Tag Archives: decommissioning

Drug Samples Under Global Serialization and Tracing Regulations

istock-526070305-smallerSome pharma manufacturers make special packages of certain drugs that they give away to certain medical practitioners as a way of promoting the product and introducing the practitioner and their patients to it.  The method of distribution is usually through field sales people employed directly by the drug manufacturer, and the drug samples are delivered by them directly to the practitioner.

What could go wrong with that?  Probably diversion of the product contained within the “free sample” packaging back into the supply chain, but without the “free sample” indicator on the package.  Should these special packages be tracked?  Should they be serialized?  Continue reading Drug Samples Under Global Serialization and Tracing Regulations

The Coming Battle Over Decommissioning At The Pharmacy

Certificate of Serial Number Death
Certificate of Serial Number Death

The U.S. pharma supply chain will operate under two major phases as dictated by the Drug Supply Chain Security Act (DSCSA).  We are now operating under the first major phase.  Well, OK, it won’t be fully operational until July 1st when dispensers (see “Who Is A DSCSA Dispenser?”) are required to begin receiving, saving and retrieving Transaction Information (TI)Transaction History (TH), and Transaction Statements (TS) for each shipment they receive.  Drug manufacturers, repackagers and wholesale distributors were supposed to begin exchanging those documents on January 1st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).  But be aware that according to the DSCSA, as of January 1st, all trading partners must be properly licensed and everyone may only buy and sell drugs legally from/to companies who hold a valid State or Federal license.  Those and other requirements of the DSCSA were not delayed by the FDA.

The second major phase of the DSCSA will not occur until November 27, 2023 when the law transforms into something that is fairly nebulous right now.  That is, between now and Continue reading The Coming Battle Over Decommissioning At The Pharmacy