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Senate committee approves Idaho Board of Pharmacy pending rules after striking compounding labeling subsections
Summary
The Senate Health and Welfare Committee approved the Idaho State Board of Pharmacypending rule docket but voted to remove two labeling subsections that had prompted stakeholder concerns about compounding and federal guidance.
The Senate Health and Welfare Committee on Tuesday approved the Idaho State Board of Pharmacypending rule docket (docket 24-3601-2402) after removing two subsections of a labeling provision that had drawn late stakeholder concerns over compounded drugs.
Nikki Chopsky, bureau chief of health professions at the Division of Occupational and Professional Licenses and executive officer for the Idaho State Board of Pharmacy, told the committee the board had conducted five public meetings, two negotiated rule-making sessions and a public hearing before finalizing the pending rule chapter. Chopsky said the board consolidated more than 35 changes to the chapter to remove duplication with statute and move certain provisions into the pharmacy practice act following passage of House Bill 527.
Committee members first voted to take no action on an earlier temporary rule docket (24-3601-2401). During discussion of the pending docket, Senator Lenny moved to approve docket 24-3601-2402 while striking sections 214(e)(i) and 214(e)(ii) (the transcript refers to these as E, I and II). Senator Seiderfield seconded the motion. The committee adopted the substitute strike on a roll-call vote, 7-2, and then approved the pending rule chapter with that exception.
The contested language concerns labeling for distribution of compounded products; Chopsky said the provision (old rule 40605, now new rule 214(e)) mirrors federal labeling requirements historically reviewed by the legislature since 2015. Several stakeholders who contacted the board late in the process referenced an FDA draft guidance from June 2023 that the federal government has not finalized. Chopsky told the committee the board was unwilling to incorporate a draft FDA guidance by reference and noted legal uncertainty nationwide over early adoption of federal draft guidance into state rules.
Senator Lenny summarized concerns over potential access and cost effects if Idaho enforces labeling more strictly than evolving federal practice, saying, "It seems like Idaho is the teacher saying, I know this the principal said we can have snacks on campus, but we're gonna enforce this no snack rule." Chopsky agreed the analogy was apt and said the board preferred to follow a deliberate rulemaking process and to work with stakeholders on solutions.
Senator Wintrow emphasized safety when asking about compounding risks, and Chopsky described two categories of compounders: FDA-registered manufacturers (503(b)) and pharmacy compounders (503(a)), noting different standards and oversight across the spectrum. She said the board believes compounding can be done safely but acknowledged the marketplace includes a range of practices.
The committee recorded no further amendments to the pending chapter. The pending rule will be filed as approved by the Legislature with the two subsections removed from the labeling provision; the temporary rule docket was left to expire.
