Tuesday, September 28, 2010

FDA - Medical Devices and Disaster Preparedness

Updated March 17, 2026

Whether it's a hurricane, gas main explosion, or something else, it's important to be thinking about how it'll affect one's use of a medical device in the setting of a disaster, according to FDA Offers Tips about Medical Devices and Hurricane Disasters.

The recent devastating gas main explosion in San Bruno, CA, just 20 minutes by car from where I live, highlights the need for preparedness.

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Tuesday, September 14, 2010

HMDR - Home Medical Device Retailer License Applications

We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students.

HMDR - Home Medical Device Retailer License Applications

According to the California Department of Public Health (CDPH), the California Home Medical Device Retailer (HMDR) License Applications page:
"links to the current application forms for both the firm license application needed by each individual facility location where home medical devices (prescription Rx devices and non prescription devices) will be sold, leased or rented when ordered by a physician or other prescriber. The application for the HMDR exemptee is also linked here for firms who wish to sell prescription Rx devices such as respiratory equipment, medical oxygen and other equipment identified as dangerous or legend devices under California law."

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California HMDR Exemptee Training Certification Course for home medical device retailers (accepted by the California Department of Public Health - Food and Drug Branch)
California HMDR Exemptee Training Certification Course for home medical device retailers (accepted by the California Department of Public Health - Food and Drug Branch)


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, August 31, 2010

CA Pharmacy - Wholesaler Surety Bond Info

Sign-up for Board-approved Designated Representative training:
Updated December 26, 2021

According to the California Board of Pharmacy - Instructions for Filing a Nonresident Wholesaler Application webpage, in addition to addressing other requirements, an application for a nonresident wholesaler must also include a surety bond or other equivalent means of security.

Here's how to find the forms and more information about surety bonds. I haven't provided the pdf links because it's important to me that you access the most current forms and information available. Therefore, it's best to follow this clickpath:  
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Tuesday, August 17, 2010

CA Pharmacy Designated Representative - Contact Information

Updated July 31, 2026

The Board has an updated Contact Us webpage. They've streamlined it, posting only very general contact information.

The most important change is a "Send a Message to the Board" feature. There is a Designated Representative option in the drop-down menu for the "Reason" of your message.

- -  the original post follows below  - -

Here's the contact information that appears on the California State Board of Pharmacy Designated Representative Requirements and Application Form:
California State Board of Pharmacy
1625 N. Market Blvd, Suite N219, Sacramento, CA 95834
Phone (916) 574-7900
Fax (916) 574-8618
http://www.pharmacy.ca.gov/

Source:  Form 17M-27 (Rev. 1.10)
 

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Training programs for California Designated Representative license applicants


- - -

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, August 3, 2010

Licensure Standards for Medical-Surgical Products Distributors - from HIDA

Updated 8/30/2021:

The original post below is out of date with broken links.

You might also be interested in: 
Licensure - HIDA.org

= = = original post follows = = =

I stumbled across this resource the other day and hope you can make use of it, Licensure Standards for Medical-Surgical Products Distributors.

It's intended to provide licensure information to single-state and multi-state distributors.

For more information:
Health Industry Distributors Association (HIDA)

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California Designated Representative Training and Exemptee Certification Training
California Designated Representative Training and Exemptee Certification Training - State Approved Courses

- - -

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, July 21, 2010

Group Letter - Repeal Medicare Competitive Bidding for HME and Services

Updated July 26, 2021

The original link broke.

You can still read about this topic here:

---  the original post follows below  ---

Thought you'd be interested in this Medical News Today article, Nearly 60 Homecare And Patient Advocacy Groups Urge Congress To Repeal Medicare's "Competitive" Bidding For Home Medical Equipment And Services.

Tyler J. Wilson, president of the American Association for Homecare in the open letter to Congress says:
"Our national, state and local organizations believe that this program is fundamentally flawed and will create significant obstacles to patient care while threatening the homecare infrastructure for our nation's seniors and disabled."

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Monday, July 19, 2010

FDA Orders Baxter Colleague Pump Refunds and Replacements


The FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall - Company must provide transition guide for facilities using Colleague infusion pumps.
 
In brief, in a Colleague Pump - Consent Decree letter to two Baxter executives, the FDA orders Baxter to take the following actions:

  • Recall and destroy all Colleague infusion pumps covered by the Consent Decree that are manufactured, distributed, or sold by Baxter or that are under the custody and control of Baxter's agents, distributors, or customers from the US market..
  • Provide either a replacement infusion pump (other than the Colleague model) or refund to all owners, and a lease termination to all lessees, of Colleague infusion pumps no later than the date that is twenty four months after the date of this final order (“the transition period”).
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