The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think - JDSupra

• California Board-approved California Designated Representative online training courses for: Wholesalers | 3PL (third-party logistics providers) | Reverse Distributors

Updated May 27, 2022:

The FDA has extended the due date for comments. 

"The Agency has received a request for a 90-day extension of the comment period for the proposed rule. The request conveyed concern that the current 120-day comment period, which ends on June 6, 2022, does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.

FDA has considered the request and is extending the comment period for the proposed rule for 90 days, until September 6, 2022. The Agency believes that a 90-day extension allows adequate time for interested persons to submit comments."  

Source: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers; Extension of Comment Period - SUPPLEMENTARY INFORMATION dated May 17, 2022 - Federal Register

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According to the article:

"On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay increased the variation across wholesale and 3PL licensure that the federal Drug Supply Chain Security Act (DSCSA) intended to resolve. The proposed rules create more questions than answers and will likely require significant time and litigation before the rules are finalized." ...

"Here are some of the highlights we saw and questions we have about gaps or challenges in the proposed rules." ...

Read the full source article: The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think - JDSupra

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California Board-approved California Designated Representative online training courses for:

     Wholesalers | 3PL (third-party logistics providers) | 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

Exemptee Training - For Exemptee Licensure

Earns a course completion certificate suitable for your California HMDR Exemptee license application

• Buy now! - California HMDR Exemptee License Training Certification
• California Exemptee Training - for home medical device retailers. State approved by the CDPH. $525 per student. Learn more and buy.

California Exemptee Training - for home medical device retailers. State approved by the CDPH. $525 per student. Learn more and buy.

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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

FDA Offers Draft Guidance to Further Secure Drug Supply Chain

• If your company needs another a California Designated Representative - Wholesaler, or a California Designated Representative - 3PL, they'll need Board-approved training to apply for their Designated Representative license application. 
•  Board-approved California Designated Representative courses:
   - Wholesaler Training Course
   - 3PL Training Course
   - Reverse Distributor Training Course

Updated December 1, 2025

One of the original links broke.

You might also be interested in:

Identifying Trading Partners Under the Drug Supply Chain Security Act - Guidance Document - FDA.gov

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Read the full article: FDA Offers Draft Guidance to Further Secure Drug Supply Chain | RAPS:

"Last Friday, FDA released new draft guidance to help industry, state and local governments categorize the entities in the drug supply chain in accordance with the DSCSA and help clarify which companies are engaged in activities that require licensure and annual reporting.

The 18-page draft, titled "Identifying Trading Partners Under the Drug Supply Chain Security Act," notes the confusion related to defining wholesale distributor and wholesale distribution, as well as confusion over what an affiliate of a manufacturer means."

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Training program for California drug or device wholesaler license applicants

Training program for California third party logistics (3PL) providers license applicants

- - -

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

Apria Brings to Light New OIG Report Highlighting Concerns Surrounding CMS Competitive Bidding Program for Home Medical Equipment | Business Wire

Read the full article: Apria Brings to Light New OIG Report Highlighting Concerns Surrounding CMS Competitive Bidding Program for Home Medical Equipment | Business Wire:

"Report findings show that more than 40% of the 146 suppliers examined did not meet licensure requirements and were incorrectly awarded contracts by CMS due to database inaccuracies. An additional 14 of the examined suppliers still require further research by CMS to determine whether they have met the necessary licensure requirements. These database deficiencies and inaccuracies were attributed to complex variations in state licensure requirements and the challenges that CMS has faced in maintaining a current and accurate database."

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Read the OIG report:
Department of Health and Human Services - OFFICE OF INSPECTOR GENERAL - INCOMPLETE AND INACCURATE LICENSURE DATA ALLOWED SOME SUPPLIERS IN ROUND 2 OF THE
DURABLE MEDICAL EQUIPMENT COMPETITIVE BIDDING PROGRAM THAT DID NOT HAVE REQUIRED LICENSES (pdf)

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For CA Home Medical Device Retailer (HMDR) Exemptee license applicants

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

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

Exemptee Licensure Requirements - HMDR

• California HMDR Exemptee Training - Online Training Certification Course. $525 per student. State approved. Earns a course completion certificate.

Question:
What are the minimum qualifications to apply for an HMDR Exemptee license?

Answer:
The minimum qualifications are described in the Application For Home Medical Device Retailer Exemptee License - New and Renewal (aka HMDR Exemptee Application).

Refer to Section 6 of the application form, and the associated application instructions for Section 6 (Minimum Qualifications).

Section 6 covers the following areas:

• Education
• On-the-Job Training
• Work Experience, and 
• Training Programs.

You might also be interested in:

        

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

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

Licensure Standards for DME Suppliers by Research and Markets

• The top choice for Exemptee training! Enroll now: California Exemptee Training - for HMDR (home medical device retailers). $525 per student (no extra fees to retake quizzes). State approved by the California Department of Public Health. Earns a course completion certificate suitable for your Exemptee license application. #HMDR #HME #DME #HMDRexemptee
  

Updated December 1, 2025

The original link broke.

You might also be interested in:

DMEPOS Licensure Database - search by state and product
https://dominoapps.palmettogba.com/palmetto/npewest.nsf/DID/P4LF7PNQM8

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Read the full announcement: Research and Markets: Licensure Standards for Durable Medical Equipment Suppliers | Business Wire:

"Research and Markets (http://www.researchandmarkets.com/research/h8n856/licensure) has announced the addition of the "Licensure Standards for Durable Medical Equipment Suppliers" report to their offering.

This report addresses the states that have relevant licensure requirements for suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). The report includes a listing of each state's oversight agency for DMEPOS suppliers, links to online applications, references to included statutes and regulations, and licensure requirements/guidelines."

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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

Related articles

• 
  New CA Licenses Required For Third-Party Logistics Providers (3PLs)

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)

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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 Renew Your CA Pharmacy Designated Representative License

According to the CA Board of Pharmacy:

"Approximately 6 weeks before the expiration date of your license, a renewal application will be mailed to your last known address of record. Licensees are responsible for renewing their licenses even if they do not receive a renewal notice. The Board does not send duplicate renewal applications. If you have not received the renewal notice within 4 weeks of expiration of the license, you may renew your license by submitting a Request for Renewal form. Do not submit a renewal request more than 60 days before the expiration date of the license." (Source: Information for Licensees)

In case you need the Request for Renewal form, go here, to License Renewal, to find the link to the most current version of the Request for Renewal of Designated Representative form.

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