Showing posts with label supply chain. Show all posts
Showing posts with label supply chain. Show all posts

Friday, June 9, 2023

DSCSA Readiness - A Long Way To Go

Updated July 31, 2026

Companies Are Not Ready

The end to end pharmaceutical supply chain still isn't ready for DSCSA implementation.

Some articles are warning that the November 2023 date will be a challenge:

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Friday, May 12, 2023

Scrutinizing Drug Wholesaler Pricing

Read the full source article:
Drug Wholesalers Elude Congress Scrutiny in Pricing Debate (1) - Bloomberg Law

According to the news article:

"Wholesalers that distribute prescription drugs to pharmacies need scrutiny as Congress investigates the roles of supply chain middlemen in drug pricing, analysts say."

"Wholesalers have gotten limited attention on Capitol Hill, even as tackling high drug costs has become a major priority among key lawmakers in both chambers. Various entities can benefit from higher list prices from drugmakers, researchers and analysts say. Any examination of how drug prices are formed should include wholesalers and all other components of the supply chain, they argue."

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     California (earn a training affidavit):
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     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

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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, July 23, 2019

Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

Read the full text of the Op-Ed:  Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

From the Op-Ed:
"As we see it, there is no legal or operational way of transforming a drug packaged for a foreign market into a drug that meets the U.S. requirements of our in-progress track-and-trace system. What’s more, there is no way to alter the law to enable importation without undermining the law’s purpose and value.  ... 
Importation laws undermine the country’s progress in building a modern technology infrastructure to track and trace prescription drugs. Making exceptions to the in-progress track-and-trace system would ignore the many instances of drug diversion and counterfeiting that led to the creation and passage of the law in 2013."

The Op-Ed covers the following areas:
  • State drug importation laws undermine the process that keeps our supply chain safe
  • Why the U.S. is building a track-and-trace system 
  • How track-and-trace works 
  • Importation undermines the track-and-trace system
  • Importation enables counterfeits 
  • Forgetting the lessons 
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California Designated Representative Training Courses (for wholesaler, 3PL, reverse distributor). Largest selection of Board-approved California Designated Representative online training courses. Earns a training affidavit accepted by the California State Board of Pharmacy.
California Designated Representative Training Courses (for wholesaler, 3PL, reverse distributor). Largest selection of Board-approved California Designated Representative online training courses. Earns a training affidavit 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):

Thursday, March 14, 2019

TraceLink proposes blockchain system for DSCSA pilot - SecuringIndustry.com

Read the full article:  TraceLink proposes blockchain system for DSCSA pilot - SecuringIndustry.com

"TraceLink says that its offering – called Trace Histories – is built on its digital supply network which is already widely used in the pharma supply chain. Adding blockchain means that it can now offer a system that is “designed specifically to help pharmaceutical manufacturers, wholesale distributors, pharmacies, and hospitals securely exchange information and satisfy the 2023 DSCSA requirement.”"

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

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."

'via Blog this'

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

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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, December 13, 2017

Top 10 Logistics Stories of 2017 | Logistics Viewpoints


"2017 is just about in the books, and it has been a busy year for the supply chain industry. Let’s look back at ten of the top logistics stories of the year."

'via Blog this'

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Training program for third-party logistics providers (3PL) handling dangerous drugs or devices who are applying for a California Designated Representative 3PL license - Earn a training affidavit


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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, November 24, 2017

UPS makes move deeper into drugmaker supply chain - CNBC

Read the full article:  UPS makes move deeper into drugmaker supply chain - CNBC:

"United Parcel Service has acquired a manufacturing pharmacy license from Georgia's Board of Pharmacy, enabling the company to not only ship pharmaceuticals, but to relabel them."

'via Blog this'

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Training program for third party logistics (3PL) providers applying for a California Designated Representative 3PL license - Earn a training affidavit


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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 4, 2016

Brink’s Life Sciences transports delicate pharmaceuticals to patients worldwide | Miami Herald

Read the full article: Brink’s Life Sciences transports delicate pharmaceuticals to patients worldwide | Miami Herald:

"Seeing a major business opportunity for its existing international logistics and security network, Brink’s set up its Life Sciences Division and began rolling out its specialized services in North America and throughout the world. “Our focus on securing the supply chain for life sciences products is an area where we feel we have a competitive advantage,” Moreira said."

'via Blog this'

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Wednesday, February 10, 2016

3 Big Wins Health Care Companies Are Doing To Contain Costs - Forbes


Read the full article: 3 Big Wins Health Care Companies Are Doing To Contain Costs - Forbes:

"Health care costs hit the spotlight in a big way with the implementation of Obamacare in 2014. However, the cost spotlight shines even brighter now – especially with respect to supply chain costs."

'via Blog this'

The article cited above references these two reports:
  1. HIDA - Healthcare Supply Chain 2015 - Strategic Insights for the Distribution Channel (PDF)
  2. Eighth UPS Pain in the Chain Survey - Survey Snapshot (PDF)


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

     California (earn a training affidavit):
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For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Tuesday, December 8, 2015

UPS identifies new series of “Pain Points’’ in pharma supply chains - Article from Logistics Management

Sign-up for a Board-approved California Designated Representative course now:
 - Wholesaler Training Course
 - 3PL Training Course
 - Reverse Distributor Training Course

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"The 2015 Pain in the (Supply) Chain survey recently conducted by UPS coincided this year with qualitative interviews of healthcare executives in North America to gain further insights into trends, challenges and opportunities having an impact on healthcare logistics.

