Tag Archives: wholesaler

DSCSA, Grandfathering

Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again

Grandfather clockThis week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids.  Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA.  Here it is again.

Regulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet.  When allowed, grandfathering allows Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again →

DSCSA, Grandfathering

Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?

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Grandfather clockRegulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet.  When allowed, grandfathering allows a company to continue doing something after a regulatory deadline that mandates a change, as long as one or more pre-conditions apply.  For example, Section 582(a)(5)(B) of the Drug Supply Chain Security Act (DSCSA) allows wholesale distributors, and repackagers to sell drugs that were already within the supply chain on January 1, 2015 without passing the necessary transaction data.  This makes sense because companies were not obligated to supply that data before that date and so some of the assertions required in the Transaction Statement would not be true (among other problems that grandfathering eliminates).  [Of course, Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? →

DSCSA Product Identifier, serialization

InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA

Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.
Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.

The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers).  These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).

A common question is, what is the smallest level of packaging that must be serialized?.  The DSCSA text provides the answer. Continue reading InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA →

DSCSA

3PL Operation Under The DSCSA

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Distribution_centre
Photo from Wikipedia

Another type of business affected by the U.S. Drug Supply Chain Security Act (DSCSA) is the third party logistics provider (3PL) business.

I wrote an RxTrace essay about the impact of the California pedigree law on 3PLs back in 2013 (see “3PL Operation Under California ePedigree“).  This is an update of that essay to address the impacts of the new DSCSA on 3PLs since the California pedigree law is now obsolete.

There are a number of important differences between wholesale distributors and 3PLs as defined in the DSCSA. Continue reading 3PL Operation Under The DSCSA →

HDMA

InBrief: HDMA Updates DSCSA Q&A

HDMA LogoThe Healthcare Distribution Management Association (HDMA) recently updated their “HDMA Qs and As on the Drug Supply Chain Security Act (DSCSA)” to version 2.0.  This is a very well thought through document that will help companies understand how wholesale distributors are interpreting confusing or ambiguous sections of the law.  The document leans heavily toward questions about how wholesale distributors will need to react in various situations, but it will also be a resource that manufacturers, repackagers and dispensers will want to obtain and review.  What is really needed is for someone to do the same kind of analysis for questions that mainly affect those other supply chain entities.   Continue reading InBrief: HDMA Updates DSCSA Q&A →

Aggregation

When Will The DSCSA Ever Require Investments In Aggregation?

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Packaging Hierarchy. Drawing by Omega Design
Packaging Hierarchy. Drawing by Omega Design

I have been outspoken on the question of whether or not the Drug Supply Chain Security Act (DSCSA) requires companies in the supply chain to provide their customers with serial number-based aggregation data prior to 2023.  In my view, it does not, but others disagree, saying that there are requirements in the law that lead to the need for aggregation data during that time.  I do not agree with that either.  If you would like to review those arguments and find out exactly what “aggregation data” is, here is a list of RxTrace essays you should read:

Date Published Title/link
March 26th, 2012 Pharma Aggregation: How Companies Are Achieving Perfection Today
November 22nd, 2013 DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?
February 10th, 2014 Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…
June 9th, 2014 The Aggregation Hoax and PIA

BUT WHAT ABOUT AFTER 2023?

The DSCSA requires the FDA to conduct at least 5 topical public meetings between now and Continue reading When Will The DSCSA Ever Require Investments In Aggregation? →

Transaction Data Exchange

Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?

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??????????????We are now more than six weeks past the date that the DSCSA originally mandated drug manufacturers, repackagers and wholesale distributors to pass Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) to their customers in the U.S. and save a copy for six years (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”).  Of course, just before Christmas, the FDA pushed out that part of the requirement until May 1, 2015 to ensure that the requirement did not induce or exacerbate drug shortages (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).

Despite the delay, many companies are already passing the required data to their trading partners through Electronic Data Interchange (EDI) Advance Shipment Notices (ASNs) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).  In fact, the vast majority of companies have Continue reading Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data? →

Data Exchange, DSCSA

The Coming Transition To Serialized Data

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???????????In less than one month the Drug Supply Chain Security Act (DSCSA) will require all sales of drugs in the U.S. pharma supply chain to be accompanied by some very specific data (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”).  The law requires companies to begin exchanging data on January 1 in either paper or electronic form, but because it would be virtually impossible for the big 3 wholesale distributors to accept even a single piece of paper for even a single shipment, the bulk of the U.S. sales by pharma manufacturers will be documented electronically from day-one.  It turns out, the vast majority of that electronic documentation will be passed in the form of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) (see “DQSA: Getting To Electronic Transaction Data Exchange”, “Just Released – The HDMA EDI ASN Guidance For DSCSA”, “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again” and “The HDMA Supply Chain Product Transaction Scenarios For DSCSA”).

But the vast majority of those EDI ASN documents are not likely to Continue reading The Coming Transition To Serialized Data →