HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act

President Obama signing new law“The Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act) was enacted on November 27, 2013. The act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S.

The law will transform how the domestic supply chain operates to the benefit of healthcare providers and pharmacists — and their patients. HDMA and the nation’s primary pharmaceutical distributors have long advocated for this national solution.

With enactment of the law:

All existing state pedigree requirements that went above and beyond the Prescription Drug Marketing Act (PDMA) of 1987 are immediately preempted. The baseline requirements of the original law will remain in place until January 1, 2015, when statutory requirements, assisted by guidances currently being developed by FDA, will go into effect.

In 2015, enhanced product tracing requirements begin, which over 10 years, will lead to the establishment of a single system of federal electronic, unit-level traceability requirements across the entire supply chain.

National distributor licensure standards also have been strengthened. Instituting strong, consistent distributor licensing standards is a critical component in ensuring that the supply chain remains safe and secure.”

Read the full article, and reference a great collection of fact sheets and educational material about this subject: via HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Share