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California Designated Representative Online Training for Drug/Device Wholesalers
“The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product.
If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.”
“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.”
“Supply chain theft is estimated at $35-40 billion per year in the US, and today’s threats to the commercial supply chain are different than those of the past. Logistics companies are perfect targets, and those that aren’t aware of the changes are more likely to fall prey.”
“Brandman discussed why theft-related loss is getting worse, and said that the value of the product plus a low risk factor, lax security and an inadequate criminal justice system equals high gain, low risk. Plus, says Brandman, the internet combined with small parcel delivery service make it easy to distribute stolen goods. Thieves – often internal – who work together can result in significant loss to the company.”
The Growing Trend of PBM Track-And-Trace Audits – Frier Levitt
“Pharmacies are being asked [to] provide transaction history, transaction information, and transaction statement, and to maintain such records for not less than six years after the transaction.”
“Pharmacies are expected to ensure that wholesalers provide the aforementioned information at the time of purchase or be in a position to provide this information at the time of a request. Such requests are being made despite pharmacies having purchased from duly, licensed, and verifiable wholesalers.”
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.)
“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.”
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.”