Department of Health and Human Services Food and Drug Administration
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Thursday, February 26, 2004 Part III Department of Health and Human Services Food and Drug Administration 21 CFR Parts 201, 606, et al. Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule VerDate jul<14>2003 19:16 Feb 25, 2004 Jkt 203001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\26FER3.SGM 26FER3 9120 Federal Register / Vol. 69, No. 38 / Thursday, February 26, 2004 / Rules and Regulations DEPARTMENT OF HEALTH AND 1. Should Prescription Drug Samples 1. Introduction HUMAN SERVICES Be Excluded From the Rule? 2. Costs to Manufacturers and 2. Which OTC Drug Products Must Packagers of Affected Products Food and Drug Administration Have a Bar Code? 3. Costs to Retailers and Distributors 3. Must Vaccines Have a Bar Code? 4. Costs to Hospitals 21 CFR Parts 201, 606, and 610 4. What Other Types of Drugs Should 5. Costs to the Food and Drug Administration [Docket No. 2002N–0204] Be Subject to a Bar Code Requirement? 6. Total Regulatory Costs Bar Code Label Requirement for 5. Should Medical Devices Be G. Other Anticipated Expenditures Human Drug Products and Biological Excluded From the Rule? H. Reduction in Preventable Adverse Products C. What Must the Bar Code Contain? Drug Events and Preventable Acute (§ 201.25(c)(1)) Hemolytic Transfusion Reactions AGENCY: Food and Drug Administration, 1. Should We Require the Bar Code to I. Value of Avoided ADEs and AHTRs HHS. Contain the NDC Number? 1. Value of Avoided ADEs ACTION: Final rule. 2. Should the Bar Code Contain Lot 2. Value of Avoided AHTRs Number and Expiration Date J. Aggregate Benefit of Avoiding ADEs SUMMARY: The Food and Drug Information? and AHTRs Administration (FDA) is issuing a new 3. Can Information Be Omitted from K. Cost Effectiveness of Bar Coding rule to require certain human drug and the Label to Accommodate the Bar L. Other Benefits of Bar Code biological product labels to have bar Code? Technology codes. The bar code for human drug D. Does the Rule Require a Specific M. Distributional Effects of Bar Code products and biological products (other Type of Bar Code? (§ 201.25(c)(1)) Technology than blood, blood components, and 1. Should the Rule Require Linear Bar N. Comparison of Costs, devices regulated by the Center for Codes? Expenditures, and Benefits Biologics Evaluation and Research) 2. Should the Rule Impose Any O. Uncertainty and Sensitivity must contain the National Drug Code Conditions on the Bar Code? 1. Voluntary Share of Labeling Costs (NDC) number in a linear bar code. The E. Where Does the Bar Code Go? 2. Packaging Decisions rule will help reduce the number of (§ 201.25(c)(2)) 3. Implementation Period medication errors in hospitals and other F. Must Blood and Blood Components 4. Value of Mortality Associated with health care settings by allowing health Bear ‘‘Machine-Readable’’ ADEs care professionals to use bar code Information? (§ 606.121(c)(13)) 5. Value per QALY scanning equipment to verify that the G. Must Biological Products Have a 6. Boundary Analysis right drug (in the right dose and right Bar Code? (§ 610.67) 7. Hospital Response Rates route of administration) is being given H. What Other Comments Did We 8. Hospital Intercept Rates with to the right patient at the right time. The Receive? Machine-Readable Technology rule also requires the use of machine- 1. Comments Seeking More Action by 9. Productivity Losses in Hospital readable information on blood and FDA Wards blood component container labels to 2. Comments Relating to Bar Code 10. Investments by Hospital Size help reduce medication errors. Problems or Quality P. Small Business Analysis and Discussion of Alternatives DATES: Effective Date: This rule is 3. Comments Regarding FDA’s Future 1. Affected Sectors and Nature of effective on April 26, 2004. Involvement with Bar Codes Impacts Compliance Dates: Drug products that 4. Miscellaneous Comments 2. Alternatives receive approval on or after the rule’s I. How Will We Implement the Rule? 3. Outreach effective date must comply with the bar III. Legal Authority 4. What Comments Did We Receive code requirement within 60 days after IV. Environmental Impact on Our Economic Analysis? the drug’s approval date. Drug products V. Paperwork Reduction Act of 1995 A. What Is the Estimated Information Q. Conclusion that received approval before the final R. References rule’s effective date must comply with Collection Burden? the bar code requirement within 2 years B. What Comments Did We Receive I. Introduction on Our Estimates? after the final rule’s effective date. In the Federal Register of March 14, Specific information on how the rule VI. Federalism VII. Analysis of Impacts 2003 (68 FR 12500), FDA (we) will be implemented can be found in A. Introduction published a proposed rule that would section II.I of this