The March 26 California State Board of Pharmacy Enforcement and Compounding Committee meeting focused on the latest iteration of the drafted regulations (Attachment 7 from above link) for third-party logistics providers.
Executive Officer Giny Herold, briefly reviewed the draft proposal. As there was no quorum in attendance, the committee took no action. Herold indicated that this was an early draft and not ready for final adoption.
IWLA Washington Representative Pat O’Connor and John Spence, UPS, attended. The committee did discuss the role of the 3PL in the supply chain. O’Connor invited the committee to make a site visit to a 3PL to better understand this unique role.
O’Connor also raised the most pressing issue: many of the provisions in the proposed rule are subject to federal preemption under section 585 (b) of Drug Supply Chain Security Act (DSCSA). The DSCSA’s objective was to replace the current patchwork of state laws with uniform national standards that improve safety, eliminate duplicative regulation, and create certainty and predictability.
Herold challenged the claim that the DSCSA preempted California. She referenced the October 2014 Food and Drug Administration guidance that says the federal standards are a floor not a ceiling, “Thus, states may not impose standards, requirements, or regulations with respect to 3PLs that fall below the minimum standards established by Federal law.” She also said that the October guidance gives the states more enforcement authority over 3PLs than it does for wholesalers.
IWLA and others have challenged FDA’s position in the October guidance document.
To support the board’s contention that 3PLs needed to be regulated, a board inspector advised the committee that she had inspected a 3PL and that security procedures and safe handling conditions were lacking. The feeling was that final action on the proposed regulations would likely come after FDA issues the licensing standards.
IWLA’s representative vocalized the association’s disagreement with the board – as they have since the beginning stages of this proposed ruling on 3PLs. IWLA will continue to do so throughout the process. Stay tuned for updates.