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

Return Home:  The Designated Representative and Exemptee Blog

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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

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."

'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

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)

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