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When Will The DSCSA Ever Require Investments In Aggregation?

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 Read the rest of this essay »

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

??????????????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 Read the rest of this essay »

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Interoperability And The DSCSA

Divi-Divi tree Aruba.  Click image to enlarge.

Divi-Divi tree in Aruba. Click image to enlarge.

I just arrived home from a vacation in Aruba so I missed out on the winter weather many of you experienced last week.  Here are a few pictures to help warm you up!

While I was in Aruba I spent some time thinking about interoperability as it applies to the provisions of the U.S. Drug Supply Chain Security Act (DSCSA).  The text of the law uses the term “interoperable” multiple times with regard to the exchange of data between trading partners, but interestingly, it does not define the term.  That leaves the definition of the term up to the FDA.

Before we look at the FDA’s definition of “interoperable”, let’s Read the rest of this essay »

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RAPS Explains The 21st Century Cures Act

House Engergy and Commerce CommitteeAlexander Gaffney, RAC, Manager, Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS) is right on top of any new proposed legislation related to FDA and other health-related federal government agencies.  Last week he reported on the contents of a discussion draft of the “21st Century Cures” Act that was made public by the House of Representatives Energy and Commerce Committee (see Gaffney’s “Regulatory Explainer: The 21st Century Cures Act”).

At 393 pages, the draft bill, if enacted in its current form, would Read the rest of this essay »

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DSCSA Exception Handling: A Preview of Your Next Surprise Headache

HDMA ASN Exception GuidelinesCompanies that participate in the U.S. pharma supply chain and are subject to the U.S. Drug Supply Chain Security Act (DSCSA) are preparing to meet the FDA’s 2015 deadlines for exchanging Transaction Information (TI)Transaction History (TH), and Transaction Statements (TS) for every shipment.  Those preparations include integrating the generation, transmission, confirmation, storage and retrieval (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”) of these documents into their existing supply chain and regulatory compliance processes.  It is a big deal and it affects a large number of companies. Read the rest of this essay »

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Pharmaceutical Traceability Forum Offers Strategic and Solution Focused Discussions to Prepare Organizations for the Upcoming Compliance Deadlines

PharmaTraceability Forum.300x250RxTrace is pleased to announce a partnership with the Pharmaceutical Traceability Forum, taking place March 30-April 1 in Boston, MA. In line with the upcoming regulatory and compliance deadlines, the Pharmaceutical Traceability Forum is the #1 event bringing together the brightest minds in the industry to discuss personal experiences and best strategies for preparing your serialization programs for 2015 and beyond.

Download the event agenda or request a copy via e-mail.

The Forum program, created for Read the rest of this essay »

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The Coming Battle Over Decommissioning At The Pharmacy

Certificate of Serial Number Death

Certificate of Serial Number Death

The U.S. pharma supply chain will operate under two major phases as dictated by the Drug Supply Chain Security Act (DSCSA).  We are now operating under the first major phase.  Well, OK, it won’t be fully operational until July 1st when dispensers (see “Who Is A DSCSA Dispenser?”) are required to begin receiving, saving and retrieving Transaction Information (TI)Transaction History (TH), and Transaction Statements (TS) for each shipment they receive.  Drug manufacturers, repackagers and wholesale distributors were supposed to begin exchanging those documents on January 1st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).  But be aware that according to the DSCSA, as of January 1st, all trading partners must be properly licensed and everyone may only buy and sell drugs legally from/to companies who hold a valid State or Federal license.  Those and other requirements of the DSCSA were not delayed by the FDA.

The second major phase of the DSCSA will not occur until November 27, 2023 when the law transforms into something that is fairly nebulous right now.  That is, between now and Read the rest of this essay »

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Pharma Industry Attention Returns to Serialization

FDA sNDC example plus lot and expiry as a GS1 DataMatrix symbolBefore the passage of the Drug Supply Chain Security Act (DSCSA) on November 27, 2013, the pharma industry was focused pretty well on getting the California-mandated serial numbers on 50% of their drug packages by last Thursday (January 1, 2015), and the remainder of their products by next January.  But that mandate evaporated by federal preemption as soon as the Federal bill was signed into law.  From that moment on, everyone turned their sights toward meeting the data exchange requirements of the DSCSA by last Thursday (see “DQSA: How Should Transaction Data Be Exchanged?”).  Of course, just before Christmas, the FDA pushed that effective date out to May 1, 2015 (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).

That extension in enforcement is a blessing to a few Read the rest of this essay »

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ROC IT Solutions uses RxTrace to help keep abreast with the industry view(s) on the DQSA legislation and how companies are dealing with meeting the mandates. The views and insights are valuable to our assessment of how our product roadmap reacts to best serve our clients.
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