Federal Register, Volume 76 Issue 207 (Wednesday, October 26, 2011)

[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