Showing posts with label wholesalers. Show all posts
Showing posts with label wholesalers. 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

- - -

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):


Thursday, December 3, 2020

Hackers targeting groups involved in COVID-19 vaccine distribution, IBM warns - Reuters

According to the article:

"IBM’s cybersecurity unit said it had detected an advanced group of hackers working to gather information about different aspects of the cold chain, using meticulously crafted booby-trapped emails sent in the name of an executive with Haier Biomedical, a Chinese cold chain provider that specializes in vaccine transport and biological sample storage.  ...

The hackers went through “an exceptional amount of effort,” said IBM analyst Claire Zaboeva, who helped draft the report. Hackers researched the correct make, model, and pricing of various Haier refrigeration units, Zaboeva said."

Read the full source article: Hackers targeting groups involved in COVID-19 vaccine distribution, IBM warns - Reuters

Return Home:  The Designated Representative and Exemptee Blog

-------

California - Florida - Designated Representative Training. California Designated Representative online training for 3PL and wholesalers. Florida Certified Designated Representative (CDR) training and examination preparation.
California - Florida - Designated Representative Training. California Designated Representative online training for 3PL and wholesalers. Florida Certified Designated Representative (CDR) training and examination preparation. California HMDR Exemptee Training Certification.



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, December 1, 2020

Six Crucial Trends Facing U.S. Drug Wholesalers - Drug Channels

According to the article:

"This year has demonstrated the underlying resilience of U.S. distribution channels for prescription drugs. Pharmaceutical wholesalers have maintained shipments and operational capacity. They are now poised to play a vital role in distributing COVID-19 vaccines and therapeutics as they become available. However, there are substantial uncertainties about the timing and level of financial impact on wholesalers’ economics.

Below, I highlight six trends that will affect the U.S. drug wholesaling industry."

Read the full source article:  Six Crucial Trends Facing U.S. Drug Wholesalers - Drug Channels

Return Home:  The Designated Representative and Exemptee Blog

--------

California Designated Representative Training - Board-approved online training courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board for your license application.
California Designated Representative Training - Board-approved online training courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board 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):

Wednesday, October 28, 2020

FDA Takes Actions to Help Lower U.S. Prescription Drug Prices

Read the full FDA press release:  FDA Takes Actions to Help Lower U.S. Prescription Drug Prices - FDA.gov

In summary, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The rule allows FDA-authorized programs to import certain prescription drugs from Canada under specified conditions designed to ensure that the imported drugs pose no additional risk to the public’s health and safety, as well as to provide a “significant reduction” in costs to American consumers.

View the FDA guidance document:  Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

Return Home:  The Designated Representative and Exemptee Blog

------

California Designated Representative (wholesaler, 3PL) Training by SkillsPlus Intl Inc.
California Designated Representative (wholesaler, 3PL) Training by SkillsPlus Intl Inc.



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)

Return Home:  The Designated Representative and Exemptee Blog

------

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):

Saturday, December 21, 2019

Canadian drug distributors say no to Trump import plan - Reuters

Read the full article:  Canadian drug distributors say no to Trump import plan - Reuters

According to the article:
"Many of Canada’s drug suppliers cannot, or will not, agree to ship cheaper prescription medicines into the United States, a new challenge to the Trump administration’s push to reduce drug prices, companies and industry officials told Reuters."

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):

Thursday, November 21, 2019

The FDA Considers PI a Closed Issue – So Why the Confusion? - LSPediA

Updated August 19, 2026

You might also like:

Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers - 
Guidance for Industry - FDA.gov:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-identifiers-under-drug-supply-chain-security-act-questions-and-answers

---  the original post follows below  ---

Read the full article:  The FDA Considers PI a Closed Issue – So Why the Confusion? - LSPediA

I hope this doesn't come as a surprise.

According to the article:

"It’s been 14 months since the FDA advised manufacturers, wholesalers, and repackagers on Product Identifier (PI) requirements. You’ll remember that it came as a bit of a shock to most in the industry that what they’d been doing—following the GS1 standard of a GTIN with an embedded 10-digit National Drug Code (NDC) number, plus the serial number, lot number, and expiration date—was insufficient for PI purposes.

The FDA’s draft guidance said that was close to what they wanted, but not close enough. They dismissed the GTIN and confirmed the requirement of using the NDC number as one of the building blocks of a PI. The exact language was found in the answers to questions 4 and 5 of the guidance."

