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You hear our perspectives twice a month —this time we’d like to hear yours.

FDA has just released a new draft guidance for industry, “Bar Code Label Requirements, Questions and Answers.” There aren’t any new actions in this guidance; rather, it is a clarification of certain requirements in the final rule.

What I’d like to hear from you is, how are your bar coding efforts progressing? FDA touches upon some of the confusing or challenging aspects of the rule. Do you find the added guidance helpful?

For instance, FDA explains that exemptions are not available simply because a product’s package is too small for a bar code. FDA will consider an exemption only if bar code placement interferes with “a product’s safety, effectiveness, purity, or potency or is otherwise technologically not feasible and the problem cannot be solved by a package redesign or overwrap.” FDA believes that bar codes have an important role to play in product safety, and it expects you to make it happen.

FDA also says it expects you, not hospitals or clinics, to apply bar codes. Many hospitals have added bar codes, but FDA says that that is not enough. Manufacturers, repackers, relabelers, and private label distributors need to add bar codes.

Also, while FDA is requiring linear bar codes that are encoded with National Drug Codes, the agency will consider other automatic identification technologies by April 2006.

Another important clarification is that FDA expects each blister package unit to bear a scannable bar code, rather than one per blister package or those that become unscannable after opening because they are printed across perforations. Also, bar codes must appear both on primary packaging and overwrap, unless the bar code on the primary package can be scanned through the overwrap. These points show that FDA expects packagers to take care when adding bar codes, even if it requires substantial redesign, retooling, or new materials.

What do you think? I’d like to publish your comments, either by name or anonymously, in an upcoming issue of PMP News. I hope to give our readers a snapshot of healthcare product bar coding. We are currently preparing our annual reference issue, which will include detailed reports on pharmaceutical and medical packaging. Your input could be valuable additions to that issue. FDA’s bar coding rule for pharmaceuticals has demanded some pretty significant changes to packaging processes and materials, and we would like to hear how your world has changed because of it.

For instance, are you putting bar codes on each pharmaceutical dose? Have you redesigned your packaging? Are you encoding more information than is required, such as lot code and expiration date? Are you using new printing and verification technologies, perhaps right on your packaging lines?

If you package medical devices, are you considering adding them to your packaging? Do you believe that FDA should issue similar rules, or just voluntary guidance, for medical devices?

I have posed a lot of questions to you, I know. I’d like to leave you with just one more, multipart question: What have you heard from your customers, those professionals charged with the safe use of your products? Is bar coding reducing medical errors? Did FDA have the right idea in choosing automatic identification?

Daphne Allen

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