Tuesday, July 21, 2009

CA - Forms for Drug Wholesalers and Designated Representatives

There will be times when you need to submit new or revised forms to the CA State Board of Pharmacy. Here's a collection of forms that might be useful to drug wholesalers, and designated representatives.

Just a tip, make sure to pay attention to the requirements for when some of these forms need to be submitted. For example, changes in the designated representative in charge need to be reported within 30 days of a change.

Go to the California Board of Pharmacy - Applications and Forms Page


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The largest selection of Board-approved California Designated Representative online training programs. 3 distinct training courses for wholesalers, 3PL, reverse distributors. Earns a Board-recognized training affidavit.
The largest selection of Board-approved California Designated Representative online training programs. 3 distinct training courses for wholesalers, 3PL, reverse distributors. Earns a Board-recognized training affidavit.

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, July 14, 2009

Watch Your Back - I mean safety!

Updated October 23, 2022

The original link broke.

You might also be interested in:

---  the original post follows below  ---

We all do some heavy lifting from time to time, so it's critical to pay attention to back safety. Here's a useful article from the NAW, Material Handling - Do's and Don'ts. The article frames the situation in this way:
Manual handling, and the twisting and turning that occur when they perform these tasks, can lead to musculoskeletal disorders (MSDs) or cumulative disorders (CTDs), such as injuries to the back, shoulder and neck. The cumulative effect of even minor injuries of this nature can become more pronounced over time.

Return Home:  The Designated Representative and Exemptee Blog

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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, July 9, 2009

Reinforce Key Regulatory Messages - Use Posters

Updated 12/6/2022

The original links broke, as the posters are no longer available.

---  the original post follows below  ---

Drug wholesaler designated representatives and medical device exemptees often need to recruit the help of staff around them to ensure the company complies with regulatory requirements.

If you're looking to make your company's training or quality programs more robust, consider using posters to reinforce your key messages.

SkillsPlus International Inc. announces, "Poster! Posters! and More Posters!" in the release of their brand new GMP poster series, SkillsPlus International Inc. - GMP Good Manufacturing Practice and QSR Quality System Regulation - Large Posters (23" x 35"). Alternatively, you can also scan their offerings in the SkillsPlus GMP Poster Catalog. I find these posters strikingly beautiful, and convey very simple and understandable messages.

By the way, if you think these posters don't apply to your work situation, I encourage you to think twice. Many of them apply to many diverse work settings. Folks have been clamoring for more work-related posters, so it's great to see these new additions to poster offerings. Check it out!

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SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog

Tuesday, July 7, 2009

CA HMDR FAQs

California Home Medical Device Retail FAQs

Here's something you might find helpful, The CA Home Medical Device Retailer (HMDR) licensing program Frequently Asked Questions (FAQs) - find this PDF on the California Home Medical Device Retail Program website

Here are the questions that are answered:
  1. What is an HMDR business and who needs an HMDR license from the DHS, Food and Drug Branch?
  2. Where can I get an HMDR license application and what are the fees?
  3. Are there exceptions to the kinds of facilities that are required to have an HMDR license?
  4. What is the licensing process and how long does the process take?
  5. Can I operate my HMDR business without a valid license?
  6. After my facility is inspected, how long afterwards must I wait for my facility license?
  7. If my facility fails to meet compliance standards, what happens?
  8. If I move or sell my business, can my license be transferred?
  9. What is a Temporary License, and what are the criteria for receiving one?
  10. What are dangerous or “legend” devices?
  11. I wish to dispense legend medical devices from my HMDR. Do I need a special license?
  12. How can I obtain an HMDR exemptee license?
  13. Can I obtain an exemptee license without working at a HMDR facility?
  14. What about HMDR renewal inspections? How frequently are they conducted, and what are some common violations found?
  15. How can I get a copy of the HMDR Law and/or guidance on requirements?
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California Exemptee Training - SkillsPlus International Inc. - for home medical device retailers (HMDR) - $525 per student - state approved
California Exemptee Training - SkillsPlus International Inc. - for home medical device retailers (HMDR) - $525 per student - state approved

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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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