Representatives from RXTransparent had an opportunity to attend the October 17th to October  -19th Healthcare Distributors Alliance (HDA) Traceability Seminar in DC, and as a result, we wanted to summarize our findings and insights from the perspective of healthcare providers and drug dispensers.

FDA Update

RXTransparent had an opportunity to speak to Captain Connie Jung RPh, PhD (Associate Director; Office of Drug Security, Integrity, & Recalls, U.S. Food and Drug Administration) about specific dispenser DSCSA issues.  We discussed resalable returns, and dispenser to dispenser (pharmacy to pharmacy) drug product borrow, loan, trading, selling and returning practices.

  • FDA would like to see the dispenser community migrate to sales transactions in lieu of borrow, loan, and or barter transactions.
  • FDA would like the dispenser community to be more rigorous in providing pedigree documentation for any situation involving the transfer of drug products and would like to discourage temporary loaning of any drug product based on anticipated patient need.

Dr. Ilisa Bernstein, PharmD Deputy Director, Office of Compliance Food and Drug Administration presented to the assembled audience and made some significant statements.  Her first statement was that there will be, “No Extensions” to the DSCSA timeline.  Dr. Berstein stated that she is a triathlete and that we will get to the finish line of the DSCSA race if we have to run, walk or crawl.  She likened the industry situation to that of an ironman distance triathlon where the industry is at mile 66 of the 110-mile bike race with a marathon still to go.  Dr. Bernstein reviewed existing fundamentals of the Act and focused on the importance of utilizing Form 3911, and its process, for reporting and ending a suspect or illegitimate drug product after an investigation.    She also emphasized the timing of the process (24 hours).  Finally,  Dr. Bernstein  stated that FDA will be further focusing on registering wholesale distributors as well as beginning the era of enforcement for DSCSA.

DSCSA Enforcement

From an enforcement perspective FDA divulged one of the first DSCSA sanctions which was filed against McKesson Corporation.  As expected, RXTransparent predicted that FDA would use the 483 processes (the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.)  Specific issues outlined in the 483 includes:

“Transaction data for prescription drug purchases from the firm show that lot/batch numbers are not captured/retained; as such the firm does not have sufficient processes in place to determine and notify, within 24 hours, all the immediate trading partners that the firm had reason to believe may have received illegitimate product,”   McKesson produced over 10,000 pages of pedigrees and documentation to comply with this investigation by FDA.

The following is a link to the 483 Warning Letter:.      

HDA Looking for Input from Healthcare

Up until know HDA’s membership has been comprised of mostly pharmaceutical manufacturers and pharmaceutical wholesalers and been what we would consider and boxes and barcodes type of organization but know with requirements for US DSCSA halfway complete it is essential for healthcare to be represented within this industry consortium.  Over the next few months, RXTransparent will be reaching out to our GPO partners and customers to actively invite them into the HDA member community in an effort to round out the voices in the room.