[Federal Register Volume 73, Number 55 (Thursday, March 20, 2008)]
[Notices]
[Pages 14988-14991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-5597]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0120]


Standards for Standardized Numerical Identifier, Validation, 
Track and Trace, and Authentication for Prescription Drugs; 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 seeking information 
and comments on issues related to standards for identification, 
validation, tracking and tracing, and authentication for prescription 
drug products. Particularly, we are requesting information and comments 
from drug manufacturers, distributors, pharmacies, other supply chain 
stakeholders, foreign regulators, standards organizations, and other 
Federal agencies and interested parties. This request is related to 
FDA's implementation of the Food and Drug

[[Page 14989]]

Administration Amendments Act of 2007 (FDAAA).
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a related document entitled ``Technologies for Prescription Drug 
Identification, Validation, Track and Trace, or Authentication; Request 
for Information.''

DATES: Submit written or electronic comments by May 19, 2008.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Ilisa Bernstein, Office of Policy, 
Office of the Commissioner, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-3360, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On September 27, 2007, FDAAA (Public Law 3580) was signed into law. 
Section 913 of this legislation created section 505D of the Federal 
Food, Drug, and Cosmetic Act (the act), which requires the Secretary of 
Health and Human Services (the Secretary) to develop standards and 
identify and validate effective technologies for the purpose of 
securing the drug supply chain against counterfeit, diverted, 
subpotent, substandard, adulterated, misbranded, or expired drugs. 
Section 913 directs the Secretary to consult with specific entities to 
prioritize and develop standards for identification, validation, 
authentication and tracking and tracing of prescription drugs. Section 
913 of this legislation also directs the Secretary to develop a 
standardized numerical identifier which, to the extent practicable, 
shall be harmonized with international consensus standards for such an 
identifier, no later than 30 months after the date of the enactment of 
FDAAA. This standardized numerical identifier is to be applied to a 
prescription drug at the point of manufacturing and repackaging (in 
which case the numerical identifier shall be linked to the numerical 
identifier applied at the point of manufacturing) at the package or 
pallet level, sufficient to facilitate the identification, validation, 
authentication, and tracking and tracing of the prescription drug.
    FDA has been engaged in an intense effort to address counterfeit 
drugs for several years. In 2004, FDA's Counterfeit Drug Task Force 
released a report (Task Force Report) outlining a framework for public 
and private sector actions that could further protect Americans from 
counterfeit drugs, including implementation of new track and trace 
technologies to meet and surpass goals of the Prescription Drug 
Marketing Act, the Federal pedigree law.
    In 2006, FDA issued an update report after conducting a fact-
finding effort to determine how much progress had been made toward e-
pedigree and electronic track and trace. FDA found that although 
significant progress was made to set the stage for widespread use of e-
pedigree in 2007, this goal likely would not be met. Currently, there 
is no widespread use of e-pedigree.
    Currently, e-pedigree is not in widespread use across the supply 
chain.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a related document entitled ``Technologies for Prescription Drug 
Identification, Validation, Track and Trace, or Authentication; Request 
for Information.'' This related document seeks information from 
technology vendors and others regarding available and emerging 
technologies for identification, validation, track and trace, and 
authentication of prescription drugs, as set forth in 505D(b)(3) of the 
act.
    With this document, as a first step in developing standards under 
section 505D(b) of the act, we are seeking information from drug 
manufacturers, distributors, pharmacies, other supply chain 
stakeholders, foreign regulators, standards organizations, other 
Federal agencies, and other interested parties related to 
identification, validation, authentication, and tracking and tracing of 
prescription drugs. Consistent with the act, it is FDA's preference 
that such standards be the result of existing private and public sector 
collaborative standards processes. FDA intends to use the response to 
these comments to determine the state of standards development in these 
areas and determine how aggressively it may move forward. Recognizing 
the importance of uniform standards as well as the need to allow for 
updating over time, FDA would consider adopting such standards through 
a guidance process as quickly as possible.

II. Request for Comments

    Please comment on the following questions regarding the development 
of standards related to section 505D of the act.

A. Standard Numerical Identifier

1. Characteristics
    a. Should the standardized numerical identifier contain 
recognizable characteristics (e.g., National Drug Code number) or be 
random codes?
    b. Should there be a common header for item/product segregation 
based on product type: biologic, solid oral dosage form, etc.? If so, 
please elaborate.
    c. How can parties in the supply chain ensure that the numbers are 
unique and are not duplicated?
    d. How much value would there be in having the numerical identifier 
in more than one place for the product (e.g., package and pallet 
level)?
    e. Should the numerical identifier be machine readable, human 
readable, or both?
    f. Should the numerical identifier include the lot number and/or 
batch number?
2. Standards
    a. Do standards currently exist for a standardized numerical 
identifier of prescription drugs?
    1. If so, please describe and comment on their application and use.
    2. To what extent do these standards reflect stakeholder consensus?
    3. Comment on whether any of these standards should be the standard 
adopted by FDA.
    4. If yes, why? Compare this standard with other standards that 
exist.
    5. If not, is there some aspect that could be changed to make it 
acceptable as the FDA standard?
    6. Has this standard been adopted by other countries?
    b. Are standards in development or planned for standardized 
numerical identifiers of prescription drugs in the supply chain? If so, 
who is developing these standards and what is the timeline for 
completion?
    c. What are the elements, provisions, and particular considerations 
that should be included in a standardized numerical identifier of 
prescription drugs? Please be specific in your response and include 
examples, where possible.
    d. Please comment on implementation of standardized numerical 
identifiers of prescription drugs in the U.S. supply chain.
    e. Please comment on any technical or information technology 
concerns related to a standardized numerical identifier.
    f. Comment on any ``lessons learned'' from foreign experience with 
standardized numerical identifiers.
3. Economic Impact
    a. What are the usual practices and associated costs that now exist 
for applying bar codes and other technologies for standardized 
numerical identifiers on packages and pallets?

