[Federal Register Volume 76, Number 207 (Wednesday, October 26, 2011)]
[Proposed Rules]
[Pages 66235-66238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 610

[Docket No. FDA-2011-N-0719]


Bar Code Technologies for Drugs and Biological Products; 
Retrospective Review Under Executive Order 13563; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a review 
of the ``Bar Code Final Rule,'' under Executive Order 13563, 
``Improving Regulation and Regulatory Review.'' The Bar Code Final 
Rule, which was published in 2004, requires

[[Page 66236]]

certain human drug products and biological products to have a bar code. 
Information submitted can help FDA to reassess the costs and benefits 
of the rule and to identify any relevant changes in technology that 
have occurred since it went into effect. FDA is establishing a public 
docket to receive information relevant to reassessing the Bar Code 
Rule. This is an opportunity for interested persons to share 
information, research, and ideas on the need, maturity, and 
acceptability of alternative identification technologies for the 
identification, including the unique identification, of drugs and 
biological products. FDA will use the information received to assess 
whether the Bar Code Final Rule is achieving its intended benefits as 
effectively as possible or should be modified.

DATES: FDA will accept both initial comments and reply comments in 
response to this notice. Initial comments must be received on or before 
January 9, 2012 and reply comments on or before February 23, 2012. (See 
the ``Comments'' section of this document for more information.)

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: On February 2, 2011, President Barack Obama 
issued Executive Order (E.O.) 13563, ``Improving Regulation and 
Regulatory Review'' (76 FR 3821). One of the provisions in the new 
Executive order is the affirmation of retrospective reviews of existing 
significant regulations. As one step in implementing the new Executive 
order, FDA published a notice in the Federal Register on April 27, 2011 
(76 FR 23520), entitled ``Periodic Review of Existing Regulations; 
Retrospective Review Under E.O. 13563.'' In that document, FDA 
announced that it is conducting a review of its existing regulations to 
determine, in part, whether they can be made more effective in light of 
current public health needs and to take advantage of and support 
advances in innovation that have occurred since those regulations took 
effect. Under E.O. 13563, and under the Department of Health and Human 
Services' Plan for Retrospective Review of Existing Rules, FDA will 
consider strengthening, complementing, or modernizing rules where 
necessary or appropriate.
    As FDA conducts its retrospective review of regulations, the Agency 
will take into account the following factors: \1\
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    \1\ Department of Health and Human Services, ``Plan for 
Retrospective Review of Existing Rules,'' pp. 21-22 (August 22, 
2011).
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     Whether an action will have a positive impact on 
innovation in an area of public health, safety, or delivery of or 
access to care;
     Whether the public health benefits of an action have been 
realized;
     Whether the public or regulated community view 
modification or revocation of a regulation as important and have 
offered useful comments and suggestions for change;
     Whether the impact and effectiveness of a regulation has 
changed or been superseded by changes in conditions or advances in 
scientific or technological information;
     Whether there are significant, unresolved issues with 
implementation or enforcement; and
     How long the regulation has been in effect and whether it 
has been subject to prior reviews.
    The first rule FDA is reviewing under E.O. 13563 is the Bar Code 
Final Rule. The Agency plans to reassess its costs and benefits and to 
determine if the Bar Code Final Rule should be modified to take into 
account changes in technology that have occurred since the rule went 
into effect in 2004.

