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FDA Seeking Comments on How to Handle Prescription Drugs

Contributed by Joanne Kelleher

FDA Amendments Act of 2007 (FDAAA), Section 505D(b)(3) states that the standards developed for identification, validation, authentication, and tracking and tracing of prescription drugs shall address promising technologies, which may include(A) radio-frequency identification; (B) nanotechnology; (C)encryption technologies; and (D) other track and trace or authentication technologies.

As instructed by Congress in the FDAAA, the FDA is now seeking comments on these standards and technologies. Comments are due May 19, 2008.

FDA Federal Register Documents
Docket No. FDA-2008-N-0120, OC 200841. Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments. Pages 14988-14991 [FR Doc. E8-05597]

Docket No. FDA-2008-N-0121, OC 200842. Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information. Pages 14991-14992 [FR Doc. E8-05599]

http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2008&mn=3&dy=20

How to Comment on Proposed Regulations and Submit Petitions
http://www.fda.gov/opacom/backgrounders/voice.html

If you are involved in the pharmaceutical industry we encourage you to submit your comments.  This is your opportunity to share your views about security and privacy for RFID or other track and trace or authentication technologies.