Bar Code Rules Clarified—Again

By Daphne Allen

Now that it is official, FDA’s bar code rule is getting some further clarification. In April, the agency released a new guidance, “Bar Code Label Requirements, Questions and Answers.” According to the rule, certain drug and biological products commonly used in hospitals must carry a linear bar code containing the National Drug Code (NDC).

Drugs manufactured on or after April 26, 2006, must bear a bar code. Any drugs made and distributed before April 26, 2006, without a bar code need not be recalled or repackaged.

In addition, the April guidance says that the agency will not object to products packaged and labeled without bar codes before April 26, 2006, being distributed and sold after April 26, 2006. “Although we would consider subsequent distribution of those drug products to be a violation of the bar code rule and a misbranding under section 502 of the act, we will allow distribution and sale of the drug products until the existing supply is exhausted, rather than requiring the products to be relabeled or destroyed,” FDA writes. 

For drugs made before April 26, 2006, that have not left the manufacturer’s control by April 26, 2006, FDA will use its “enforcement discretion.”  

FDA is careful in doling out exemptions. For instance, small packages don’t qualify for an excuse. “We declined to exempt small vials or containers (including suppositories, prefilled syringes, and other small products) and stated that firms may, alternatively, modify the drug’s immediate container to accommodate a label bearing a bar code,” the agency writes. In addition, products that are subject to a “low frequency of error” are not exempt. “Even if we could establish a threshold or baseline figure, that figure may not be reliable, because healthcare professionals are not required to submit adverse-event reports to us,” FDA says.

Companies may not be able to excuse themselves from the rule just because they didn’t plan for hospital dispensing. “Manufacturers, repackers, relabelers, and private-label distributors of human prescription drug products, biological products, and over-the-counter (OTC) drug products that are dispensed pursuant to an order and are commonly used in hospitals are subject to the bar code requirement, regardless of the method they use to distribute their drug products,” the agency writes. Also, “a distributor that does nothing to the drug itself is not subject to registration and listing requirements and thus is not required to place a bar code on the product. However, any drug that requires a bar code and does not have one is misbranded under section 502 of the act.” Hospitals, too, are exempt from the bar code rule.

Other important points of the guidance include the following:

• Even though they haven’t been granted an exemption, OTC drug products in LDPE form-fill-seal containers that do not have an overwrap do not need a bar code just yet. FDA is sorting out the potential leaching problems with LDPE containers before any enforcement.

• While linear bar codes encoded with the NDC must be presented on most prescription drug products and certain OTC drug products, other technologies to encode lot and expiry-date codes may be used, too. “We will consider revising the rule to accommodate new technologies and may begin examining other automatic identification technologies,” FDA says.

• Nothing should be added to the bar code to represent the asterisk in an NDC number, because FDA uses the asterisk for internal purposes only.

• Each blister cavity must bear a bar code, if that cavity has a label. The bar codes must not be printed over perforation lines.

• Even though FDA states that the bar code must remain intact under normal use conditions, it does not intend to issue guidance regarding bar code quality, size, etc.

• Bar codes must be on the “drug’s outside container or wrapper as well as on the immediate container, unless the bar code is readily visible and machine-readable through the outside container or wrapper,” FDA writes.

For more guidance details, visit www.fda.gov/cder/guidance/7156fnl.htm.