I. Background

    In the Federal Register of March 14, 2003 (68 FR 12500), FDA 
published a proposed rule (Bar Code Proposed Rule) that would require 
certain human drug product labels and biological product labels to have 
a linear bar code that would contain, at a minimum, the drug's National 
Drug Code (NDC) number. In the Federal Register of February 26, 2004 
(69 FR 9120), the Agency finalized the proposed rule (Sec. Sec.  201.25 
and 610.67 (21 CFR 201.25 and 610.67)). As discussed in the preamble to 
the Bar Code Proposed Rule, the rule was intended to help reduce the 
number of medication errors that occur in hospitals and other health 
care settings (68 FR 12500 at 12501 through 12502). FDA envisioned that 
bar codes would be part of a system, along with bar code scanners and 
computerized databases, that would enable health care professionals to 
check whether they are giving the right drug (in the right dose and via 
the right route of administration) to the right patient at the right 
time (Id. at 12501).
    The events that led FDA to propose requiring bar codes are 
described in the preamble to the Bar Code Proposed Rule. In brief, 
medication errors are known to be a serious public health problem and 
can occur at several points from the time a health care provider 
prescribes the drug to a patient to the time when the patient receives 
the drug. The use of bar codes on drug products was expected to 
significantly reduce medication errors. Bar codes also can complement 
other efforts to reduce medication errors, such as computer physician 
order entry (CPOE) systems (where a physician enters orders 
electronically into a computer instead of writing the order on paper, 
and subsequently the order can be checked against the patient's 
electronic records for possible drug interactions, overdoses, and 
patient allergies) and retail pharmacy-based computer systems that use 
a bar-coded NDC number to verify that a consumer's prescription is 
being dispensed with the correct drug. FDA refers readers to the 
preamble to the Bar Code Proposed Rule should they wish to obtain 
details on the events, recommendations, meetings, and literature that 
shaped the proposed rule.
    In the preamble to the Bar Code Proposed Rule, the Agency discussed 
in detail the challenge of requiring the use of linear bar codes, 
which, while enabling hospitals to buy scanning equipment with the 
confidence that their purchased equipment would not be rendered 
obsolete by new technology, could affect future technological 
innovation (68 FR 12500 at 12508 through 12510). Comments received 
related to a public meeting on bar coding, presented an array of 
differing opinions on the issue of whether to require a specific 
technology (68 FR 12500 at 12508). Given the complexity of the issues, 
FDA requested in the Bar Code Proposed Rule comment concerning 
alternatives that could replace or be used in conjunction with the 
linear bar code such as another symbol, standard, or technology (Id. at 
12510 and 12529).
    In response to the Bar Code Proposed Rule, FDA received comments 
including those opposing the use of linear bar codes or asking the 
Agency to consider other technologies or to eliminate any reference to 
linear bar codes in the final rule. Such comments primarily argued that 
selecting a symbology or standard would inhibit technological 
innovation.

[[Page 66237]]

