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HHS/FDA RIN: 0910-AC26 Publication ID: Fall 2003 
Title: Bar Code Label Requirements for Human Drug Products and Blood 
Abstract: This regulation is one component of the Secretary's initiative to reduce medical errors. The final rule would require human drug products and biological products to have a bar code. The bar code would contain certain information about the product, and when used in conjunction with bar code scanners and computer equipment, would help reduce the number of medication errors. The final rule would also require the use of machine-readable information on blood and blood component container labels. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 201.25    21 CFR 601.67   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 358    21 USC 360    21 USC 360b    21 USC 360gg to 360ss    21 USC 371    21 USC 374    21 USC 379e    42 USC 216    42 USC 241    42 USC 262    42 USC 264   
Legal Deadline:  None

Statement of Need: In 1999, the Institute of Medicine (IOM) report titled, "To Err Is Human: Building a Safer Health System," cited studies and articles estimating that between 44,000 and 98,000 Americans may die each year due to medical mistakes made by health care professionals, with many deaths attributable to medication errors. The report also indicated that, between 1983 and 1993, the medication error rate leading to a patient's death may have increased by over 2.5 times. While later medical articles have questioned the IOM's estimates, other studies have indicated that, regardless of the medication error rate, many medication errors are or were preventable. Medication errors are a significant economic cost to the United States. An article published in 1995 estimated the direct cost of preventable drug-related mortality and morbidity to be $76.6 billion, with drug-related hospital admissions accounting for much of the cost. The authors suggested that indirect costs, such as those relating to lost productivity, might be two to three times greater than the direct costs, making the total cost of all preventable drug-related mortality and morbidity range from $138 to $182 billion. Another article, published in 2001, used updated cost estimates derived from current medical and pharmaceutical literature to revise the $76.6 billion estimate to exceed $177.4 billion; hospital admissions accounted for $121.5 billion in costs, and long-term care admissions accounted for another $32.8 billion. Various organizations and health professional associations have advocated the use of bar codes as a method for reducing medication errors. For example, if a health professional could use a bar code scanner to compare the bar code on a human drug product to a specific patient's drug regimen, the health professional would be able to verify that the patient is receiving the right drug, at the right dose, at the right time. Most organizations and associations have recommended that the bar code contain, at a minimum, a unique numerical code identifying the manufacturer, product, and package size or type. In addition, some have advocated including the lot number and expiration date. FDA proposed to require certain drug products to be bar coded. The bar code would contain certain information about the product, such as its National Drug Code number. The bar code, when used in conjunction with bar code scanners and computer equipment, will enable health professionals to decrease the medication error rate. For blood and blood components intended for transfusion, FDA proposed to require the use of machine-readable informatin in a format approved by the Director of the Center for Biologics Evaluation and Research.

Summary of the Legal Basis: Section 502 of the Federal Food, Drug, and Cosmetic Act (the Act) considers a drug to be misbranded unless it bears a label containing (in part) the name of the manufacturer and the drug's name (see sections 502(b) and 502(e)(1)(A) of the Act). 502(a) of the Act prohibits the false or misleading labeling of drugs. 502(f) of the Act requires drug labeling to have adequate directions for use, adequate warnings against use by patients where its use may be dangerous to health, as well as adequate warnings against unsafe dosage or methods or duration of administering in such a manner and form as necessary to protect uses. Section 501(a)(1) of the Act considers a drug to be adulterated if, among other things, the methods used in, or the facilities and controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that the drug meets the requirements of the Act as to safety and "has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess...." Section 701(a) of the Act, in turn, authorizes FDA to issue regulations for the efficient enforcement of the Act. A bar code requirement for human drug products and biological products would be consistent with, and aid in the efficient enforcement of, sections 501 and 502 of the Act. For example, if the bar code merely contained the drug's National Drug Code number, the bar code would identify the manufacturer and the drug, and this would be consistent with sections 502(b) and 502(e)(1)(A) of the Act. If the bar code contained other information, such as lot number and expiration date (pieces of information required under FDA's good manufacturing practice regulations (see 21 C.F.R. 211.130 and 211.137), this would be consistent with section 501(a)(1) of the Act. Therefore, using its general rulemaking authority at section 701(a) of the Act, the agency has sufficient authority to propose requiring human drug products to have a bar code.

Alternatives: FDA considered a voluntary bar coding program, but this would be akin to a "no action" alternative as many products are not bar coded or not coded in a manner that would help health professionals. A voluntary bar coding system might also lead to the adoption of multiple incompatible bar coding formats on human drug products and biological products, thereby deterring hospitals and health care professionals from buying bar code scanners and computer equipment. FDA also considered allowing the use of automatic identification technologies either in place or in addition to the bar code. However, use of incompatible or expensive technologies could deter hospitals and health care professionals from buying scanning or reading equipment.

Anticipated Costs and Benefits: FDA is continuing to examine the potential costs and benefits associated with bar coding. The anticipated costs may vary greatly depending on the amount of information required in a bar code and the products to be bar coded. FDA's preliminary estimate is that the rule would cost approximately $78 million over a 20-year period. The rule's principal benefit would be a reduction in the number of medication errors, including reduced mortality and morbidity. FDA's preliminary estimate is that the reduced mortality and morbidity will yield a benefit of $44.8 billion over a 20-year period.

Risks: The proposed rule invited comment on whether the final rule should contain a general exemption provision. There is a risk that an exemption provision could result in many exemption requests which, if granted, could reduce the rule's effectiveness.

Action Date FR Cite
NPRM  03/14/2003  68 FR 12500   
Final Rule  01/00/2004    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
Agency Contact:
Philip L. Chao
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Room 15-61 (HF-23), Office of Policy and Planning (HF-23), Room 14C-17, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 827-0587
Fax:301 827-4774

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