> ![](media/image1.png){width="1.9in" height="0.5576388888888889in"}
>
> August 9, 2002
>
> Dockets Management Branch (HFA-305)
>
> Food and Drug Administration
>
> 5630 Fishers Lane, Rm. 1061
>
> Rockville, MD 20852
>
> RE: Bar Code Label Requirements for Human Drug Products; Notice of
> Public Meeting
>
> \[Docket No. 02N-0204\]
>
> To Whom It May Concern:

Cardinal Health (http://www.cardinal.com) is the leading provider of
products and services supporting the health-care industry. Cardinal
Health companies develop, manufacture, package, and market products for
patient care; develop drug-delivery technologies; distribute
pharmaceuticals, medical-surgical, and laboratory supplies; develop and
market automated dispensing equipment and related technologies; and
offer consulting and other services that improve quality and efficiency
in health care. Headquartered in Dublin, Ohio, the company employs more
than 49,000 people on five continents.

> We commend the Department of Health and Human Services and the Food
> and Drug Administration for exploring rule making relative to the bar
> coding of pharmaceuticals and for inviting comments from interested
> parties. As a company committed to improvements in safety, quality,
> and efficiency in health care, we look forward to working with you on
> this important topic. We hear consistently from our provider-based
> customers that they need immediate, creative solutions to help them
> improve quality, increase productivity and efficiency, and manage
> costs in their delivery of care. Improved patient safety is among
> their very top concerns. Our mission is to help our customers find
> solutions to the challenges they face.
>
> The comments that follow are in response to the specific questions
> posed by the FDA in its solicitation of comments.

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 bar code?

> [Comments]{.underline}:

-   Bar-code standards should be identified for the immediate
    unit-of-use (e.g., unit-dose) package for prescription
    pharmaceuticals (including blood products and vaccines) and those
    OTCs specifically packaged for and sold for use in the institutional
    setting.

> Technology necessary to utilize machine-readable codes for the
> explicit purpose of reducing medication errors is virtually
> non-existent in all but the institutional setting, and there is
> currently no evidence that suggests that labeling with
> machine-readable codes would reduce medication errors in
> non-institutional settings. Further, bar codes for OTCs in the retail
> setting are based upon UPC numbers, not upon NDC numbers, and a
> mandatory change in that system would occur only with great expense
> and disruption while yielding no discernable patient safety benefit.
>
> Any FDA regulation that would require that all drug products --
> regardless of the setting for use -- be labeled with machine-readable
> code would increase costs associated with and delay implementation of
> this important patient safety, bar-code initiative. An unintended
> consequence of the latter would be lost opportunity in the
> institutional setting to prevent errors readily avoidable with today's
> standards and technologies.

-   Unit-dose bar codes should be placed on all drug dosage forms
    possible while considering extenuating circumstances such as space
    issues related to very small ampules and vials and unique
    characteristics of certain packaging materials. The latter is
    illustrated by the material used in the "blow-fill-seal" process
    employed for producing one-piece, plastic, ampule-like containers
    commonly used for respiratory therapy agents. Labeling for these
    containers must be imprinted directly into the packaging material as
    it cannot be labeled with adhesive labels or directly with ink.

> 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.
>
> [Comments]{.underline}:

-   The FDA should establish and implement uniform bar-code standards
    for the immediate unit-of-use (e.g., unit-dose) package for
    pharmaceuticals including blood products, vaccines, and OTCs
    specifically packaged for use in the institutional setting.

-   Bar-code elements should include, at a minimum, the NDC number using
    a linear, one-dimensional bar-code symbology conforming to current,
    commonly accepted industry standards. The NDC number -- the standard
    drug identifier mandated by FDA regulation and currently used
    extensively within the health- care industry -- provides for the
    identification of the manufacturer/distributor, drug product, and
    package size. When the NDC number is incorporated into the bar-code
    label on the immediate unit-of-use package (e.g., a unit-dose
    package), critical data elements can be captured *via* the scanning
    process prior to drug administration to ensure that the patient
    receives the appropriate drug and dose.

-   Relative to machine-readable labeling, secondary identifiers, e.g.,
    lot number and expiration date which are currently provided as
    human-readable labeling, do not represent as significant a
    contribution to patient safety (i.e., medication error reduction) as
    does the NDC number. It is recognized that, with implementation of
    scanning processes, these identifiers, if incorporated into
    machine-readable labeling, could contribute marginally to patient
    safety *via* the potential to identify recalled medications and
    expired (outdated) medications, respectively, immediately prior to
    the administration of the drug. However, data supporting the value
    of these secondary identifiers when incorporated into
    machine-readable labeling appears to be absent -- except in the case
    of biologicals such as blood products and vaccines. Moreover,
    management of recalled or expired medications should occur upstream
    from the point of drug administration. In institutional settings,
    other systems based upon the human-readable labeling of the lot
    number and expiration date are generally in place to identify and
    remove recalled or outdated medications. Human-readable labeling for
    both lot number and expiration date should still be required.

