“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.”
“In the face of a tough pricing market that has weighed on generic drugmakers and their distributors, wholesaling giant AmerisourceBergen has decided to go out and snarf up a bigger share. It will pay $815 million in cash for H. D. Smith, the largest independent drug distributor left in the U.S.”
“The Post-Dispatch was able to confirm through public records that Amazon has been approved as a pharmaceutical wholesaler in the states of Alabama, Arizona, Connecticut, Idaho, Louisiana, Michigan, Nevada, New Hampshire, New Jersey, North Dakota, Oregon, and Tennessee. An application in Maine is still pending.”
“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.”
“The state of California wants to revoke the wholesale license for a facility run by Cardinal Health, one of the nation’s largest pharmaceutical distributors, for failing to note a series of unusual sales of an opioid painkiller and three other tightly regulated medicines to a pharmacy.”
“We project that U.S. drug distribution revenues at the Big Three public wholesalers—AmerisourceBergen, Cardinal Health, and McKesson—will reach $425 billion in 2017, a 4.5% increase from the 2016 figure.” said Drug Channels Institute CEO Adam J. Fein, Ph.D., the study’s author and a widely regarded expert on pharmaceutical economics and the drug distribution system. “This is the slowest revenue growth since 2013. We also estimate that core U.S. drug distribution margins peaked in 2015 and have declined ever since.”
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.”
California 3PL Provider License – CA Board of Pharmacy
ICYMI – The California Board of Pharmacy oversees 3PL providers and their Designated Representative-3PL.
“Third-party logistics provider” means an entity that provides or coordinates warehousing or other logistics services for a dangerous drug or dangerous device in intrastate or interstate commerce on behalf of a manufacturer, wholesaler, or dispenser of the dangerous drug or dangerous device, but does not take ownership of the dangerous drug or dangerous device, nor have responsibility to direct its sale or disposition. … The Designated Representative-3PL Responsible Manager must file a separate application with the board if he or she is not already licensed as a Designated Representative-3PL in California. The application form is available by selecting the following link Designated Representative-3PL Application.