Return Home:  The Designated Representative and Exemptee Blog

----------------

Board-approved California Designated Representative online training courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.
Board-approved California Designated Representative online training 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):
     Florida:

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

     California (earn a training completion certificate):

Friday, March 15, 2019

SAP blockchain service helps fight counterfeit drugs - TechTarget

Updated June 12, 2026

The original link broke.

You might also be interested in:

---  the original post follows below  ---

Read the full article:  SAP blockchain service helps fight counterfeit drugs - TechTarget

"SAP is working to combat counterfeit drugs. The company has released a blockchain offering that is aimed at authenticating drugs in the supply chain. 
The SAP blockchain application for the pharmaceutical industry is designed to ensure that any drugs returned to a wholesaler from hospitals and pharmacies are validated before they are resold, according to SAP. The blockchain was developed in the SAP Information Collaboration Hub for Life Sciences, a public cloud network involving several large pharmaceutical wholesalers and manufacturers, which SAP launched in November 2017."

It's getting competitive.  Looks like a lot of companies are trying to offer a DSCSA blockchain solution.

Return Home:  The Designated Representative and Exemptee Blog

-------------------

California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - courses for wholesalers or third-party logistics providers (3PL)
California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - courses for wholesalers 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):

Friday, February 1, 2019

Prescription Drug Wholesalers Reaped Windfall From Alleged Price-Fixing - The Washington Post

Read the full article:  Prescription drug wholesalers reaped windfall from alleged price-fixing - The Washington Post

"Multiple state attorneys general have joined forces in civil antitrust litigation against the makers of generic drugs. As part of the probe, they say wholesale distributors — who have not been named as defendants — should have held the line on anti-competitive behavior by manufacturers and alerted authorities to suspicious activity. 
Instead, end consumers paid a steep price as alleged price-fixing conspiracies boosted costs of common drugs as much as 1,000 to 4,000 percent."


Return Home:  The Designated Representative and Exemptee Blog

---------------------

California Designated Representative Training Courses for wholesalers, 3PL, reverse distributors (approved by the California State Board of Pharmacy)
California Designated Representative Training Courses for wholesalers, 3PL, reverse distributors (approved by the California State Board of Pharmacy)


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 2, 2018

AmerisourceBergen to pay $625M in drug distribution settlement - Modern Healthcare

Read the full article:  Modern Healthcare - AmerisourceBergen to pay $625M in drug distribution settlement

"In order to avoid the Food and Drug Administration's regulatory oversight, AmerisourceBergen did not register Medical Initiatives as a repackager or manufacturer with the agency, records show. Instead, the group portrayed Medical Initiatives as a state-regulated pharmacy, exploiting an exemption to the FDA registration requirement that is reserved for legitimate pharmacies, not for manufacturers or repackagers, authorities said."

Return Home:  The Designated Representative and Exemptee Blog

-------------------------------------

California Designated Representative Training Courses - accepted by the California State Board of Pharmacy
California Designated Representative Training Courses - accepted by the California State Board of Pharmacy


- - -


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, August 3, 2018

US subpoenas AmerisourceBergen over opioid products - CNBC


Read the full article:  US subpoenas AmerisourceBergen over opioid products - CNBC (click this link)

"AmerisourceBergen, which is among the defendants, is one of the largest drug distributors in the country. AmerisourceBergen and rivals Cardinal Health and McKesson control 85 percent of the U.S. prescription drug market.  The subpoena came from the U.S. Attorneys Office for the Southern District of Florida."

This topic is related to the opioid epidemic and reporting suspicious orders of controlled substances.

