“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”
SkillsPlus International Inc. proudly offers the largest selection of Board-approved California Designated Representative online training courses. Earns a Board-recognized training affidavit. More than 6,000 students trained!
California Designated Representative Online Training for Drug/Device Wholesalers
Heavy Phone Call Volume at The California State Board of Pharmacy Office
According to an email sent by the Board (dated July 22, 2019):
“The Board of Pharmacy is currently experiencing heavy call volume. If you are not able to reach staff by phone, please email us. Visit the Contact Us page on the board’s website, www.pharmacy.ca.gov., for an email address related to your concern.
The board’s main phone number is (916) 518-3100. Staff is available 8 a.m. to 5 p.m. Monday through Friday. Thank you for your patience and understanding.”
““Health care trends suggest that 2.5 million number is just going to continue to grow as more people opt to age in place,” Marriele Mango, lead author of the study and resilient power fellowship program associate for Clean Energy Group, told HHCN. “In the end, energy security just isn’t there for them in the way that it is in a nursing home, assisted living home or a hospital.”
In the event of a natural disaster, lack of energy security can be fatal.”
“DHL Supply Chain, the Americas leader in contract logistics and part of Deutsche Post DHL Group, is expanding its pharmaceutical and medical device distribution network by 40 percent this year with an investment of $150 million. With the ultimate goal of bringing critical healthcare products closer to trade partners and patients, DHL Supply Chain plans for nine new sites by the end of 2019. The investment includes costs to invest in new buildings and technology, as well as the fit-out and start-up of new or expanded operations.”
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.
“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. . . .”
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.