Regulatory Focus: FDA Asked to Clarify Bar Code Rule Compliance

Is bar coding mandated for products shipped after the deadline, or packaged after the deadline?




by Daphne Allen, Editor


In response to FDA’s draft guidance on its bar coding rule, several drug companies have asked the agency to clarify its upcoming deadline.

In “Bar Code Label Requirements, Questions and Answers,” issued in June 2005, the agency wrote that “we expect drugs approved before the effective date of this rule to comply with the bar code requirements within two years of the effective date, i.e., on or before April 26, 2006. Drugs approved on or after April 26, 2004, the effective date of this rule, must comply within 60 days after the drug’s approval date.”

Pfizer, Wyeth Pharmaceuticals, and Bristol-Myers Squibb wrote FDA during July and August requesting an explanation of its meaning of comply.

Gerald P. Migliaccio, vice president of Pfizer’s qlobal quality and EHS operations, wrote: “Pfizer has a concern that this section of the regulation can be interpreted as ‘all product shipped after April 26, 2006,’ must comply with the regulation. This interpretation will make compliance to the rule hard to enforce both for industry and the FDA and may necessitate relabeling or repackaging goods which have already been packaged but not yet distributed.”

Added Roy J. Baranello Jr., assistant vice president, worldwide regulatory affairs, for Wyeth: “For certain products it is likely that manufacturers could have inventory that was manufactured and packaged without bar codes well in advance of the two-year implementation date. . . . Inventory may still be on hand after the implementation date.”

The Healthcare Information and Management Systems Society (HIMSS) also wrote to FDA asking for clarification. “Either packaged or shipped, so that manufacturers, supply-chain managers, and hospitals are appropriately prepared and that the mandate is followed consistently.”

All three drug firms ask the agency to define “comply” as “package.” For instance, “FDA could help prevent the need for destruction of certain product inventories, as well as the potential back order situation this could cause, by defining the compliance date for packaging of new materials,” wrote Richard L. Wolgemuth, senior vice president, global regulatory sciences, for Bristol-Myers Squibb.

“We recommend that . . . the two-year implementation date applies to product approved before April 26, 2004, and packaged on or after April 26, 2006,” wrote Baranello.

The Health Industry Group Purchasing Association (HIGPA), however, argues in favor of “shipped.” Robert Betz, president and CEO of HIGPA, wrote, “healthcare providers are best served if compliance is based upon the ship date. For example, a manufacturer could produce a lot of a specific product on April 1, 2006, sufficient to supply the marketplace for a six-month period. It is conceivable that it could take nine to 12 months before there would be a consistent supply of bar code–labeled product available to the provider. This would cause significant confusion in the marketplace.”

As of press time, FDA had not publicly responded to the letters. PMP News called Philip Chao in FDA’s Office of Policy and Planning, who was listed as the contact on the published rule in 2004, for further clarification. He explained that FDA is preparing a response but has not decided whether to amend the guidance.

To read the draft guidance, go to


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