Sunday, May 13, 2018

FDA Publishes Long-Awaited Draft Guidance on Waivers, Exceptions, and Exemptions from the DSCSA (FDC Act Section 582) - FDA Law Blog

Read the entire article:   FDA Publishes Long-Awaited Draft Guidance on Waivers, Exceptions, and Exemptions from the DSCSA (FDC Act Section 582) - FDA Law Blog:

"Pursuant to Section 582, trading partners in the pharmaceutical distribution supply chain must implement over a period of time certain tracking, tracing, and product identification requirements."

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View the referenced guidance document:
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry - FDA (PDF)


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Earn a training affidavit  -  Training programs for California Designated Representative license applicants

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, April 19, 2018

New HMDR Application Forms Take Effect July 2018

New California Home Medical Device Retailer (HMDR) Applications Forms - Effective July 2018 (click this link)

  • Facility application forms
  • Exemptee application form
If you're looking to submit a facility or Exemptee license application, be sure you're choosing the correct form.  The HMDR home page (at the time of writing) posts the soon to expire "outgoing" forms, and the soon to become effective "incoming" application forms.

CA HMDR Exemptee Training
If you have questions about which version to submit, you might want to reach out to the HMDR office.  For example, if you look at the new Exemptee application, it states, "If you have any questions, please contact the Home Medical Device Retailer Exemptee Licensing Desk at (916) 341-7354, (800) 495-3232."

Return Home:  The Designated Representative and Exemptee Blog

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, April 16, 2018

Amazon shelves plans to sell, distribute drugs to hospitals: CNBC

Read the full article: Amazon shelves plans to sell, distribute drugs to hospitals: CNBC

"Amazon.com Inc has shelved plans to sell and distribute pharmaceutical products to hospitals, CNBC reported on Monday, citing sources familiar with the matter."


Return Home:  The Designated Representative and Exemptee Blog

Training programs and courses for California Designated Representative license applicants  -  Earn a training affidavit - For wholesalers, or reverse distributors, or third party logistics providers (3PL)

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, April 5, 2018

New Products Wow at Medtrade Spring | HomeCare Magazine

View the list of winners:   New Products Wow at Medtrade Spring | HomeCare Magazine:

"Medtrade Spring 2018 attendees voted on their favorite new products in the long-running New Product Pavilion Providers’ Choice Awards, sponsored by HomeCare Magazine. Top vote getters at the Spring version of the nation’s premiere HME-focused trade show were:"

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Training certification course for California HMDR Exemptee license applicants  -  Earn a course completion certificate - for home medical device retailers

Return Home:  The Designated Representative and Exemptee Blog

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):

McKesson accused of skimming profit, harming patients - Modern Healthcare

Read the complete article:  McKesson accused of skimming profit, harming patients - Modern Healthcare:

"Allegedly, an Omni employee saw McKesson employees pool overfill from the FDA-approved packages of the cancer drugs in a non-sterile environment and facility in Frisco, Texas. The products were then placed into pre-filled syringes that were re-labeled—in some instances with fake product codes and expiration dates, according to the lawsuit. "

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Training program for California Designated Representative Reverse Distributors  -  Earn a training affidavit  -  CA Board of Pharmacy approved

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative Reverse Distributor online training certification by SkillsPlus Intl Inc.- Earn a training affidavit

CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- Earn a training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

The Designated Rep and Exemptee Professionals Blog
SkillsPlus Intl Info Blog

Thursday, March 22, 2018

Monday, March 12, 2018

Designated Representative-Reverse Distributor License - California State Board of Pharmacy

Updated April 4, 2018

California Designated Representative Reverse Distributor training program for license applicants

  • approved by the California State Board of Pharmacy
  • successful course completion earns a training affidavit
  • Buy Now! - $625 per student

- -  original post follows below  - -

View the Board's webpage:  Designated Representative Reverse Distributor License - California State Board of Pharmacy:

"Designated Representative-Reverse Distributor License

To be licensed as a Designated Representative-Reverse Distributor in California, you must satisfy the requirements under Business and Professions Code section 4053.2. A designated representative-reverse distributor license is responsible for supervision over a licensed wholesaler that ONLY acts as a reverse distributor pursuant to Business and Professions Code section 4022.6.

Applications and Instructions
Designated Representative - Reverse Distributor (PDF)"

You might also be interested in:

Training program for California Designated Representative Reverse Distributor license applicants

About - California Designated Representative Reverse Distributor Training


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Return Home:  The Designated Representative and Exemptee Blog

Training programs for California Designated Representative license applicants  -  Earn a training affidavit
CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

The Designated Rep and Exemptee Professionals Blog
SkillsPlus Intl Info Blog

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