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.
Are you a pharmaceutical manufacturer who is acting as a wholesale distributor, as defined by the U.S. Drug Supply Chain Security Act (DSCSA), for some of your products? This might occur if you are buying pre-packaged drugs from the New Drug Application (NDA)-holder or Abbreviated New Drug Application (ANDA)-holder and offering them for sale to U.S. wholesale distributors. If you cannot justifiably fit into the DSCSA definitions of either a “co-licensed partner”, or an “exclusive distributor” for those drugs, you might as well remove them from your catalog because the “Big-3” wholesale distributors—AmerisourceBergen, Cardinal Health and McKesson—probably will not be willing to buy them anymore as of next January.
That’s because the DSCSA, which begins to take effect at that time, will most likely consider you as a Read the rest of this 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. 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. Read the rest of this essay »
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Thanks for reading, and thanks for helping to make RxTrace a better resource. Read the rest of this essay »
Last Friday was the five year anniversary of RxTrace and this is the 255th essay. I started RxTrace on July 4, 2009 as an outlet for ideas (see my very first essay, “Welcome to rxTrace”). The results of the last five years have been very rewarding.
Rather than looking back this year, let’s look to the future. What is coming next?
I always maintain a fairly informal RxTrace list of ideas I want to explore when I get the chance. With the switch in attention from the California pedigree law to the new Federal Drug Supply Chain Security Act (DSCSA) in the last year, my list grew pretty long and continues to grow. Here is a list of things I’ve been thinking about and may end up exploring in full RxTrace essays in the coming twelve months: Read the rest of this essay »
Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain. Let me explain.
The text of the Drug Supply Chain Security Act (DSCSA) was developed last year by Congressional staff in consultation/negotiation with various lobbying organizations—primarily the Prescription Drug Security Alliance (PDSA). The effect of the legislation is to create a way of protecting the U.S. pharmaceutical supply chain that relies primarily on product identifier authentication (PIA) (see “Product Identifier Authentication” and “The Aggregation Hoax and PIA”) for at least the first 10 years and possibly beyond. Read the rest of this essay »
The FDA published the draft guidance on the identification of suspect product and notification of suspect and illegitimate product on June 11 as mandated by Congress in the Drug Supply Chain Security Act (DSCSA). The document provides helpful suggestions for those who wish to reduce the risk that they will unknowingly acquire illegitimate product through increased vigilance. The suggestions are based on the experience the FDA has gained in their investigations over the years of many situations where companies have been duped by criminals into purchasing drugs that turned out to be counterfeit, diverted, stolen, adulterated, or otherwise unfit for consumption. No legitimate company wants to be a party to buying, selling or dispensing to patients that kind of product, so Read the rest of this essay »
In my last essay I touched on the use of Product Identifier Authentication, or PIA, as an alternative to the collection and distribution of aggregation data to allow wholesale distributors and repackagers to meet the verification requirements of the Drug Supply Chain Security Act (DSCSA). Starting in November of 2018 for repackagers and in November of 2019 for wholesalers, the DSCSA will require these companies to verify that the standardized numerical identifier (SNI)—commonly referred to as “the serial number”—corresponds with one that the manufacturer originally applied to drugs that are found to be suspect, and for any returned drug that will be resold.
As I pointed out in my previous essay (see “The Aggregation Hoax and PIA”), manufacturers and repackagers may be able to choose to pass on aggregation information that would allow wholesale distributors to meet their requirements, or they might choose to offer a PIA service that would allow these companies to check the authenticity of one or more SNIs via a web service. Read the rest of this essay »