Comments opposed to a linear bar code requirement generally advocated 
the following alternatives: (1) Two-dimensional symbologies, (2) the 
European Article Number/Uniform Code Council (EAN/UCC) system 
generally, (3) radio frequency identification (RFID) chips, or (4) no 
standard or symbology at all (69 FR 9120 at 9136).
    Ultimately, FDA determined that, based on data and public comment, 
a linear bar code requirement was appropriate (Id. at 9137 through 
9138). In the preamble to the Bar Code Final Rule, the Agency addressed 
comments concerning alternatives to the linear bar code and stated 
that, while it believed that linear bar codes were an established, 
cost-effective, widely used and easily recognized technology, it also 
acknowledged that linear bar codes have several disadvantages. For 
example, linear bar codes may take up more label space than alternative 
technologies and may encode less data compared to other technologies. 
Thus, if more data need to be encoded on the packaging or labeling for 
any other reason (such as to allow tracking and tracing of drug 
products through the drug distribution system), a linear bar code might 
prove too limiting (Id. at 9137). FDA also stated that, although it had 
decided to preserve the linear bar code requirement, it would consider 
revising the rule to accommodate newer technologies as they become more 
mature and established (Id. at 9137 through 9138).
    Since FDA issued the Bar Code Final Rule, advances in alternative 
technologies have occurred. In addition, it has become increasingly 
clear from industry, health care providers, and other FDA initiatives, 
that certain FDA-regulated products present unique bar coding concerns. 
For example, the Agency has since learned that certain vaccines present 
unique challenges in the bar coding context, particularly with respect 
to compliance with recordkeeping and mandatory adverse event reporting 
requirements that are specific to the administration of childhood 
vaccines.\2\
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    \2\ The National Childhood Vaccine Injury Act of 1986 (Pub. L. 
99-660) (42 U.S.C. 300aa-25(a)) requires health care providers to 
report certain adverse events related to identified childhood 
vaccines to the Vaccine Adverse Event Reporting System (42 U.S.C. 
300aa-25(b)). Although health care providers are encouraged to 
report adverse events related to other drugs and biological products 
to FDA, they are not required to do so.
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    In recognition of these challenges, in the Federal Register of 
August 11, 2011 (76 FR 49772), FDA announced the availability of a 
final guidance document entitled ``Guidance for Industry: Bar Code 
Label Requirements--Questions and Answers'' \3\. This guidance amended 
and superseded the final guidance of the same title dated October 2006, 
by incorporating a revised response to question 12 (Q12), which 
pertains to the use of alternate coding technologies for vaccines. The 
Agency explained in the Federal Register notice announcing the final 
guidance that it believes alternative technology such as two-
dimensional symbology has advanced, allowing the Agency to reconsider 
the use of such technology. Accordingly, it will now consider requests 
from vaccine manufacturers who request to use alternate coding 
technologies, such as two-dimensional symbology, that encode lot number 
and expiration date information, for an exemption under Sec.  
201.25(d)(1)(ii) to the linear bar code requirement. FDA limited the 
scope of its revised response to Q12 to vaccines because of the 
mandatory reporting concerns specific to these products as described in 
the guidance.
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    \3\ ``Guidance for Industry: Bar Code Label Requirements--
Questions and Answers'' dated August 2011 (http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdf).
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    FDA recognizes, however, that since alternative technologies 
continue to advance, it may now be feasible for these technologies to 
address other stakeholder coding needs in other contexts and for other 
products. For example, under section 505D of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) (21 U.S.C. 355e), FDA is developing 
standards for identification, validation, authentication, and tracking 
and tracing of prescription drugs. The goal of this initiative is to 
implement a system to further ensure patient safety and to improve the 
security of the drug supply chain against counterfeit, diverted, 
subpotent, substandard, adulterated, misbranded, or expired drugs. In 
March 2010, FDA issued a guidance that discusses a standard for 
uniquely identifying prescription drug packages using a Standardized 
Numerical Identifier (SNI).\4\ In the guidance, the Agency did not 
specify the means of incorporating the SNI onto the package. However, 
the guidance recognizes that the SNI is a flexible standard that can be 
encoded into a variety of machine-readable forms of data carriers, such 
as two-dimensional bar codes, alternate coding systems, and RFID. Thus, 
the guidance leaves options open while technologies for securing the 
supply chain continue to be identified, and standards making use of SNI 
are developed. Similarly, while FDA recognizes that the underlying 
primary goals of the Bar Code Final Rule and section 505D of the FD&C 
Act are different, the Agency wants to leave options open with respect 
to how the same technology may be used for both purposes.
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    \4\ ``Guidance for Industry: Standards for Securing the Drug 
Supply Chain--Standardized Numerical Identification for Prescription 
Drug Packages'' dated March 2010 (http://www.fda.gov/downloads/RegulatoryInformation/Guidance/UCM206075.pdf).
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    FDA is announcing the establishment of a public docket to provide 
an opportunity for interested persons to share information, research, 
and ideas on the effectiveness of the current regulation and the need, 
maturity, and acceptability of alternative technologies for the 
identification, including the unique identification, of drugs and 
biological products. FDA will use the information received to assess 
coding technologies in relation to current bar code requirements and 
other initiatives.

II. Request for Comments and Information

    FDA is requesting comments and supporting information on (1) bar 
code labeling standards for drugs and biological products and (2) the 
identification of current alternative technologies for use by industry 
and others.
    To facilitate this discussion, FDA sets forth some questions in the 
following paragraphs. These questions, which are not meant to be 
exhaustive, are provided to stimulate public comments that will help 
FDA evaluate the Bar Code Final Rule and the accommodation of 
alternative technologies to the linear bar code requirement (Sec.  
201.25). The public is encouraged to address these and/or other related 
questions.
    The Agency encourages responses to the following questions about 
the costs and benefits of any alternative to the linear bar code. FDA 
also encourages you to provide as much detail and context as possible 
in your responses. Furthermore, the Agency specifically invites small 
businesses to provide information about the potential impact of 
alternatives to the linear bar code.
    1. Is there a need for alternative technologies to the linear bar 
code? Does the current linear bar code requirement meet the current 
needs of the health care industry and health care providers?
    2. How has product coding technology changed since FDA issued the 
Bar Code Final Rule on February 26, 2004? Please provide information 
about the maturity, degree of adoption, cost, and ease of use of coding 
technologies

