Despite vocal opposition from Novo Nordisk, the Iowa Board of Pharmacy passed what was essentially a major rewrite of the state’s pharmacy regulations, notably including language related to compounding and 503B sourcing for 503As.
Novo tried to argue that the proposed state rules conflicted with federal law governing 503B outsourcing facilities. According to Novo (but not to reality), federal law only allows 503B compounded drugs to be dispensed to medical offices — that they had to be labeled “office use only” and couldn’t be resold or distributed. Iowa’s rule, they said, would remove these restrictions and redefine “office use” to allow pharmacies or hospitals to send those drugs home with patients, a change they believe was never intended by Congress. (In fact, FDA draft guidance suggested there was definitely a path toward allowing pharmacies or hospitals to send such drugs home with patients.)
Luckily, thanks to a lot of hard work by Aaron McDonough of Towncrest Pharmacy, Adam Jones from University of Iowa Hospitals, and Brett Barker (a current Iowa state representative, former board of pharmacy member, and former Iowa Pharmacy Association staff member), the Iowa board saw past Novo’s hyperbole and sky-is-falling rhetoric. On August 11 it passed the new regulations 10-0.
This is why we work so hard to support pharmacist candidates for public office. Having someone like Barker in our corner made a huge difference with the Iowa BoP — it was a perfect example of how the right person with the right creds in the right place can dispel incorrect information and keep elected officials from falling for pharma’s tall tales.