Last week the FDA finally published their draft guidance for submitting a waiver, exception or exemption from certain Drug Supply Chain Security Act (DSCSA) requirements. Originally, the latest possible date FDA could delay publishing this particular guidance was May 31, 2017. That is, 180 days before the manufacturer’s serialization and verification requirement was due to go into effect on November 27, 2017. Once that date passed without publishing this draft, they were forced to delay the start of the serialization/verification deadline, as they did in late June last year (see “FDA Tea Leaves: Are They About To Delay The November Deadline?” and “FDA Delays Enforcement of DSCSA November Deadline: What It Means”). That bought the FDA another year to publish, with the new publication deadline for the guidance being May 31, 2018, which they have now met (see “FDA To Publish Key Draft Guidance Tomorrow”). Continue reading FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption
Tag Archives: FDA
FDA To Publish Key Draft Guidance Tomorrow
This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow. The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers. In fact, if they had failed to meet their late May deadline for publication of this particular draft guidance Continue reading FDA To Publish Key Draft Guidance Tomorrow
Data Ownership In The Track And Trace Cloud, Reprised And Updated
Back in January of 2013 I wrote an important essay called “Data Ownership In The Track And Trace Cloud” which analyzed a potential future where members of the pharma supply chain would need to deposit and maintain track and trace data in a centralized or semi-centralized data repository in the “cloud”. As the title implies, my main focus was on who would own that data, which was, and continues to be, a hot topic.
But now, five years on, things are getting less “potential” and more real. Continue reading Data Ownership In The Track And Trace Cloud, Reprised And Updated
I Receive My First Serialized Drug From My Pharmacy: Is It Right?
Normally drugs dispensed by American pharmacies are repackaged into the “standard” amber vial. The pharmacy places their own label on that bottle so the patient normally doesn’t receive the manufacturer’s package that would have the new 2D barcode mandated by the Drug Supply Chain Security Act (DSCSA). There are a few drugs that are not repackaged by US pharmacies, like most things in an inhaler and drugs in “compliance packaging” like birth control pills. But even then, the pharmacy puts their label on the package
somewhere.
One of the few drugs I take daily is a statin, which has always been put into an amber bottle by my pharmacy. A few months ago I received a three months supply, and to my surprise, the pharmacy dispensed the prescription in the manufacturer’s original 90-count bottle, and there was the DSCSA 2D barcode on the label. The pharmacy label was positioned so that it formed a “flag” and did not cover the 2D barcode, and the pharmacy label was easily removed to expose the entire manufacturer’s label. This drug was made by Lupin Pharmaceuticals, a generic drug manufacturer base in India. How did they do? Continue reading I Receive My First Serialized Drug From My Pharmacy: Is It Right?
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
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
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?
