Thursday, April 23, 2015

California Board of Pharmacy Issues Licensing Guidance for 3PLs | iwla1891

Read the full article: California Board of Pharmacy Issues Licensing Guidance for 3PLs | iwla1891:

"The California Board of Pharmacy issued guidance this week outlining the process for obtaining the licensing as third-party logistics providers or non-resident third-party logistics providers in the state. This requirement extends to all 3PLs that ship pharmaceuticals to or from California.

Prior to the Drug Supply Chain Security Act (DSCSA), 3PLs were required to obtain licensing as a wholesaler—now 3PLs and wholesalers are separate entities under California law." . . .

"Please see the complete guidance and visit www.pharmacy.ca.gov to access the online application."

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California Designated Representative 3PL Training Course - Board-approved online training program for third-party logistics providers. Earns a training affidavit to include in your license application.
California Designated Representative 3PL Training Course - Board-approved online training program for third-party logistics providers. Earns a training affidavit to include in your license application.


For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Wednesday, April 8, 2015

Home Medical Device Retail Exemptee Training


Home Medical Device Retail (HMDR) Exemptee Training by SkillsPlus Intl Inc.

This online training course satisfies application requirements for anyone applying for an Exemptee License through the CA Department of Public Health, and who is responsible for overseeing prescription devices.

This web-based training course addresses the following areas of HMDR knowledge and training:
  • State and Federal laws relating to the distribution of: dangerous drugs & devices, and controlled substances
  • Safe storage and handling of: drugs (USP standards), and home medical devices
  • Prescription terminology, abbreviations, and format.
Learn more:  Home Medical Device Retail Exemptee Training by SkillsPlus Intl Inc.

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CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

Wednesday, April 1, 2015

InBrief: HDMA Updates DSCSA Q&A - RxTrace

Read Dirk Rodgers' full update: InBrief: HDMA Updates DSCSA Q&A - RxTrace:

"This is a very well thought through document that will help companies understand how wholesale distributors are interpreting confusing or ambiguous sections of the law.  The document leans heavily toward questions about how wholesale distributors will need to react in various situations, but it will also be a resource that manufacturers, repackagers and dispensers will want to obtain and review."

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Reference:
HDMA Questions and Answers on the Drug Supply Chain Security Act (March 1, 2015) - Click to download the PDF

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):


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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- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):


Thursday, March 12, 2015

Licensure Standards for DME Suppliers by Research and Markets

Updated December 1, 2025

The original link broke.

You might also be interested in:

DMEPOS Licensure Database - search by state and product
https://dominoapps.palmettogba.com/palmetto/npewest.nsf/DID/P4LF7PNQM8

---  the original post follows below  ---

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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- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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