FDA’s DSCSA Guidance in 2014

iStock_000025908089SmallerWhen Congress penned the Drug Supply Chain Security Act (DSCSA) last year it laid out specific dates and subjects for which it expected the FDA to publish guidance on.  So far in 2014, the FDA has kept up with that schedule by holding a public meeting, publishing multiple draft guidances and setting up a website to collect information from wholesale distributors and third-party logistics providers.

The public meeting was held on May 8th and 9th to collect ideas for the standards that FDA should support for the interoperable exchange of transaction data in paper and electronic form, starting with manufacturers, repackagers and wholesale distributors on January 1, 2015 and dispensers on July 1, 2015 (see “The 2014 FDA DSCSA Workshop“).  During the workshop, the attendees raised a large number of questions they felt needed to be answered.  Those questions went well beyond just the standards necessary to exchange the actual data.  See the RxTrace essay on the workshop for a partial list of those questions.

Not long after the workshop concluded, the FDA published their notes from the workshop.  Those notes included a similar list of questions that the industry provided them.

In June, the FDA published their draft guidance on the identification of suspect product and notifications (see “The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus“).

Then in October, the FDA published a DSCSA-related draft guidance aimed at State regulators and others called “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party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  Guidance for Industry” (see “The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA“).  In this draft guidance, the FDA explained their interpretation of Section 585 of the FD&C Act as modified by the DSCSA as it relates to the split between state and federal regulation of the pharma supply chain.

In November the agency published the much anticipated draft guidance on standards for the interoperable exchange of DSCSA transaction data (see “FDA Publishes Draft Guidance For DSCSA Data Exchange“).

Finally, just last week the FDA published draft guidance on wholesale distributor and 3PL licensing (see “FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting“).

All of the guidances are in draft form, which means they are technically not final and should not be treated as “official” until the FDA can collect stakeholder and public input and then publish the final versions.  All of these guidances have associated dockets that the FDA uses to collect that input.

Dockets are only held open for a few months after the draft is published so those associated with the earlier documents are now closed, but I understand that the FDA will still accept your comments.  If past performance can be used as an indicator of future performance, the FDA is not likely to publish the final versions of any of these guidances for quite a while yet.

Click on the image to enlarge.
Click on the image to enlarge.

With the publication of this most recent draft guidance, the FDA has fulfilled their DSCSA requirements for 2014.  Here is another look at the FDA’s DSCSA implementation timeline.  Notice that the next deadlines do not occur until November 27, 2015.  By that date, the FDA must:

  • Develop regulations establishing standards for licensing of wholesale distributors
  • Develop regulations establishing standards for licensing of third-party logistics providers
  • Publish guidance on processes for waivers, exceptions and exemptions
  • Publish final guidance on grandfathering product.

The FDA timeline also indicates that they could begin to hold the required minimum of five topical public meetings specified by Congress after January 1, 2015.  Technically, the law allowed them to begin holding the first of those meetings after the one-year anniversary of the law, but, of course, December is no time to hold such an important meeting.  This date only marks the earliest time Congress allowed the FDA to hold these meetings and they must hold all five of them by the middle of 2021.

I’m betting the FDA will hold at least one of these meetings sometime in 2015.  If so, be on the lookout for the notice and be ready to react fast if you want to attend, because FDA public meetings for track and trace always fill up fast.  They will cut off registrations, and they typically limit the number of attendees per company so be ready to pick who is most appropriate from your company to attend.

Also after January 1, 2015 the FDA will hold at least one industry pilot, but I do not think that will get started in 2015.  Maybe 2016 or even 2017.


In all of the draft guidances published by the FDA for the DSCSA this year, the authors have stuck very closely to the letter of the law.  This limits their usefulness because everyone can read the DSCSA.  What is really needed are answers to the questions people have that go well beyond simply regurgitating the text of the law (see “DSCSA: Many Questions, Few Answers“).

A common complaint after the FDA’s DSCSA workshop in May was that people did not learn anything of substance.  That was intentional.  The workshop and the dockets associated with the draft guidances have one thing in common:  they are designed for the FDA to collect your input.  That is, they are intentionally structured so that the information goes one-way–from you to the FDA.  Only the guidance documents are intended to convey information in the opposite direction, and they are intended to provide the same information to everyone at the same time, thus maintaining a level playing field for all.

This is also why you do not learn much from the public speaking appearances by FDA officials.  They cannot provide any new guidance in a public or semi-public appearance with a limited audience (like at an HDMA or GS1 US event) because providing new information at such an event would not be fair to anyone who does not–or cannot–attend.  Of course, sometimes the FDA speakers provide information inadvertently–sometimes by what is not said (see “Will The DSCSA Cause Drug Shortages After January 1?“).

Keep in mind, however, that the passage of the DSCSA represents the first time the FDA really needs to understand the operation of the supply chain.  As far as I know, they have not had anyone on staff with a supply chain background.  It must be really hard to develop standards, rules and guidance for a supply chain as complex as the U.S. pharma supply chain without having some expertise in that area.  I hope the FDA has either begun to employ people with a supply chain background, or engaged at least one consultant with that background.


If you have not yet taken the RxTrace 2015 U.S. Pharma Traceability Survey, sponsored by Frequentz, make sure you do before the year ends!  Click here to take the survey.  Make sure you are counted.  Watch for results of this year’s survey in January.