Section 4040.5 of the Business and Professions Code is amended to read:
4040.5. “Reverse distributor” means every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs or dangerous devices.
Section 4022.6 is added to the Business and Professions Code, to read:
4022.6. “Designated representative-reverse distributor” means an individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling the duties of Section 4053.2 shall not be required to obtain a license as a designated representative-reverse distributor.
“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.”
“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.”
“The assessment shall be performed before July 1 of every odd-numbered year. The self-assessment forms must remain on-site at the facility. Only submit the form to the board if requested by board staff. The board is in the process of updating the Self-Assessment forms through a formal rulemaking. The updates include references to statutory and regulatory changes that occurred between 2014 and 2016. The last time the forms were formally updated was 2014.Current regulation requires a pharmacy or wholesaler to complete the 2014 version of the Self-Assessment form. Please be advised, however, the board will accept completion of either the 2014 version OR the 2016 version. The latter version is likely to be a more helpful assessment to the pharmacy or wholesaler completing it.”
“Specifically, how to mark pharmaceutical products with a National Drug Code (NDC), serial number, lot number, and expiration date in both machine-readable and human-readable format will be covered, as will the use of GS1 identifiers, application identifiers, and data carriers.”
The Florida Department of Business and Professional Regulation (DBPR) – Division of Drugs, Devices, & Cosmetics (DDDC) maintains a webpage full of commonly posed questions. Many of the questions are related to the Florida Certified Designated Representative (CDR) license: FL DBPR DDDC Permitting FAQs