ATS makes recommendations on home oxygen therapy for COPD - HME News

• California Home Medical Device Retail Exemptee Training - online training certification course for HMDR. This online training certification course: 1) offers a course completion certificate for your application, 2) satisfies Exemptee license application requirements, and 3) is also appropriate for those responsible for overseeing prescription devices (e.g., business owners, managers, etc.).

Read the full source article:  ATS makes recommendations on home oxygen therapy for COPD - HME News

According to the article:

"The American Thoracic Society has posted online its latest clinical practice guideline on home oxygen therapy, addressing long-term and ambulatory therapy for adults with COPD. 

The guideline makes the following recommendations: 

• In adults with COPD who have severe chronic resting room air hypoxemia, we recommend prescribing long-term oxygen therapy at least 15 hours per day. 
• In adults with COPD who have moderate chronic resting room air hypoxemia, we suggest not prescribing LTOT. 
• In adults with COPD who have severe exertional room air hypoxemia we suggest prescribing ambulatory oxygen."

Additional References:

• Home Oxygen Therapy for Adults with Chronic Lung Disease. An Official American Thoracic Society Clinical Practice Guideline - ATS Journals
• Home Oxygen Therapy for Adults with Chronic Lung Disease. An Official American Thoracic Society Clinical Practice Guideline (formatted in journal article form)

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California Home Medical Device Retail Exemptee Training - online training certification course for HMDR. This online training certification course: 1) offers a course completion certificate for your application, 2) satisfies Exemptee license application requirements, and 3) is also appropriate for those responsible for overseeing prescription devices (e.g., business owners, managers, etc.).

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

GS1 Lightweight Messaging Standard

• The largest selection of Board-approved California Designated Representative online training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.

Open the full guideline document:   GS1 Healthcare US - Implementation Guideline - Applying the GS1 Lightweight Messaging Standard for DSCSA Verification of Returned Product Identifiers (PDF)

According to the guideline document:

"In preparation, pharmaceutical supply chain stakeholders collaborated with GS1® and GS1 US® to develop a verification messaging standard to enable system interoperability and prevent the proliferation of multiple messaging formats. In addition, the GS1 Messaging Standard Workgroup collaborated with the Healthcare Distribution Alliance (HDA) Verification Routing Services (VRS) Taskforce. These efforts produced the GS1 Lightweight Messaging Standard for Verification of Product Identifiers.

The GS1 Lightweight Messaging Standard was designed to support requests and responses for verification of product identifiers for serialized pharmaceutical products. It is intended to provide a simple, standardized lightweight messaging framework for asking verification questions and receiving actionable information. Designed to support Verification Routing Services (VRS) systems for DSCSA verification, the messaging standard defines a verification request message and a corresponding response message."

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The largest selection of Board-approved California Designated Representative online training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.

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

Companies Collaborate on DSCSA Guideline as Deadlines Approach | RAPS

• Register now for a Board-approved California Designated Representative training course for:
       Wholesalers | 3PL | Reverse Distributors

Read the full article: Companies Collaborate on DSCSA Guideline as Deadlines Approach | RAPS:

"GS1 Guideline

The 600+ page GS1 guideline and compendia offer information and examples to the wider industry looking to meet the law's obligations and record each shipping event and data element needed to support serialization, pedigree and track and trace. The guideline also shows industry how to apply the standards to their own businesses."

'via Blog this'

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Training for Designated Representative and Designated Representative-3PL license applicants

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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

Free Download - Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to support DSCSA - GS1 US

• California Designated Representative Training (for wholesalers, third-party logistics providers) - Approved by the California State Board of Pharmacy - Earns a training affidavit
• Register for a course now, for:  Wholesalers | 3PL | Reverse Distributors

Updated June 1, 2025

The original link got outdated and broke.

You might also be interested in:

GS1 US DSCSA Implementation Suite

-----  original post follows below  ------

Request to download the free guide: Implementation Guideline - Applying GS1 Standards to US Pharma Supply Chain Business Processes to support DSCSA - GS1 US:

"This guideline offers pharmaceutical industry stakeholders best practices for meeting immediate lot-level management deadlines, and sets the foundation for serialized item-level traceability. Release 1.1 of the GS1 Healthcare US Implementation Guideline, “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to support DSCSA”, will help companies comply with early term, mid term and later requirements defined in the 2013 DSCSA law."

'via Blog this'

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California Designated Representative Training Courses (wholesaler, third-party logistics provider, 3PL) - Approved by the California State Board of Pharmacy - Earns a training affidavit

- - -

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

• 
  HDMA - Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act
• 
  FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop
• 
  Drug Supply Chain Security Act - Drug Supply Chain Security Act (DSCSA) Implementation Plan
• 
  
  

Designated Representative Violations

• Buy a California Designated Representative training course now, for:
  
• Wholesalers
• 3PL
• Reverse Distributors

Updated July 31, 2026

The California Board of Pharmacy files cases against designated representatives where the violation(s) involve significant misconduct on the part of the licensee. The board believes that revocation is typically the appropriate penalty when grounds for discipline are found to exist. Grounds for discipline include, but are not limited to, the following violation(s) of law(s) involving:

• Possession of dangerous drugs and/or controlled substances
• Use of dangerous drugs and/or controlled substances
• Possession for sale of dangerous drugs and/or controlled substances
• Personal misuse of drugs or alcohol

If revocation is not imposed, the board recommends a minimum Category III level of discipline be imposed on the designated representative. This would include suspension and probation.

Source:  California Board of Pharmacy - Disciplinary Guidelines - A Manual of Disciplinary Guidelines and Model Disciplinary Orders (this navigates to the link for the 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