Showing posts with label internet. Show all posts
Showing posts with label internet. Show all posts

Monday, December 12, 2022

Happy Holidays!

Wishing you the best during the holidays!

Image of a dark red orchid
The best Designated Representative training. The best Exemptee training.

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):

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."

'via Blog this'

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

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):


Monday, November 19, 2012

California HMDR Exemptee Training Requirements

Q.  I'm submitting an application for a Home Medical Device Retailer (HMDR) Exemptee license, as a new applicant. What are the things that I need to pay attention to, regarding training requirements?

A.  According to the referenced CDPH HMDR license application form:
  • New applicants must meet minimum qualifications, including proof of completing a training program (that addresses 5 topic areas).
  • In order to prove training completion, the applicant must submit a copy of the completed training certificate (or transcript).
  • Specifically, in the Minimum Qualifications - Training Programs section: Indicate by yes or no the training you have completed specific to the five topics listed. Attach copies of certificates or transcripts.
Be forewarned, the application states, "Unsigned or incomplete applications cannot be processed and will be returned."

Reference:
Application for Home Medical Device Retailer (HMDR) Exemptee license - New and Renewal (Form CDPH 8695 (04/18))


California HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)

Return Home:  The Designated Representative and Exemptee Blog

-------------------------------------

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, November 14, 2012

California HMDR Law (Home Medical Device Retailer)

Updated January 26, 2022

HMDR Law and FAQ:
"The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety and Youth Tobacco Enforcement Section and is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law.  The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program.  This section of the Sherman Law can be found by following the link below.  It is in the Adobe PDF format so you will need an Adobe reader program to open and print the document."

'via Blog this'

California HMDR Sherman Law (FDB) 

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, November 9, 2012

Will The CA e-Pedigree Dates Slip Again?

Updated November 24, 2025

"In response to enactment of the [DSCSA] Act, the California Board of Pharmacy (Board) has issued a public notice stating that California's e-Pedigree provisions have been inactivated. The Board also noted that it will sponsor legislation this year to repeal the e-Pedigree provisions that have been inactivated."

Source:  
California Board of Pharmacy issues notice stating that it has inactivated California's e-Pedigree provisions:
https://www.lexology.com/library/detail.aspx?g=39a9104b-16b0-4b3b-8560-3053977dc425#

---  the original post follows below  ---

Another good read from Dirk Rodgers . . .

Will The California ePedigree Dates Slip Again?:

". . . AND MY PREDICTION IS…

I predict that it will NOT get delayed again.  Here’s how I arrive at that prediction.

Things are different now than any time prior to any of the earlier delays. . . ."

'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):

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)

Return Home:  The Designated Representative and Exemptee Blog

California HMDR Exemptee Training Certification Course


Return Home:  The Designated Representative and Exemptee Blog

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'

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):

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


Return Home:  The Designated Representative and Exemptee Blog

CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
Enhanced by Zemanta

Monday, July 2, 2012

Exemptee Must Be On Premises When Prescription Devices Are Being Dispensed

On the CDPH Application for Home Medical Device Retailer Exemptee License - New and Renewal (located on the CDPH HMDR Program webpage) there's a place for the Employer to certify that:
". . . it is my understanding that a person certified by the Food and Drug Branch must be on the premises and actively supervising operations at all times when prescription devices are being dispensed."

You might also be interested in this highly recommended course:
CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.

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):

Tuesday, May 1, 2012

No Significant Difference - Compares distance education to face-to-face

Updated August 26, 2021

The original link broke.

You can still explore the exact same topic at this website:

---  the original post follows below  ---

This body of research supports distance education as neither better or worse than face-to-face education.  Once you factor in cost and convenience, it would seem that online training is the big winner.

No Significant Difference - Presented by WCET:

"Does taking a course via distance education lower a student's chances for success as compared to the same student taking the same course in a face-to-face format?

Mr. Russell collected research studies addressing this question from as far back as 1928. The studies included in his collection involve a wide array of distance delivery modes including correspondence (printed materials sent out to students), radio, television, video, and online. Mr. Russell found that an overwhelming number of studies showed that when the course materials and teaching methodology were held constant, there were no significant differences (NSD) between student outcomes in a distance delivery course as compared to a face to face course. In other words, student outcomes in distance delivery courses were neither worse nor better than those in face to face courses. Mr. Russell referred to this collection of results as the "No Significant Difference Phenomenon", thus coining the now-common identifier phrase for this body of literature."

