[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74668-74669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30297]


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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, 2014.

FOR FURTHER INFORMATION CONTACT: Connie Jung, Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 51, Rm. 4268, Silver Spring, MD 20993-
0002, 301-796-3130.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 17, 2004 
(69 FR 67360), FDA announced the

[[Page 74669]]

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, 2008, and 2010 (72 FR 65750, November 23, 2007; 73 
FR 78371, December 22, 2008; 75 FR 80827, December 23, 2010). 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 (Pub. L. 110-85) (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 must 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 also are 
relevant 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, 
2014.

    Dated: December 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30297 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P