[Federal Register Volume 69, Number 221 (Wednesday, November 17, 2004)]
[Notices]
[Pages 67360-67361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25527]


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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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a new compliance policy guide (CPG) Sec. 400.210 
entitled

[[Page 67361]]

``Radiofrequency Identification Feasibility Studies and Pilot Programs 
for Drugs.'' The CPG describes the agency's intent to exercise 
enforcement discretion, until December 31, 2007, concerning certain 
regulatory requirements to facilitate the performance of feasibility 
studies and pilot programs involving Radiofrequency Identification 
(RFID) tags for drugs. The goal of the CPG is to allow industry to gain 
experience with the use of RFID technology to ensure the long-term 
safety and integrity of the U.S. drug supply.

DATES: You may submit written or electronic comments at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Compliance Policy (HFC-230), Office of Enforcement, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your request or include a fax number to which the guidance 
may be sent.
    Submit written comments on the guidance to the Division of Dockets 
Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit 
electronic comments to http://www.fda.gov/dockets/ecomments. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Paul Rudolf, Office of Policy (HF-11), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-3360.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 18, 2004, FDA published a report entitled ``Combating 
Counterfeit Drugs'' which is available on the FDA Web site at http://www.fda.gov/oc/initiatives/counterfeit. In that report the agency 
identified RFID technology as the cornerstone in the fight against 
counterfeit drugs and announced our intention to facilitate the 
adoption of RFID technology by participants in the pharmaceutical 
supply chain. We also stated that widespread adoption of RFID 
technology was feasible by 2007.
    Recently, FDA has received inquiries focusing on whether certain 
regulatory requirements, including those related to labeling, 
electronic records, and product quality, apply to pharmaceutical 
manufacturers, repackagers, relabelers, distributors, retailers, or 
others who participate in feasibility studies and pilot programs 
(collectively ``a study'' or ``studies'') using RFID tags for drugs. 
This CPG describes how we intend to exercise our enforcement discretion 
regarding such studies. The exercise of such enforcement discretion 
expires on December 31, 2007. The goal of this CPG is to facilitate the 
performance of RFID studies and allow industry to gain experience with 
the use of RFID.
    FDA is issuing this document as a level 1 guidance consistent with 
FDA's good guidance practices regulation (Sec.  10.115 (21 CFR 
10.115)). The new CPG Sec. 400.210 is being implemented immediately 
without prior public comment under Sec.  10.115(g)(2), because the 
agency has determined that prior public participation is not feasible 
or appropriate, but comments are welcome at any time. The agency also 
thinks that use of RFID technology is critical to ensuring the long-
term safety and integrity of the U.S. drug supply and immediate 
guidance is needed to facilitate studies of RFID.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance 
document. Submit two copies of written comments, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance and received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    An electronic version of this guidance is available on the Internet 
at http://www.fda.gov/ora under ``Compliance Reference.''

    Dated: November 10, 2004.
John Taylor,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-25527 Filed 11-15-04; 9:19 am]
BILLING CODE 4160-01-S