Pay Attention To The Version! – Florida Certified Designated Representative (CDR)

Beware! – There are multiple versions of forms and booklets for Florida Certified Designated Representative (CDR) license applicants

Florida state websites are getting reorganized and redesigned. As a result, an internet search for Florida Certified Designated Representative (CDR) application forms and candidate information booklets can lead you to outdated versions.

At the time of writing this post, there are CDR forms and publications that have an effective date of December 2017 or January 2018.  In my small sampling of search results, I was able to locate a form as old as 2014.

If you’re not sure you’ve got the latest forms or publications, here’s what the 2018 application form says, “If you have any questions or need assistance in completing this application, please contact the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics, at 850.717.1800.”


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California Designated Representative Training Programs

Find California Designated Representative Training Programs – Earn a training affidavit

Question:  Who offers California Designated Representative training courses?

AnswerSkillsPlus International Inc. offers these popular online classes:


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Where To Get Live Scan Fingerprinting

California Designated Representative license applicants who are California residents must only use Live Scan fingerprinting (refer to the various Designated Representative license applications for additional information).

Here’s the link to find Live Scan locations in California


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New – California Designated Representative-Reverse Distributor License

California Designated Representative-Reverse Distributor License Created – New!

Designated Representative Reverse Distributor License – CA Board of Rx website

About California Designated Representative Reverse Distributor Training

California Senate Bill – SB 752 (Chapter 598, Statutes of 2017, Stone) Designated Representative-Reverse Distributor has been “chaptered” by the Secretary of State (enacted October 8, 2017). It includes the creation of a designated representative-reverse distributor license. At a high level:

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.


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AmerisourceBergen snaps up independent wholesaler H. D. Smith for $815M | FiercePharma

“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.”

Source: AmerisourceBergen snaps up independent wholesaler H. D. Smith for $815M | FiercePharma


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Amazon Has Obtained Pharmaceutical Wholesaler Licenses In 12 States – Consumerist

“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.”

Source: Amazon Has Obtained Pharmaceutical Wholesaler Licenses In 12 States – Consumerist


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California wants to pull Cardinal Health license over ‘red flags’

“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.”

Source: California wants to pull Cardinal Health license over ‘red flags’


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Drug Distributor Profits Will Remain Weak, Says New Drug Channels Institute Study

“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.”

Source: Drug Distributor Profits Will Remain Weak, Says New Drug Channels Institute Study


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FDA Clarifies DSCSA Entities And Trading Partners

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.”

Source:
Identifying Trading Partners Under the Drug Supply Chain Security Act – Guidance for Industry – DRAFT GUIDANCE (PDF)


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California Designated Representative Training Program – New Website

There’s a new website for California Designated Representative training

That website is intended for California Designated Representative license applicants.

Go to that new website:
Training program for California Designated Representative license applicants


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