RxTrace readers are already well aware that multiple new laws around the world will require prescription drug manufacturers to put a new 2D barcode on their products in the next few years. But what if your drug package is too small to fit the new mandated 2D barcode and human readable information on the label? Let’s take a look at what the regulations say in the E.U., Brazil and the United States. From that, we can come up with some strategies.
IN THE E.U.
The E.U. Delegated Regulations (EUDR) under the Falsified Medicines Directive (FMD) addresses this issue directly. Paragraph 2 of Article 7 says:
“[The requirement to print the Product Code, the Serial Number, and national reimbursement number (where required) in human readable form] shall not apply where the sum of the two longest dimensions of the packaging equals or is less than 10 centimetres.”
Even when the two longest dimensions of the packaging is equal or less than 10 centimeters, you still have to print the new 2D barcode, but you don’t have to include the human readable. Often, it takes more label space to print the human readable than it does to print a square 2D Datamatrix barcode, so this is a step in the right direction. Notice that you still have to include the lot number and expiration date on the package, but this was a requirement prior to the adoption of the FMD so you should already be doing that. But not matter what, you still need to add the new barcode to the label.
Today in Europe, most countries require drugs to be marked with a linear barcode. Each sub-market has its own identifier that must be on the package. Neither the FMD nor the EUDR dictates that those legacy identifiers or barcodes may be totally replaced by the new identifiers and the new 2D barcode (unless the legacy barcode is also a 2D, in which case the EUDR says having multiple 2D barcodes on packages “should be avoided”). It will be up to the local governments of each member state to enact regulations that remove their existing requirements to print the old identifiers in linear barcodes on drugs distributed within their borders. Drug companies should keep track of which countries do that, the specific timing and actions necessary to ensure you may continue to market drugs there.
Recently ANVISA stated that their current draft regulations will not be finalized until after the pilot ends—probably sometime next year (see “Brazil Gets Rational With Their New Pharma Traceability Law”). Until then, you can’t assume anything in the draft will remain, and that new things won’t be added. That is, everything is, in a way, still up in the air.
That said, the draft requires the identification of secondary packages of drugs, or the primary packaging if there is no secondary packaging. Primary packaging is the package component that touches the drug itself. Secondary packaging is the next layer of packaging. If a drug is dispensed only in its primary packaging, then that drug does not have secondary packaging.
Unfortunately, neither the draft regulation being developed for the pilot nor RDC-71 from 2009 (which contains drug label requirements) mentions what to do if your primary or secondary packaging is too small to accommodate the new unique identifier. I guess they assume your package or label needs to include the necessary information, and if your package or label isn’t big enough to show it all, then perhaps you need to increase the size of your package.
In Brazil, barcodes on drug packages were optional prior to the future effective date of the new regulation (currently expected to be in early 2022), so you won’t have the same problem as you do in the E.U. with regard to removal of existing barcodes.
IN THE U.S.
The Drug Supply Chain Security Act (DSCSA) does not specify a product size under which the manufacturer may not include the human readable or allows a smaller barcode. However, Section 582(a)(3) requires the FDA to establish a process for companies to apply for a waiver from the product identifier requirements when a container is “…too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance…” (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”).
The due date for that process was November 27, 2015. So far, no process has been published (see “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?”). We are now less than one month from the absolute latest date which the DSCSA allows the FDA to delay the waiver application submission process. If they had published the guidance on time, they might have begun accepting applications earlier. If the FDA does not publish a waiver process by May 27, companies with small packages will have a good argument to ignore the product identifier requirements on November 27 (check with your lawyer first).
I’ve discussed many times in the past the fact that you need to leave the linear barcode containing the National Drug Code (NDC) on drug packages even when you put a 2D barcode on your packages. That is true, despite the fact that the 2D barcode you apply to your package also contains the NDC. This will likely cause some real artwork heartaches for some products (see “DSCSA: Label Artwork Heartaches”). It is unfortunate that the FDA didn’t take my advice back in 2012 or this situation could have been avoided (see “Why NOW Is The Time To Move Away From Linear Barcodes”).
The more information governments demand on drug packages the larger the smallest drug packages can be. With the effective dates of new drug serialization regulations approaching, some companies may find that they must enlarge the size of their packaging, just to accommodate all of the new information. And as usual, your response in each market will be different.