Showing posts with label faq. Show all posts
Showing posts with label faq. Show all posts

Friday, September 25, 2020

HMDR Renewal Inspection Violations - for home medical device retailers

Updated May 26, 2026

Common California HMDR Renewal Inspection Violations

Renewal Inspections & Frequency

“Renewal inspections can take place annually, unannounced, at any HMDR facility during normal business hours. A customer complaint or other referral may also trigger an inspection.”

Some Common Inspection Violations

“Common violations of the California Health and Safety Code include: 

  • Dispensing prescription devices without a valid HMDR exemptee on the premise
  • Lack of dispensing records for prescription devices
  • Inadequate procedures for the cleaning and maintenance of rental devices
  • Inadequate staff training or patient/caregiver consultation
  • Inadequate quality assurance procedures and/or lack of documentation of quality assurance procedures.”

Source: California Home Medical Device Retailer (HMDR) Frequently Asked Questions (PDF) -  the source document is no longer available on the California Home Medical Device Retail Program website


Return Home:  The Designated Representative and Exemptee Blog

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For Home Medical Device Retailers. If you are applying for a California HMDR Exemptee license, you need to include proof of required training in your application. Take this online course to earn a course completion certificate for 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):

Friday, February 5, 2016

Where Do I Send Fingerprint Cards? - California Designated Representative

Question:
Where do I send my fingerprint cards for the California Designated Representative application?

Answer:
  • Non-California Residents must submit fingerprints, using the Board's fingerprint cards (unless the applicant is able to visit California to obtain Live Scan fingerprinting service).
  • You must submit new fingerprint cards with the application, even if those were submitted to the Board with other applications.
  • For complete and detailed instructions on fingerprinting, please reference the application form instructions.

Resources:


The top choice in DR and Exemptee training!
The top choice in DR and Exemptee training! Learn more about our Designated Representative and Exemptee online training courses.


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):

Monday, November 2, 2015

Didn't Pass The Florida Certified Designated Representative (CDR) Examination?

Updated March 15, 2026

Question:
I took the Florida Certified Designated Representative Laws and Rules Examination, and did not pass. What could happen next?

Answer:
"A candidate who fails to achieve the required passing score on the examination must wait 30 days before retaking the examination. A candidate will have 18 months, from the date they are authorized to test, to pass the examination. After 18 months the candidate must reapply to the Department. Pertinent reexamination information is provided to all affected candidates along with the original grade report"  (source: Florida CDR CIB)

'via Blog this'

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):

Tuesday, May 6, 2014

HMDR Frequently Asked Questions (FAQs) - California Department of Public Health

Updated January 9, 2025:

Sadly, the state has removed the FAQ document.

---  the original post follows below  ---

HMDRLawsandFAQ-EM - find this PDF on the California Home Medical Device Retail Program website

". . . the compiled Frequently Asked Question (FAQ) list.  These questions were collected during the establishment of the HMDR Program and represent the most frequently answered questions documented by department staff."

'via Blog this'

View the:  California Dept of Public Health - Home Medical Device Retailer (HMDR) Frequently Asked Questions List (PDF) - find this PDF on the California Home Medical Device Retail Program website

Here's a bonus FAQ:



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, January 8, 2013

HMDR FAQs - Now Available from CDPH!

Updated June 4, 2025

The HMDR FAQs are available on the California Department of Public Health Home Medical Device Retail Program website.  (NOTE: the CDPH inconsistently posts the FAQ document)

"The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety Section and is governed by law 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.  Also found below is a link to the compiled Frequently Asked Question (FAQ) list. "

'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, December 27, 2011

Some FL CDR Permitting FAQs

This is a pretty good FAQs page.

Many are specifically related to Certified Designated Representative (CDR).

FL Dept of Business and Professional Regulation - Permitting FAQ's - Drugs, Devices and Cosmetics Program '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, August 16, 2011

CA HMDR FAQs

Updated September 12, 2025

Sadly, the FAQ PDF is no longer available on the CDPH website.

---  the original post follows below  ---

CA HMDR FAQs:  CA HMDR FAQs - find this PDF on the California Home Medical Device Retail Program website

Return Home:  The Designated Representative and Exemptee Blog
SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog

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:  
Return Home:  The Designated Representative and Exemptee Blog

Tuesday, May 25, 2010

Common HMDR Renewal Inspection Violations

Updated June 9, 2026

The PDF is no longer posted on the program's website.

---  the original post follows below  ---

California HMDR renewal inspections can take place annually, unannounced, at any HMDR facility during normal business hours. A customer complaint or other referral may trigger an inspection.

Common violations reported include:
  • Dispensing legend devices without a valid HMDR exemptee on premise
  • Lack of dispensing records for legend devices
  • Inadequate procedures for the cleaning and repair of rental devices
  • Inadequate staff training or patient/caregiver consultation
  • Inadequate record of complaints or review of customer complaints to prevent reoccurrence
Source:   California HMDR FAQ Listing (PDF) - find this PDF on the California Home Medical Device Retail Program website

Return Home:  The Designated Representative and Exemptee Blog

Buy now! California Exemptee license training certification course
Buy now! California Exemptee license training certification course


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, April 6, 2010

CA HMDR Commonly Asked Questions

Navigating the paperwork can be daunting. Here's a helpful document for folks having some questions, California (CA) Home Medical Device Retailer (HMDR) Frequently Asked Questions - find this PDF on the California Home Medical Device Retail Program website.


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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):

Tuesday, December 15, 2009

FAQ: Designated Representative or Exemptee?

Updated May 25, 2022

Unfortunately, the originally linked document is no longer available.

---  the original post follows below  ---

Question:

Am I a "Designated Representative" or "Exemptee" in the eyes of the California State Board of Pharmacy?

Answer:
Designated Representative.

According to the DESIGNATED REPRESENTATIVE* - REQUIREMENTS AND APPLICATION 17M-27 (Rev. 1/08):

Under California law, the name used to describe any individual who is in charge of any wholesale drug premises (in California or elsewhere) will change on January 1, 2006, from the former name, exemptee, to designated representative. For conventional use, the board will refer to such an individual as a designated representative throughout this application.

Return Home:  The Designated Representative and Exemptee Blog

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California Board of Pharmacy Designated Representative Training Courses | by SkillsPlus Intl Inc.  - for wholesalers, 3PL, and reverse distributors. Board Approved.
California Board of Pharmacy Designated Representative Training Courses | by SkillsPlus Intl Inc.  - for wholesalers, 3PL, and reverse distributors. Board Approved.


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 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?
Return Home:  The Designated Representative and Exemptee Blog

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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