To be in full compliance with pharmacy law, refer to Business and Professions Code (BPC) section 4059.5(a), which states:
“Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist.” (Emphasis added.)
The California Board of Pharmacy provided this latest update:
“Board staff were advised there have been significant delays in approvals necessary to begin construction within the office space. Based on these delays it is currently anticipated the move will occur in May or June 2019. Board staff continues to work with DCA and the Department of General Services and will continue to provide updates to the Organizational Development committee.”
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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.
“McKesson has announced the retirement of its chairman and CEO John Hammergen, effective March 31, 2019. The company’s board has unanimously elected Brian Tyler, who currently is president and COO of the San Francisco-based company, to succeed him as CEO, effective April 1, 2019. Edward Mueller, McKesson’s lead independent director, will become chairman, also effective April 1, 2019.”
“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.”
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 … “
“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
“Amazon is striving to make the patient’s access to medical supplies easier and comfortable with the help of this project. Notably, this project will allow the doctors to prescribe medical products necessary for their patients after a surgery or in general cases through the hospital’s online portal.”