HMDR Renewal Inspection Violations - for home medical device retailers

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

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

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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):

• 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

NCDQS Launches QAS Accreditation and Inspection Programs - NCDQS

• The most popular Board-approved California Designated Representative online training program for wholesalers. Earns a Board-recognized training affidavit. Nearly 10,000 students trained!
• Register for a course now, for:  Wholesalers | 3PL | Reverse Distributors

Read the brief post:  NCDQS Launches QAS Accreditation and Inspection Programs - NCDQS

Read the robust press release:  NCDQS Launches New Wholesale Drug Distributor Accreditation Program and a Wholesale Drug Distributor Inspection Program (PDF)

According to the press release:

"The National Coalition for Drug Quality & Security (NCDQS) today announced the launch of two new programs for wholesale drug distributors, the Quality and Security (QAS*) Accreditation and the QAS Inspection. These national programs are important tools in protecting the prescription drug supply chain. With a 90-day timeline, the QAS Accreditation offers a robust accreditation process with an efficient, streamlined approach and responsive accreditation team."  

*pronounced “case” 

Learn more about NCDQS

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

The most popular Board-approved California Designated Representative online training program for wholesalers. Earns a Board-recognized training affidavit. Nearly 10,000 students trained!

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

Avoid These Common California HMDR Inspection Violations

• Buy now! California Exemptee license training class
• California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Health - Food and Drug Branch)

Common California HMDR Inspection Violations

California HMDR (home medical device retailer) 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.

Be prepared. Be aware of these common violations.

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:   HMDR Frequently Asked Questions (FAQs) (PDF) (You'll find this link on the HMDR Program website)

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Health - Food and Drug Branch)

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

Wholesalers, are you ready for an inspection? - California State Board of Pharmacy

Wholesalers, are you ready for an inspection? - A newsletter article by the California State Board of Pharmacy (The Script - July 2018 Page 12 - click this link)

SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy - Learn more and buy!

"Be prepared. Whether the Board is conducting an inspection related to a complaint or a request is made for a routine inspection, having important records readily retrievable will help expedite the process. The Board recommends wholesalers' Designated Representatives and Designated Representatives-In-Charge become aware of the location of the following records. Maintaining these records in a centralized area may help when a board inspector arrives at your front door."

California Designated Representative Training Courses

Here's a list of the major categories of records:

• Policies and Procedures
• Records
• Controlled Substances
• Training Records
• Licenses and Registrations
• Miscellaneous Reports

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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 - 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

Be Ready! Common CDPH HMDR Facility Inspection Violations

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

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

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

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):

• 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

Florida inspections reveal drug compounding health violations - South Florida Business Journal

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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 - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Exam Prep Course

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Violations also included improperly acting as a wholesaler.  For details, follow the link below . . .


Florida inspections reveal drug compounding health violations - South Florida Business Journal:

"Consumers often assume drugs are manufactured with the utmost care before injecting them into their veins or dropping them into their eyes, but Florida pharmacy inspectors have found that’s not always the case.
Since October 2012, 11 South Florida pharmacies have had their licenses revoked, relinquished or permanently suspended as compounders by the state Board of Pharmacy because of violations that directly impacted product safety. "

'via Blog this'

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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

• Florida inspections reveal drug compounding health violations (bizjournals.com)

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

• People also look for Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.
  
• Register now to take a Board-approved California Designated Representative training course for:
     Wholesalers | 3PL | Reverse Distributors

Updated June 26, 2023:

The original link broke.

You might also be interested in:

Sterile Compounding/Nonresident Sterile Compounding/Hospital In-Patient Sterile Compounding Pharmacy/Hospital Satellite Compounding Pharmacy License - California State Board of Pharmacy

---  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):

• 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

FDA Summary - 2013 Compounding Pharmacy Inspections

• California Board of Pharmacy Designated Representative Training Courses by SkillsPlus International Inc.  |  Board Approved  |  for wholesalers, 3PL, reverse distributors.  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

Updated Aug 28, 2020:

You might also be interested in this FDA webpage:  Human Drug Compounding - FDA.gov

or

this recent headline story:  Cardinal Health sued over alleged fraudulently obtained contracts - SeekingAlpha.com

- - -   original post follows below   - - -

Pharmacy Compounding > Summary: 2013 FDA Pharmacy Inspection Assignment:

"The agency is currently evaluating the information obtained during the inspections and where applicable, will apply its existing legal authority to protect the public health. For the firms that are operating outside the bounds of traditional pharmacy compounding and who had significant sterile production issues, FDA plans to take aggressive action, including through enforcement actions, as appropriate."

Return Home:  The Designated Representative and Exemptee Blog

---------

• California Board of Pharmacy Designated Representative Training Courses by SkillsPlus International Inc.  |  Board Approved  |  for wholesalers, 3PL, reverse distributors.  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

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

FDA - 2013 Pharmacy Inspections - Form 483 Observations

The FDA is posting their observations, via Form 483, of pharmacies that they've inspected re: compounding.

ORA FOIA Electronic Reading Room > 2013 Pharmacy Inspections:

"2013 Pharmacy Inspections"

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
The Designated Representative Institute

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

SkillsPlus Intl Info Blog

Related articles

• High-Risk Compounding Pharmacies Targeted for FDA Review - Bloomberg
• FDA: Problems found at another facility of sister company of pharmacy tied to meningitis

Common HMDR Renewal Inspection Violations

• Buy now! California Exemptee license training certification course

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

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