Document ID: FDA-2004-D-0298-0005
Agency: fda
Document Type: Notice
Title: Compliance Policy Guides: Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
Posted Date: 2010-12-23T05:00Z

[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Page 80827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32274]

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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, 2012.

FOR FURTHER INFORMATION CONTACT: Connie Jung, Office of the 
Commissioner, Office of Policy, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, rm. 4254, 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.'' Previous extensions of the expiration date 
of the CPG were published in 2007 and 2008 (72 FR 65750, November 23, 
2007; 73 FR 78371, December 22, 2008). 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 addressed 
pharmaceutical safety and created section 505D of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355e). Section 505D(b) 
of the FD&C Act requires the development of standards for the 
identification, validation, authentication, and tracking and tracing of 
prescription drugs. Section 505D(b)(3) of the FD&C Act states that 
these new standards shall address promising technologies, which may 
include RFID technology.
    In implementing section 505D of the FD&C 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, 
2012.

    Dated: December 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32274 Filed 12-22-10; 8:45 am]
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