According to the most recent federal decision on the topic, state regulations of outsourcing facilities are not preempted by federal law. And therefore, facilities should comply with both.
The state-preemption challenge was brought by a federally-registered outsourcing facility against California on a ground that it denied its application under certain pharmacy-related regulations. Namely, a California regulation prohibits outsourcing facilities from operating under the same address as a registered pharmacy. This facility was attempting to do just that.
In the complaint, the outsourcing facility argued that California pharmacy rules do not extend to federally registered outsourcing facilities because Congress did not intend state laws to apply. The facility also argued that California rules pertaining to outsourcing facilities conflict with the federal law and impermissibly interfere with interstate commerce.
California Federal District court judge disagreed holding that section 503B does not contain express preemption of state regulations of outsourcing facilities. It also found that (1) regulations pertaining to outsourcing facilities were not meant to be solely dominated by federal law; (2) state and federal law do not contradict each other; and (3) state laws do not materially impact interstate commerce. In addition, the court decided that the facility failed to exhaust administrative remedies as required by California law (meaning that the facility should have gone through an administrative process prior to bringing this action).
For more information see: Fusion IV Pharm., Inc. v. Becerra, No. CV 18-2561 PA (FFMX), 2018 WL 6137606, at *1 (C.D. Cal. July 16, 2018)