Senate committee approves pharmacy rule rewrite after compounding debate; removes two compounding subsections

The Senate Health and Welfare Committee on Tuesday approved a pending rule chapter from the Idaho State Board of Pharmacy that rewrites more than 35 sections of the board's rules, but the committee struck two subsections of a compounding labeling provision after stakeholder concerns.

The board presented docket 24-3601-2402 and asked the committee to adopt the pending rules as final. Nikki Chopsky, bureau chief of health professions for the Division of Occupational and Professional Licenses and executive officer for the Idaho State Board of Pharmacy, told the committee the rewrite moves duplicative material into statute and reorganizes the chapter by authority, scope, definitions, licensure, practice standards, discipline, fees, compounding and prescription drug monitoring.

"The board took a comprehensive review of its rules and made more than 35 changes to this chapter," Chopsky said. She told senators the rewrite removes duplicated statutory language, combines scattered definitions, adopts a standard-of-care approach in several areas and relocates fee tables into a single rule.

The rewrite also changes several substance-specific items: biennial intern renewal, elimination of a separate certified technician track, and replacement of an annual inventory requirement with a biannual inventory. Chopsky said the board updated controlled-substance reporting to require submission by the end of the business day and revised compounding sections to adopt clearer terminology and a standard-of-care approach.

Committee discussion focused on a compounding labeling provision that stakeholders raised late in the rule process. Senator Fred Lenny pressed staff on whether Idaho's labeling rule could limit access or raise costs because the U.S. Food and Drug Administration had issued draft guidance about distribution and labeling of compounded products but had not finalized that guidance. "So it seems like Idaho is the teacher saying, I know the principal said we can have snacks on campus, but we're going to enforce this no snack rule," Lenny said, using an analogy to question whether Idaho's rule could be more restrictive than federal practice.

Chopsky said the board was cautious about incorporating a federal draft guidance by reference. "The draft guidance document of the FDA is clearly marked draft, not for implementation and contains non binding recommendations," she said, and added that the board preferred to keep Idaho's statutory and rule framework and work with stakeholders on a solution if federal rules change.

Senator Lenny offered a substitute motion to approve the pending pharmacy docket while striking subsection 214 E.i and 214 E.ii (the redistributed-compounded-product labeling subsections). After a roll-call, the motion to remove those subsections passed on a 7-2 tally.

The committee earlier took no action on the temporary rule docket (24-3601-2401) that had been published after House Bill 527 moved sections of practice into statute. Chopsky said the temporary rules were allowed to expire because stakeholder feedback asked the board to remove an "incomplete list" that lacked enforceability; the board incorporated the feedback into the pending docket instead.

The approved pending chapter will take effect consistent with rule-adoption procedures unless further legislative action is taken. Chopsky said the board engaged broadly: five open public meetings, two negotiated rulemaking hearings and one public hearing, with participation from Idaho's two pharmacy associations, industry stakeholders, the Idaho Medical Association and several payers.

The committee did not adopt any new statutory language; it approved the board's pending rule chapter as revised and removed the two contested subsections.

Votes at a glance

- Motion to take no action on temporary docket 24-3601-2401: passed (voice vote). - Motion to approve pending docket 24-3601-2402 with strike of subsections 214 E.i and 214 E.ii: passed (yeas 7; nays 2).