PDSA Comments Re: the Effect of Uniform National Policy on Drug Product Tracing and Wholesaler and 3PL Standards
Source: PDSA
The national uniformity of the DSCSA is achieved through preemption of certain state requirements, as set out in Section 585 of the Food, Drug, and Cosmetic Act (FDCA). PDSA appreciates the FDA’s efforts to bring greater clarity to the preemptive effect of Section 585, but is deeply concerned by its characterization of the scope of the DSCSA’s preemptive effect on wholesale distributor and 3PL licensing standards.