Friday, March 20, 2015

New Licenses Required For Third-Party Logistics Providers (3PLs)

Read the full article, "New Licenses Required For Third-Party Logistics Providers (3PLs)," recently published in the Winter 2015 edition of The Script - by the California State Board of Pharmacy (PDF):

"Companies that do not own, but receive, store, select and ship prescription drugs and prescription devices into or within California need to obtain a third-party logistics provider (3PL) license immediately with the California State Board of Pharmacy.

Federal legislation enacted in November 2013 directed that 3PLs must be regulated as a separate class and not as a drug wholesaler."

AB 2605 (a new law):
  • "Creates a new licensure class of 3PLs and nonresident 3PLs for those businesses that do not own, but receive, store and ship prescription drugs and prescription devices;
  • Creates a new licensure class of “designated representative-3PL” for individuals who work in the 3PLs and possess the knowledge and experience necessary to be responsible for the quality of stored and shipped prescription items on a 3PL premises; and
  • Creates a new qualifying category of licensure for a responsible manager called “designated representative-3PL,” who acts as the facility manager and representative in charge of the 3PL."
 For more information:

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Monday, March 16, 2015

FDA Establishes Public Docket on Drug Compounding - FDA.gov

Read the entire announcement: Compounding > FDA Establishes Public Docket on Drug Compounding - FDA.gov:

"However, stakeholders have expressed interest in providing comments and information to FDA on a variety of issues that are not related to the specific regulations, guidance documents or Federal Register notices that FDA has published. FDA has established this public docket so that stakeholders can share information, research, and ideas on any matters related to human drug compounding that are not specific to the documents or issues on which we have already sought public comment in other dockets."

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CA Designated Representative online web-based training certification by SkillsPlus Intl Inc - Available around-the-clock 24 x 7 - Available for iPad
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Thursday, March 12, 2015

Licensure Standards for DME Suppliers by Research and Markets | Business Wire

Read the full announcement: Research and Markets: Licensure Standards for Durable Medical Equipment Suppliers | Business Wire:

"Research and Markets (http://www.researchandmarkets.com/research/h8n856/licensure) has announced the addition of the "Licensure Standards for Durable Medical Equipment Suppliers" report to their offering.

This report addresses the states that have relevant licensure requirements for suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). The report includes a listing of each state's oversight agency for DMEPOS suppliers, links to online applications, references to included statutes and regulations, and licensure requirements/guidelines."

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CA Designated Representative online web-based training certification by SkillsPlus Intl Inc - Available around-the-clock 24 x 7 - Available for iPad
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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Monday, March 2, 2015

Cardinal Health To Acquire Cordis, A Worldwide Leader In Cardiac And Endovascular Medical Products For $1.944 Billion In Cash - Mar 2, 2015

Read the full article: Cardinal Health To Acquire Cordis, A Worldwide Leader In Cardiac And Endovascular Medical Products For $1.944 Billion In Cash - Mar 2, 2015 - Cardinal Health Media Room:

"Cardinal Health today announced plans to acquire Johnson & Johnson's Cordis business, a leading global manufacturer of cardiology and endovascular devices, for $1.944 billion in cash, or approximately $1.594 billion, net of the present value of tax benefits. The acquisition is expected to be financed with a combination of $1.0 billion in new senior unsecured notes and the remainder with existing cash. The transaction is expected to close in the United States and key non-U.S. countries towards the end of calendar 2015."

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Return Home:  The Designated Representative and Exemptee Blog

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc - Enhanced for iPad
The Exemptee Institute

CA Designated Representative online web-based training certification by SkillsPlus Intl Inc - Available around-the-clock 24 x 7 - Available for iPad
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

The Designated Rep and Exemptee Professionals Blog
SkillsPlus Intl Info Blog

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