-   When the state of technology ensures a minimal negative impact on
    cost and adoption rate, secondary identifiers (e.g., lot number and
    expiration date) should also be included in labeling as
    machine-readable code. With current technology, the inclusion of
    secondary identifiers as machine-readable code would represent an
    unqualified increase in the costs of medication and devices.

> **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?**
>
> [Comments]{.underline}:

-   Initial requirements should be limited to one-dimensional
    symbologies (including any such symbology that conforms to current,
    commonly accepted industry standards) incorporating the NDC number
    only. A two-dimensional symbology (or other format) enabling
    incorporation of secondary identifiers (e.g., lot number and
    expiration date) should only be adopted when technology supports a
    cost/benefit justification. Current scanners are capable of reading
    different symbologies, and many scanners, new or otherwise, are
    capable of reading various types of linear bar codes with minimal
    software upgrades. Therefore, a less prescriptive requirement that
    does not limit the machine-readable symbology, mandate a
    two-dimensional symbology, or impede the development of other
    "auto-identifiers" would minimize expense and avoid delays that
    otherwise would be associated with the adoption of machine-readable
    labeling and scanning among health-care providers. As noted
    previously, the contribution of machine-readable secondary
    identifiers such as lot number and expiration date to the reduction
    in medication errors has not been documented -- except in the case
    of biologicals (e.g., blood products and vaccines). Therefore, any
    FDA mandate for a two-dimensional symbology for all prescription
    drugs would appear to be premature and thus unwarranted at the
    present time.

-   Highly reliable scans will be critical to the adoption of
    machine-readable scanning among health care providers.

> **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?**
>
> [Comments]{.underline}:

-   The FDA should not limit flexibility by specifically mandating the
    location of the bar code on the package and other bar-code features
    that are only peripherally related to patient safety. Issues of
    package size, shape, and material will require flexibility relative
    to bar-code placement. Rather than consistency in location, the more
    critical factor in the adoption of scanning practices is thought to
    be the achievement of consistently successful, reliable scans by the
    health-care practitioner (e.g., nurse) on all products, including
    small or rounded packages.

-   FDA should evaluate the process for label changes that may be
    necessary to accommodate inclusion of bar codes. Additionally, the
    FDA may need to consider eliminating some labeling information
    currently required in order to provide adequate space for placement
    of the bar code.

-   The failure of the FDA to effectively address the two elements cited
    above might contribute to an unintended consequence of some
    manufacturers/distributors discontinuing unit-dose packaging or
    substantially increasing the cost of unit-dosed products to the
    health-care provider.

-   

> **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.**
>
> [Comments]{.underline}:

-   The vast majority of intermediate packages (e.g., shipping units or
    units-of-sale) of medications are commonly bar-coded for
    supply-chain purposes (e.g., logistical efficiencies, inventory
    management, etc.), and the current system supports these purposes
    well. The FDA should avoid regulation that would mandate changes at
    the level of such intermediate packaging that would be disruptive to
    the current system or otherwise increase costs.

-   Only a minority (from our experience, approximately 30%) of
    medications is bar-coded at the dose level (i.e., at the level of
    the immediate unit-of-use or unit-dose package). Therefore,
    health-care providers implementing scanning processes at the point
    of medication administration in an effort to reduce medication
    errors must complement that minority with products repackaged by
    themselves or by third-party repackagers. Either of the latter
    scenarios introduces additional costs secondary to the repackaging
    process (e.g., costs associated with supplies, labor, and quality
    control functions). Moreover, such repackaged products have
    shortened expiration dating and shorter shelf life potentially
    resulting in an additional cost associated with product
    obsolescence.

-   The adverse labor impact on hospitals initiating an internal
    repackaging solution should not be minimized given the recognized
    shortage of pharmacists and pharmacy technicians that exists
    nationally.

## 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.
>
> [Comments]{.underline}:

-   The major benefits to be derived from bar coding of medical devices
    are believed to be related to efficiency gains and cost reductions
    in supply-chain logistics.

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-   Medical devices should be bar coded and, for the most part, to the
    unit-of-use level; however, some exceptions would exist (as will be
    discussed in response to the following question). The
    machine-readable information should include a primary identifier --
    i.e., the UPN number. Secondary identifiers (e.g., lot number and
    expiration date) should not be required until such time as a
    two-dimensional symbology (or another format) enabling incorporation
    of such secondary elements can be justified on the basis of costs to
    benefits.

