[Federal Register Volume 73, Number 55 (Thursday, March 20, 2008)]
[Notices]
[Pages 14991-14992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-5599]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0121]


Technologies for Prescription Drug Identification, Validation, 
Track and Trace, or Authentication; Request for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA) is requesting comments 
and information regarding technologies used for the identification, 
validation, tracking and tracing, and authentication of prescription 
drugs. This request is related to FDA's implementation of the Food and 
Drug Administration Amendments Act of 2007 (FDAAA).
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a related document entitled ``Standards for Standardized Numerical 
Identifier, Validation, Track and Trace, and Authentication for 
Prescription Drugs; Request for Comments.''

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

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

FOR FURTHER INFORMATION CONTACT: Ilisa Bernstein, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, rm. 14C-03, 
Rockville, MD 20857, phone: 301-827-3360, FAX 301-594-6777, 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 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. Specifically, section 913 
created section 505D(b) of the Federal Food, Drug, and Cosmetic Act 
(the act), which directs the development of standards for the 
identification, validation, authentication, and tracking and tracing of 
prescription drugs. Section 505D(b)(3) states that the standards 
developed under 505D ``shall address promising technologies, which may 
include--(A) radio-frequency identification; (B) nanotechnology; (C) 
encryption technologies; and (D) other track and trace or 
authentication technologies.''
    FDA has previously identified counterfeit drugs as a threat to the 
safety of the public and the pharmaceutical supply chain.
    1. In 2004, FDA's Counterfeit Drug Task Force issued a report (Task 
Force Report) on the threat of counterfeit medications and measures 
that can be taken by private and public stakeholders to make the U.S. 
drug supply chain more safe and secure. The 2004 Task Force Report 
stated, among other things, that:
     Widespread use of electronic track and trace technology 
would help secure the integrity of the drug supply chain by providing 
an accurate drug ``pedigree,'' which is a record of the chain of 
custody of the product as it moves through the supply chain from 
manufacturer to pharmacy;
     Radio Frequency Identification (RFID) is a promising 
technology as a means to achieve e-pedigree; and
     Widespread adoption and use of electronic track and trace 
technology would be feasible by 2007.
    2. In 2006, the Task Force issued an update report which stated 
that the goal of widespread use of e-pedigree and track and trace 
technologies by 2007 would probably not be met. The voluntary approach 
taken did not provide enough incentives for the adoption and 
implementation of the technologies and e-pedigree.
    As part of the efforts listed above, we received information about 
various technologies for the identification, track and trace, and 
authentication of prescription drugs, and we met with companies to 
learn more about these technologies. We are aware that significant 
progress has been made and new technologies are emerging for the 
identification, track and trace, and authentication of prescription 
drugs. In order to address the ``promising technologies'' related to 
standards development, as described in section 505D(b)(3) of the act, 
we are seeking information from technology vendors and others. Rather 
than meet individually with companies, for efficiency and to further 
our understanding and knowledge, we are requesting that information be 
submitted to the docket number listed above.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a related document entitled ``Standards for Standardized Numerical 
Identifier, Validation, Track and Trace, and Authentication for 
Prescription Drugs; Request for Comments.'' Under section 505D(b)(1) 
and (b)(2) of the act, this related document seeks information from 
drug manufacturers, distributors, pharmacies, other supply chain 
stakeholders, foreign regulators, standards organizations, and other 
Federal agencies and interested parties on issues related to standards 
for identification, validation, tracking and tracing, and 
authentication for prescription drug products.
    We are particularly interested in the following information 
regarding available and emerging technologies for identification, 
validation, track and trace, and authentication of prescription drugs:
    1. What are the RFID technologies, encrypting technologies, and 
nanotechnologies that are relevant? What are other relevant 
technologies?
    2. Please provide information related to:
     Strengths for identification, validation, track and trace, 
or authentication;
     Limitations for identification, validation, track and 
trace, or authentication;
     Costs of implementation and use;
     Benefits to the public health;
     Feasibility for widespread use;
     Utility for e-pedigree.
    3. Is the technology interoperable with other technologies? If so, 
describe.
    4. What standards are necessary for supply chain use of the 
specific technology? What is the status of development of such 
standards?

[[Page 14992]]

II. 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 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. E8-5599 Filed 3-19-08; 8:45 am]
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