Plan ahead if you’re thinking about submitting a California Board of Pharmacy individual license application (e.g., California Designated Representative license).
As of this writing, here’s why:
The holiday season is here
Year-end business processes and activities could get in the way
California Designated Representative license application (wholesaler, 3PL) processing times can take some time. Based on September/October 2018 data, processing times could take anywhere between 13-39 days. If there are application deficiencies, it could add an additional 10-30 days of processing time.
The California Board of Pharmacy office relocation move was originally planned for February 2019, and could be delayed.
In a nutshell, plan ahead if you’re planning to submit a California Designated Representative license application.
“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. . . .”
“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.”
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).
“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.
“So, what about those future numbers? You may want to cover your eyes, as they are not pretty. According to the ATA, the driver shortage is projected to hit 50,000 by the end of 2017, with the possibility, if things remain the same, that the number could exceed 174,000 by 2026.”
Entities & Trading Partners Defined Under The DSCSA
“The Food and Drug Administration (FDA or the Agency) is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). DSCSA establishes product tracing requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers. DSCSA also requires that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must meet the applicable requirements for being “authorized trading partners.” DSCSA also requires FDA to issue regulations that establish Federal standards for the licensing of wholesale drug distributors (WDDs) and third-party logistics providers (3PLs). The Agency is currently drafting these regulations. This guidance, when finalized, will explain FDA’s current thinking on how licensing and certain other requirements apply to entities that may be considered trading partners in the drug supply chain.
This guidance is intended to (1) assist industry and State and local governments in understanding the applicability of DSCSA requirements to the various types of entities that take part in the distribution of prescription drugs in the United States, and (2) help clarify for industry whether they are engaged in activities that require licensure and annual reporting, as well as other requirements related to being an authorized trading partner in the drug supply chain. The guidance does not address all requirements described in DSCSA, but is limited to describing the activities that would determine what type of trading partner an entity may be and the applicable requirements under DSCSA.”