The 2 Most Helpful Requirements In The DSCSA

There are lots of impactful requirements in the Drug Supply Chain Security Act (DSCSA), but there are two whose impact will likely increase the safety of patients far more than all of the others.  That is, they are the most helpful requirements.  Do they include serialization?  Verification?  Transaction documentation?  Wholesaler and 3PL licensing?  Not even close.

The two requirements that I believe will have the biggest impact on the safety of drugs in the US supply chain are the requirement to only engage in transactions with authorized trading partners, and the lot number being included in the 2D barcode.  Let me explain. Continue reading The 2 Most Helpful Requirements In The DSCSA

Sponsored: Newly Updated Global Serialization Regulation Map

I just helped IQPC update their printable global pharma serialization regulation map.  Get a copy here.  Things change around the world pretty often so it’s important to update resources like this frequently.  The information for most of the existing countries was updated and I added a few new countries.  It’s a great resource to print and pin up on your office wall, or the company bulletin board to keep everyone focused on the approaching deadlines around the world.  And it looks great too! Continue reading Sponsored: Newly Updated Global Serialization Regulation Map

DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing

The second—and longer—draft guidance document the FDA published on the day of the third DSCSA public meeting is a “catch-all” (see also “DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations” and “FDA DSCSA Public Meeting #3: A Difference?”).  It contains lots of diverse recommendations, all related to the standardization of data contained in the DSCSA transaction information (TI), transaction history (TH), and transaction statement (TS).  This draft guidance applies to every member of the supply chain, including drug manufacturers, CMOs, 3PLs, wholesale distributors, repackagers and dispensers of all kinds.  Everyone should read it and submit comments to the FDA when something isn’t clear enough.  Continue reading DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing

Sponsored: Interview With Four Pharma Supply Chain Thought Leaders

The IQPC PharmaTrace Summit will be held on June 4-6 in Princeton, NJ.  In preparation for the event, IQPC asked four industry veterans to respond to a set of forward-looking questions to get a glimpse of the future of serialization and track & trace in the US pharma supply chain.  The four include: Continue reading Sponsored: Interview With Four Pharma Supply Chain Thought Leaders

DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations

As I mentioned last week, the FDA published two new draft DSCSA guidance documents on the day of the recent FDA DSCSA Public Meeting (see “FDA DSCSA Public Meeting #3: A Difference?”).  Let’s take a closer look at what’s in them and their significance to companies facing the Drug Supply Chain Security Act (DSCSA).  I’ll cover one of the two in this essay and cover the other document in the next essay. Continue reading DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations

FDA DSCSA Public Meeting #3: A Difference?

Last Wednesday the FDA held the third in a series of three Drug Supply Chain Security Act (DSCSA) public meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).  I noticed a few important differences at this meeting compared with the two previous meetings (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”, and “FDA DSCSA Public Meeting #2, Still A Gulf”).

Overall, these differences indicate that the FDA may be beginning to recognize how much ground they and the industry must cover between now and November of 2023, and it appears that has led them to get a little more rational.  One meeting is not enough to establish a change in pattern, but if it eventually proves true, then this meeting would be the beginning of that change.  A big injection of rationality is what happened in Brazil back in late 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”) and that seems to have put them on a course for success.  Could something similar be happening here? Continue reading FDA DSCSA Public Meeting #3: A Difference?