[[Page 66238]]

that may be considered as alternatives or in addition to the linear bar 
code.
    3. What factors other than those listed in question 2 should FDA 
take into account in considering technologies alternative to or in 
addition to the linear bar code?
    4. What technologies or coding systems warrant FDA's consideration 
as alternatives to the linear bar code? In your response, the Agency 
particularly invites comments on the following issues for each 
technology identified:
    A. What is the current state of development and availability of the 
alternative technology?
    B. Would adoption of this technology as an alternative to the 
linear bar code further reduce medication errors in hospitals and 
health care settings? Please provide supporting data, if available.
    C. Would adoption of this alternative technology advance public 
health protections? If so, how? If supporting data exist, please 
provide this information.
    5. Does the adoption of this alternative technology have 
implications for other FDA or Department of Health and Human Services 
initiatives (e.g., SNI)?
    6. Have you used the linear bar code for authentication or tracking 
and tracing of prescription drugs?
    A. If so, how?
    B. Please describe any successes or challenges that you have 
encountered in adopting linear bar code technology for this purpose.
    C. If not, which if any alternative technologies could reduce 
medication errors while also serving other functions?
    7. For hospitals and other health-care facilities that have adopted 
bar code technologies using linear bar codes:
    A. What difficulties did you encounter in adopting the technology?
    B. How have productivity and operating costs changed?
    C. What differences have you seen in medical outcomes?
    D. What problems have you experienced with the technology?
    8. For hospitals and other health-care facilities that have adopted 
alternative technologies or non-linear coding:
    A. What difficulties did you encounter in adopting the technology?
    B. How have productivity and operating costs changed?
    C. What differences have you seen in medical outcomes?
    D. What problems have you experienced with the technology?
    9. For hospitals and other health-care facilities that have not 
adopted bar code technologies using linear bar codes:
    A. Do you plan to adopt the technology within the next 12 months?
    B. If you do not plan to adopt the technology, please explain what 
factor(s) most influenced the decision not to adopt it.
    10. How would technology adoption have proceeded since 2004 had the 
Bar Code Final Rule not gone into effect?
    11. What are hospitals' and other health-care facilities' forecasts 
for technology adoption once incentives in the Economic Stimulus Act of 
2008 (Pub. L. 110-185) are no longer in effect?
    12. Would there be an economic impact on those parties who may not 
be subject to the bar code requirement but who nonetheless may use or 
adopt or have adopted bar code technology (e.g., hospitals, clinics, 
public health agencies, and health care providers)? Please use the 
following questions to guide your responses.
    A. Current practices. Describe your current practice(s) at your 
institution with respect to those products that are required to be 
labeled with a bar code under Sec. Sec.  201.25 and 610.67. Have you 
encountered any barriers to your ability to use technology at your 
institution?
    B. Using an alternative to the linear bar code. If an alternative 
to the linear bar code could be placed on the label of at least some of 
your products, what impact, if any, would that have on your current 
practice(s)? How would you change your practices, if at all?
    C. Expenses. What unplanned expenses, if any, would you incur, if 
an alternative to the linear bar code could be placed on the label of 
at least some of your products? If you could foresee using an 
alternative to the linear bar code, would you modify operations in your 
facility, and if so, how?
    D. Adverse event reporting and recalls. Have you encountered 
challenges/successes in drug identification or reporting with respect 
to products that contain a bar code on their labels? If so, please 
describe them. Would an alternative to the linear bar code have an 
impact on your recall management or adverse event reporting, and if so, 
how?
    13. Are there other parties whose economic interests we should 
consider?

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please allow sufficient time for mailed comments to be timely 
received by the due dates in the event of delivery delay. Comments must 
be received by these dates to be considered. We request that comments 
be identified clearly as an ``initial'' comment or a ``reply'' comment. 
Initial comments may address any issue raised in this notice. Initial 
comments will be made available electronically, online at http://www.regulations.gov, or for public inspection in the Division of 
Dockets Management (see ADDRESSES). To allow sufficient opportunity for 
interested persons to prepare and submit any reply comments, late-filed 
initial comments will not be considered. Reply comments must address 
only matters raised in initial comments and must not be used to present 
new arguments, contentions, or factual material that is not responsive 
to the initial comments. To be considered, reply comments must identify 
which initial comments they are replying to, and which specific 
issues(s) are being addressed. We will not consider comments received 
during the reply comment period that do not identify the specific 
issue(s) raised during the initial comment period on which the reply 
comment is based. It is the Agency's intent to comply with Executive 
Order 13563 as quickly as possible, so we will not look favorably on 
requests for extensions of the comment period.
    Comments previously submitted to the Division of Dockets Management 
for the following docket will also be considered by FDA and do not need 
to be resubmitted: ``Draft Guidance for Industry: Bar Code Label 
Requirements (Question 12 Update)'' (75 FR 54347 September 2010; Docket 
No. FDA-2010-D-0426).

    Dated: October 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27657 Filed 10-25-11; 8:45 am]
BILLING CODE 4160-01-P