Tag Archives: DSCSA

DSCSA

The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA

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Regulations.govThe FDA published draft guidance earlier this week that might seem a little confusing.  The full title is “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements:  Questions and Answers.  Guidance for Industry”.  Because it is in “draft” form, it is published only to encourage people to submit comments about it.  (See also, “The Differences Between The DSCSA, FDA Rules and Guidance”.)

You should not treat it as real guidance until it is published in final form sometime in the future (if ever—many draft guidances are left handing in the breeze and never finalized).  As with all draft guidances, this one comes with a docket to provide the ability for people to leave comments to help the FDA figure out how to improve it before it becomes final.

The draft covers all of the topics that were contained in the Drug Supply Chain Security Act (DSCSA) Section Continue reading The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA →

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 that data in case of future investigations starting this coming January; and applying the necessary 2D barcode with serial numbers starting in November of 2017.

This may seem perfectly logical.  After all, absorbing responsibilities is one of the big benefits that contract organizations offer their customers.  But by passing on certain obligations under the law, DSCSA manufacturers may end up with higher risks in the future. Continue reading Should You Off-Load Your DSCSA Obligations To Your Contract Partners? →

DSCSA

Will The FDA Delay The DSCSA?

Dirty Harry.Do you Feel Lucky
Do you feel lucky?

More and more people are asking if the FDA will delay the January 1, 2015 requirements of the Drug Supply Chain Security Act (DSCSA).  On that day, drug manufacturers, repackagers and wholesale distributors must begin exchanging Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), (dispensers join them next July) and the FDA is not even due to publish guidance on how to do that until November 27 (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act“).  While they have said they hope to publish that guidance earlier than that date, it still won’t give companies much time to prepare.  So, will they delay it? Continue reading Will The FDA Delay The DSCSA? →

Global Alignment

Pharma Serialization: Going Totally Global Soon

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World map.iStock.smallerOne of the best sessions during last week’s LogiPharma conference held in Princeton, NJ was called “Staging Your Implementation To Meet The 2017 Deadline”.  The “deadline” refers to the November 27, 2017 deadline for drug manufacturers to apply unique serial numbers to all drug packages and cases shipped into the U.S. market as required in the Drug Supply Chain Security Act (DSCSA), but it can also refer to similar deadlines with similar requirements in a number of other regions of the world.  The panel included knowledgeable representatives from two of the largest global pharma manufacturers selling into the U.S. market.  Both manufacturers are facing serialization mandates in the E.U., Brazil, Turkey, South Korea, China, India, Argentina and a few countries in Africa as well as the U.S.

As they spoke about their respective programs for meeting the requirements, one of the speakers mentioned that roughly 90% Continue reading Pharma Serialization: Going Totally Global Soon →

GS1 Healthcare US

GS1 Healthcare US Publishes Updated Guidance For DSCSA

GS1 HcUS ImplGuide 1.1I happened to be chatting with Bob Celeste of GS1 Healthcare US yesterday at the LogiPharma conference in Princeton, NJ where he was about to speak, when he found out that version 1.1 of their guideline had just been published on their website.  The full title of the 137 page document is “IMPLEMENTATION GUIDELINE, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes FOR THE DRUG SUPPLY CHAIN SECURITY ACT AND TRACEABILITY R1.1 — SEP 12, 2014”.  You can download a free copy from their web page.

I will have more to say about this document in a few weeks when I have time to review it more fully, but this is the long awaited update that brings the earlier version up-to-date with the Drug Supply Chain Security Act (DSCSA).  The 1.0 version of the guideline, published in March of last year, was Continue reading GS1 Healthcare US Publishes Updated Guidance For DSCSA →

Dispensers, DSCSA

Who Is A DSCSA Dispenser?

???????????????????????????????????When the U.S. Drug Supply Chain Security Act (DSCSA) was signed into law last November, it introduced a new term into the supply chain lexicon:  “Dispenser”.  It is unfortunate that the authors chose not to use a more recognizable word—like “pharmacies”, or “hospitals”, or “physicians”—because, if they had, more organizations in the dispensing sector might have taken more notice of the requirements they are facing.  But, of course, they could not do that because they wanted to refer to all of those organizations using a single term.  All of those types of organizations fall into the DSCSA definition of “dispensers” and the use of that word appears to have led to some confusion, and therefore some amount of complacency.

“Dispenser” is one of the terms the DSCSA defines so that the rest of the text does not need to repeat the full list of organizations the authors are referring to (see “Don’t Skip The DQSA Definition of Terms Section”).  Its definition is only applicable Continue reading Who Is A DSCSA Dispenser? →

DSCSA, exemptions

Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited

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Exempt signI am working this week, but I know this is a popular time for vacations, especially for those who do not have children in school.  I typically write my Monday essays over the weekend, but because it was a holiday weekend and my wife and I did some leisure traveling, I decided to re-post a popular essay from earlier this year:  “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?“.

I wrote this essay to help companies, large and small, figure out whether or not their products might be exempt from the DSCSA.  In it, I provide a kind of a formula that you can use to determine if a given product is exempt or not.  At least it’s a series of questions or statements that you can ask yourself about your product.  So without further ado,

IS YOUR DRUG EXEMPT FROM THE FEDERAL DRUG SUPPLY CHAIN SECURITY ACT?

Ever since the Drug Quality and Security Act (DQSA) was signed into law last November Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited →

Traceability models

Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture

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rx-360-logoLast Friday a new committee formed by Rx-360 held their first meeting of parties interested in identifying architectures—or at least “conceptual models”—useful for efficiently meeting the full diversity of pharmaceutical track and trace regulations around the globe.  Rx-360 is a non-profit organization “…formed in 2009 to support an industry-wide commitment to ensure patient safety by enhancing quality and authenticity throughout the pharmaceutical supply chain”, according to their press releases.

The new committee is called the “Traceability Data Exchange Architecture Work Group” and it seeks Continue reading Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture →