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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The presentation was similar to those given in the past except she provided an update on the progress of the next draft guidance the Agency is expected to publish on standards for data exchange (see “DSCSA: Many Questions, Few Answers”).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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Global Traceability Data Exchange: Troubled Waters Ahead

iStock_000008540261SmallerAs we near the end of 2014, several important pharma traceability deadlines around the world are approaching.  Besides the U.S. Drug Supply Chain Security Act (DSCSA), these include deadlines in Brazil and South Korea.  Of course, each regulation is different.  Now that the initial implementation of the exchange of transaction data in the U.S. is widely being implemented in Electronic Data Exchange (EDI) Advance Ship Notices (ASNs), the next hurdle for drug manufacturers will be to deploy serialization technologies on their U.S. and Korea market packaging lines.  The data exchange technology problem will shift to Brazil, and that’s where I see trouble. Read the rest of this essay »

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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 Read the rest of this essay »

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The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1

GS1 US logoA few weeks ago, GS1 Healthcare US published version 1.1 of their guidance for using the GS1 Electronic Product Code Information Services (EPCIS) standard to meet the U.S. Drug Supply Chain Security Act (DSCSA).  See “GS1 Healthcare US Publishes Updated Guidance For DSCSA”.  I was too busy at that time to review the document properly, but it is an important addition to the spectrum of information that companies can use to help them understand how to best meet the requirements of the DSCSA so I wanted to get back to it when I had time.  That time is now.

As long term readers of RxTrace know, I did not believe EPCIS would ever be usable to meet the now obsolete California Pedigree law (see “The California Pedigree Law Is Now Officially Inoperative”), or any other State pedigree laws, and I do not believe it will be widely used to meet the Federal DSCSA before maybe 2021 or 2022, but I do believe it will take center-stage for meeting the long-term requirements of the DSCSA.

In 2023 the DSCSA transitions into Read the rest of this essay »

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The Partnership For Safe Medicines Interchange 2014

PSM Interchange 2014The 2014 Partnership for Safe Medicines (PSM) Interchange event was held on September 18 in Washington DC.  This was the fifth year of the event and every year it gets better.  That’s why RxTrace has been a media sponsor of the event for the last four years.  This year, I found every speaker to be compelling.  Next year I am elevating this event to my “highly recommended” short list.

Attendance at the event has grown each year and this time they reached the capacity of the venue and were forced to cut off registrations some time before the day of the event.  A number of RxTrace readers were present at the this year’s event but more ought to attend going forward.

The PSM interchange is a different kind of event.  It’s not a “how to” event.  Over the years, the speaker lineup has included State and Federal pharma regulators, criminal justice professionals (investigators and prosecutors), academics, politicians, pharmaceutical industry associations, medical professionals and occasionally, victims of counterfeit drugs.  The audience includes all of the above, plus Read the rest of this essay »

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Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange?

????????????????????????????????????????I am confident that GS1’s Electronic Product Code Information Services (EPCIS) standard will take center stage in 2023 when the U.S. Drug Supply Chain Security Act (DSCSA) transitions into what that law calls the “Enhanced Drug Distribution System”, or EDDS.  That’s when the DSCSA mandates that supply chain changes of ownership of prescription drugs must be documented in an interoperable electronic system based on their unique serial numbers.

Each of the steps that must be implemented by the industry between now and Read the rest of this essay »

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

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 Read the rest of this essay »

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

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

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