[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Notices]
[Page 78371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30297]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0298] (formerly Docket No. 2004D-0499)


Compliance Policy Guide; Radiofrequency Identification 
Feasibility Studies and Pilot Programs for Drugs; Notice to Extend 
Expiration Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of expiration date.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
expiration date of compliance policy guide (CPG) Sec. 400.210 entitled 
``Radiofrequency Identification (RFID) Feasibility Studies and Pilot 
Programs for Drugs'' to December 31, 2010.

FOR FURTHER INFORMATION CONTACT: Ilisa Bernstein, Office of the 
Commissioner, Office of Policy, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 1, rm. 4341, Silver Spring, MD 20993-0002, 301-
796-4830.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 17, 2004 
(69 FR 67360), FDA announced the availability of CPG Sec. 400.210 
entitled ``Radiofrequency Identification (RFID) Feasibility Studies and 
Pilot Programs for Drugs.'' FDA has identified RFID as a promising 
technology to be used in the various efforts to combat counterfeit 
drugs. The CPG describes how the agency intends to exercise its 
enforcement discretion regarding certain regulatory requirements that 
might otherwise be applicable to studies involving RFID technology for 
drugs. The goal of the CPG is to facilitate performance of RFID studies 
and to allow industry to gain experience with the use of RFID 
technology and its effect on the long-term safety and integrity of the 
U.S. drug supply.
    On September 27, 2007, the Food and Drug Administration Amendments 
Act of 2007 (FDAAA) was signed into law. Section 913 of FDAAA addresses 
pharmaceutical safety and creates section 505D of the Federal Food, 
Drug, and Cosmetic Act (the act). Section 505D(b) of the act requires 
the development of standards for the identification, validation, 
authentication, and tracking and tracing of prescription drugs. Section 
505D(b)(3) of the act states that these new standards shall address 
promising technologies, which may include RFID technology.
    In implementing section 505D of the act, FDA is currently 
addressing issues, such as promising technologies, that are relevant 
also for the CPG. In addition, FDA is considering further the 
experience of stakeholders and the agency under the CPG. As we consider 
all of these issues, the CPG will remain in effect until December 31, 
2010.

    Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30297 Filed 12-19-08; 8:45 am]
BILLING CODE 4160-01-S