As expected, the FDA has published the draft guidance on standards for paper and electronic data exchange that was mandated by the U.S. Drug Supply Chain Security Act (DSCSA). And the guidance is early–by one day–fulfilling the intent of the FDA as expressed in the DSCSA Data Exchange workshop held last spring (see “The 2014 FDA DSCSA Workshop“).
A while back I posted an essay called “Who Is A DSCSA Dispenser?”. I don’t think many actual dispensers read it because about half of the dispensers I run into think the earliest they have to do anything is July of next year. The other half don’t think there is anything in the Drug Supply Chain Security Act (DSCSA) about them at all. Too bad. Both are wrong.
Fortunately I think repackagers know better. At least they should, because the DSCSA contains a lot of specific requirements for them. Repackagers have most of the same requirements that manufacturers do, plus they have many of the wholesale distributor requirements. A double whammy.
Most people in the industry know what a repackager is. Typically they are companies that buy drugs from a manufacturer or a wholesale distributor and then open the packages and put the drug into a new package type. This can include putting the drug into a larger or smaller quantity package, or from bottles into blister cards or even unit dose packs for use in an automated picking machine. It can also include companies who Continue reading Who Is A DSCSA Repackager?→
…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.