June 23, 2023
Nevada authorizes 503Bs to sell compounded drugs to 503As
Nevada SB 161 has been signed into law by the governor and contains provisions that affect 503B outsourcing facilities:
Any entity authorized to dispense controlled substances and dangerous drugs (including a pharmacy) may purchase controlled substances and dangerous drugs compounded or repackaged by a 503B outsourcing facility directly from the outsourcing facility without an order from a practitioner and dispense them to the same extent as any acquired through other authorized means.
This is a pivot by the state, says APC’s Scott Brunner. “Nevada previously was one of the only states to explicitly prohibit in law a 503B outsourcing facility wholesaling compounded medications to 503A pharmacies. Now the state has explicitly authorized it. This syncs well with the model that FDA implemented via guidance document related to ibuprofen suspension in February 2023, and it may be a sign of things to come with continued adoption of this standard going forward. If so, it’s a positive step in strengthening the 503B model.”
