Decoding FDA’s Bar Code Rule

What packaging levels does the rule apply to? Should different coding be used for product and packaging? Bert Moore of AIM Global clears up the confusion.

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By Bert Moore
Director, Communications and Media Relations
AIM Global


At a recent pharmaceutical compliance labeling conference, there was a great deal of confusion about the FDA Bar Code Rule. The AIM Global document, "The FDA Bar Code Rule Decoded,” provides answers to most questions. (For a free copy, visit www.aimglobal.org/estore/ProductDetails.aspx?productID=290.) Nevertheless, two questions came up that are not covered by that document. Both questions relate to packaging levels and how to address them.

1. Which packaging levels does the rule apply to?

While the Rule seems to concentrate on unit of use — which may or may not be unit dose depending on packaging type — the Rule applies to other packaging levels as well.

A simple way to determine whether the Rule applies is whether or not the label, packaging or item has FDA-mandated or regulated text on it. If so, the Rule applies. If not, it doesn't. Once you know the answer, it becomes obvious.

It should be noted that the Rule applies only to medication that will be administered to a patient in a healthcare facility. Medication administered in private doctors' offices or sold in retail pharmacies are not subject to the Rule, primarily because the FDA recognizes that the bar code won't be scanned at the time of administration.

Let's take a look at tablet medication as an example of how the Rule applies.

Many manufacturers supply tablets in bulk packaging, typically a plastic container. Since this is the sale unit, it is the unit of use. The Rule then applies to the container.

However, many manufacturers are responding to customer requests for medication in unit-dose form. Manufacturers typically supply unit-dose blisters in a package containing one or more blister strips. In this case, the Rule applies to the package (sale unit) and the individual blisters (unit-of-use/unit dose) but not to the strip itself. (It is a practical consideration not to bar code the strip itself since it is neither a sale unit nor is it truly a unit-of-use.)

Obviously, for billing and inventory purposes, the packaging level indicator (or indicator digit) of the individual blister will be different from the indicator on the packaging.

2. Should a different GTIN or NDC code be used for packaging and product?

If you have product packaging that contains the unit-of-use (in other words, quantity = one), both must comply with the Rule since the packaging might not go to the bedside, whereas the product would. But should a different GTIN or NDC code be used for the packaging and the product? (GTIN is the Global Trade Item Number as defined by EAN.UCC that includes the NDC in one of EAN.UCC's standard bar code symbols.)

The answer is no. The same code is used on the packaging and the item since they are, essentially, interchangeable from an inventory and administration point-of-view. (Obviously, there's a difference between administering packaging to a patient as opposed to administering medication.) The bar code symbology on the item, however, does not need to be the same as on the product packaging. The code may be encoded in any of the linear EAN.UCC symbologies, including RSS if space is an issue. (At this point, the FDA does not recognize the Data Matrix 2D symbology under the Rule.)

For more information on the GTIN, the use of the NDC within the GTIN, and packaging level indicators, contact the Uniform Code Council (UCC), www.uc-council.org, 1-800-543-8137.

As a side note, EAN.UCC have merged and are transitioning to the name "GS1." UCC will later this year officially change its name to GS1-US. To avoid confusion, the designation of the existing EAN.UCC symbologies will not be changed.

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