On April 26, 2004, the United States Food and Drug Administration’s (“FDA”) Final Rule to require that certain human drug and biological product labels feature linear bar codes (similar to those found on many consumer goods) will come into effect.1

The bar code to appear on drugs will have to feature the product’s National Drug Code (“NDC”) listing, but companies will also have the option of including information about product lot numbers and expiration dates. The bar code requirement for drugs will be codified at 21 Code of Federal Regulations (C.F.R.) § 201.25. Bar code requirements will be extended to biological products other than blood and blood components by means of a cross-referencing provision to appear at 21 C.F.R. 610.67.

The rule also requires the use of FDA-approved machine-readable symbols on blood and blood-component container labels by amending a previously voluntary provision at 21 C.F.R. 606.121(c)(13). These symbols, which are already used by most blood establishments, identify the collecting facility, the lot number relating to the donor, the product code, and the donor’s blood group (A, B, AB, O) and Rh type.

The bar code rule is intended to foster the widespread adoption of advanced information systems that, according to the FDA, have reduced medication error rates by as much as 85 percent in some hospitals. Typically, such arrangements provide patients with identification bracelets that bear an individualized bar code. On administration of drugs and biologics, health care professionals scan the patient’s bar code and the product bar code. The information system then compares stored data regarding the patient’s treatment regimen to the product to verify that the right patient is getting the right drug (or biologic) at the right time, dose and route of administration. The FDA estimates that the bar code rule, when fully implemented, will help prevent nearly a half million adverse events and transfusion errors over the next two decades.

The new rule applies to most prescription and Over-The-Counter (OTC) drugs considered likely to be involved in medication errors. Radiopharmaceuticals are excluded from the rule because existing Nuclear Regulatory Commission regulations minimize the chance of error during administration. Investigational new drugs are excluded because it is believed that they would exhaust pool of available NDC numbers; their inclusion could also confuse record keeping for clinical trials. Also excluded are drug samples, allergenic extracts, intrauterine contraceptive devices that are regulated as drugs, medical gases, drugs dispensed in low-density polyethylene form fill and seal containers, and prescriptions sold directly to patients. The FDA stated that compounding pharmacies would probably fall outside the requirements of § 201.25(a) and that compounded drugs made by such a pharmacy would not have to bear a bar code.

The bar code rule becomes effective on April 26, 2004. When a particular drug actually falls under the requirements of the rule depends on the timing of that drug’s approval. Drugs that receive approval on or after the rule’s effective date, on the other hand, must comply with the bar code requirement within 60 days after the drug’s approval date.

Drug and biological products approved before April 26, 2004, as well as blood and blood components, will, in the main, have to achieve compliance by April 26, 2006.