[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Notices]
[Page 65750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22818]



[[Page 65750]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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 the compliance policy guide (CPG) entitled ``Sec. 
400.210--Radiofrequency Identification (RFID) Feasibility Studies and 
Pilot Programs for Drugs'' to December 31, 2008.

FOR FURTHER INFORMATION CONTACT: Ilisa Bernstein, Office of the 
Commissioner, Office of Policy, Planning, and Preparedness ( HF-11), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-3360.

SUPPLEMENTARY INFORMATION: On November 17, 2004, FDA announced the 
availability of the CPG entitled ``Sec. 400.210--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) (21 U.S.C. 355D). 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.
    As FDA considers the overlapping and complementary issues raised in 
the CPG and section 505D of the act, as well as the experience of 
stakeholders and the agency under the CPG, and whether to amend, 
revoke, or further extend the CPG, the CPG will remain in effect until 
December 31, 2008.

    Dated: November 15, 2007.
David Horowitz,
Assistant Commissioner for Regulatory Affairs.
[FR Doc. E7-22818 Filed 11-21-07; 8:45 am]
BILLING CODE 4160-01-S