Showing posts with label analysis. Show all posts
Showing posts with label analysis. Show all posts

Tuesday, May 24, 2022

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think - JDSupra

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

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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):
     Florida:

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

     California (earn a training completion certificate):


Monday, August 5, 2019

Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? - RxTrace

Read the full article:  Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? - RxTrace.com


According to Dirk Rodgers:

"Can President Trump, HHS Secretary Azar and Acting FDA Commissioner Sharpless eliminate/adjust/reinterpret any part of the Drug Supply Chain Security Act (DSCSA) to allow Florida, Colorado, Vermont, Maine or any other US state or territory to import drugs from foreign markets?  Let’s take a closer look at what’s been going on recently with the idea of importing drugs from other markets in an attempt to help American citizens buy them at a lower cost."

His analysis of the situation is a worthy read.

You might also be interested in his book, "The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances 2nd Edition:"




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California Designated Representative Online Training Classes. Largest selection of Board-approved courses for: wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board.
California Designated Representative Online Training Classes. Largest selection of Board-approved courses for: wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board.

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, November 7, 2016

Why prescription drugs costs so much - Business Insider

Read the full article with illustrations: Why prescription drugs costs so much - Business Insider:

"Don’t just blame drug companies for rising prescription prices. For all the outrage over Mylan increasing EpiPen prices by 500%, and insulin prices, which are up 300% over the past decade, drug prices are a lot more complicated than pointing the finger at a lone villain.

For a single prescription drug, there are often five companies involved, from development all the way to your medicine cabinet. Each company makes a tidy profit along the way. And as prices increase, so do those profits."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training for drug wholesaler 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):

Tuesday, September 27, 2016

Drug Distributors Still Benefiting from Drug Price Inflation but Face Major Profit Challenges, Says New Drug Channels Institute Study - PRWeb

Updated July 23, 2026
You might also be interested in:

- - -  original post follows below  - - -

Read the full press release: Drug Distributors Still Benefiting from Drug Price Inflation but Face Major Profit Challenges, Says New Drug Channels Institute Study - PRWeb:

"The 2016–17 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors provides a thorough analysis of each public wholesaler’s business segments and underlying profitability, based upon DCI’s proprietary economic models. It also analyzes many crucial healthcare trends that will affect wholesalers and distributors, including: the growth of specialty pharmacies, changes in the generic drug market, new government regulations, hospitals’ acquisition of physician practices, the growth of narrow pharmacy networks, and much more."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

Return Home:  The Designated Representative and Exemptee Blog

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California Board of Pharmacy Designated Representative Training | SkillsPlus International Inc. - for wholesalers, 3PL, reverse distributors
California Board of Pharmacy Designated Representative Training | SkillsPlus International Inc. - 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):

Friday, September 9, 2011

CA e-Pedigree - Board of Pharmacy Mtg Update - Sept 7, 2011

Updated 12/6/2011:

The minutes finally got posted. You can find them here, and they include:
Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Drug

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):

Friday, September 2, 2011

CA e-Pedigree - Nice Analysis

Big Sur Coast in Central California looking so...Image via Wikipedia
Updated May 26, 2022:
California Board of Pharmacy Re-awaken:  'via Blog this'

If you're following the evolution of California e-Pedigree, then you'll want to read this analysis by Dirk Rodgers.

The key takeaway for me is, Board of Pharmacy guidance is needed before folks can plan and act:
". . . the Board needs to provide some guidance on, but there are some other very important questions that need to be answered before companies are likely to fully invest in pedigree solutions.  Here I’m referring to both solution providers and companies within the supply chain."

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):

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