According to the California State Board of Pharmacy, “To be licensed as a Designated Representative – 3PL in California, you must satisfy the requirements under Business and Professions Code section 4053.1. Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider’s customer specifications, except where the customer’s specifications conflict with state or federal laws. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager.”
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The California Designated Representative training course for wholesalers is the most popular class offered by SkillsPlus International Inc.
SkillsPlus International Inc. has been providing this course continuously since 2002. We have a loyal following, having trained nearly 7,000 students who have taken one of our state license-related online training programs.
The pharmaceutical industry has been on the leading edge of anticounterfeiting and brand protection efforts for many years. “Anticounterfeit solutions are usually tailor-made according to the needs of the brand owner,” says Paavo Sillanpää, senior business manager, Pharma at UPM Raflatac.
A diverse strategy considering threat scenario and product is needed. “Most pharma companies have a multi-layered approach,” notes Farrell. The most common physical solutions are tamper-evident labels and packaging materials, designs that prevent the placement of a counterfeit product into the original packaging, serialization, and overt and covert authentication methods such as holograms, invisible markers, and taggants. “Ideally, multi-level security concepts should be used that are individually tailored to a specific use case, combining analog and digital features, which can be verified by different stakeholders within the supply chain,” says Dul.”
“The Drug Quality and Security Act (DQSA) was signed into law almost seven years ago on Nov. 27, 2013. Title II of this Act, known as the Drug Supply Chain Security Act (DSCSA), …
… initial requirements of the DSCSA, introduced in a phased manner, were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities. EDDS will be enabled by the establishment of standards for the interoperable exchange of data, combined with the inclusion of individual serial numbers in the product shipment transaction information transmitted for the NDCs/Lot #s sold and distributed. …
There is little doubt that the prescription drug product traceability and reporting requirements at the individual, serialized unit-level will require considerable planning, assessment, decision-making, change control, and execution. Manufacturers need to proceed quickly but thoughtfully and should approach this upcoming era of serialized product traceability holistically by expanding their objectives beyond achieving and maintaining compliance.”