Retrospective Review of Bar Code Final Rule

Food and Drug Administration Documents, 2011 Federal Information & News Dispatch, Inc., October 26, 2011

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 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/

FOOTNOTE 1 Department of Health and Human Services, ” Plan for Retrospective Review of Existing Rules, ” pp. 21-22 (August 22, 2011). END FOOTNOTE

* 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 (SUBSEC 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. 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/

FOOTNOTE 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. END FOOTNOTE

–This is a summary of a Federal Register article originally published on the page number listed below–

Notice; request for comments.

CFR Part: “21 CFR Parts 201 and 610”

Citation: “76 FR 66235”

Document Number: “Docket No. FDA-2011-N-0719”

Federal Register Page Number: “66235”