Category Archives: DSCSA

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The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA

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Regulations.govThe FDA published draft guidance earlier this week that might seem a little confusing.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all of the topics that were contained in the Drug Supply Chain Security Act (DSCSA) Section Continue reading The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA →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? →

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 →

DSCSA

DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 3

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AB ZoomIn Part 2 of this series I explained exactly what the “special privileges” are in the Drug Supply Chain Security Act (DSCSA) for wholesale distributors who purchase directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager who buys directly from the manufacturer (see “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 1”, and “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2”).  In this third part, I will explain why all of this matters to drug manufacturers and how, in some situations, the “Big-3” wholesale distributors may not want to handle your product after the end of this year. Continue reading DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 3 →

DSCSA

DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2

iStock_000001015002SmallerIn Part 1 of this series I explained how the “Big-3” wholesale distributors in the U.S. changed their buying practices back in the mid-2000s so now they only buy their inventory directly from each drug manufacturer.  But in a small number of cases, that isn’t possible.  In those cases, they are forced to buy from an exclusive distributor, or from a company who buys pre-packaged drugs from the NDA- or ANDA-holder.  (See “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 1”.)  And I pointed out that the DSCSA contains “special privileges” for any wholesale distributor who can buy direct from the manufacturer.  In this second part, I will explain exactly what these “special privileges” are in the Drug Supply Chain Security Act (DSCSA). Continue reading DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2 →