2011-72. 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.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Determination of System Attributes for the Tracking and Tracing of Prescription 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 [e-mail]. 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: [e-mail].

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.

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 [e-mail] 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.

Footnotes

1.  http://www.fda.gov/​RegulatoryInformation/​Guidances/​ucm125505.htm.