Two years ago, NABP asked APC to weigh in on proposed compounding provisions for its Model State Pharmacy Act and Model Rules. We did — agreeing sometimes, pushing back other times.
This month, NABP published the updated model, and a lot of our fingerprints are on it. Annual self-inspections can now stand in for a yearly Board inspection at sterile compounding facilities. "Serious adverse drug experience" are specifically defined, substantially along the lines APC recommended. Delivery rules now focus on what pharmacies can actually control — temperature and instructions — not how patients store medication once it's in their hands.
A few other updates reflect that same thoughtfulness. On the veterinary side, several provisions now give more weight to pharmacist and prescriber professional judgment, permit office-stock preparations for administration or dispensing, and align more closely with FDA's bulk-substances framework. The rule also swapped in "prescription labeling" for the FDA adverse-event statement, aligning with a distinction APC had flagged between federal labeling requirements and the physical container label. The biggest shift may be this one: it removed provisions tying the Model Act to FDA's still-unresolved compounding MOU and its own interstate reporting network.
NABP didn't take every recommendation we offered, and that's a normal part of any real review process. We're grateful NABP asked for our input, and just as grateful they took it seriously once we gave it.