“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.”
California Board Of Pharmacy Designated Representative Training
When you’re applying for a California Designated Representative license, you’ll need to include proof of training from a training program that covers specified topics listed on the Designated Representative license application that you’re applying for (i.e., wholesaler, 3PL, reverse distributor).
Here’s how to go about getting that proof of training, specifically, the Board’s training affidavit form. You’ll need to earn a completed training affidavit, filled out by the company that provided the training. California Board Of Pharmacy Designated Representative Training by SkillsPlus International Inc. teaches three (3) distinct online training programs (for wholesalers, 3PL, reverse distributors), and all three (3) online courses are approved by the California State Board of Pharmacy. Successful course completion earns a training affidavit, accepted by the California Board of Pharmacy, to include in your license application.
The California Board of Pharmacy oversees a wide range of Designated Representative licenses, including:
Designated Representative (for wholesalers)
Designated Representative 3PL (for third-party logistics providers), and
Designated Representative Reverse Distributor
Each of the three distinct license applications requires proof of training program completion. Specifically, license applicants must submit a training affidavit with their application submission. We offer three (3) different Designated Representative training courses because each license application “type” requires the coverage of different subjects and topics.