By Andrew J. Hull* & William T. Koustas –
FDA has published its second draft guidance in a much-awaited series of industry guidance documents related to the implementation of the Drug Supply Chain Security Act ("DSCSA"), enacted on November 27, 2013. (We posted on the first draft guidance issued in June 2014 here.) The draft guidance, entitled “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers” (hereinafter "Draft Guidance"), addresses the effect of DSCSA preemption provisions on state track and trace (i.e., pedigree) laws as well as on state wholesaler distributor and third-party logistics provider ("3PL") license requirements.
The Draft Guidance confirms the following: State pedigree laws are preempted, and DSCSA track and trace provisions prevail as of January 1, 2015. State licensing requirements continue as is, provided they meet the minimum standards required by federal law. The Draft Guidance does not address directly those states that do not currently license 3PLs at all.
Regarding the new federal track and trace requirements in the DSCSA, the Draft Guidance clarifies that all state requirements for tracing drugs that are “inconsistent with, more stringent than, or in addition to any requirements” contained in the federal law are preempted. Draft Guidance at 3. Essentially, state pedigree laws, to the extent they exist, must conform exactly to federal law, including any waiver, exception, or exemption under sections 581 and 582 of the FD&C Act. Since DSCSA preemption provisions became effective upon enactment, the Draft Guidance indicates that the drug pedigree provisions of the Prescription Drug Marketing Act of 1987 ("PDMA") preempted state pedigree laws as of November 2013. PDMA pedigree requirements (as discussed in prior blog posts here and here) remain in effect until the new DSCSA track and trace provisions take effect on January 1, 2015.
With respect to the licensing of wholesale drug distributors, the Draft Guidance indicates that the DSCSA will preempt state licensing standards and requirements that are “inconsistent with, less stringent than, directly related to, or covered” by those required by federal law. Id. at 5. Because the new wholesale drug distributor regulations will not take effect until two years after they are finalized by FDA (notice of these regulations has yet to be made), states will continue to license wholesalers under their current standards as long as their regulations are “not inconsistent with, less stringent than, directly related to, or covered by” the PDMA. Id.
The DSCSA also preempts state licensing of 3PLs according to the same preemption standard as applied to wholesale drug distributors (i.e., meet minimum requirements). However, as is clear from the statute, the Draft Guidance notes that, while states license 3PLs, they cannot license 3PLs as wholesale drug distributors.
*Not admitted in D.C.