[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]
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