The Drug Quality and Security Act (DQSA) was constructed back in 2013 by Congressional staff, with input from the FDA, members of the industry and who knows who else. There was one bill in the House of Representatives and a different bill in the Senate. Once these bills passed their respective houses, they formed a conference committee who merged the two bills into the final text that we know today as the DQSA (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). Chapter 2 of that act is the Drug Supply Chain Security Act (DSCSA). Most readers of RxTrace haven’t forgotten that history but it is important to look back at that history to explain why most companies can ignore certain requirements in the law. That’s right. There are requirements in the law that you can ignore because they will not be enforced by anyone. They are the result of the disjoint way the DQSA was written. Let me explain. Continue reading 3 DSCSA Requirements You Can Totally Ignore→
A couple of days before President Obama signed the DQSA legislation back in 2013 I published an RxTrace essay that looked at what was going to be necessary in the next year from the FDA and the industry (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure“). The initial standards necessary at that time were for data exchange, and the FDA had one year to come up with them. My essay was about the need for the industry to work with the FDA to come up with the standards that would work. The FDA didn’t have the expertise or the knowledge of how the supply chain operated and so I felt it was imperative for the industry to help them out.
Yesterday the FDA published a preview of two announcements related to the Drug Supply Chain Security Act (DSCSA). One was announcing a new pilot program, “…to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States.” That is, the system that will comprise the “Enhanced Drug Distribution Security” (EDDS) system in 2023. The other announcement was for a series of DSCSA public meetings—also intended to work on the system in 2023. Both announcements include a docket for use by stakeholders and the public to submit written comments to the FDA. Continue reading FDA Announces New DSCSA Pilot Program and Public Meeting Series→
RxTrace readers are already well aware that multiple new laws around the world will require prescription drug manufacturers to put a new 2D barcode on their products in the next few years. But what if your drug package is too small to fit the new mandated 2D barcode and human readable information on the label? Let’s take a look at what the regulations say in the E.U., Brazil and the United States. From that, we can come up with some strategies. Continue reading Is Your Drug Too Small For The Mandated 2D Barcode?→
I recently wrote about several letters sent to the FDA by the Pharmaceutical Distribution Security Alliance (PDSA) regarding the overdue guidance documents (see “In Absence Of FDA Guidance, Follow PDSA Recommendations”). I highly recommend that you read those letters. But there was one letter from the PDSA to the FDA that I did not reference in that essay because it is not related to missing guidance. Instead, it’s about PDSA’s fear about the potential inability of some manufacturers to verify, in the DSCSA sense, certain drugs between now and November of 2019. To be exact, the type of verification they are worried about is the kind that will be based on a drug’s Standardized Numerical Identifier (SNI). Continue reading Will Manufacturers Have Trouble Verifying Some Drugs Next Year?→
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.