While you were sitting in traffic, making pie crust, or absorbing the menu and vending labeling rules…
FDA Opens Portal For Wholesale Distributor and 3PL Reporting
At OFW Law, we hope you all had a terrific Thanksgiving. (If you followed the advice of our food safety expert, Dr. Barb Masters, there should not have been any unwelcome microbial problems, either!)
As we reported on Wednesday, FDA came in under the wire with the release of its Drug Supply Chain Security Act (DSCSA) Standards Draft Guidance. However, unless you were haunting the FDA website, you would have missed another, very important DSCSA update that appeared with no fanfare on Wednesday afternoon.
FDA added an option in the CDER Direct Electronic Submissions Portal and updated its DSCSA webpage with information on wholesale distributor and third-party logistics provider (3PL) annual reporting. The DSCSA requires that wholesale distributors and 3PLs make an annual report to FDA with facility and State licensure information. Reporting for wholesale distributors begins on January 1, 2015. The issue of reporting for 3PLs was becoming especially urgent as it was to begin last Friday, on November 27, the anniversary of the DSCSA.
The CDER Direct Electronic Submissions Portal provides a tutorial for wholesalers and 3PLs in a .pdf format, which you can find in a drop down menu on the right of the portal page. We’ve noticed some difficulty downloading the tutorial from different browsers, so we’ve provided a copy of the file here.
Reviewing the tutorial and webpages, we did have some questions and concerns.
- Although reporting of a suspended or revoked license is clear enough, what is meant by “other” disciplinary action?
- The submission process could prove cumbersome for larger operations if the interface does not allow for entry from a single facility screen of multiple (which could be dozens of) State licenses and numbers.
- How long do facilities have to register? Obviously, latitude and flexibility by the agency will be necessary as facilities storm the CDER portal to make their submissions, some of which will be very large. Any problems reporters have with the actual interface should be reported to FDA.
- More publicity of this important update would be very welcome.
- New §503(e)(2)(B) requires FDA to establish by January 1, 2015, a public, searchable database that identifies each authorized wholesale distributor by name, including contact information and each State where the wholesale distributor is licensed. FDA states it will provide this information “in the future.”
The February 2014 CDER Annual Guidance Agenda had stated that the agency intends to issue a Guidance on Reporting Licensure by Wholesale Drug Distributor and Third-Party Logistic Providers. Some questions might be answered if, and when, that Guidance issues.
With steps 1-5 of FDA’s DSCSA implementation plan complete, FDA’s focus may shift to national licensure standards for wholesale distributors and 3PLs, with proposed rules slated to be issued in March 2015. The agency has done a terrific job in meeting these official milestones so far; our holiday wish list includes a hope that the pace continues and that the agency finds time to address some of the significant DSCSA questions and concerns that stakeholders have posed.
