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
NOTICE: The HDMA has updated this guideline again only a few months after this essay was published. Please see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again” for additional information. — Dirk.
The Healthcare Distribution Management Association (HDMA) has just published their much anticipated new guidance on applying the Electronic Data Interchange (EDI) 856 Advance Ship Notice (ASN) transaction set toward compliance with the new U.S. Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA). HDMA members and non-members can download a copy of the new document here. Make sure you look for “HDMA Electronic Data Interchange (EDI) Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA“. (See the image to the right.)
The new guidance is voluntary, like all HDMA guidance (see “GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance” and “Updated HDMA Bar Code Guidance: A Must Read“), but companies who Continue reading Just Released – The HDMA EDI ASN Guidance For DSCSA
This is the third in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January. The previous essays in this series include DSCSA Transaction Information (TI) and DSCSA Transaction History (TH). The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines Transaction Statement (TS) this way:
“(27) TRANSACTION STATEMENT.—
The ‘transaction statement’ is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—