Nonresident medical device sellers operating in CA may face fines with few options for compliance - DOTmed

• California Designated Representative Training Course for Wholesalers (approved by the California State Board of Pharmacy)

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Read the full editorial by Robert J. Kerwin:  Nonresident medical device sellers operating in CA may face fines with few options for compliance - DOTmed

"In California, the Board of Pharmacy, which regulates matters pertaining to wholesaling of medical devices, is requiring sellers of medical devices who do not reside in California (“nonresident wholesalers”) to have a wholesalers’ license from their home state or else be subjected to a fine for conducting business in California without an appropriate license. This, despite the fact that many states do not issue medical device wholesalers’ licenses." 

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Designated Representative Training Courses - wholesalers, 3PL, reverse distributors (California & Florida)

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

You Snooze, You Lose: How Insurers Dodge The Costs Of Popular Sleep Apnea Devices - NPR

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• California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (approved by the California Department of Public Health - Food and Drug Branch)

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Read the full article:   You Snooze, You Lose: How Insurers Dodge The Costs Of Popular Sleep Apnea Devices - NPR

"Medicare, the government insurance program for seniors and the disabled, began requiring CPAP "compliance" after a boom in demand. Between 2001 and 2009, Medicare payments for individual sleep studies almost quadrupled to $235 million. Many of those studies led to a CPAP prescription. Under Medicare rules, patients must use the CPAP for four hours a night for at least 70 percent of the nights in any 30-day period within three months of getting the device. Medicare requires doctors to document the adherence and effectiveness of the therapy."

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California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (approved by the California Department of Public Health - Food and Drug Branch)

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

Survey: Turnover on the rise among hourly workers - Drug Store News

• California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)
• Enroll now to take California Exemptee training!

Read the full article:

Survey: Turnover on the rise among hourly workers - Drug Store News

Key excerpts from the article: 

Respondents cited “better opportunities/promotions” as the No. 1 reason for departures in the retail industry, followed by more money and a desire for a more hours. When asked what retailers will be looking to do to curb turnover moving forward, “training” and “career pathing” were cited as the top focus areas, followed by “better communications on the employee value proposition” and “changes to compensation packages.”  

“To retain top employees, employers need to lay out clear career paths, offer training and pay competitive wages. It’s critical that employees feel nurtured and that they feel part of the organization instead of just having a job.”

Maintaining business continuity and regulatory compliance are top priorities in the HMDR niche. It's wise to consider the items mentioned in the article above.

Additionally, it's not unusual for some businesses to manage with just one HMDR Exemptee, or keep the bare minimum of licensed HMDR Exemptees on staff.  However, these companies can run into a situation that can affect the company's business financial health. In the event the company loses a licensed Exemptee (for example, the Exemptee quits and cross-coverage by another licensed Exemptee isn't possible), then the business operation could get into trouble with regulatory agencies, or just as bad, must suspend operation (until a licensed Exemptee can be on premise).

It's a difficult scenario, to be left scrambling, trying to find, hire, and get a new employee properly licensed as an Exemptee.  Therefore, consider the risks, and keep just the "right" number of licensed HMDR Exemptees.

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California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)

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

Who Can You Call? - Ask A Board Inspector

• California Designated Representative Training (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy
• Register now to take a Board-approved online training course for:
• California Designated Rep Wholesaler course 
• California Designated Representative 3PL course 
• California Designated Rep Reverse Distributor course

Read the full notice:  Got a question? Ask an Inspector - California Board of Pharmacy

"The board can be contacted via email, fax or telephone with questions pertaining to pharmacy law and regulations. On Tuesdays and Thursdays, a board inspector will be available to answer telephone inquiries. 

Note: The board’s inspectors and staff cannot provide you with legal advice, but they will assist you by identifying any statutory or regulatory sections that may pertain to your questions. Should you need legal advice, you are advised to contact a lawyer."

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Designated Representative Training Courses - California (wholesaler, 3PL, reverse distributor) - Florida CDR Exam Prep Course

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

AmerisourceBergen's compounding site still on ice despite beefed-up oversight - BioPharma Dive

• California Designated Representative Training Course for Wholesalers (approved by the California State Board of Pharmacy)
       Buy this Wholesaler course now!

• FDA QSR and cGMP Training Courses by SkillsPlus International Inc.

Updated June 13, 2026

AmerisourceBergen does not own PharMEDium anymore because the drug compounding business was permanently shut down in 2020.

---  the original post follows below  ---

Read the full article:

AmerisourceBergen's compounding site still on ice despite beefed-up oversight - BioPharma Dive

"PharMEDium, a drug compounder and subsidiary of AmerisourceBergen, received a series of Form 483s over the last year as regulators observed issues at several of its manufacturing plants. Some of the more common issues included failing to have procedures that adequately protect against contamination or ensure quality control."

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Root Cause Analysis and Deviation Investigation Report Writing - An online self-study FDA cGMP training course

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

Amazon to sell exclusive brand of consumer medical devices - Becker's Hospital Review

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• California Home Medical Device Retailer - HMDR Exemptee Training Certification Course  (accepted by the California Department of Public Health - Food and Drug Branch)

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Read the full article: 

Amazon to sell exclusive brand of consumer medical devices - Becker's Hospital Review

"Amazon, through a partnership with health brand consultancy Arcadia Group, will sell an exclusive new brand of consumer-focused medical devices, including blood pressure cuffs and glucose monitors" . . . 

"Arcadia Group said it had created a brand of at-home medical devices for Amazon, called Choice. It will be sold exclusively on the e-commerce giant's website."

Return Home:  The Designated Representative and Exemptee Blog

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California Home Medical Device Retailer - HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)

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

FDA Publishes DSCSA-Related Guidance on Verification Systems

• California Designated Representative Training (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy
• Sign-up for a course now, for:
     Wholesalers | 3PL | Reverse Distributors

Updated October 6, 2025

You might also be interested in a collection of the FDA's DSCSA-related guidances, all in one location:

Drug Supply Chain Security Act Law and Policies - FDA.gov

- - - original post follows below - - -

According to this newly published FDA guidance:

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry (PDF)

"Certain trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) are required to have verification systems in place" . . .

Background  

Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), established requirements to facilitate the tracing and verification of certain prescription drug products through the U.S. pharmaceutical distribution supply chain.

FDA is issuing this guidance to describe FDA’s interpretation of the requirements of section 582 of the FD&C Act regarding verification systems. This guidance provides recommendations for a robust verification system for the determination, quarantine, and investigation of suspect products, as well as the quarantine, notification, and disposition of illegitimate products.

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California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy

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