Drug manufacturers facing the November 27, 2017 deadline for applying unique identifiers to their products should take care when interpreting the FDA’s recent draft compliance policy. All the headlines scream (including last week’s RxTrace essay: “FDA Delays Enforcement of DSCSA November Deadline: What It Means”) that the Drug Supply Chain Security Act (DSCSA) serialization deadline is delayed, but there are important nuances to the delay. Don’t just read the headlines, read the whole articles. Officially, the deadline remains the same. Yes, the FDA will look the other way for some drugs, but for others, the deadline still appears to apply. How do you know if your drugs are those where the deadline still applies? Read on. Continue reading DSCSA and RxTrace: The Song Remains The Same
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than Dirk Rodgers.
RxTrace, a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance.
Contact Us | Privacy Statement
Copyright © 2009-2017 Dirk Rodgers Consulting, LLC. All Rights Reserved.
RxTrace is a registered trademark of Dirk Rodgers Consulting, LLC
L, A, S, C