulatory text at the meeting; instead members directed staff to prepare a full rulemaking package reflecting the 90‑day approach for the board's consideration.
What happens next: Staff will revise the draft rule to reflect the committee discussion, evaluate the product‑discontinuance question and any disciplinary‑order implications, and present a rulemaking package to the full board. The committee’s recommendation is advisory and the full board will vote on whether to initiate formal rulemaking.
