Document ID: FDA-2010-N-0633-0001
Agency: fda
Document Type: Notice
Title: Determination of System Attributes for Tracking and Tracing of Prescription Drugs; Public Workshop
Posted Date: 2011-01-07T05:00Z

[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1182-1183]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-72]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0633]

Determination of System Attributes for the Tracking and Tracing 
of Prescription Drugs; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Determination of System Attributes for the Tracking 
and Tracing of Prescription

[[Page 1183]]

Drugs.'' This public workshop is intended to provide a forum for 
discussing potential approaches toward a track and trace system and 
obtaining input from supply chain partners on attributes and standards 
for the identification, authentication, and tracking and tracing of 
prescription drug packages, and to further the Agency's goal of 
protecting public health by securing the drug supply chain against the 
introduction of counterfeit and other substandard drugs.

DATES: The public workshop will be held on February 15 and 16, 2011, 
from 9 a.m. to 5 p.m. Submit electronic or written comments on the 
posted information or on the workshop to the docket by April 16, 2011.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, room 1503, Silver Spring, MD 20993. 
To register for the public meeting, e-mail your registration 
information to drug.trackandtrace@fda.hhs.gov. See section III of this 
document for registration details. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be 
identified with the docket number found in the brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Connie Jung, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-4830, e-mail: connie.jung@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Since the formation of the first Counterfeit Drug Task Force in 
2003, FDA has strongly advocated for a multi-layered approach to 
securing the supply chain and protecting consumers from the threats 
posed by counterfeit drugs. The ability to track and trace finished 
drug products in the supply chain plays a significant role in providing 
transparency and accountability in the drug supply chain. On September 
27, 2007, the Food and Drug Administration Amendments Act of 2007 
(FDAAA) (Pub. L. 110-85) was signed into law. Section 913 of this 
legislation created section 505D of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), which requires the Secretary of Health and 
Human Services (the Secretary) to develop standards and identify and 
validate effective technologies for the purpose of securing the drug 
supply chain against counterfeit, diverted, subpotent, substandard, 
adulterated, misbranded, or expired drugs. In addition, section 505D of 
the FD&C Act directs the Secretary to consult with specific entities to 
prioritize and develop standards for identification, validation, 
authentication, and tracking and tracing of prescription drugs.
    In March 2010, FDA issued a final guidance for industry which 
describes the Agency's current recommendation for standardized 
numerical identification (also known as serialization) for prescription 
drug packages (Standards for Securing the Drug Supply Chain--
Standardized Numerical Identification for Prescription Drug Packages, 
Guidance for Industry--Final Guidance \1\). This guidance is intended 
to be the first of several steps that FDA may take to implement section 
505D of the FD&C Act and further improve the security of the drug 
supply chain. As FDA continues to work on developing additional 
standards for securing the drug supply chain, the agency is seeking 
public input to ensure that we consider information regarding all 
supply chain participants.
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    \1\ http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm.
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II. Purpose of the Workshop

    This public workshop is intended to explore approaches for 
achieving an effective and feasible track and trace system for finished 
prescription drug products from the supply chain stakeholder's point of 
view, including industry and the public, and to obtain views on system 
attributes and standards that would facilitate identification, 
authentication, and tracking and tracing of prescription drug packages. 
We intend to discuss with stakeholders the necessary elements to 
accomplish effective authentication and identify desirable features of 
a track and trace system. Participants will not be asked to develop 
consensus opinions during the discussion, but rather to provide their 
individual perspectives.
    By February 4, 2011, FDA will post information on our Web site 
(http://www.fda.gov/Drugs/DrugSafety/ucm169828.htm) under ``Standards 
Development for Prescription Drug Supply Chain Security.'' as follows:
     Workshop agenda,
     Workshop discussion topics.

III. How To Register for the Workshop

    To register for the workshop either: (1) E-mail your registration 
information to drug.trackandtrace@fda.hhs.gov or (2) mail your 
registration information to the contact person (see FOR FURTHER 
INFORMATION CONTACT). Registration information should include 
registrant name, company or organization, address, phone number, and 
email address. Registration requests should be received by February 1, 
2011. Registration is free. Seats are limited. FDA may limit the 
numbers of participants from each organization based on space 
limitations. Registrants will receive confirmation upon acceptance for 
participation in the workshop. Onsite registration on the day of the 
meeting will be based on space availability on the day of the event 
starting at 8 a.m. If registration reaches maximum capacity, FDA will 
post a notice closing meeting registration for the workshop on FDA's 
Web site at: http://www.fda.gov/Drugs/DrugSafety/ucm169828.htm. If you 
need special accommodations due to a disability, please contact Connie 
Jung (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance.

IV. Parking Information

    If you are driving to FDA's White Oak Campus, you should proceed to 
the South East Surface Parking Lot to park your vehicle. Shuttle 
service is available from the bus shelters in the South East Lot to 
Building 1. The FDA campus is a Federal facility, therefore all meeting 
attendees must enter through Building 1 and follow security procedures.

    Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-72 Filed 1-6-11; 8:45 am]
BILLING CODE 4160-01-P