[Federal Register Volume 67, Number 117 (Tuesday, June 18, 2002)]
[Proposed Rules]
[Pages 41360-41361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15208]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 211, and 601

[Docket No. 02N-0204]


Bar Code Label Requirements for Human Drug Products; Notice of 
Public Meeting

Agency: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to solicit comments for the development of a regulation on bar 
code labeling for human drug products, including biologic products. We 
(FDA) will also explore issues surrounding bar codes on medical 
devices. We are holding this meeting to support the initiative of the 
Secretary of Health and Human Services to reduce medication errors.

DATES: The public meeting will be held on July 26, 2002, from 9 a.m. to 
5 p.m. Registration to attend the meeting must be received by July 12, 
2002. Submit written or electronic comments for consideration during 
the meeting by July 12, 2002.

ADDRESSES: The meeting will be held at the Natcher Auditorium, Building 
45, National Institutes of Health (NIH), Bethesda, MD. Parking will be 
limited and there may be delays entering the NIH campus due to 
increased security. We recommend arriving by Metro if possible. NIH is 
accessible from the Metro's red line at the Medical Center/NIH stop.

FOR FURTHER INFORMATION CONTACT:   
    Registration for Speaking Attendees: If you wish to speak at the 
public meeting, please contact Mary C. Gross, Office of Drug Safety, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5600 Fishers Lane, rm. 15B-32, Rockville, MD 20857, 301-827-3193, FAX 
301-443-9664, e-mail: [email protected]. Speakers must register and 
submit a short summary of your presentation by July 12, 2002, to Mary 
C. Gross; faxed copies of presentations are permissible. We encourage 
consolidation of like-minded presentations to enable a broad range of 
views to be presented.
    Registration for General Attendees: If you wish to attend the 
public meeting, register with Elizabeth French, Office of Policy, 
Office of the Commissioner, Food and Drug Administration, 5600 Fishers 
Lane, rm. 14-101, Rockville, MD 20857, 301- 827-3360, FAX 301-827-6777, 
e-mail: [email protected]. General attendees should register no later 
than July 12, 2002. As time permits, we will accept oral comments from 
the audience. More information is available on the Internet at http://internet-dev.fda.gov/oc/meetings/barcodemtg.html.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1999, the Institute of Medicine (IOM) report entitled ``To Err 
is Human: Building a Safer Health System'' cited research stating that 
there are an estimated 100,000 deaths in the United States every year 
from preventable medical errors in hospitals alone.\1\ The range of 
deaths reported, between 44,000 and 98,000 deaths, was based on the 
1984 Harvard Medical Practice Study and confirmatory studies done in 
Colorado and Utah. These numbers reflect the entire area of medical 
errors, including, for example, surgical errors, iatrogenic infections, 
medication errors, and incorrect use of medical products. Of the 
projected 100,000 deaths, we believe that approximately 30 to 50 
percent are associated with errors involving FDA regulated medical 
products (e.g., drugs, devices, blood and blood products, or vaccines). 
In addition to the human cost of errors involving drugs, there are also 
significant economic costs. 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.\2\ 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; of which hospital admissions accounted for $121.5 billion in 
costs, and long-term care admissions accounted for another $32.8 
billion.\3\
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    \1\ Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, 
editors; ``To Err Is Human: Building a Safer Health System,'' 
Committee on Quality of Health Care in America, Institute of 
Medicine, November 29, 1999.
    \2\ Johnson, J. A. and J. L. Bootman, ``Drug-Related Morbidity 
and Mortality: A Cost-of-Illness Model,'' Archives of Internal 
Medicine, pp. 1949-1956 (1995).
    \3\ Ernst, F. R. and A. J. Grizzle, ``Drug-Related Morbidity and 
Mortality: Updating the Cost-of-Illness Model,'' Journal of the 
American Pharmaceutical Association, vol. 41, pp. 192-199, March/
April 2001.
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    Medication errors are a subset of the wider category of medical 
errors. Medication errors are defined by the National Coordinating 
Council for Medication Error Reporting and Prevention as:
    * * *  any preventable event that may cause or lead to 
inappropriate medication use or patient harm while the medication is 
in the control of the healthcare professional, patient, or consumer. 
Such events may be related to professional practice; healthcare 
products, procedures, and systems, including prescribing; order 
communication; product labeling, packaging, and nomenclature; 
compounding; dispensing; distribution; administration; education; 
monitoring; and use.\4\
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    \4\ National Coordinating Council for Medication Error Reporting 
and Prevention, ``What is a Medication Error?'' (Undated).

    Medication errors can lead to adverse drug events. It is estimated 
that 770,000 adverse drug events leading to injury or death occur 
yearly in U.S. hospitals alone, and that between 28 to 95 percent of 
these are preventable, i.e., can be defined as errors. Computerized 
hospital medication use and monitoring systems could prevent many of 
these medication errors.\5\
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    \5\ Agency for Health Care Quality and Research, ``Research in 
Action: Reducing and Preventing Adverse Drug Events (ADEs) to 
Decrease Hospital Costs,'' April 11, 2001. (http://www.ahrq.gov/qual/aderia/aderia.htm)
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    In response to the IOM report, the Secretary of Health and Human 
Services directed FDA to explore possible regulatory approaches to 
reduce these preventable errors. Errors related to dispensing and 
administration can be minimized through the use of bar codes. 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 
right patient is receiving the right drug, at the right dose, and at 
the right time. Bar code advocates have recommended that the bar code 
contain a unique numerical code that is dose specific to identify the 
manufacturer, product, and package size or type, lot number, and 
expiration date.
    The availability of bar codes for pharmaceuticals would also 
facilitate other patient safety initiatives, for example, automated 
drug prescribing or ordering, automated monitoring for drug toxicities 
in hospitals, and as a component of the automated medical record. 
Automation of the drug prescribing and ordering system, if linked to a 
bar coding system, has the potential not only to minimize drug mixups, 
but also to make sure prescribers have access to crucial information at 
the point of prescribing.
    We are considering whether to require bar codes on human drug 
products, including certain biologic products. The bar code would 
contain certain information about the product, such as a dose-specific 
individual identifying

