NABP asked, APC answered, and the model act got better

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.