document. B. Objective of the Rule require certain human drug and FOR FURTHER INFORMATION CONTACT: C. Estimate of Preventable Adverse biological product labels to have a linear Philip L. Chao, Office of Policy and Drug Events and Acute Hemolytic bar code (the March 2003 proposal). The Planning (HF–23), Food and Drug Transfusion Reactions proposal would require the bar code to Administration, 5600 Fishers Lane, D. The Final Rule contain the drug’s NDC number. For Rockville, MD 20857, 301–827–0587. E. Description of Affected Sectors blood and blood components, the SUPPLEMENTARY INFORMATION: 1. Current Machine-Readable proposal would require the use of Technologies machine-readable information on the Table of Contents 2. Manufacturers and Packagers of container label. Our intent was to help I. Introduction Affected Products reduce the number of medication errors II. Comments on the Proposed Rule and 3. Retail Outlets in hospitals and health care settings by FDA’s Responses 4. Hospitals allowing health care professionals to use A. Who Is Subject to the Bar Code 5. Nursing Homes and Long-Term bar code scanning equipment to verify Requirement? (§ 201.25(a)) Care Facilities that the right drug, in the right dose and B. What Products Must Have a Bar 6. FDA Oversight and Responsibilities right route of administration, is being Code? (§ 201.25(b)) F. Regulatory Costs of the Final Rule given to the right patient at the right VerDate jul<14>2003 19:16 Feb 25, 2004 Jkt 203001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\26FER3.SGM 26FER3 Federal Register / Vol. 69, No. 38 / Thursday, February 26, 2004 / Rules and Regulations 9121 time. For blood and blood components, • Each drug would have a bar code. Label Requirements.’’ (For biological the machine-readable information The bar code would provide unique, products other than blood and blood would perform a similar function and identifying information about the drug components, the bar code requirement help prevent errors such as transfusion that is to be dispensed to the patient. would exist through a cross-reference at errors. • In hospitals, health care a new § 610.67 (21 CFR 610.67.) The The preamble to the March 2003 professionals, such as pharmacists and proposal also would amend the proposal described the events that led nurses, would use bar code scanners preexisting, voluntary provision us to issue the proposal (see 68 FR (also called bar code readers) to read the regarding ‘‘machine-readable’’ symbols 12500 through 12503), and we refer bar code on the drug before dispensing on blood and blood component readers to that preamble if they wish to the drug to the patient and to read a bar container labels at § 606.121(c)(13) (21 obtain details on the events, coded wristband on the patient before CFR 606.121(c)(13) to require the use of recommendations, meetings, and giving the drug to the patient. In an machine-readable information. literature that shaped the proposed rule. outpatient setting, the health care professional (such as a pharmacist) We received approximately 190 In brief, medication errors are a serious comments on the proposal, and almost public health problem, and putting bar could scan the bar code on the drug and compare the scanned information all comments supported the rule in codes on drug products is expected to whole or in part. For example, one significantly reduce medication errors. against the patient’s electronic prescription information before giving comment said that ‘‘FDA is to be highly Medication errors can occur at several commended for both the proposed points from the time the physician the drug to the patient. • The bar code scanner’s information regulation and the process leading to it’’ prescribes the drug to a patient to the while another said that the rule was an time when the patient receives the drug. would go to the computer where it would be compared against the patient’s ‘‘excellent step toward reducing For example, the physician may write a medication errors.’’ Other comments prescription for the right drug, but in drug regimen information to check whether the right patient is receiving reported favorably on their own the wrong dose. The pharmacist might experiences with bar codes on drugs. misread the prescription and provide the right drug (including the right dose of that drug in the right route of One comment from a hospital said that the wrong drug, or read the prescription the hospital had recently begun bedside correctly and dispense the wrong drug. administration). The system could also be designed to check whether the verification of medications, using bar The health care professional patient is receiving the drug at the right codes, and that the bar codes were a administering the drug might give it to time. valuable tool for reducing medication the wrong patient or give it to the right • If the identity of the health care errors.