Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”). The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). But time spent by the FDA to meet their obligations under the DSCSA is “unfunded”. That is, Congress did not provide any specific additional money to pay for the FDA’s new obligations under the DSCSA. It is an unfunded mandate.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of RxTrace. The material contained in RxTrace is not legal advice. The writers of RxTrace are not lawyers. 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 RxTrace.