[[Page 14990]]

    b. What are the associated costs for the application, use, and 
maintenance of standardized numerical identifiers?
    c. What are the associated costs or processes for updating the 
standards as needed?
    d. What are the benefits of using standardized numerical 
identifiers?
4. Harmonization With Other Countries
    a. What standards or unique identification systems do other 
countries have in place, currently under development, or planned for 
the future? If they are under development, please include a timeline 
for completion.
    b. Comment on any ``lessons learned'' from foreign experience with 
standardized numerical identifiers.

B. Standards for Validation

1. Do standards currently exist for validation of prescription drugs?
    a. If so, please describe and comment on their application and use.
    b. To what extent do these standards reflect stakeholder consensus?
    c. Comment on whether any of these standards should be the standard 
adopted by FDA.
    d. If yes, why? Compare this standard with other standards that 
exist.
    e. If not, is there some aspect that could be changed to make it 
acceptable as the FDA standard?
    f. Has this standard been adopted by other countries?
2. Are standards in development or planned for validation of 
prescription drugs in the supply chain?
    If so, who is developing these standards and what is the timeline 
for completion?
3. What are the elements, provisions, and particular considerations 
that should be included in a validation standard for prescription 
drugs? Please be specific in your response and include examples, where 
possible.
4. Please comment on implementation of validation of prescription drugs 
in the U.S. supply chain.
5. Please comment on any technical or information technology concerns 
related to validation.
6. Comment on any ``lessons learned'' from foreign experience with 
validation.

C. Standards for Track and Trace

1. Do standards currently exist for track and trace of products in the 
supply chain, generally?
    a. If so, please describe and comment on their application and use.
    b. To what extent do these standards reflect stakeholder consensus?
    c. Comment on whether any of these standards should be the standard 
adopted by FDA.
    d. If yes, why? Compare this standard with other standards that 
exist.
    e. If not, is there some aspect that could be changed to make it 
acceptable as the FDA standard?
    f. Has this standard been adopted by other countries?
    g. If standards are under development or planned for the future, 
please include a timeline for completion.
2. Do standards currently exist for track and trace of prescription 
drug products in the supply chain?
    a. If so, please describe and comment on their application and use.
    b. To what extent do these standards reflect stakeholders 
consensus?
    c. Comment on whether any of these standards should be the standard 
adopted by FDA.
    d. If yes, why? Compare this standard with other standards that 
exist.
    e. If not, is there some aspect that could be changed to make it 
acceptable as the FDA standard?
    f. Has this standard been adopted by other countries?
3. Are standards in development for track and trace of prescription 
drugs in the supply chain?
    If so, who is developing these standards and what is the timeline 
for completion?
4. What are the elements, provisions, and particular considerations 
that should be included in a track and trace standard for prescription 
drugs? Please be specific in your response and include examples, where 
possible.
5. Please comment on implementation of track and trace for prescription 
drugs in the U.S. supply chain, including, but not limited to, 
feasibility, costs, timeline, interoperability, information technology, 
and data storage.
6. Discuss how the data generated from track and trace should be held, 
where it should be held, concerns related to data security, and means 
for access to ensure interoperability for data sharing. What elements 
should be included in such a standard for data exchange, storage, and 
interoperability?
7. Comment on any ``lessons learned'' from foreign experience with 
track and trace.

D. Standards for Authentication

1. Do standards currently exist for authentication of products in the 
supply chain, generally?
    a. If so, please describe and comment on the application and use.
    b. To what extent do these standards reflect stakeholders 
consensus?
    c. Comment on whether any of these standards should be the standard 
adopted by FDA.
    d. If yes, why? Compare this standard with other standards that 
exist.
    e. If not, is there some aspect that could be changed to make it 
acceptable as the FDA standard?
    f. Has this standard been adopted by other countries?
2. Do standards currently exist for authentication of prescription drug 
products in the supply chain?
    a. If so, please describe and comment on the application and use.
    b. To what extent do these standards reflect stakeholders 
consensus?
    c. Comment on whether any of these standards should be the 
numerical identifier standard adopted by FDA.
    d. If yes, why? Compare this standard with other standards that 
exist.
    e. If not, is there some aspect that could be changed to make it 
acceptable as the FDA standard?
    f. Has this standard been adopted by other countries?
3. Are standards in development for authentication of prescription 
drugs in the supply chain?
    If so, who is developing these standards and what is the timeline 
for completion?
4. What are the elements, provisions, and particular considerations 
that should be included in an authentication standard for prescription 
drugs? Please be as specific as possible and include examples, where 
possible.
5. Please comment on implementation of authentication for prescription 
drugs in the U.S. supply chain, including, but not limited to, 
feasibility, costs, timeline, interoperability, information technology, 
and data storage.
6. Comment on any ``lessons learned'' from foreign experience with 
authentication.

E. Prioritization

Please comment on the priority for development and implementation of 
identification, validation, authentication, and tracking and tracing 
standards.
    1. Should certain standards be developed and implemented before 
others?
    2. Should certain standards be developed and implemented 
concurrently?

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments and information. Submit 
a single copy of electronic comments and information or two paper 
copies of any mailed comments and information, except that individuals 
may submit one paper copy. Comments and information are to be 
identified with the name of the technology and the docket number

[[Page 14991]]

found in brackets in the heading of this document. A copy of this 
notice and received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.


    Dated: March 13, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-5597 Filed 3-19-08; 8:45 am]
BILLING CODE 4160-01-S