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

---  the original post follows below  ---

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

- - -

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

California HMDR Laws for 2018

California HMDR Laws for 2018

New CA Home Medical Device Retailer (HMDR) Law - Effective Jan 1, 2018

Read the full Bill:   Bill Text - AB-1387 Home medical device retail facility business: licensing: inspections.:

"AB 1387, Arambula. Home medical device retail facility business: licensing: inspections.

The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.

This bill would modify, until January 1, 2023, the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited, as specified, by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually."

'via Blog this'

Source: The legislation above is referenced on the CA HMDR Program website

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Training program and certification for California Home Medical Device Retailers (HMDR) Exemptee license applicants - Earn a completion certificate

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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

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

HMDR Licensing - 30% Fee Increase

Updated March 25, 2023

The original link broke.

You can find the current fee schedule PDF on the HMDR Program Home Page, 

as "HMDR License Fees."

---  the original post follows below  ---

Go to the announcements on: HMDR Licensing Program Home Page:

"News, Hot Topics, & Updates:

HMDR License Fees (Effective July 1, 2016)"

'via Blog this'

In a nutshell:

Effective July 1, 2016, the California Department of Public Health (CDPH), Food and Drug Branch (FDB) licensing fees will increase by 30 percent pursuant to the California Health and Safety (H&S) Code Sections 111630 and 111656.1 authorizing CDPH to establish and adjust licensing fees to cover the estimated program costs.

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

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

• Board-approved California Designated Representative online training programs for wholesale, 3PL, reverse distribution Des Rep license applicants

Read the full article, "New Licenses Required For Third-Party Logistics Providers (3PLs)," recently published in the Winter 2015 edition of The Script - by the California State Board of Pharmacy (PDF):

"Companies that do not own, but receive, store, select and ship prescription drugs and prescription devices into or within California need to obtain a third-party logistics provider (3PL) license immediately with the California State Board of Pharmacy.

Federal legislation enacted in November 2013 directed that 3PLs must be regulated as a separate class and not as a drug wholesaler."

AB 2605 (a new law):

• "Creates a new licensure class of 3PLs and nonresident 3PLs for those businesses that do not own, but receive, store and ship prescription drugs and prescription devices;
• Creates a new licensure class of “designated representative-3PL” for individuals who work in the 3PLs and possess the knowledge and experience necessary to be responsible for the quality of stored and shipped prescription items on a 3PL premises; and
• Creates a new qualifying category of licensure for a responsible manager called “designated representative-3PL,” who acts as the facility manager and representative in charge of the 3PL."

 For more information:

• Go to the CA Board of Pharmacy "Apply For A License" webpage

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)
• 
  Coming Soon! California Designated Representative-3PL Training Course

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

---  the original post follows below  ---

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)

California Licenses Required For Third-Party Logistics Providers (3PLs) | The Best Designated Representative Training & Exemptee Training

• Buy Now! Board-approved California Designated Representative training courses for:
     3PL | Wholesalers | Reverse Distributors

Updated July 15, 2026

Licenses For California 3PLs

Read the full post with links: New CA Licenses Required For Third-Party Logistics Providers (3PLs) | The Best Designated Representative Training & Exemptee Training:

"Companies that do not own, but receive, store and ship prescription drugs and prescription devices into or within California need to obtain a third-party logistics provider (3PL) license immediately with the California State Board of Pharmacy."

'via Blog this'

By the way:
On February 20, 2015, the California Board of Pharmacy announced that third-party logistics providers (3PLs) must obtain a third-party logistics provider license, as well as designate a responsible manager, and secure licensure of specialized employees who will serve as designated representatives-3PLs (DR-3PL). DR-3PL applicants must provide proof of DR-3PL training. SkillsPlus Intl Inc. now offers a DR-3PL training course:  California Designated Representative-3PL Certification Course - Buy Now!

Buy Now! Training program for California Designated Representative license applicants - Earn a training affidavit

Return Home:  The Designated Representative and Exemptee Blog

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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)
• 
  Coming Soon! California Designated Representative-3PL Training Course

Mind the mo: Moustaches may raise burn risk with home oxygen therapy - MedCity News

• California Exemptee Training Certification Course - Buy now! - For home medical device retailers (HMDR)

Updated July 13, 2021

The original link broke.

You can still read about the topic here:

Mustaches may raise burn risk with home oxygen therapy

---  the original post follows below  ---

Read the full article: Mind the mo: Moustaches may raise burn risk with home oxygen therapy - MedCity News:

"To test their theory that facial hair places oxygen therapy users at a higher risk for burns, the researchers set up mannequins with and without human hair mustaches, outfitted them with the nasal tubing and exposed them to a spark.

The tubing on the mustached models ignited while those without mustaches did not, suggesting that concentrated oxygen together with kindling in the form of facial hair is a dangerously flammable combination."