Return Home:  The Designated Representative and Exemptee Blog

California Designated Representative training courses accepted by the California State Board of Pharmacy. For wholesalers, 3PL, and reverse distributors.  Earn a training affidavit.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 

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, February 6, 2018

A Lesson from McKesson: How Specialty Pharmacy Growth Is Hurting Wholesalers - Drug Channels

Read Adam Fein's full article:  Drug Channels: A Lesson from McKesson: How Specialty Pharmacy Growth Is Hurting Wholesalers:

"Wholesalers have been trying to alter their conventional pricing and contracting approaches to address these pressures, though it’s not clear how successful these efforts have been. The specialty boom may prove to be a mixed blessing for wholesalers."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training programs for California Designated Representative (for wholesalers or 3PL) license applicants - Earn a training affidavit


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 

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 31, 2017

Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software - Health Law & Policy Matters

Read the full article:  Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software - Health Law & Policy Matters:

"On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software, alleging a conspiracy to lock up long-term contracts with customers and exclude competition in violation of the Sherman Act and the Virginia Antitrust Act. "

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training program for drug wholesalers and 3PLs applying for a California Designated Representative license - 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

Wednesday, October 11, 2017

Thanks, California! SB17 Will Trigger Massive Speculative Buying, Windfall Pharmacy Profits, and Supply Chain Disruption - Drug Channels

Updated April 7, 2019
You might have been searching for Texas SB17:

- - -

California SB17 - An Analysis

Read the full article:  Drug Channels: Thanks, California! SB17 Will Trigger Massive Speculative Buying, Windfall Pharmacy Profits, and Supply Chain Disruption:

"As I explain in Section 4.6.2. of our new 2017–18 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, drug wholesalers will benefit very little from the new law’s advance purchasing of inventory.

That’s because inventory profits are eliminated by almost all manufacturer-wholesaler distribution service agreements. Manufacturers typically negotiate agreements that recapture the value of price appreciation on inventory held in wholesalers’ warehouses and on order with the manufacturer. If a manufacturer recaptures the full inventory appreciation value, then a wholesaler does not benefit from buying inventory at the old price and then selling it at the new, higher price."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

California Designated Representative Training Courses (wholesaler; 3PL) - Approved by the California State Board of Pharmacy
Training programs for California Designated Representative license applicants. 
Drug wholesalers and 3PLs can earn a training affidavit.

-------------

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 3, 2017

The 2017–18 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors - Drug Channels

-----

-----
Updated December 29, 2018:

You might also be interested in:
THE 2018-19 ECONOMIC REPORT ON PHARMACEUTICAL WHOLESALERS AND SPECIALTY DISTRIBUTORS

- - -  original post follows below  - - -

Get the latest info: Drug Channels: NEW: The 2017–18 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors:


"The 2017–18 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors—our eighth edition — remains the most comprehensive tool for analyzing the economic and business realities of U.S. pharmaceutical distribution.

This year's edition has been thoroughly updated, revised, and expanded. It contains the most current market and industry and data. The report is the only resource of its kind available anywhere."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

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, July 10, 2017

Cardinal Health’s Unhappy Profit Surprise: The Coevolution of Pharmacy Buying Groups and Wholesaler Economics (rerun) - Drug Channels

Read the full article: Drug Channels: Cardinal Health’s Unhappy Profit Surprise: The Coevolution of Pharmacy Buying Groups and Wholesaler Economics (rerun):

"Independent pharmacies have been backed into a corner—and have responded by pushing back against their wholesale suppliers. Cardinal’s warning highlights the coevolution of profits within the pharmacy channel ecosystem. Expect wholesalers to be increasingly desperate to make up these lost funds. "

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training program for California Designated Representative license applicants

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):

Wednesday, April 12, 2017

LA drug wholesalers accused in $20M federal 'structuring' conspiracy - MyNewsLA.com

Read the full article: LA drug wholesalers accused in $20M federal 'structuring' conspiracy - MyNewsLA.com:

"The owners of two Los Angeles-area drug wholesale companies were among four defendants arrested Wednesday on federal “structuring” charges for allegedly making millions of dollars in cash deposits to circumvent federal reporting requirements."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training program for CA 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, December 15, 2016

Five Industry Trends for U.S. Drug Wholesalers in 2017 - Drug Channels

Updated October 29, 2024

You might also be interested in the most current industry reports by Drug Channels:
https://www.drugchannels.net/p/our-industry-reports.html

---  the original post follows below  ---

This is a must read.

Read the full article:  Drug Channels: Five Industry Trends for U.S. Drug Wholesalers in 2017:

"Below, I republish the section highlighting five significant industry trends affecting the U.S. drug wholesaling industry. I think Drug Channels readers will enjoy this summary as we look toward an eventful 2017."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training for drug wholesaler Designated Representative license applicants



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):

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

-----

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):

Custom Search

From SkillsPlus International Inc.