California Health and Safety Code Section 111656.4

• Buy now! California HMDR Exemptee License Training Certification Course

Updated July 18, 2020

California Health and Safety Code Section 111656.4 - California Attorney Resources - California Laws:

"Section 4051 of the Business and Professions Code shall
not prohibit a home medical device retail facility from selling or dispensing prescription devices if the department finds that sufficient qualified supervision is employed by the home medical device retail facility to adequately safeguard and protect the public health. Each person applying to the department for this exemption shall meet the following requirements to obtain and maintain the exemption: . . . "

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California Exemptee Training Certification

If you are applying for an Exemptee license, then you might need required training. Take this online course to earn a State-accepted (i.e., CDPH) course completion certificate to include in your Exemptee license application packet, as proof of required training:  California HMDR Exemptee Training Course - presented by SkillsPlus International Inc.

Take this California Exemptee online training course to earn a State-accepted (i.e., CDPH) course completion certificate to include in your Exemptee license application packet, as proof of required training.

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):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

E-pedigree: California Board of Pharmacy 3/21/2012 meeting

• California Board of Pharmacy Designated Representative Online Training Programs. Board-approved courses for: 3PL, wholesalers, reverse distributors.
• Enroll now to take a Board-approved course for:
• California Designated Rep Wholesaler online training course 
• California Designated Representative 3PL online training course 
• California Designated Rep Reverse Distributor online training course
  

Updated November 5, 2020:

This was just sent out from the CA Board of Pharmacy:

The Board of Pharmacy announces the scheduling of an E-pedigree meeting which will be held in conjunction with the board’s Enforcement Committee Meeting on March 21, 2012 in Burlingame, California (near the San Francisco Airport).  An agenda for the meeting will be available at least 10 days before the meeting.

E-pedigree/Enforcement Committee Meetings for the year have been scheduled, please visit our website for a complete listing of meeting dates: http://www.pharmacy.ca.gov/about/meetings.shtml

Return Home:  The Designated Representative and Exemptee Blog

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California Board of Pharmacy Designated Representative Online Training Programs. Board-approved courses for: 3PL, wholesalers, reverse distributors.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• California HMDR Exemptee - Online CBT Training (skillsplusinfo.blogspot.com)
• e-Pedigree - CA Board of Pharmacy Mtg 9/7/2011 (skillsplusinfo.blogspot.com)
• Don't Get Caught Without A California HMDR Exemptee (skillsplusinfo.blogspot.com)

What is a CA HMDR Exemptee license?

What Is A California HMDR Exemptee License?

Updated January 11, 2024

• Buy Now! - California Exemptee Training
• California Home Medical Device Retailer (HMDR) Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch) - You might need this online course to earn a CDPH-accepted course completion certificate to include in your Exemptee license application, as proof of required training.

California HMDR Licensing Program Home Page

California HMDR Licensing Program Home Page:

"The Home Medical Device Retail Program's mission is to promote and improve the health and well-being of all California residents and to facilitate the growth and vitality of California home medical device retail product industries, while ensuring that products are not adulterated, misbranded or falsely advertised.

The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California 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.

For any questions, please contact us using the information on the left or email us as the following address: FDBMedDevice@cdph.ca.gov."

The California HMDR licensing program home page lists 3 helpful items:

1. A category of several "Certificates and Licenses" forms
2. A "Regulations and Statutes" link to an abstract of the California Sherman Food, Drug and Cosmetic Law that authorizes creation, regulation and licensing of HMDR firms and personnel, and 
3. A "Frequently Asked Questions (FAQs)" link to a list of frequently asked questions is provided to guide the user through common occurrences during the HMDR licensing process.

Return Home:  The Designated Representative and Exemptee Blog

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• California HMDR Exemptee - Online CBT Training (skillsplusinfo.blogspot.com)
• CA HMDR Facilities Must Have Policies and Procedures (skillsplusinfo.blogspot.com)
• CA Home Medical Device Retailer Exemptee License Application (skillsplusinfo.blogspot.com)
• Don't Get Caught Without A California HMDR Exemptee (skillsplusinfo.blogspot.com)

Florida Certified Designated Representative Candidate Information Booklet (FL CDR CIB)

Updated July 18, 2020

• You might also need Florida CDR Exam preparation, support, and coaching by CDR Resource 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."

Return Home:  The Designated Representative and Exemptee Blog

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

Dr. Sharon Roberts. You might also need Florida CDR Exam preparation, support, and coaching by CDR Resource Center

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• FL Certified Designated Representative (CDR) Exam Prep Course  

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• Pearson VUE: Florida Certified Designated Representative (skillsplusinfo.blogspot.com)

California HMDR Exemptee License Fees

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

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Updated May 13, 2017

Fees constantly change. The most current fee schedule can be found on the CA HMDR webpage.

- -  original post follows below  - -

Question:
How much does it cost to submit a California - Application for home medical device retailer exemptee license - new and renewal.

Answer:
It depends.
According to the application form:

• For a new (never licensed) Exemptee application fee/license fee, it's $250. For an annual renewal, additional license, relocation, or change of ownership, it's $150. 
• Oh, and by the way, if you're more than 30 days late, tack on an additional $10 in late fees.

