FDA Bar Code Labeling: Just What Is “Unit of Use”?

Bert Moore of AIM Global clears up the confusion about what qualifies as an “FDA compliant label.”

By Bert Moore, Director, Communications and Media Relations, AIM Global

The article I wrote for the March Track & Trace Insider on FDA product labeling generated a lot of discussion in the healthcare labeling arena. During a phone conference with the Healthcare Distributors Management Association (HDMA) committee revising the HDMA bar code standard, concerns were expressed about two points in the article that several committee members felt were misleading.

First, there was concern about the paragraph: "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."

Second, there was discussion about the use of the term "unit of use" to define packaging levels. The group agreed that this term actually confused, rather than clarified, the issue.

Fair enough. When writing an article, it's easy to forget what you didn't know before you knew what you know now. [Confusing enough? It's supposed to be.] In other words, writers sometimes skim over certain points that seem relatively obvious -- but they're only "obvious" because the writer knows the topic. Criticism of the sort offered by the HDMA committee is a valuable reality check that all writers need from time to time. So, "thank you" to the committee members who pointed out the problems.

What these discussions pointed out was that there is a need to clarify labeling of schedule drugs and what constitutes "unit of use" packaging.

Let's take the second point first. The solution to this confusion, according to these discussions, is to get rid of the term "unit of use" in favor of the more accurate term "immediate packaging."

The term "immediate packaging" itself, however, does seem a bit fuzzy. For example, if you have a bottle of medicine in a shelf pack, which is considered the "immediate packaging"? In this case, both are. For inventory or some dispensing purposes, the shelf pack is what's handled or handed out. For administration at bedside, however, the shelf pack may be discarded and only the bottle handled by the healthcare professional.

However, the easiest way to determine what needs to carry the NDC in bar code was mentioned in the last article -- a point that might have been obscured by the discussion about "unit of use." Look at the existing label.  If there is FDA mandated or controlled text on the label, then it the label must needs to behave an FDA bar code marked. In other words, rather than try to untangle the definitions of "unit of use" or "immediate packaging," consider the term "FDA compliant label." Any FDA compliant label will carry a bar code. The only exceptions are clearly stated in the Rule:
  • Samples
  • Allergenic extracts
  • Intrauterine devices regulated as drugs
  • Medical gasses
  • Radiopharmaceuticals
  • Low-density polyethylene form fill and seal containers without over-wraps (i.e., nebules)
  • Prescription drugs dispensed or shipped directly to patients (not administered in hospitals)
  • Drugs compounded for patient use in hospitals or at home
  • Drugs being tested (investigational drugs).
This leads to the topic of schedule pharmaceuticals. Since the "immediate packaging" of all schedule drugs must have an FDA compliant label, all must be bar code marked -- even those sold to retail pharmacies.

The reference in the March article to pharmaceuticals "dispensed directly to patients in private doctors' offices or sold in retail pharmacies" referred to the third-to-last bullet above. This is intended to mean that doctors and pharmacies do not have to bar code label medication dispensed directly to the patient. However, products distributed to doctors and pharmacies must be bar code labeled.

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