[[Page 41361]]

number. We are considering whether to require the bar code to contain 
other information, such as the drug product's expiration date and lot 
number, to make it easier to identify expired drugs and recalled drugs 
that may not be safe and effective for use. We are also exploring 
issues surrounding bar codes on medical devices.

II. Scope of Discussion

    We will hold a public meeting on June 13, 2002, from 9 a.m. to 5 
p.m., to discuss bar code labeling. We will give careful consideration 
to technical issues regarding the development and implementation of a 
possible bar code label. We anticipate that discussions will include 
presentations from invited speakers as well as from members of the 
public.
    We invite public comment on this issue, and we intend to focus on 
the following questions:

A. General Questions Related to Drugs and Biologics:

    1. Which medical products should carry a bar code? For example, 
should all prescription and over-the-counter (OTC) drugs be bar coded? 
Should blood products and vaccines carry a barcode?
    2. What information should be contained in the bar code? What do 
you consider to be critical bar code information that will reduce 
medical product errors? If data exists, please provide it for the 
record. What information would be helpful but not necessarily critical, 
for reducing medication errors? Provide data.
    3. Considering current scanners and their ability to read certain 
symbologies, should the rule adopt a specific bar code symbology (e.g., 
reduced space symbology (RSS) and 2-dimensional symbology)? Should we 
adopt one symbology over another, or should we allow for ``machine 
readable'' formats? What are the pros and cons of each approach?
    4. Assuming that we require bar codes on all human drug products, 
where on the package should the bar codes be placed? Are there benefits 
to placing bar codes on immediate containers, such as the bottles, 
tubes, foiled-wrapped tablets, and capsules, found inside prescription 
or OTC product cartons? Is there a way to distinguish whether certain 
containers with a bar code will have a more significant effect on 
preventing errors than others?
    5. What products already contain bar codes? Who (i.e., hospitals, 
nursing homes, outpatient clinics, retail pharmacies, etc.) uses these 
bar codes and how? As with all comments, if data exists, please provide 
it for the record.

B. Medical Device Questions

    1. Should medical devices carry a bar code? What information should 
be included in the bar code? For example, unlike drug products, medical 
devices do not have unique identifier numbers.
    2. If medical devices are bar coded, should all medical devices, or 
only certain devices be bar coded? For example, tongue depressors, 
syringes, and crutches are medical devices, but perhaps do not need a 
bar code.
    3. Should reprocessed, repackaged, refurbished, or multiple-use 
medical devices be bar coded? Who should be responsible for generating 
and applying the new bar codes and how should these barcodes be 
different from the original manufacturers' bar codes?
    4. What public health/patient safety benefits can be derived from 
bar coding medical devices? If data exists, please provide it for the 
record.

C. General Questions and Economic Impact Questions

    1. Will bar code printing costs cause you to modify your packaging 
choices, such as reconsidering the use of blister packages or 
influencing future package choices? If so, how?
    2. Have you implemented bar code technology in your product line? 
If so, what elements and symbology are included in the bar code?
    3. If you manufacture and bar code products, how do verification 
requirements for bar codes affect your ability to add bar codes? How 
much barcode verification is appropriate as part of the quality system?
    4. Can bar codes be produced with a dose specific unique 
identifying number, lot number, and expiration date at your highest 
production line speeds?
    5. What equipment solutions are vendors offering to manufacturers 
for bar coding or scanning? How quickly can such systems run? What type 
of packaging line is equipment used for?
    6. What is the expected rate of technology acceptance in all health 
care sectors of machine-readable technologies? What are the major 
inhibiting factors to the current use of machine readable technologies? 
What would be the expected benefit of using machine readable technology 
in the delivery of health care services (including drug products)? What 
would be the expected benefit of machine readable technology for other 
potential uses (e.g., reports, recordkeeping, inventory control, 
formulary setting, etc.)?
    7. Assuming a final rule is issued requiring bar coding, when 
should it become effective? For example, would some industries or 
products require more time than others to comply with a bar coding 
requirement? Would a certain compliance time sharply reduce costs of 
relabeling?

III. Comments

    Interested persons, who wish their comments to be considered during 
the meeting, may submit to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, written or electronic comments by July 12, 2002. Comments 
will be accepted after the meeting until August 9, 2002. Submit 
electronic comments to [email protected] or http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. A copy of the 
document and received comments are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

IV. Transcripts

    You may request a transcript of the meeting in writing from the 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857. The transcript of 
the public meeting will be available approximately 15 working days 
after the meeting, at a cost of 10 cents per page. You may also examine 
the transcript of the meeting after June 28, 2002, at the Dockets 
Management Branch (see Comments) between 9 a.m. and 4 p.m., Monday 
through Friday and on the Internet at http://www.fda.gov.

V. Electronic Access

    Persons with access to the Internet may obtain additional 
information on the public meeting at http://internet-dev.fda.gov/oc/meetings/barcodemtg.html.

    Dated: June 11, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15208 Filed 6-17-02; 8:45 am]
BILLING CODE 4160-01-S