'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):

Monday, January 16, 2012

California HMDR Licensing Program - Home Page

CA HMDR Licensing Program Home Page:
"The HMDR Program is a CDPH program mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This Program licenses all California and Out-of-State facilities and businesses who supply medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. There are three distinct licenses issued by the HMDR Program, in-state California firms, out-of-state firms, and (pharmacist) exemptees who are required employees of firms selling prescription, dangerous medical devices as described under California and Federal medical device laws. . . . Please contact the home medical device retail desk at (916) 650- 6500 should you have further questions."

'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):

Tuesday, October 11, 2011

Select e-Learning That Is Pure, Safe and Effective

This post, Select e-Learning That Is Pure, Safe and Effective | SkillsPlus International Info: 'via Blog this', originally appeared on the SkillsPlus International Info Blog and is reproduced with permission from the author.

Selecting an online e-Learning course is really rather simple.
  1. Identify the course you really need. An Internet search is a great way to learn what is offered.
  2. If they boast about being the least expensive, remember that you get what you pay for. The best business advice I ever got from one of my accountants was, never purchase cheap.
  3. Compare the objectives of each course versus your requirements.
  4. Call the vendor and ask if there is a handout. If not, begin to wonder if the vendor is afraid that the lesson content may not be accurate and not stand up to a critical review.
  5. Ask to see a preview of the course. If they do not offer a free preview, question what they are hiding. Be concerned that you will be paying a lot of money to read a book on your computer screen.
Demand more!

Return Home:  The Designated Representative and Exemptee Blog

CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.
CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.
FL Designated Representative online CBT exam preparation by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
Enhanced by Zemanta

Monday, October 10, 2011

An E-learning Black Box Warning: Caution, This Course May Be Hazardous to Your Sanity

This post, An E-learning Black Box Warning: Caution, This Course May Be Hazardous to Your Sanity | SkillsPlus International Info:   'via Blog this', originally appeared on the SkillsPlus International Info Blog and is reproduced with permission from the author.

I have taken many e-learning courses over many years. Recently I purchased an e-learning course that really needed to carry a black box warning: Caution this course may be…

After purchasing the class I signed in and after some struggling I finally found the first lesson. I clicked the link that said “start.” Well it did, sort of. A PowerPoint slide popped up. Now, I like PowerPoint if done well. However, this slide was full of text so small that I could not read it except by switching to my large screen monitor. There were two paragraphs of text. Now I must admit that I am getting a little older and perhaps the eye glasses need an update. So I waited for something to happen. I waited and waited, until I realized this was it. Read the text baby. So read I did, clicked continued, and finally got to the quiz. While taking the quiz, I wanted to review some content. No, that was not allowed. I responded to the questions the best that I could. If I missed the answer, the only feedback I got was, Incorrect!.

After one lesson I decided that there had to be a better way to learn. I found someone who offered the course in a true online e-learning environment.

Watch tomorrow’s blog to learn how to choose an e-learning provider.

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):

Tuesday, October 4, 2011

FL CDR - Exam Grade Results


Updated February 4, 2026

According to the March 2024 version of the CDR CIB:

"Notification of Results. All candidates will receive an official photo-bearing exam result report immediately following completion of their examination. Please verify that all information is correct on your exam result report prior to leaving the test center. "


Florida Certified Designated Representative Candidate Information Booklet (CDR CIB)

CAUTION - there are old versions of the candidate information booklet (CIB) that can be found on the internet. Be sure you're referencing the most current version. Here's how to find it.

Go to the home page of the Florida Department of Business & Professional Regulation:
http://www.myfloridalicense.com/dbpr/

In the search box, enter "candidate information booklets."  Then click "DDC – Certified Designated Representative."

- - - - -  original post follows below  - - - - -

Once you've taken the Florida Certified Designated Representative Laws and Rules Examination - Computer Based Test (CBT), no doubt you'll be eager to find out your grade and whether you passed or not.

According to the Candidate Information Booklet for the Florida Certified Designated Representative Laws and Rules Examination - Computer Based Test (CBT), dated March 2011, here's how you'll get your score:
  1. Preliminary Score
    - The preliminary report is intended to give you a general idea of how you scored, but is not official or legally binding, and cannot be used to gain licensure or employment
    - On Screen:  The preliminary score will be given to you immediately following completion of the examination, and will appear immediately on the computer screen
    - On Paper:  A preliminary score report will be printed at the examination site
  2. Official Score
    - Scores may  be changed after expert review if they find a technical problem, misconduct, or unusual pattern in exam question responses.  This means that your preliminary score report may not reflect your true score.
    - Official examination results can be obtained online after ten business days from:
    Florida Department of Health - Examination Grade Report Search Page
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):

Custom Search

From SkillsPlus International Inc.