Monday, October 26, 2020

Saleable Returns Verification Delayed to 2023 - Healthcare Packaging

Read the full source article: Saleable Returns Verification Delayed to 2023 - Healthcare Packaging

According to the article:

"Additional three-year delay: FDA guidance says distributors will not be required to verify the product identifier of returned drugs before resale until Nov. 27, 2023.   ...

With the 2020 enforcement date approaching in November, FDA has announced an additional three-year delay, noting, “FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under the DSCSA."

View the FDA guidance document:  Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies - FDA.gov

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California Board of Pharmacy Designated Representative Training. Board-approved. Taught by SkillsPlus International Inc. for reverse distributors, wholesalers, 3PL. If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.
California Board of Pharmacy Designated Representative Training. Board-approved. Taught by SkillsPlus International Inc. for reverse distributors, wholesalers, 3PL. If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.


For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Tuesday, October 20, 2020

CMS Releases Updated Guide to Home Oxygen and Other Durable Medical Equipment Coverage - U.S. COPD Coalition

Read the full source article:  CMS Releases Updated Guide to Home Oxygen and Other Durable Medical Equipment Coverage - U.S. COPD Coalition

According to the article:

"The Centers for Medicare & Med[i]caid Services (CMS) has released an updated durable medical equipment (DME) guide.

This official government booklet, Medicare Coverage of Durable Medical Equipment & Other Devices, explains:

  • What durable medical equipment is
  • Which durable medical equipment, prosthetic, and orthotic items are covered by Original Medicare
  • Where to get help with your questions"

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California HMDR Exemptee Training Certification - online training certification class for home medical device retailers. If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application.
California HMDR Exemptee Training Certification - online training certification class for home medical device retailers. If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application.


For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Tuesday, October 13, 2020

New Drug Channels Institute Study Examines Impact of COVID-19 on U.S. Drug Distribution Industry - PRweb

According to the press release:

"Today Drug Channels Institute (DCI), a leading management educator for and about the pharmaceutical industry, released its exclusive analysis of U.S. prescription drug distribution channels. DCI’s new 2020–21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors delves into the business operations of the Big Three public drug wholesalers—AmerisourceBergen, Cardinal Health, and McKesson. Three new sections address COVID-19 and its impact on wholesalers, including the potential financial effects on wholesalers of widespread distribution of one or more COVID-19 vaccines."

Read the source press release:  New Drug Channels Institute Study Examines Impact of COVID-19 on U.S. Drug Distribution Industry - PRweb

View the free report overview:  The 2020-21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors - Overview (PDF)

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California Board of Pharmacy Designated Representative Training - by SkillsPlus International Inc. - for wholesalers, 3PL, reverse distributors. State Board Approved.

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Friday, September 25, 2020

HMDR Renewal Inspection Violations - for home medical device retailers

Updated May 26, 2026

Common California HMDR Renewal Inspection Violations

Renewal Inspections & Frequency

“Renewal inspections can take place annually, unannounced, at any HMDR facility during normal business hours. A customer complaint or other referral may also trigger an inspection.”

Some Common Inspection Violations

“Common violations of the California Health and Safety Code include: 

  • Dispensing prescription devices without a valid HMDR exemptee on the premise
  • Lack of dispensing records for prescription devices
  • Inadequate procedures for the cleaning and maintenance of rental devices
  • Inadequate staff training or patient/caregiver consultation
  • Inadequate quality assurance procedures and/or lack of documentation of quality assurance procedures.”

Source: California Home Medical Device Retailer (HMDR) Frequently Asked Questions (PDF) -  the source document is no longer available on the California Home Medical Device Retail Program website


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For Home Medical Device Retailers. If you are applying for a California HMDR Exemptee license, you need to include proof of required training in your application. Take this online course to earn a course completion certificate for your license application.


For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Thursday, September 17, 2020

How to avoid getting pulled into healthcare fraud - Medical Economics

According to the article:

"Many fraudulent schemes appear as legitimate business opportunities"

"Here are just some examples of the types of arrangements that should be subjected to a comprehensive regulatory analysis (many may be acceptable, but that conclusion should be reached only after legal review): ... 

Any contract with a DME manufacturer, wholesaler or distributor;

Any contract with a drug manufacturer, wholesaler or distributor;"

Read the full source article:  How to avoid getting pulled into healthcare fraud - Medical Economics

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee and Designated Representative Online Training Courses



For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Monday, September 14, 2020

Manufacturing FDA ticks off list of grievances over California drug repackager's quality issues in warning letter - FiercePharma

This should interest wholesalers specializing or involved in drug repackaging.

According to the article:

"Unlike drugmakers that make their meds in-house, a cottage industry of repackagers exists to resell premade drugs with shiny new labels. But what happens when one of those companies fails at its primary job: safely repackaging drugs? A California firm has just found out, courtesy of the FDA. 

Newport Beach, California-based Calvin Scott & Co., a wholesaler specializing in drug repackaging, failed to adequately address quality issues at its New Mexico plant that may have compromised the listed expiration date on one of its drugs, according to a warning letter posted online this week."

Read the full source article:  Manufacturing FDA ticks off list of grievances over California drug repackager's quality issues in warning letter - FiercePharma

Return Home:  The Designated Representative and Exemptee Blog

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California Board of Pharmacy Designated Representative Training - online training courses by SkillsPlus International Inc. - Board-Approved. For wholesalers, 3PL, reverse distributors.
California Board of Pharmacy Designated Representative Training - online training courses by SkillsPlus International Inc. - Board-Approved. For wholesalers, 3PL, reverse distributors.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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