The FDA published draft guidance earlier this week that might seem a little confusing. The full title is “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. Guidance for Industry”. Because it is in “draft” form, it is published only to encourage people to submit comments about it. (See also, “The Differences Between The DSCSA, FDA Rules and Guidance”.)
You should not treat it as real guidance until it is published in final form sometime in the future (if ever—many draft guidances are left handing in the breeze and never finalized). As with all draft guidances, this one comes with a docket to provide the ability for people to leave comments to help the FDA figure out how to improve it before it becomes final.
The draft covers all of the topics that were contained in the Drug Supply Chain Security Act (DSCSA) Section 204 “NATIONAL STANDARDS FOR PRESCRIPTION DRUG WHOLESALE DISTRIBUTORS”, and Section 205, “NATIONAL STANDARDS FOR THIRD-PARTY LOGISTICS PROVIDERS; UNIFORM NATIONAL POLICY”. Both of these DSCSA sections resulted in updating the Food, Drug and Cosmetics Act (FD&C Act) that establishes the regulatory responsibilities of the FDA. (For more on the DSCSA, see “The Drug Supply Chain Security Act Explained”.)
The draft guidance provides some Q&A aimed at industry and State legislatures and regulators around those sections, including:
- Preemption of State ePedigree, track and trace and serialization laws (see also “Preemption: What Does It Mean?”);
- Licensing of wholesale distributors;
- Licensing of Third-Party Logistics providers (3PLs);
The document is a little comical because so many answers to the questions posed over its five-plus pages repeat the statement from the DSCSA that “…no state may establish or continue in effect any requirements…” regarding the three topics listed above “…that are inconsistent with, more stringent than, or in addition to…”, those found in the DSCSA. There, that’s the whole document summarized in three bullets and one sentence, with the word “comical” thrown in exclusively for your entertainment.
If you’d like to submit a formal comment to the FDA regarding this draft guidance document, do so before December 7, 2014 by going to http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-1411-0001.
If you’d like to submit a comment to me regarding this essay, and my snarky use of words intended exclusively for your entertainment in describing FDA draft guidance, submit it below.