Last week the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published their second report on the experience of selected members of the pharma supply chain with the exchange of drug product tracing information as required by the DSCSA. This one was aimed at dispensers. The one published last fall was aimed at wholesale distributors. As you know, starting in January 1, 2015 (delayed until May 1, 2015), pharmaceutical wholesale distributors have been required to pass to their customers for non-exempt prescription drug shipments, and retain for six years, transaction documents (TI, TH and TS). Since July 1, 2015 (delayed until March 1, 2016), dispensers have been required to receive and store these Continue reading DSCSA: OIG Report Exposes Likely Enforcement Approach
The second—and longer—draft guidance document the FDA published on the day of the third DSCSA public meeting is a “catch-all” (see also “DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations” and “FDA DSCSA Public Meeting #3: A Difference?”). It contains lots of diverse recommendations, all related to the standardization of data contained in the DSCSA transaction information (TI), transaction history (TH), and transaction statement (TS). This draft guidance applies to every member of the supply chain, including drug manufacturers, CMOs, 3PLs, wholesale distributors, repackagers and dispensers of all kinds. Everyone should read it and submit comments to the FDA when something isn’t clear enough. Continue reading DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing
I have now read the FDA’s new draft Grandfathering Policy that was published on Monday (see “FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late”) and for the life of me, I can’t figure out why it took two extra years beyond the due date to get it out. Back in September of 2015 I posted an essay that analyzed the options they had in front of them (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”). All they really had to do was chose from a short list of events that could trigger the drug’s transition into the pharmaceutical distribution supply chain at the time of the effective date. They had the following options: Continue reading FDA’s New DSCSA Grandfathering Guidance
It was a very beautiful weekend here in the Chicago area, and consequently I could not bring myself to spend any part of it sitting in front of a computer hammering out a new essay, so for the second week in a row (sorry), here is a re-run of a popular essay from July 14, 2014. I promise to return next week with a brand new essay.
The Drug Supply Chain Security Act (DSCSA) contains record-keeping requirements for drug manufacturers, wholesale distributors, repackagers and dispensers that begin on January 1st, 2015, All companies must keep a copy of the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) they receive and those they send for at least six years. In addition, manufacturers and repackagers must also retain Continue reading Again, A Closer Look At The Six-Year Record-Keeping Requirement
The Healthcare Distribution Management Association (HDMA) had just published another update to their guidance for meeting the U.S. Drug Supply Chain Security Act (DSCSA) using Electronic Data Interchange (EDI) 856 Advance Ship Notice (ASN). In case you thought they already did that a few months ago, you are right. This is an update (July) to the earlier update, and this one is important, so make sure you replace your old copy with this one.
The previous guidance document (see “Just Released – The HDMA EDI ASN Guidance For DSCSA”) was pulled together very quickly to meet the demands of everyone in the supply chain. However, it missed a few critical characteristics, like how to document:
- the identity of the buyer and seller when either differs from the ship-to or ship-from locations;
- when the drugs were originally purchased directly from the manufacturer or exclusive distributor;
- when the seller received a direct purchase statement from their supplier.
The Drug Supply Chain Security Act (DSCSA) contains record-keeping requirements for drug manufacturers, wholesale distributors, repackagers and dispensers that begin on January 1st. All companies must keep a copy of the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) they receive and those they send for at least six years. In addition, manufacturers and repackagers must also retain knowledge about the “product identifier” on each unit they sell into the supply chain for a period of six years after the date it was sold. Companies who perform investigations into suspect product must also keep records of their process and the outcome for six years.
There are a few implications of these record-keeping requirements. Let’s take a look at some of them. Continue reading DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement
About 3 years ago I published an essay called “U.S. Pharma Supply Chain Complexity” where I attempted to provide a more realistic understanding of the U.S. pharma supply chain than the typical supply chain drawing offers. That essay was aimed at helping the industry select an approach to meeting U.S. state pedigree laws, which are now preempted by the Drug Supply Chain Security Act (DSCSA). But, as with many of my older essays, the underlying ideas still have value despite preemption.
In this case, the ideas also provide a clear explanation for why pharma manufacturers should expect to meet the electronic data exchange requirements that are dictated by the large U.S. wholesale distributors, rather than attempting to get them to accept some alternate approach.
So I have copied and pasted that essay below and then edited to serve this new purpose. Continue reading U.S. Pharma Supply Chain Complexity–Revisited
The U.S. FDA held their first industry workshop focusing on the new Federal Drug Supply Chain Security Act (DSCSA) last Thursday and Friday at FDA Headquarters in Silver Spring, MD. The goal of the workshop was to help the FDA collect ideas and preferences from industry stakeholders and technology providers for meeting the January 1, 2015 DSCSA requirement to exchange Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS). The FDA must publish a draft guidance document on the same topic before November 27, 2014, so this workshop, plus the responses to the recent docket, will help them write that draft.
The workshop was held in a large room with eleven big tables, each with about 18 chairs around them. The FDA had Continue reading The 2014 FDA DSCSA Workshop