Here we are, waiting for the FDA to publish new draft guidance related to the Drug Supply Chain Security Act (DSCSA) after a deadline that passed more than a year ago, and what do we get? A final version of a guidance document that was originally published in draft form two and a half years ago: “Identification of Suspect Product and Notification”. Well, OK, thanks.
I have to say, this is important guidance. In fact, it is probably the most important DSCSA guidance that the FDA has published yet, whether in draft or final forms. And, unfortunately, too many people may gloss over it. They shouldn’t. I wrote about the original draft version back in 2014 (see “The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus”). In this new version, FDA has improved the readability of almost every section, and they have included an extensive new section (the only part that is actually still “draft” and open for comment) for drug manufacturers on “High Risk of Illegitimacy Notifications”. You can download a copy of the updated guidance here.
As I said before, this document explains what should constitute “suspect product”, and what elevates something from being just “suspect” to full blown “illegitimate”. These terms are defined in the DSCSA itself but with this guidance, the FDA makes it clear exactly what they believe rises to those levels. It has been a requirement of the law since January of 2015 that all companies in the supply chain be on the watch for suspect product, and to have systems necessary to quarantine them and conduct a proper investigation.
In the guidance, FDA puts special emphasis (by repeating it multiple times) on the following:
“Again, under section 582 of the FD&C Act, trading partners must have systems in place that enable them, upon determining that a product in their possession or control is suspect or upon receiving a request for verification from the FDA that has made a determination that a product within the possession or control of the trading partner is a suspect product, to quarantine suspect product and promptly conduct an investigation, in coordination with other trading partners, as applicable, to determine whether a suspect product is illegitimate.”
This applies to every member of the supply chain, including DSCSA dispensers (see “Who Is A DSCSA Dispenser?”).
The new section provides needed details for manufacturers around what the DSCSA means when it talks about notification of the FDA for products that have a “high risk of illegitimacy”. This DSCSA language is a little cryptic, but the new section covers it well, providing example scenarios that show what it means. This section is the only one for which the FDA is looking for comments from the public, because it is the only section that is entirely new. To submit comments, see the guidance document itself.
This guidance should be part of every company’s standard operating procedures (SOPs) and employee training programs, from drug manufacturers here in the U.S. and those overseas, to wholesale distributors and repackagers, and to dispensers—including chain, mailorder and mom & pop pharmacies, hospitals, clinics, nursing homes and even individual healthcare practitioners. If it is not part of yours, you are at risk of being caught up in a violation without even realizing it until it is too late. It is everyone’s responsibility and obligation to watch for anything suspicious about the drugs they receive, conduct an investigation, and report those that are found to be illegitimate. This guidance document is indispensable for knowing what to look for and what to do when you find it.
You can bet there will be no excuses allowed the next time illegitimate product is found to have been dispensed to patients.