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Board approves updated self‑assessment forms for ADDS, compounding and outsourcing; motions pass unanimously
Summary
The California State Board of Pharmacy on June 24 approved updated self‑assessment forms for automated drug delivery systems (ADDS), compounding, and outsourcing facilities, delegating final non‑substantive edits to committee chairs; each motion passed with recorded unanimous 'yes' votes.
The California State Board of Pharmacy approved three updated self‑assessment forms on June 24 aimed at clarifying compliance expectations for automated drug delivery systems (ADDS), compounding operations and outsourcing facilities.
Chair Maria Serpa presented changes to the ADDS form, noting updated formatting and a plan to solicit subscriber feedback before broad release. The board moved to approve the updated ADDS self‑assessment form and delegated to the chair the authority to incorporate non‑substantive changes and staff suggestions. Renee Barker seconded the motion. President S O called the roll and recorded unanimous yes votes from members present; the motion passed.
The board then considered updates to the compounding self‑assessment form. Members identified technical edits — for example correcting an ISO classification from '9' to '8' — and moved to approve the revised compounding form with the same delegation to the chair to finalize non‑substantive edits. The motion passed on a unanimous recorded vote.
Finally, the board reviewed a new outsourcing facility self‑assessment form. Members requested two clarifications added after public comment: an explicit cross‑reference that federal current Good Manufacturing Practice (CGMP) requirements referenced in the form should be interpreted as applying to outsourcing facilities, and a footnote directing readers to relevant FDA guidance documents. Public commenters representing non‑resident 503B outsourcing facilities welcomed the clarification and suggested recognizing other evolving industry guidance. The board approved the outsourcing facility form, again delegating final non‑substantive edits to the chair; the motion recorded unanimous yes votes.
Taken together, the approvals streamline the board’s self‑assessment tools across facility types and aim to align state forms with federal CGMP expectations where relevant. Staff will issue subscriber alerts and post updated forms once the chair completes delegated edits.
