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FDA’s DSCSA Guidance in 2014

iStock_000025908089SmallerWhen Congress penned the Drug Supply Chain Security Act (DSCSA) last year it laid out specific dates and subjects for which it expected the FDA to publish guidance on.  So far in 2014, the FDA has kept up with that schedule by holding a public meeting, publishing multiple draft guidances and setting up a website to collect information from wholesale distributors and third-party logistics providers.

The public meeting was held on May 8th and 9th to collect ideas for the standards that FDA should support for the interoperable exchange of transaction data in paper and electronic form, starting with manufacturers, repackagers and wholesale distributors on January 1, 2015 and dispensers on July 1, 2015 (see “The 2014 FDA DSCSA Workshop“).  During the workshop, the attendees raised Read the rest of this essay »

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FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting

Annual Reporting Draft GuidanceThe FDA posted new draft guidance for pharma wholesale distributors and third-party logistics providers to follow to meet their obligation to register their licensing information annually.  The new requirement is from the Drug Supply Chain Security Act (DSCSA) that was enacted last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“).  The draft guidance explains who, what, when and how companies must report.  The FDA will make the data reported available to the public through a web site at some point in the future.

The information the FDA will collect as part of the report from both wholesale distributors and 3PLs include facility location and contact information, a unique facility identifier, license information for each State–including expiration dates–and any significant disciplinary action Read the rest of this essay »

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What will happen next? The 2015 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz

Frequentz LogoFor the second year in a row RxTrace is partnering with Frequentz to conduct a survey about U.S. Pharma Traceability.  This year the survey has been improved with separate sets of questions for each segment of the supply chain and also for companies who are not actual supply chain members.  The survey asks questions about the readiness of companies for the 2015 requirements of the DSCSA as well as preparations for the 2017 serialization requirements.  A few of the questions are the same as last year so we can track any change in thinking.

Click here to take the 2015 survey.

The answers you provide Read the rest of this essay »

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HDMA Expresses Concerns About Industry Readiness for DSCSA

HDMA LogoLast week the Healthcare Distribution Management Association (HDMA), the industry association for the U.S. primary healthcare distributors, published a letter from HDMA President and CEO John M. Gray to the FDA expressing concerns that not all members of the supply chain will be ready to exchange the transaction data mandated by the Drug Supply Chain Security Act (DSCSA) by the January 1 deadline.

The letter expresses concern about the potential that complexities of implementing the law across the entire supply chain… Read the rest of this essay »

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The Coming Transition To Serialized Data

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

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FDA Publishes Draft Guidance For DSCSA Data Exchange

As expected, the FDA has published the draft guidance on standards for paper and electronic data exchange that was mandated by the U.S. Drug Supply Chain Security Act (DSCSA).  And the guidance is early–by one day–fulfilling the intent of the FDA as expressed in the DSCSA Data Exchange workshop held last spring (see “The 2014 FDA DSCSA Workshop“).

The new guidance document can be found on the FDA website at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM424895.pdf

I will provide my full analysis in Read the rest of this essay »

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The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys

Thanksgiving is my favorite holiday!

Giving thanks!  It is my favorite holiday and I have a lot to be thankful for.

Until the Drug Supply Chain Security Act (DSCSA) was passed as part of the Drug Quality and Security Act (DQSA) last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), companies could use whatever code they wanted to refer to the prescription drug products in supply chain operations and for their own inventory management.  Some probably chose the 10-digit National Drug Code (NDC), some probably chose the 11-digit reimbursement code that is based on the 10-digit NDC, and some probably chose to use a 12- or 14-digit GS1 Global Trade Item Number (GTIN) as a reference code for their inventory data.  But now that the DSCSA mandates the use of the 10-digit NDC when exchanging transaction data on January 1, companies using the other codes that are based on the NDC might need to Read the rest of this essay »

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Will The DSCSA Cause Drug Shortages After January 1?

FDALogoDr. Connie T. Jung, Acting Associate Director for Policy & Communications, Office of Drug Security, Integrity and Recalls, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spoke last week at the 2014 Healthcare Distribution Management Association (HDMA) Traceability Seminar in Arlington, VA.

The presentation was similar to those given in the past except she provided an update on the progress of the next draft guidance the Agency is expected to publish on standards for data exchange (see “DSCSA: Many Questions, Few Answers”).  The deadline imposed on the FDA by the Drug Supply Chain Security Act (DSCSA) is November 27, 2014 for that draft, but during the FDA DSCSA Workshop last spring (see “The 2014 FDA DSCSA Workshop”), Dr. Jung said that the Agency recognized the need to publish earlier than that.  Last week she indicated that they will Read the rest of this essay »

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