Top 3 Named for Innovative HME Retail Product Awards at Medtrade | HomeCare Magazine

• Buy now! California HMDR Exemptee License Training Certification Course

Read the full announcement: Top 3 Named for Innovative HME Retail Product Awards at Medtrade | HomeCare Magazine:

"Judges and attendees at the biannual Innovative HME Retail Product Awards, sponsored by HomeCare Magazine, have tabulated the top three vote getters on day two of Medtrade."

'via Blog this'

Follow the link above to learn more about the Top 3 winners:

1. MyPainAway Fibro Cream from Topical BioMedics
2. The SoClean® 2 CPAP Sanitizer (also known as SoClean®) from So Clean
3. The Tour (Walker) from Motivo

The awards are all about promoting and recognizing products that contribute to providers' bottom lines though cash sales.

Training certification class for 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):

• 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 To Dispensers - Guidance on DSCSA July & Nov Timelines

The FDA published a new guidance:

DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry - FDA (PDF)

In a nutshell:

"The product tracing requirements in sections 582(d)(1) of the FD&C Act take effect for
dispensers on July 1, 2015. ... "

"FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept
ownership of product without receiving the product tracing information, as required by section
582(d)(1)(A)(i) of the FD&C Act."

There's a whole lot more in the guidance, so you'll want to review it, in its entirety.

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

• 
  Who Offers Designated Representative Training?

"The Politic" Interviews Margaret Hamburg (FDA)

• Respected FDA CGMP online training courses offered by SkillsPlus International Inc.

The Woman in Charge: Margaret Hamburg | The Politic:

". . . The Politic: Let’s move on to the recent meningitis outbreak. Was the FDA in this case supposed to have prevented the outbreak, or was the role of the FDA more in the response portion?

Sadly, the current regulatory framework for these so-called compounding pharmacies is inadequate and ambiguous as to the state role and the federal role, and we need to address that concern. I hope we can work with Congress to craft new legislation that will strengthen and clarify existing law. Within the existing legal framework, we are in a much more reactive posture rather than a preventive one.

As a public health official and the head of the FDA, I would really like to be able to see a system that could help us prevent this type of tragedy going forward. As we've seen the industry and healthcare system evolve, I think what has always been a concern about a lack of clarity between state and federal responsibilities has gotten more pronounced and more dangerous. More and more health care systems are relying on sort of hybrid  compounding pharmacy/manufacturer in order to produce products they need. These facilities are in a gray area in between state and FDA regulations. . . . "

'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):

• 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

Licensure Standards for Medical-Surgical Products Distributors - from HIDA

• California Designated Representative Training Courses (approved by the California State Board of Pharmacy) 
  Register for a course now, for: 
       Wholesalers | 3PL | Reverse Distributors

• California HMDR Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch) - For home medical device retailers.
  Register for this course now: 
       California Exemptee Training

Updated 8/30/2021:

The original post below is out of date with broken links.

You might also be interested in: 

Licensure - HIDA.org

= = = original post follows = = =

I stumbled across this resource the other day and hope you can make use of it, Licensure Standards for Medical-Surgical Products Distributors.

It's intended to provide licensure information to single-state and multi-state distributors.

For more information:
Health Industry Distributors Association (HIDA)

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training and Exemptee Certification Training - State Approved 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 
• 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 Select Your Training Vendor

• Buy now! California Designated Representative training for: 
       Wholesalers | 3PL | Reverse Distributors
• Buy now! California Exemptee training certification

I just read this book by Linda Ireland, Domino: How Customer Experience Can Tip Everything in Your Business Toward Better Financial Performance . Her writing inspired this post.

You're probably following this blog because you need Exemptee or Designated Representative training. In California, there aren't all that many training vendors in this niche space. As you go comparison shopping, keep these Domino customer experience thoughts in mind:

1. You want to learn about credible options. The vendor is trying to earn your business.
2. You envision a solution and problem solved. The vendor needs to demonstrate, and allow you to experience, how they are going to best solve your needs.
3. You want to buy products and services where you're in control, and it's convenient. The vendor wants to 'protect' you, by affirming any purchase decisions you've made.
4. You want to experience problem solved, and needs are met. The vendor needs to stay engaged, ensuring your need was truly solved.
5. You want to learn what else the vendor has to offer that solves your other problems or needs. The proactive vendor anticipates your future needs.

Bottomline, as you go shopping, keep your customer hat on, and monitor if your prospective vendor is acting in your best interests. Happy hunting!

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