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DSCSA

DSCSA Serialization: What Wholesalers Expect

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Recently, several of the larger U.S. wholesale distributors have sent letters to their suppliers to review what they expect from them relative to the Drug Supply Chain Security Act (DSCSA).  You may recall that these companies have provided requirements in advance of earlier DSCSA deadlines (see “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers“).  These expectations … Continue reading DSCSA Serialization: What Wholesalers Expect →

EPCIS, GS1 U.S.

The New GS1 US DSCSA Implementation Guidance Suite

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A few weeks ago, GS1 US published version 1.2 of the DSCSA implementation guidance that documents how to apply GS1 standards when meeting the U.S. Drug Supply Chain Security Act (DSCSA).  GS1 US is the GS1 Member Organization (MO) in the United States, of GS1, the global supply chain standards organization.  Companies who market drugs in … Continue reading The New GS1 US DSCSA Implementation Guidance Suite →

FDA

FDA To Hold DSCSA Public Meeting

The FDA is almost 10 months behind in the release of guidance documents for the Drug Supply Chain Security Act (DSCSA) as scheduled by Congress (see “FDA DSCSA Deadline Passes Quietly”, “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “FDA Speaks At GS1 Connect”, and “FDA Plans Busy Second Half of 2016 With … Continue reading FDA To Hold DSCSA Public Meeting →

FDA, HDMA

HDMA Responds To FDA Pilots RFC

A few months ago the FDA opened two “dockets”, or Requests for Comments (RFC) to collect ideas and experiences about technology pilots related to the Drug Supply Chain Security Act (DSCSA).  The first docket was associated with the FDA Public Meeting held on April 5 and 6 (see “The 2016 FDA Pilots Workshop”).  The second … Continue reading HDMA Responds To FDA Pilots RFC →

Aggregation, serialization

Aggregation –> Chargeback Accuracy –> ROI

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Last week I attended my favorite annual conference on pharma serialization and tracing in the U.S.:  The Healthcare Distribution Management Association’s (HDMA) Traceability Seminar.  They call it a “seminar” because the subject of the sessions are generally the same every year, but it is better than any other third-party conference, primarily because the right people … Continue reading Aggregation –> Chargeback Accuracy –> ROI →

DSCSA

Again, Should You Off-Load Your DSCSA Obligations To Your Contract Partners?

I spent my holiday weekend having fun with my family and I hope you did the same.  Instead of spending my holiday writing a new RxTrace essay I am re-running one of my better essays, originally posted on October 6, 2014.  If you missed it then, or even if you read it then, it is … Continue reading Again, Should You Off-Load Your DSCSA Obligations To Your Contract Partners? →

DSCSA

Should You Off-Load Your DSCSA Obligations To Your Contract Partners?

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Manufacturers who make use of third-party contract manufacturers, contract packagers and/or third-party logistics providers (3PLs) may wish to off-load their 2015 and 2017 obligations under the U.S. Drug Supply Chain Security Act (DSCSA) to those contract organizations.  These obligations include providing Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), and collecting and holding … Continue reading Should You Off-Load Your DSCSA Obligations To Your Contract Partners? →

Aggregation, Product Identifier Authentication

The Aggregation Hoax and PIA

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Pharmaceutical manufacturers should be aware that there is a lot of uninformed misinformation going around out there lately about the need for them to supply aggregation data to their trading partners to meet the Drug Supply Chain Security Act (DSCSA) (for more on aggregation, see “Pharma Aggregation: How Companies Are Achieving Perfection Today”, “DQSA: Will … Continue reading The Aggregation Hoax and PIA →