Source:

California Home Medical Device Retailer (HMDR) License Applications

Return Home:  The Designated Representative and Exemptee Blog

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

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• California HMDR Exemptee - Online CBT Training (skillsplusinfo.blogspot.com)
• e-Pedigree - CA Board of Pharmacy Mtg 9/7/2011 (skillsplusinfo.blogspot.com)
• CA HMDR Facilities Must Have Policies and Procedures (skillsplusinfo.blogspot.com)
• CA Home Medical Device Retailer Exemptee License Application (skillsplusinfo.blogspot.com)
• Don't Get Caught Without A California HMDR Exemptee (skillsplusinfo.blogspot.com)

Dietary Supplements - Responsibilities of Retailers & Distributors

The FDA says that firms that sell dietary supplement products play an integral role in preventing tainted supplements from harming consumers and have a legal responsibility to ensure that the products they sell are not tainted. Anyone who sells or distributes these illegal products may be subject to:

• Criminal liability – misdemeanors and felonies 
• Seizure of your products 
• Injunction of the responsible party or company 
• Disgorgement of profits and restitution.

Source:

FDA - Tainted Dietary Supplements and Foods: Responsibilities of Retailers and Distributors (pdf)

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 Info Blog

Related articles

• California HMDR Exemptee - Online CBT Training (skillsplusinfo.blogspot.com)
• Pearson VUE: Florida Certified Designated Representative (skillsplusinfo.blogspot.com)
• FDA Supplement Guidance Not Strict Enough, MD Says (drughealth.blogspot.com)

SkillsPlus International Inc. - Vendor Highlight

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

HMDR Exemptee Training Program

SkillsPlus International Inc. is a long running provider of training to home medical device retailers (HMDR) and durable medical equipment (DME) providers.

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 the Department of Public Health, as it meets the training requirements for this training and covers:

• California Code of Regulations 
• Business and Professions Code 
• Prescription Drug Laws 
• Controlled Substances 
• USP Storage Conditions 
• Health and Safety Code 

To meet this requirement, they offer a web-based, self-study class, and the final exam for this certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed.

Return Home:  The Designated Representative and Exemptee Blog

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• California HMDR Exemptee - Online CBT Training (skillsplusinfo.blogspot.com)
• CA Home Medical Device Retailer Exemptee License Application (skillsplusinfo.blogspot.com)
• CA HMDR Facilities Must Have Policies and Procedures (skillsplusinfo.blogspot.com)
• Don't Get Caught Without A California HMDR Exemptee (skillsplusinfo.blogspot.com)

Change of Designated Representative-In-Charge - California

Updated July 18, 2020

• If you are also applying for a California Designated Representative License, you might also need required training. Take this online course to earn a Board-accepted training affidavit to include in your Designated Representative license application packet:  California Board of Pharmacy Designated Representative Training Courses - presented by SkillsPlus International Inc.
• Buy now! | California Designated Representative online training courses

When key employees move on or are terminated, there are Designated Representative implications that you need to consider. Read on, as the consequences could invoke disciplinary action.

According to the California Board of Pharmacy Change of PIC/DRIC/RMG/Professional Director webpage:

Change of Designated Representative-in-Charge (DRIC)

"Business and Professions Code Sections 4160(f), states, “A wholesaler shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge ceases to act as the designated representative-in-charge, and shall on the same form propose another designated representative or pharmacist to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board.”  The DRIC serves as supervisor or manager and is responsible for ensuring the wholesaler’s or veterinary food-animal drug retailer’s compliance with all the state and federal laws and regulations pertaining to practice and the applicable license.

If the DRIC is a pharmacist in the home state of the nonresident wholesaler license, is currently associated with an active nonresident wholesaler license, and has electronic fingerprints on file with the California State Board of Pharmacy, new fingerprints may not be required.  You may request a set of the board fingerprint cards if you do not hold a current California pharmacist license and are not currently associated as a DRIC to a nonresident wholesaler

• Change of Designated Representative-in-Charge Application
• Request Fingerprint Cards "

Return Home:  The Designated Representative and Exemptee Blog

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Training programs for California Designated Representative license applicants - Earn a training affidavit

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• California HMDR Exemptee - Online CBT Training (skillsplusinfo.blogspot.com)
• e-Pedigree - CA Board of Pharmacy Mtg 9/7/2011 (skillsplusinfo.blogspot.com)

DEA raids 2 CVS pharmacies in drug abuse probe

DEA raids 2 CVS pharmacies [in FL] in drug abuse probe | Reuters:

"The Drug Enforcement Administration said on Monday it raided two CVS pharmacies over the weekend as part of an effort to curb the abuse of prescription painkillers and other potentially addictive substances.
The action, which occurred on Saturday, came one day after the agency suspended the license of drug distributor Cardinal Health Inc, prohibiting it from shipping such products from its facility in Lakeland, Florida. Cardinal immediately obtained a restraining order allowing it to continue shipments pending a hearing on February 13."

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Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute