A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box. A “homogenous case” is a case that Continue reading Identification Of Pharma Cases In The U.S.→
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distributors were supposed to begin exchanging those documents on January 1st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).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.
At the February 5, 2013 meeting of the California Board of Pharmacy the Board took the final vote to proceed with filing a number of important clarifying regulations–the first since the Ridley-Thomas bill was enacted in 2008 that established the current staggered effective dates. These include the recognition of the FDA Standardized Numeric Identifier (SNI) as the “unique identifier” for use on each drug package, and definition around how supply chain companies can grandfather their existing non-serialized, non-pedigreed stock at the time the law goes into effect.
The official minutes of the meeting are not yet available but the video has been posted for a few weeks now. The pertinent action occurs in the first video of the two day meeting at approximately 2:24:00 (hours:minutes:seconds). (Don’t you just love government meetings on YouTube?) The source text of the pending regulation (which is Continue reading The New Grandfathering Provisions Of The California Pedigree Law→
That’s right. We should all be ashamed of the way our supply chain handles drug recalls and we should do something about it. I will explain, but first, what is a drug recall?
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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Last week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA. But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use.