> 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.
>
> [Comments]{.underline}:

-   Clearly, a requirement to bar code all medical devices, especially
    consumables such as band-aids or tongue depressors, to the
    unit-of-use level would be impractical, cost-prohibitive, and would
    not increase patient safety. The examples cited in the question are
    indeed illustrative, but by no means are they exhaustive.

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-   As in the case of pharmaceuticals, the lack of space on the current
    packaging of some medical devices at the unit-of-use level is a
    barrier to the inclusion of machine-readable code in the product
    labeling. The FDA should evaluate the process for label changes that
    may be necessary to accommodate inclusion of bar codes and may need
    to consider eliminating some labeling information currently required
    in order to provide adequate space for placement of the 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 bar codes be
> different from the original manufacturers' bar codes?
>
> [Comments]{.underline}:

-   Reprocessed, repackaged, refurbished, or multiple-use medical
    devices should be bar coded consistent with the requirements for
    other medical devices, i.e., medical devices from the original
    manufacturer. The bar code affixed to such products should be the
    responsibility of the reprocessor/repackager and should identify the
    reprocessor/repackager. Additionally, it may be important for the
    customer to identify the number of times the product has been
    repackaged, refurbished, etc.

4.  What public health/patient safety benefits can be derived from bar
    coding medical devices? If data exists, please provide it for the
    record.

> [Comments]{.underline}:

-   As noted above, the major benefits to be derived from bar coding of
    medical devices are believed to be related to efficiency gains and
    cost reductions in supply-chain logistics. An extension of these
    benefits to a public health benefit could be made in the case of a
    major disaster (e.g., a major terrorism attack) in which large
    quantities of medical devices would be required in quick fashion.
    Again, however, the value of bar coding in this scenario would be
    derived from the labeling of intermediate containers (e.g., shipping
    units) and not from the labeling at the unit-of-use level.

> [General Comments re: Medical Device Questions]{.underline}:
>
> The bar coding of medical devices is indeed a very complex issue --
> even more complex than that of bar coding pharmaceuticals.

-   A mandate to incorporate machine-readable labeling on medical
    devices at the unit-of-use level clearly will impact production
    costs and thus the cost of health- care delivery in this country.
    However, the value of any such mandate -- at least from the
    perspective of patient safety -- is highly questionable. Yet, a
    mandate to standardize on a common primary identifier (i.e., UPN
    number) and to incorporate that identifier as machine-readable code
    on intermediate containers (e.g., shipping units, units of sale) has
    clear benefits relative to supply-chain logistics. The FDA should
    move forward with rule making specific to medical devices only in
    collaboration with the medical device industry and the health-care
    provider community.

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-   Issues relating to the bar coding of medical devices should not in
    any manner hinder or otherwise delay the FDA's action relative to
    rule making regarding the bar coding of pharmaceuticals.

### 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?**
>
> [Comments]{.underline}:

-   Any FDA requirement mandating bar coding of drugs to the immediate
    unit-of-use package (e.g., the unit-dose blister package) will
    impact manufacturers'/distributors' production costs to varying
    degrees depending, in part, upon:

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-   what elements (e.g., NCD number, lot number, and expiration date)
    must be labeled in machine-readable code and

-   whether a one-dimensional or two-dimensional symbology is adopted.

> Consequently, if FDA regulations are overly burdensome, a concern
> exists that some manufacturers/distributors would exit the unit-dose
> market or substantially increase the cost of unit-dosed products to
> the provider, thus producing an unintended consequence that would be
> contrary to the patient-safety focus of the original mandate.
> Therefore, the FDA should critically evaluate any requirement in terms
> of its impact on production costs (e.g., costs associated with machine
> re-tooling, potential throughput reductions, increased consumption of
> packaging materials, etc.).
>
> **2. Have you implemented bar code technology in your product line? If
> so, what elements and symbology are included in the bar code?**
>
> [Comments]{.underline}:

-   Bar-code technologies are currently utilized for some of our
    companies' products. Specific to drugs, the primary element
    (identifier) that is bar-coded is the NDC number using various
    one-dimensional symbologies.

> **3. If you manufacture and bar code products, how do verification
> requirements for bar codes affect your ability to add bar codes? How
> much bar code verification is appropriate as part of the quality
> system?**
>
> [Comments]{.underline}:

-   The cost associated with 100% verification of machine-readable code
    during the packaging process (i.e., production) is significant from
    several perspectives: re-tooling (e.g., incorporating appropriate
    in-line scanners), run set-up, and throughput. The impact associated
    with two-dimensional symbologies is far greater than that associated
    with one-dimensional symbologies. Regardless of the symbology
    adopted, the FDA should accept a statistical process control (SPC)
    methodology -- rather than 100% in-line verification -- relative to
    the machine-readable codes.

