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.

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) - you can find this 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

How to avoid getting pulled into healthcare fraud - Medical Economics

• California Board of Pharmacy Designated Representative Training by SkillsPlus Intl 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 theses courses.

According to the article:

"Many fraudulent schemes appear as legitimate business opportunities"

"Here are just some examples of the types of arrangements that should be subjected to a comprehensive regulatory analysis (many may be acceptable, but that conclusion should be reached only after legal review): ... 

Any contract with a DME manufacturer, wholesaler or distributor;

Any contract with a drug manufacturer, wholesaler or distributor;"

Read the full source article:  How to avoid getting pulled into healthcare fraud - Medical Economics

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California HMDR Exemptee and Designated Representative Online Training Courses - State Approved

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

Manufacturing FDA ticks off list of grievances over California drug repackager's quality issues in warning letter - FiercePharma

• California Board of Pharmacy Designated Representative Training - online training courses by SkillsPlus International Inc. - - - Sign-up for a course now, for:
         Wholesalers | 3PL | Reverse Distributors
• Recommended FDA CGMP online training courses and programs taught by SkillsPlus International Inc.

This should interest wholesalers specializing or involved in drug repackaging.

According to the article:

"Unlike drugmakers that make their meds in-house, a cottage industry of repackagers exists to resell premade drugs with shiny new labels. But what happens when one of those companies fails at its primary job: safely repackaging drugs? A California firm has just found out, courtesy of the FDA. 

Newport Beach, California-based Calvin Scott & Co., a wholesaler specializing in drug repackaging, failed to adequately address quality issues at its New Mexico plant that may have compromised the listed expiration date on one of its drugs, according to a warning letter posted online this week."

Read the full source article:  Manufacturing FDA ticks off list of grievances over California drug repackager's quality issues in warning letter - FiercePharma

Return Home:  The Designated Representative and Exemptee Blog

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California Board of Pharmacy Designated Representative Training - online training courses by SkillsPlus International Inc. - Board-Approved. For wholesalers, 3PL, 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

FAQ: What kind of work experience is accepted for a California Designated Representative license?

Here's the answer to the FAQ - What kind of work experience is accepted for a California Designated Representative license?

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses - online training by SkillsPlus International Inc.

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