“Specifically, how to mark pharmaceutical products with a National Drug Code (NDC), serial number, lot number, and expiration date in both machine-readable and human-readable format will be covered, as will the use of GS1 identifiers, application identifiers, and data carriers.”
“For 10 years, the government waged a behind-the-scenes war against pharmaceutical companies that hardly anyone knows: wholesale distributors of prescription narcotics that ship drugs from manufacturers to consumers.”
“Many in the industry had speculated that Amazon was making the investments in logistics networking merely to avoid future delays in shipping goods during peak season, as the e-tailer had experienced before with integrator such as FedEx and UPS. But the NVOCC license suggests that Amazon is interested in becoming a permanent player in the 3PL market.”
“Users either can query the database when searching for a particular company here or download the entire data set as an Excel file from this page. Although technically the law only requires a public wholesale distributor database, FDA determined that making the 3PL information public as well served the law’s goals, and it stated in a December 2014 policy document that: “The ultimate goal is for the public database to serve as a single repository of licensing and facility information for wholesale drug distributors and 3PLs conducting business in the United States.””
“They attributed the increase to growing pressure to expand services, increase geographic footprints and drive scale in specific markets. Consolidating firms will need to weather significant industry restructuring and navigate brand confusion in some markets, the report said.
This year, meanwhile, respondents expected those large 2014 deals to lead to defensive acquisitions by other firms.”
“Many years ago, I worked for a very insightful CIO who mastered communications to senior executive management. Often, when he received pressure regarding systems maintenance budgets associated with mission critical business systems such as order fulfillment, he would use an analogy of flying on a jet aircraft. “Do you expect the pilots to upgrade or change an engine while flying at 30,000 feet.” Of course not, and that is why diligent and timely maintenance and backup plans exist.”
“Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for failure to comply with the DSCSA’s two major product-tracing requirements for dispensers until November 1, 2015.”
“The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015.
“On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act (“DSCSA”) prior to May 2015. The guidance, states in relevant part:” . . .
There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for product tracing will continue to be phased in over the next nine years. FDA will continue working with trading partners and other stakeholders to effectively implement the new requirements.