Showing posts with label facility. Show all posts
Showing posts with label facility. Show all posts

Thursday, April 19, 2018

New HMDR Application Forms Take Effect July 2018

Updated June 24, 2022

The original link broke. Use this one instead:
--  the original post follows below  --

New California Home Medical Device Retailer (HMDR) Applications Forms - Effective July 2018 (click this link)
  • Facility application forms
  • Exemptee application form
If you're looking to submit a facility or Exemptee license application, be sure you're choosing the correct form.  The HMDR home page (at the time of writing) posts the soon to expire "outgoing" forms, and the soon to become effective "incoming" application forms.

If you have questions about which version to submit, you might want to reach out to the HMDR office.  For example, if you look at the new Exemptee application, it states, "If you have any questions, please contact the Home Medical Device Retailer Exemptee Licensing Desk at (916) 341-7354, (800) 495-3232."

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 18, 2016

Be Ready! Common CDPH HMDR Facility Inspection Violations

Updated July 28, 2026

Common California HMDR Inspection Violations

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 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 HMDR FAQs on the Home Medical Device Retail Program website (unfortunately, the original source document is no longer posted).

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch
California HMDR Exemptee Training Certification Class. Earns a course completion certificate 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):

Thursday, November 20, 2014

HMDR License Application

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 Application Forms

Follow this link to the 3 application forms:  HMDR License Applications (Certificates and Licenses) - CA Department of Public Health (CDPH):

. . . "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 physcian 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."

'via Blog this'

The link above gets you to the following PDF forms:
  • HMDR California Facility License Application (PDF)
  • HMDR Out of State Facility License Application (PDF)
  • HMDR Exemptee Application (PDF)
Return Home:  The Designated Representative and Exemptee Blog

Training for California Home Medical Device Retailer (HMDR) Exemptee license applicants
Training for California Home Medical Device Retailer (HMDR) Exemptee license applicants


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, May 5, 2014

California HMDR Licensing Program Home Page - CA Dept of Public Health


California Home Medical Device Retailer (HMDR) Licensing Program

HMDR Licensing Program Home Page - CDPH:

"This program licenses California [Home Medical Device Retailer] HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training program for California Home Medical Device Retailer (HMDR) Exemptee license applicants - Earn a course completion certificate


Wednesday, October 9, 2013

New CA Law - SB 294 Requires A Special License For Sterile Compounders

Updated June 26, 2023:

The original link broke.

You might also be interested in:

---  the original post follows below  ---

Governor Jerry Brown signed Senate Bill 294 into law. SB 294 will go into effect in July of 2014.

Highland News > Archives > News > Bill Increasing Oversight Of Sterile Compounding Pharmacies Signed Into Law:

"Specifically, SB 294 requires both in-state and out-of-state pharmacies that compound sterile drug products for California patients that will be inhaled, injected, or administered into the eye to apply for a special, additional license from the California State Board of Pharmacy. Under this new law, the board is required to inspect these facilities annually to provide consistent oversight and ensure compliance with pharmacy law."

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):

Thursday, May 31, 2012

Policies and Procedures - California HMDR Facilities Must Have Them

Updated September 8, 2021

A link broke in the original post. Here's how to enroll in the SOP Course.

Pricing – Standard Operating Procedures Course
  • $100 per student when co-purchased with our California Exemptee training course.
  • Select our Writing Standard Operating Procedures (SOP) Course as an optional “add-on” course when you purchase our California HMDR Exemptee license training certification course (in other words, buy the Exemptee course, then add the optional SOP course during registration).
---  the original post follows below  ---

Policies And Procedures For California HMDR Facilities

California HMDR facilities shall have written policies and procedures.  Make sure you know how to write them, have them in place, and follow them. Your staff should be well-versed with them, and you want to make sure that they are following them.  You might want to consider taking:
Writing Procedures: Drug and Device Wholesalers and HMDR - an online training course

CA HMDR Facilities Must Have Policies and Procedures | SkillsPlus International Info:  'via Blog this'
Section 111656.3 starts out with:  
"Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to . . . "  
Notice the phrase, " . . . shall have written policies and procedures . . . "
Return Home:  The Designated Representative and Exemptee Blog

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

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):


Wednesday, April 4, 2012

California HMDR Facility - Policies and Procedures

Policy And Procedure Writing - An Online Training Course

California HMDRFs shall have written policies and procedures.

Make sure you know how to write them, have them in place, and follow them.

CA HMDR Facilities Must Have Policies and Procedures | SkillsPlus International Info:  'via Blog this'
Section 111656.3 starts out with:  
"Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to . . . "  
Notice the phrase, " . . . shall have written policies and procedures . . . "
You might also be interested in:
Buy Now: Writing Procedures: Drug and Device Wholesalers and HMDR - an online training course

Return Home:  The Designated Representative and Exemptee Blog

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Training program for California HMDR Exemptee license applicants
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