Among the findings was that healthcare companies have made significant strides in just one year to address some top supply chain pain points."

'via Blog this'

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

     California (earn a training affidavit):
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For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Tuesday, November 3, 2015

MIA launches pharmaceutical transport certification program | Miami Herald

Updated July 4, 2023:

They put the linked article behind a paywall.

You can read more about this topic here:

---  original post follows below  ---

Read the full article: MIA launches pharmaceutical transport certification program | Miami Herald:

"Miami International Airport, already a major hub for pharmaceutical imports and exports, is the first U.S. airport to partner with the International Air Transport Association’s global certification program for handling and shipping pharmaceutical products.

To avoid spoilage of sensitive pharmaceutical products and boost international trade, IATA, the international airline trade association representing about 260 air carriers, is providing assessment and training in cold-chain pharmaceutical transportation to certify participants in MIA’s air cargo supply chain, including air cargo carriers, logistics companies, truckers, freight forwarders and warehouses."

'via Blog this'

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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, October 29, 2015

Drug Wholesaler AmerisourceBergen Building New Data Bridges to Manufacturers - The CIO Report - WSJ


Read the full article: Drug Wholesaler AmerisourceBergen Building New Data Bridges to Manufacturers - The CIO Report - WSJ:

"AmerisourceBergen Corp. CIO Dale Danilewitz says the global drug wholesaler is working on a number of projects meant to deliver more data to its pharmaceutical manufacturers, a move that would give drugmakers more visibility into their supply chain and help manage inventory.

“We’re trying to deliver more information about product access, product utilization, and product pricing to them,” he said during an interview at the Technology Business Management Council conference in Chicago.  The delivery methods, which could include “real-timeonline access,” is part of the company’s “roadmap for better integration with manufacturer systems."

'via Blog this'

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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 21, 2015

Ready for a makeover: What’s trending in the global pharma logistics? – The Financial Express


Read the full article: Ready for a makeover: What’s trending in the global pharma logistics? – The Financial Express:

"From using data analytics to developing cold chain capabilities, pharma companies, in tandem with logistics firms, are leaving no stone unturned to tackle the mounting challenges. Since payers and consumers are likely to continue demanding effective and proficient healthcare, the part of the supply chain that handles the last mile of delivery is changing.

Outsourcing to third-party logistics providers (3PLs)
 “More companies are outsourcing logistics than we have seen in many years”
– Joe Carlier, Senior VP – Sales, Penske Logistics (June 2015)"

'via Blog this'

You might also be interested in:
NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.

Return Home:  The Designated Representative and Exemptee Blog

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

Monday, October 5, 2015

New NCPA Report Highlights How Drug Wholesalers, Independent Drugstores Profit From Generic Price - PRNewswire


Read the full article: New NCPA Report Highlights How Drug Wholesalers, Independent Drugstores Profit From Generic Price... -- WASHINGTON, Sept. 28, 2015 /PRNewswire-USNewswire/ --:

"NCPA's report outlines several reasons for generic drug price increases within the supply chain and offers new insights into both wholesalers and pharmacies:"

'via Blog this'

. . .  specifically, the article calls out:
  • Drug Wholesalers, and
  • Independent Drugstores and the "Gray Market."
Note:  in this article, NCPA means the National Center for Policy Analysis

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

     California (earn a training completion certificate):

Thursday, September 17, 2015

Building a Pharmaceutical Supply Chain Security Strategy – From Risk Identification to the Four A’s of Protection - Pharmaceutical Compliance Monitor


Read the full article: Building a Pharmaceutical Supply Chain Security Strategy – From Risk Identification to the Four A’s of Protection - Pharmaceutical Compliance Monitor:

"Four Steps to Crafting a Smart Security Plan

Although the threats to the pharmaceutical supply chain are numerous and the consequences of not securing the chain are devastating, you can mitigate even the most aggressive risks by implementing a proactive strategy through the power of the four A’s: Assess, Access, Alert and Audit."

'via Blog this'

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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

Saturday, September 12, 2015

Cardinal Health Launches New Health Care Supply Chain Innovation Center


Read the full news release:  Cardinal Health | MediaRoom - News release archive - Cardinal Health Launches New Health Care Supply Chain Innovation Center:

"Center Employs Internet of Things Approach to Develop Innovative Solutions in Medical Device Supply Chain"

"“In a rapidly growing network of smart devices communicating with each other, IoT has gained significant traction in health care, and while much of healthcare’s IoT focus has centered on patient monitoring applications, we believe the medical devices and implantables are ripe for an IoT approach,” said Jean-Claude Saghbini, vice president and general manager for Cardinal Health™ Inventory Management Solutions. “Building on existing automated cloud-based supply chain solutions, our vision is to create a level of efficiency and connectivity that will transform the healthcare supply chain from a source of savings into a strategic asset that can significantly reduce the total cost of care.”"

'via Blog this'

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     California (earn a training completion certificate):

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