Key Product Tracing Provisions of Drug Supply Chain Security Act

FDA Issues Draft Guidance on Key Product Tracing Provisions of Drug Supply Chain Security Act

By Michael Johnsen as published in Drug Store News


ARLINGTON, Va. — The Food and Drug Administration recently issued draft guidance on key product tracing provisions of the Drug Supply Chain Security Act, which is expected to be implemented by industry by Jan. 1, 2015. 


According to the guidance, trading partners can utilize current paper-based or electronic-based methods for the interoperable exchange of data to provide product tracing information to subsequent purchasers. Such methods could include, but are not limited to, the use of:

  • Paper or electronic versions of invoices;
  • Paper versions of packing slips;
  • Electronic Data Interchange standards, such as 856 Advance Ship Notice (ASN), which is currently used to provide the receiving entity with advance data on shipments; and
  • EPCIS, or Electronic Product Code Information Services, which defines a data-sharing interface that enables supply chain partners to capture and communicate data about the movement and status of objects in the supply chain.
Dave's Corner

Posted Nov. 30, 2014

David Mayper Executive Director PFOA

Greetings PFOA Members:


November brought trips for me to California and to North Carolina. The rest of the month I focused on administrative and strategic projects. PFOA continues to make progress on many fronts.


We participated in NCPA’s annual meeting in October and have been following up on new vendors and other opportunities.


We held at the end of the month a board member webcast and phone conference. We have committed to a board meeting and staff meeting in January as well as to scheduling our annual member meetings in Las Vegas surrounding the vendor meetings of ABC and Cardinal Health. The board approved a draft outline for a business plan for 2015. We also had a lengthy discussion on concerns over product price increases. This led to a special board meeting the following week exploring options on what PFOA will do to improve information for its membership.


We are in the midst of discussion with ABC about our present contract terms and will additionally review available market options to keep our members market competitive.

Guaranteed Returns, its Owner, and two Employees Charged in Multi-Million-Dollar Fraud Scheme

Although this returns company is not on our approved vendor list, PFOA feels it is important news to pass along if your store is using this company.


According to an article published by The U.S. Attorney’s office, Devos Ltd., doing business as Guaranteed Returns (“Guaranteed Returns”), in Holbrook, NY, its Chief Executive Officer, Dean Volkes, and two others were charged by indictment in a multi-million dollar scheme to defraud customers, including the government.


The indictment alleges that more than $116 million worth of drug products had been returned for refund and more than $14 million of those drugs belonged to federal government agencies, including the Department of Defense and the Veterans Administration. Other victims include numerous hospitals, pharmacies, and long-term care facilities.


To read the full story, click on the link


NCPA Requests Pharmacists’ Assistance

We have recently received communication from Michael Rule, Associate Director, Public Affairs and Grassroots Advocacy at NCPA. He is requesting input from our pharmacists regarding price increases on generic medications.

Senator Bernie Sanders (I-VT) and Representative Elijah Cummings (D-MD) are leading a bicameral investigation into price spikes for generic medications to determine the cause of these dramatic price increases and the effect they have on patients. They have requested NCPA assistance in gathering examples from patients and pharmacists in how these price increases have impacted patient care, such as are these price increases forcing patients into the Medicare donut hole sooner or are they forcing patients to forgo their medication altogether. 

Please call or email Michael Tomberlin at 571-882-3308 and  This e-mail address is being protected from spambots. You need JavaScript enabled to view it if you have examples you would like to share. 

Thank you. 

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