Companies that participate in the U.S. pharma supply chain and are subject to the U.S. Drug Supply Chain Security Act (DSCSA) are preparing to meet the FDA’s 2015 deadlines for exchanging Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for every shipment. Those preparations include integrating the generation, transmission, confirmation, storage and retrieval (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”) of these documents into their existing supply chain and regulatory compliance processes. It is a big deal and it affects a large number of companies. Continue reading DSCSA Exception Handling: A Preview of Your Next Surprise Headache
RxTrace is pleased to announce a partnership with the Pharmaceutical Traceability Forum, taking place March 30-April 1 in Boston, MA. In line with the upcoming regulatory and compliance deadlines, the Pharmaceutical Traceability Forum is the #1 event bringing together the brightest minds in the industry to discuss personal experiences and best strategies for preparing your serialization programs for 2015 and beyond.
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distributors were supposed to begin exchanging those documents on January 1st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).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
Before the passage of the Drug Supply Chain Security Act (DSCSA) on November 27, 2013, the pharma industry was focused pretty well on getting the California-mandated serial numbers on 50% of their drug packages by last Thursday (January 1, 2015), and the remainder of their products by next January. But that mandate evaporated by federal preemption as soon as the Federal bill was signed into law. From that moment on, everyone turned their sights toward meeting the data exchange requirements of the DSCSA by last Thursday (see “DQSA: How Should Transaction Data Be Exchanged?”). Of course, just before Christmas, the FDA pushed that effective date out to May 1, 2015 (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).
That extension in enforcement is a blessing to a few Continue reading Pharma Industry Attention Returns to Serialization