FDA is the subject of a lot of criticism, some deserved, and some not. However, I don’t think FDA gets enough praise when it does something right. Therefore, I thought it was important to follow up on my previous blog and let everyone know that FDA has cleared up some of the ambiguities I mentioned there.
Specifically, on December 9th, FDA issued draft guidance making it clear that federal, and not state, law determines whether a company needs to register with FDA as a wholesale distributor or 3PL as required by the DSCSA. This clarification likely has the greatest impact on prescription drug manufacturers because the DSCSA added an exemption to the scope of activities considered to be wholesale distribution and triggering wholesale distributor licensure obligations under the DSCSA. Under the new definition, a manufacturer distributing its own drugs is no longer considered to be engaging in wholesale distribution.
FDA should be lauded not only for providing this clarification, but for the timing of its release. I am not sure if it was merely a coincidence, but FDA issued this draft guidance the day after the comment period for FDA’s Pre-emption Guidance ended. And by releasing it before the effective date of the reporting requirements for wholesale distributors, manufacturers have one less thing to worry about as they prepare to implement the track and trace requirements that commence on January 1, 2015.
Notwithstanding all of the good to come out of this guidance, there are still many ambiguities it does not address, such as whether states are permitted to require manufacturers to be licensed as wholesale drug distributors come January 1, 2015. Hopefully, now that the comment period for the Pre-emption Guidance has closed, FDA will work diligently to issue final guidance and clarify this and the other remaining ambiguities.
For those entities required to report, I encourage you to review the draft guidance and evaluate whether the requirements it imposes align with the DSCSA. FDA is accepting comments to the Draft Guidance through February 9, 2015. For those who do not have to report, I encourage you to take advantage of the opportunity to spread a little holiday joy and submit comments thanking FDA for providing this clarification in a timely manner.