“Beginning not later than January 1, 2015…a wholesale distributor shall not accept ownership of a product unless the previous owner…provides the transaction history, transaction information, and a transaction statement…” –DQSA, Title…
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On November 18, 2013, the U.S. Senate passed the Drug Quality and Security Act (H.R. 3204), setting forth a series of new compliance requirements for the pharmaceutical manufacturers, distributors, and…
On September 24, 2013, FDA published the Unique Device Identification System final rule requiring device manufacturers distributing to the United States to carry UDI compliant labels and submit UDI data to the…
Serialization is a companywide initiative that spans multiple business units including engineering, operations, RA, QA, QC, supply chain, services, and IT. The sheer complexity of the project can be overwhelming…
The serialization and ePedigree project has many touch points with various operations. Approaching the project without a proper plan and the skillful project management bears the risk of scope creep, budget…
Effective January 1, 2015, manufacturers, wholesalers, and distributors are required by the California Pharmacy Pedigree Law to ship serialized products and track the product movement using ePedigree communications. Wholesalers and…