Sunday, October 28, 2012

What is HMDR Exemptee Training?

What is HMDR Exemptee Training?

SkillsPlus International Inc. is a long running provider of training to home medical device retailers (HMDR) and durable medical equipment (DME) wholesalers.

Since 2002 SkillsPlus has provided up-to-date training for their clients. This website page, California Exemptee HMDR and DME Providers Certification Course,  provides information specific to the California Exemptee certification course. For those seeking two certifications, this course also meets the requirements for the Board of Pharmacy California Designated Representative.

California requires home medical device retailers to retain an on-site Exemptee to conduct their business. The Exemptee must be physically present during all hours of operation. This course is recommended by, and meets the training requirements of, the CA Department of Public Health, and covers:
  • California Code of Regulations 
  • Business and Professions Code 
  • Prescription Drug Laws 
  • Controlled Substances 
  • USP Storage Conditions 
  • Health and Safety Code 
Prospective Exemptees can meet the training requirement by taking SkillsPlus Intl Inc.'s web-based, self-study class (that includes a final exam) for training certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed.

For more information:
California Exemptee HMDR and DME Providers Certification Course - by SkillsPlus International Inc.  (accepted by the California Department of Public Health - Food and Drug Branch)

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California HMDR Exemptee Training Certification Course


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

     California (earn a training affidavit):

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

     California (earn a training completion certificate):


Wednesday, October 17, 2012

H.D. Smith to acquire West Coast wholesaler

H.D. Smith to acquire West Coast wholesaler | Drug Store News:

"H.D. Smith, one of the largest pharmaceutical wholesalers in the United States, announced plans to acquire Valley Wholesale Drug in a merger agreement transaction.

The acquisition will increase H. D. Smith’s customer base in California and give the wholesaler an opportunity to expand into the Pacific Northwest, a market in which it currently has a limited reach."

'via Blog this'

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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, October 15, 2012

What Is A Pharmacy Designated Representative?

If you're new to the pharmacy world of the Designated Representative, maybe this quick introduction will help. I'm going to explain, using the California (CA) State Board of Pharmacy as the example.

According to the CA Designated Representative application form:
A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.
There are quite a number of requirements that have to be met in order to qualify, including the following training requirements listed on the application form:
Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.
The trick then becomes finding a way to fulfill the training program requirement.

You might also be interested in:

CA Designated Representative online training certification - for drug wholesalers
FL Designated Representative online exam preparation - for drug wholesalers


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CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
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Sunday, October 14, 2012

Florida drug database intended to save lives is barely used by doctors

Florida drug database intended to save lives is barely used by doctors - Tampa Bay Times:

"The system can help medical practitioners determine whether a patient has a legitimate medical need for these highly addictive medications — or is a drug abuser seeking the next high.

But the program came with a major loophole: Nobody is required to check it.

Now, a Tampa Bay Times investigation has discovered what experts feared — the vast majority of medical practitioners have never touched the much-touted database:"

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

FL Designated Representative online exam preparation for drug wholesalers

CA Designated Representative online training certification for drug wholesalers
CA HMDR Exemptee online e-Learning certification by SkillsPlus Intl Inc.

SkillsPlus Intl Info Blog

Thursday, October 11, 2012

Price Gouging: A Black Mark On Gray-Market Distributors

Added August 24, 2017

You might also be interested in this recent article:
States Take on Drug Price Transparency, Gouging - RAPS.org

- - -

Updated August 19, 2017

The original article is now "hidden" behind a webpage sign-in.

You might also be interested in this article:
Should the FDA Regulate Drug 'Gray Markets'? (PDF)

- -  original post follow below  - -

Pharmacy Practice News - Price Gouging: A Black Mark On Gray-Market Distributors:

"In response to the report’s critical findings, Patricia Earl, a consultant to the National Coalition of Pharmaceutical Distributors, told hearing attendees, “I cannot emphasize enough the value that small or secondary pharmaceutical distributors bring to the health care system.” She said there were “thousands of small distributors that work with hospitals across the nation. To remain competitive they must comply with laws, follow pedigree and handling regulations to the letter and still offer an economical price point that allows for only a modest profit margin. If they do anything else, they run the risk of permanently losing a customer.”"

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Return Home:  The Designated Representative and Exemptee Blog

Training program for California Designated Representative license applicants - Earn a training affidavit

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, October 10, 2012

Meningitis cases mount as ex-FDA lawyers fault agency for not stepping in

Updated February 15, 2022

The original link broke.

A lot has happened since this original post.  

Read more about the entire situation here:

---  the original post follows below  ---

Meningitis cases mount as ex-FDA lawyers fault agency for not stepping in | The Town Talk | thetowntalk.com: "

“The FDA should have put them out of business, and the state should have put them out of business. Neither of them did their job,” said Peter Barton Hutt, who was chief counsel at the agency in the 1970s.

In the wake of the outbreak, lawmakers this week are raising questions about the regulation of the compounding firms and whether the FDA should be given more oversight authority.

However, the FDA already has the power to rein in large-scale drug compounding companies under a 1938 law, Hutt said.

“The statute is clear,” Hutt said. “First, you can’t stockpile under any circumstances, and if there is an approved drug, you can’t compound a competing drug.”"

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

- - -

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, October 5, 2012

Rare Fungal Meningitis Outbreak Spreads To Six States including FL

Rare Fungal Meningitis Outbreak Spreads To Six States : Shots - Health Blog : NPR:

"It's a troubling story authorities think will unfold over the next month or so. An untold number of Americans who got steroid injections in their spine to relieve back pain may end up with a rare fungal meningitis. The drug was contaminated with the spores of a common leaf mold — nobody knows how.


Dr. Lucille K. Georg/CDC - [includes a photo of the] head of an Aspergillus fungal organism, a common leaf mold that most people breathe in every day without getting sick.

So far, the Centers for Disease Control and Prevention has recorded 35 cases of the fungal meningitis in six states: Tennessee, North Carolina, Florida, Virginia, Maryland and Indiana. Five patients have died."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

FL Designated Representative online CBT exam preparation - for pharmacy wholesalers

CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.
CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog

Medical Equipment Technology - New Opportunities for Growth

Medical Equipment Technology - New Opportunities for Growth - Accenture:

"Companies will instead need to adapt and develop new business models to meet healthcare systems changing demands. They will need to align and build up their own capabilities, evaluate models of innovation and new partnerships that can help to unlock future growth opportunities.

The aim of this point of view is to outline three future top growth opportunities for medical equipment manufacturers in the context of the healthcare megatrends driving the industry today and in the future."

'via Blog this'
Return Home:  The Designated Representative and Exemptee Blog

CA HMDR Exemptee online training certification - for HME retailers and wholesalers

CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.
FL Designated Representative online CBT exam preparation by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog


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