Category Archives: DSCSA

DSCSA, Interoperability

Interoperability And The DSCSA

2 Comments
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 Continue reading Interoperability And The DSCSA →

DSCSA, FDA, HDMA

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… Continue reading HDMA Expresses Concerns About Industry Readiness for DSCSA →

Data Exchange, DSCSA

The Coming Transition To Serialized Data

1 Comment

???????????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all sales of drugs in the U.S. pharma supply chain to be accompanied by some very specific data (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”).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 →

DSCSA, FDA

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 Continue reading FDA Publishes Draft Guidance For DSCSA Data Exchange →

DSCSA, NDC

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

1 Comment
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 Continue reading The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys →

DSCSA

Will The DSCSA Cause Drug Shortages After January 1?

2 Comments

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 Continue reading Will The DSCSA Cause Drug Shortages After January 1? →

DSCSA, Repackaging

Who Is A DSCSA Repackager?

????????????????????????A while back I posted an essay called “Who Is A DSCSA Dispenser?”.  I don’t think many actual dispensers read it because about half of the dispensers I run into think the earliest they have to do anything is July of next year.  The other half don’t think there is anything in the Drug Supply Chain Security Act (DSCSA) about them at all.  Too bad.  Both are wrong.

Fortunately I think repackagers know better.  At least they should, because the DSCSA contains a lot of specific requirements for them.  Repackagers have most of the same requirements that manufacturers do, plus they have many of the wholesale distributor requirements.  A double whammy.

Most people in the industry know what a repackager is.  Typically they are companies that buy drugs from a manufacturer or a wholesale distributor and then open the packages and put the drug into a new package type.  This can include putting the drug into a larger or smaller quantity package, or from bottles into blister cards or even unit dose packs for use in an automated picking machine.  It can also include companies who Continue reading Who Is A DSCSA Repackager? →

DSCSA

The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA

4 Comments

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 →