Tag Archives: FDA Guidance

DSCSA, Interoperability

Interoperability And The DSCSA

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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 Web Portals

A Closer Look At Web Portals for DSCSA Transaction Data Exchange

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???????????????These are the last few days of 2014.  During the rush up to Christmas, the FDA gave the industry a gift by announcing that they will not enforce the transaction data exchange requirements of the Drug Supply Chain Security Act (DSCSA) until May 1, 2015—a four month delay (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1” for details).  So things are likely to be quieter this week than they otherwise might have been.  And if you are one of those who are working this week, why not fill out the 2015 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz?  It will be closed soon so make sure you click here to fill it out now.

One of the approaches that the FDA mentioned in their data exchange guidance, published on November 26, is the use of secure web portals (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”).  Some companies are Continue reading A Closer Look At Web Portals for DSCSA Transaction Data Exchange →

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FDA Publishes Draft Guidance For DSCSA Data Exchange

As expected, the FDA has published the draft guidance on standards for paper and electronic data exchange that was mandated by the U.S. Drug Supply Chain Security Act (DSCSA).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

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 →