'via Blog this'

• 
  CA Home Medical Device Retailer (HMDR) FAQs
• 
  Florida Certified Designated Representative (CDR) Exam Prep

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

2014 HME Software Directory | HomeCare Magazine

The directory is published by HomeCare - The Leading Business Magazine for HME Professionals.

View the entire list: 2014 Software Directory | HomeCare Magazine:

"2014 Software Directory"

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Changes in California Pharmacy Law

Updated January 5, 2019:

California Pharmacy Law changes effective this current year (PDF)

---  the original post follows below  ---

You might be interested in the following article, published in the latest edition of the California Board of Pharmacy Newsletter, The Script (Spring 2014) - PDF

The article is titled, "Changes in Pharmacy Law for 2014."  The organization and formatting make the article a very easy and useful read. Here's a snippet from the article:

"The Senate and Assembly bills listed in this article were enacted in 2013 and unless otherwise specified took effect on January 1, 2014. The new and amended Business and Professions Code (B&PC), Health and Safety Code (H&SC), and Civil Code laws are paraphrased or summarized below. For pertinent information that is not included in the summaries you are strongly urged to review the exact language at http://www.pharmacy.ca.gov/laws_regs/new_laws.pdf  "


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

CA HMDR Licensing - Info - Forms - FAQs

• People also search for California HMDR Exemptee training certification, to earn a course completion certificate to include in the license application - Register Now!

HMDR Licensing Program Home Page:

"The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws."

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

Exemptee Licensing Info and Resources - Exemptee Institute

• People think highly of this 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
  

Licensing - Exemptee Institute of SkillsPlus Intl Inc:

"The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws.

Useful License Links & Resources . . . "

'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

Application For CA Home Medical Device Retailer Exemptee License - Licensing Desk

• People also search for this California HMDR Exemptee License Training Certification Course (CDPH-approved)

The application form says:

If you have any questions, please contact the Home Medical Device Retailer licensing desk at (916) 341-7354, or (800) 495-3232. 

Application For CA Home Medical Device Retailer Exemptee License | Designated Representative and Exemptee:

"Here's where you can find the Application For CA Home Medical Device Retailer Exemptee License. 

The application for the HMDR exemptee is provided for firms who wish to sell prescription Rx devices such as respiratory equipment, medical oxygen and other equipment identified as dangerous or legend devices under California law. " 

'via Blog this'

Related articles

• California HMDR Exemptee - Online CBT Training (skillsplusinfo.blogspot.com)
• Don't Get Caught Without A California HMDR Exemptee (skillsplusinfo.blogspot.com)
• CA HMDR Facilities Must Have Policies and Procedures (skillsplusinfo.blogspot.com)
• Select e-Learning That Is Pure, Safe and Effective (skillsplusinfo.blogspot.com)

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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

Sherman Law Amendment Spawned HMDR Licensing

• Trusted California HMDR Exemptee training course for Exemptee license applicants and their managers. State-approved by the California Department of Public Health - Food and Drug Branch (FDB). Earns a course completion certificate to include in your Exemptee license application.

Updated August 6, 2026

The HMDR Program page is currently posting a link to "HMDR Legislation."

---  Updated January 26, 2022  ---

The original link broke.

Sadly, the HMDR Program page no longer contains a link to the Sherman Law.

However I found this link on the internet:

• Sherman Law - Food and Drug Branch (FDB)

---  the original post follows below  ---

According to the California Department of Public Health:

"The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety and Youth Tobacco Enforcement Section and is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law (January 1, 2008 Edition). The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program."

CA HMDR FAQs

California Home Medical Device Retail FAQs

• California Exemptee Training - SkillsPlus International Inc. - for home medical device retailers (HMDR) - $525 per student - Buy Now! 

Here's something you might find helpful, The CA Home Medical Device Retailer (HMDR) licensing program Frequently Asked Questions (FAQs) - find this PDF on the California Home Medical Device Retail Program website

Here are the questions that are answered:

1. What is an HMDR business and who needs an HMDR license from the DHS, Food and Drug Branch?
2. Where can I get an HMDR license application and what are the fees?
3. Are there exceptions to the kinds of facilities that are required to have an HMDR license?
4. What is the licensing process and how long does the process take?
5. Can I operate my HMDR business without a valid license?
6. After my facility is inspected, how long afterwards must I wait for my facility license?
7. If my facility fails to meet compliance standards, what happens?
8. If I move or sell my business, can my license be transferred?
9. What is a Temporary License, and what are the criteria for receiving one?
10. What are dangerous or “legend” devices?
11. I wish to dispense legend medical devices from my HMDR. Do I need a special license?
12. How can I obtain an HMDR exemptee license?
13. Can I obtain an exemptee license without working at a HMDR facility?
14. What about HMDR renewal inspections? How frequently are they conducted, and what are some common violations found?
15. How can I get a copy of the HMDR Law and/or guidance on requirements?

Return Home:  The Designated Representative and Exemptee Blog

California Exemptee Training - SkillsPlus International Inc. - for home medical device retailers (HMDR) - $525 per student - 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  
• 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