“Question: I need to take a California Designated Representative training course. What kind of topics will be covered in an approved training program?
Answer: It depends on the kind of California Designated Representative license type you are applying for. In other words, the required topics are different for the wholesaler, third-party logistics provider (3PL), and reverse distributor. . . .”
It’s happening here in Florida! More than 400 scientists, entrepreneurs, investors and biotech industry experts are expected to gather in Fort Lauderdale this month for the annual BioFlorida conference.
“It is designed “to showcase the business and scientific achievements in the industry and encourage collaborations and partnerships,” said Nancy Bryan, CEO and president of the West Palm Beach-based BioFlorida. Those in the industry have much to celebrate, as Florida’s biotech industry grew in companies and incubators by nearly 15 percent in 2017, one of the strongest results since 2008, according to BioFlorida.”
“A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.”
In the course of your work, you might have a need to verify a wholesaler’s license. Read on.
“Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. To verify a wholesale drug distributor is licensed in the state(s) where it is conducting business, use the link provided in the table below to access your state licensing authority’s database or contact information. (Note: The databases accessible through the links below are maintained by your state licensing authority.)
U.S. State Agencies Responsible for Licensing Wholesale Prescription Drug Distributors … “
The big license aftershock following the DSCSA earthquake came when the FDA redefined the parameters of 3PL companies. Before the passage of DSCSA, 3PL companies could be licensed as a wholesaler. Now, that’s no longer the case.”
Read the entire article to learn how the DSCSA impacts third-party logistics providers (3PLs).
“Another area of interest for TraceLink is blockchains, the online, distributed ledger systems that power cryptocurrencies such as Bitcoin. TraceLink is developing blockchain-based software to help the pharma industry meet certain track and trace requirements in the U.S. Drug Supply Chain Security Act, Dahod says. He says the company will release more details about the project by the end of the year.”
“A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.”
The Board requests, ” . . . that reports include explicit information as to why the wholesaler deemed the order suspicious. For example, indicate if (1) the order was of an unusual size, (2) the order deviated substantially from the normal pattern, or (3) the order was of an unusual frequency.”
Reference: On Oct.
7, 2017, Governor Brown signed
into law Assembly Bill 401.
This bill added Business and
Professions Code section 4169.1
“Cargo theft affects businesses across the globe. Beyond the direct cost of the stolen goods, missing cargo can have far-reaching supply chain implications. Threats to your company’s cargo can vary by commodity type, region and even day of the week. Understanding your product’s susceptibility to theft and developing appropriate strategies to reduce it can help protect your cargo and your business.”
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.