FDAnews Drug Daily Bulletin


April 28, 2006

How the FDA defines a hospital for the purpose of its rule requiring bar codes on drug labels is a key question affecting health care providers and drug manufacturers' ability to comply with the rule, a hospital official says.

The FDA's rule, "Bar Code Label Requirement for Human Drug Products and Biological Products," became effective April 26. The rule requires that drugs and biologic products distributed in hospitals include bar codes that contain at least the drug's National Drug Code (NDC) number. The NDC identifies the drug's labeler, product details and trade package size. Such labels are meant to avoid misapplication of drugs or use of the wrong drugs by hospital staff through the use of bar codes to transmit dosing data and the names of these products.

The agency issued a Federal Register notice providing common questions about the rule and the FDA's views on these topics. But the document does not go far enough in answering how the agency defines the term "hospital" for the purposes of the rule, Steven Goulet, the pharmacy informatics coordinator for St. Joseph's Mercy Health System told FDAnews. Goulet is also a member of the Auto-ID and Barcode Task Force for the Healthcare Information and Management Systems Society. The task force is currently assessing the rule to determine how to comply with it.

Whether ambulatory care settings, such as nursing homes, and behavioral care facilities are considered hospitals and must comply with the rule is uncertain and one of the "more ambiguous and gray areas" for both health care providers and industry, Goulet said. Health care providers and industry must be sure, he added, what's expected of them before investing in the bar code labeling and the equipment to read these labels.

Questions about the agency's enforcement of the rule are also an issue for industry, said Ken Kleinberg, senior director for global healthcare at Symbol Technologies. This uncertainty makes it difficult to predict the rate of compliance within industry, he said.

The Federal Register notice is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0202-gdl0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0202-gdl0002.pdf).