> **4. Can bar codes be produced with a dose specific unique identifying
> number, lot number, and expiration date at your highest production
> line speeds?**
>
> [Comments]{.underline}:

-   No, not using current technologies and 100% in-line verification.

> **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.)?**
>
> [Comments]{.underline}:

-   Machine-readable technologies are commonly used in most sectors of
    health care today -- but primarily for supply-chain efficiencies,
    not patient safety. Moreover, the use of these technologies is
    primarily associated with shipping units or units-of-sale (e.g.,
    SKUs) -- not for immediate unit-of-use (e.g., unit-dose) packages.

-   Specific to the use of machine-readable technologies at the level of
    the immediate unit-of-use (e.g., unit-dose) packaging, acceptance
    and adoption would appear to be clearly driven by a patient-safety
    focus and dominantly in the institutional setting for reasons
    discussed previously. Until recently, the approach among both
    manufacturers/distributors and health-care providers (e.g.,
    hospitals) to such technologies had been akin to the "chicken or
    egg" question. Today, however, with the increased focus on patient
    safety in both the public and private sectors, providers -- i.e.,
    hospitals -- have begun to embrace machine-readable technologies as
    a critical tool to reduce medication errors, especially at the point
    of drug administration. As discussed previously, those hospitals
    that have been on the leading edge of this movement have had to
    implement repackaging programs, either internally or externally
    through a third-party repackager, and at considerable expense. These
    organizations are leveraging this commitment to patient safety in
    their respective market places and thus are stimulating additional
    interest in these technologies among their competitors. If the
    barrier of limited availability of machine-readable drugs at the
    dose level is overcome -- e.g., *via* FDA regulations -- deployment
    of such technologies in the institutional setting is expected to
    increase much more rapidly going forward. (Further adoption in the
    non-institutional sectors will most probably be limited to shipping
    units or units-of-sale (e.g., SKUs) and driven by supply-chain
    initiatives rather than patient safety.)

-   The primary barriers to adoption of machine-readable technologies
    among institutional providers of health care relate directly to
    financial issues (e.g., lack of capital for acquisition of the
    technologies as well as the on-going expense associated with the
    technologies -- additional drug packaging costs being an example)
    and the lack of readily available, commercially packaged drugs with
    machine-readable labeling at the dose level.

-   Machine-readable technologies are currently providing considerable
    benefits within the health care supply chain -- logistical
    efficiencies, inventory management, etc.; however, as noted
    previously, these benefits are derived from labeling at the shipper
    or unit-of-sale (e.g., SKU) level of packaging. The primary benefit
    of machine-readable labeling at the dose level is clearly one of
    patient safety through the prevention of medication errors at the
    point of administration. Although other benefits might be realized
    from the latter labeling, these are considered to be marginal.

-   Inclusion of secondary identifiers (i.e., lot number and expiration
    date) would provide some potential value in supply-chain processes
    by enabling an automated approach to managing recalled or expired
    (outdated) medications, processes that today are largely manual.

> **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 certain compliance time sharply reduce costs of relabeling?**
>
> [Comments]{.underline}:

-   Any final rule requiring bar coding on medications to the immediate
    unit-of-use (e.g., unit-dose) level would require a transition or
    phased implementation. The timeframe for full implementation would
    be dependent upon a number of variables relative to the regulation's
    scope:

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-   products/setting: If limited to prescription drugs and to OTCs
    specifically packaged for institutional use, the implementation
    should be quicker than if the regulation were to encompass all drugs
    including all OTCs.

-   elements/symbology: If the coding is limited to the NDC number using
    a linear, one-dimensional bar-code symbology conforming to current,
    commonly accepted industry standards, the implementation should be
    quicker than if the regulation were to require inclusion of other
    machine-readable elements (e.g., lot number and expiration date) and
    thus a two-dimensional symbology.

In closing, we acknowledge that this is a very important topic and one
that must be carefully studied given the impact it will have on the
delivery of safer health care in our nation. We appreciate the
opportunity to provide our comments and suggestions in the hope they
will aid the Agency in its deliberations. If you have any further
questions regarding our comments, please feel free to call me at (614)
757-7769. On behalf of the Cardinal Health companies, thank you in
advance for your time and consideration.

Sincerely,

![](media/image3.png){width="3.022222222222222in"
height="0.5965277777777778in"}

Connie R. Woodburn

Senior Vice President

Professional and Government Relations

cc: James M. Hethcox

Anthony J. Rucci