United States: FDA Issues Final Rule Requiring Bar Codes

Background: On February 25, 2004, the Food and Drug Administration (FDA) announced new regulations requiring "bar codes" on most prescription drugs and certain over-the-counter drugs (the Final Rule). By promulgating this Final Rule, the FDA hopes to reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. 69 Fed. Reg. 9120, 9120 (Feb. 26, 2004).

Manufacturers, repackers, relabelers, and private-label distributors of a human prescription drug product or an over-the-counter (OTC) drug product that is regulated under the Federal Food, Drug, and Cosmetic Act (FD&CA) or the Public Health Service Act (PHSA) unless they are exempt from the registration and drug listing requirements in the FD&CA.

• Prescription drug products except that:
• The bar code requirement does not apply to the following:
• Prescription drug samples;
• Allergenic extracts;
• Intrauterine contraceptive devices regulated as drugs;
• Medical gases;
• Radiopharmaceuticals; and
• Low-density polyethylene form fill and seal containers that are not packaged with an overwrap.
• The bar code requirement does not apply to prescription drugs sold by a manufacturer, repacker, relabeler, or private-label distributor directly to patients, but versions of the same drug product that are sold to or used in hospitals are subject to the bar code requirement.
• Biological products; and
• OTC drug products that are dispensed pursuant to an order and are commonly used in hospitals (i.e., if it is packaged for hospital use, labeled for hospital use or marketed, promoted or sold to hospitals).

• The bar code must contain, at a minimum, the National Drug Code (NDC) number in a linear bar code that meets European Article Number/Uniform Code Council or Health Industry Business Communications Council standards.
• It must:
• Be surrounded by sufficient blank space so that it can be scanned correctly and remain intact under normal conditions of use; and
• Appear on the drug’s label.

• On the FDA’s own initiative or in response to a written request from an entity subject to this regulation, the FDA may exempt a drug product from the bar code label requirements.
• The exemption request must document why:
• Compliance with the bar code requirement would adversely affect the safety, efficacy, purity or potency of the drug or not be technologically feasible, and the concerns underlying the request could not reasonably be addressed by measures such as package redesign or use of overwraps; or
• An alternative regulatory program or method of product use renders the bar code unnecessary for patient safety.

Requests for exemption should be sent to either:

• The Office of New Drugs, Center for Drug Evaluation and Research, if the request involves a drug product; or
• The Office of Compliance and Biologics Quality, Center for Biologics and Research, if the request involves a biological product.

69 Fed. Reg. 9120, 9171 (February 26, 2004).

How does the final rule apply to blood and blood component container labels?

• All blood establishments that manufacture, process, repack, or relabel blood or blood components intended for transfusion and regulated under the FD&CA or the PHSA must implement the use of machine-readable information on blood and blood component container labels.
• Each label must have machine-readable information that contains, at a minimum:
• A unique facility identifier;
• Lot number relating to the donor;
• Product code; and
• ABO and Rh of the donor.

Relevant dates: The FDA published the Final Rule in the Federal Register on February 26, 2004. See 69 Fed. Reg. 9120. Although the Final Rule became effective on April 26, 2004, compliance will be as follows: Drug products that receive approval on or after that effective date must comply with the bar code requirement within 60 days after the drug’s approval date. Drug products that received approval before April 26, 2004 must comply with the bar code requirement within 2 years of that date.

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