Posted by Joanne C. Kelleher
Late last week Congress sent to the White House H.R.3580. The full title of this legislation is “To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.”
The Pharmaceutical Security section of the bill states that the Secretary shall prioritize and develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs and shall develop a standardized numerical identifier to be applied to a prescription drug at the point of manufacturing and repackaging at the package or pallet level. RFID and Encryption are mentioned as potential technologies, but to protect the data on the RFID tag these technologies should be used together.
This bill sounds good, but there is no language about implementing these standards or requiring manufacturers, distributors and wholesalers to comply with them. A big issue to be determined is who will maintain and be responsible for the database that contains the standardized numerical identifier (and related data), how can supply chain stakeholders easily acccess this information for validation purposes and who will pay for it. With 30 months to determine the standardized numerical identifier, I don’t expect to see any implementations before Spring 2010. The next step is a signature from the White House. (Note: This was signed into law.)
The full legislative text of this section is below and was taken from The THOMAS database. Additional details can be found at http://thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.03580:
SEC. 505D. PHARMACEUTICAL SECURITY.
- (a) In General- The Secretary shall 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.
- (b) Standards Development-
- (3) PROMISING TECHNOLOGIES- The standards developed under this subsection shall address promising technologies, which may include–
- (4) INTERAGENCY COLLABORATION- In carrying out this subsection, the Secretary shall consult with Federal health and security agencies, including–
(A) radio frequency identification technology
(C) encryption technologies; and
(D) other track-and-trace or authentication technologies.
(A) the Department of Justice;
(B) the Department of Homeland Security;
(C) the Department of Commerce; and
(D) other appropriate Federal and State agencies.
(c) Inspection and Enforcement-
(d) Definition- In this section, the term `prescription drug’ means a drug subject to section 503(b)(1).’.