Showing posts with label pharmaceutical. Show all posts
Showing posts with label pharmaceutical. Show all posts

Friday, July 28, 2023

AAM White Paper Breaks Down Drug Shortage Crisis

According to the article:

"A white paper created by the Association for Accessible Medicines (AAM) explaining the myriad of causes that have resulted in mass drug shortages around the world proposed several actions that stakeholders can take to address current challenges and prevent future ones.

“Policymakers, healthcare providers, and manufacturers each play an important role in reducing drug shortages, and all should be cautious of short-term patches that create long-term barriers to robust generic competition and patient access to low-cost medicines,” wrote the authors."

Read the full source article:  AAM White Paper Breaks Down Drug Shortage Crisis: Causes and Solutions - The Center For Biosimilars

Go to the AAM White Paper:  Association for Accessible Medicines Drug Shortages: Causes & Solutions

Return Home:  The Designated Representative and Exemptee Blog

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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, 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:

Return Home:  The Designated Representative and Exemptee Blog


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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, 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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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

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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):

Friday, October 30, 2020

Seven Recent Statistics in Pharma Cargo Theft - Healthcare Packaging

Updated June 13, 2026

You might also like:

Cargo Thefts - FDA.gov:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/criminal-investigations/cargo-thefts

---  the original post follows below  ---

Read the full source article:  Seven Recent Statistics in Pharma Cargo Theft - Healthcare Packaging

According to the article:

"The median value of a pharma theft is $100,000. Pelli said, “Even the smaller pharma thefts are larger than the typical thefts in other industries,” including food and apparel. “When pharmaceutical thefts happen, they tend to be big… an entire truck, a facility break-in.” Pelli advised attendees to focus less on the number of incidents but more on the potential impact of those incidents."

Return Home:  The Designated Representative and Exemptee Blog

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California Board of Pharmacy Designated Representative Training (wholesaler, 3PL) - provided by SkillsPlus International Inc. - Board-approved. 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 (wholesaler, 3PL) - provided by SkillsPlus International Inc. - Board-approved. 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 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.

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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, February 12, 2020

4 Ways to Recognize a Good Pharmaceutical Distributor - Drug Topics

Read the full article:  4 Ways to Recognize a Good Pharmaceutical Distributor - Drug Topics

The article suggests the following criteria:
  1. Distributors must be licensed to be an authorized trading partner.
  2. A distributor with the VAWD seal can ensure that the supplies you receive are safe.
  3. A distributor should be well informed about the many laws and regulations that govern the industry.
  4. Pharmaceutical distributors and the pharmacists should share priorities.

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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, December 20, 2019

4 reasons Trump’s drug importation plan won’t work - Politico

Read the full article:  4 reasons Trump’s drug importation plan won’t work - Politico

Importers would need the cooperation of the Canadian government and the drug industry, both of which oppose it.

According to the article:
"President Donald Trump has promised that the plan his administration rolled out Wednesday to bring in cheaper prescription drugs from Canada will immediately lower medication costs. Experts say the plan won’t work — and many write it off as a political stunt. 
Under the proposal, importers would need the cooperation of the Canadian government and the drug industry, both of which oppose it. Importers would have to take many expensive and complicated steps to prove to the FDA that importation wouldn’t harm Americans, and to weave through complex regulations and the intricacies of the U.S. health delivery system."

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Board-approved California Designated Representative online training programs for wholesalers, 3PL, third-party logistics provider, reverse distributors. Earns a training affidavit.
Board-approved California Designated Representative online training programs for wholesalers, 3PL, third-party logistics provider, reverse distributors. Earns 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):

Tuesday, December 17, 2019

The industry-wide governance body for DSCSA compliance comes to life - Pharmaceutical Commerce


Read the full article:  The industry-wide governance body for DSCSA compliance comes to life - Pharmaceutical Commerce

According to the article:

"As has been known for years, establishing a successful implementation of the Drug Supply Chain Security Act (DSCSA) will require close coordination among manufacturers, wholesaler-distributors, pharmacies and health systems (even, conceivably, individual doctor’s offices)—a tall order. Yet there has been no reliable mechanism for accomplishing this coordination—apart from banging on FDA’s door—to date. That is changing now with the establishment of the Partnership for DSCSA Governance, Inc. (PDG), an independent, nonprofit, “sector neutral” (as it characterizes itself) group to work out the steps toward DSCSA compliance by the law’s 2023 deadline.

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California Designated Representative online training courses for wholesalers, 3PL, reverse distributors. 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, September 5, 2019

Preorder Now: Our 2019–20 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors - Drug Channels

Updated October 29, 2021

You can also order reports here:

---  the original post follows below  ---

Read the full announcement:   Preorder Now: Our 2019–20 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors - Drug Channels
"On October 2, 2019, Drug Channels Institute will release The 2019–20 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. 
This new tenth edition is the most comprehensive, fact-based tool for understanding and analyzing all aspects of the U.S. pharmaceutical distribution industry. It also contains detailed information about the largest companies: AmerisourceBergen, Cardinal Health, and McKesson."

Return Home:  The Designated Representative and Exemptee Blog

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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, October 9, 2018

FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products - RAPS.org


Read the full news article:   FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products - RAPS.org
"“Transaction data for prescription drug purchases from the firm show that lot/batch numbers are not captured/retained; as such the firm does not have sufficient processes in place to determine and notify, within 24 hours, all the immediate trading partners that the firm had reason to believe may have received illegitimate product,” the 483 says."

Read the FDA Form 483:   McKesson Corporation, San Francisco, CA. Form 483 issued 07/03/2018 (PDF)

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy)
California Designated Representative Training Courses (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):

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.

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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 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."

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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)



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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, 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'

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Training programs for California Designated Representative (for wholesalers or 3PL) license applicants - 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):

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'

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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

Tuesday, October 3, 2017

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

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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'

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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

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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, September 27, 2017

Industry Wants FDA Help, Guidance on New Drug Tracking System | Bloomberg Law

Updated August 3, 2019

You might also be interested in a collection of the FDA's DSCSA-related guidances, all in one location:

Drug Supply Chain Security Act Law and Policies - FDA.gov


- - - original post follows below - - -

Read the full article:  Industry Wants FDA Help, Guidance on New Drug Tracking System | Bloomberg Law:

"Kelly said the HDA is concerned about whether the 2023 deadline for implementation will be met without specific directions from the FDA on how to do it. The HDA represents wholesale distributors that purchase drugs from manufacturers and sell them to pharmacies, hospitals, and others. Three of the biggest distributors are AmerisourceBergen Corp., Cardinal Health, and McKesson Corp."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training program for California Designated Representative (including 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):

Friday, September 15, 2017

A Distribution Revolution in the Making: A Wholesaler Uses Mobile, Picking Robots :: Logistics Viewpoints

Read the full article: A Distribution Revolution in the Making: A Wholesaler Uses Mobile, Picking Robots :: Logistics Viewpoints:

. . . "this is still an ongoing journey to fully leverage the capabilities of this technology, the potential is clearly huge. Amazon paid $775 million for Kiva, a provider of autonomous mobile robots, but these robots are not capable of picking. In contrast, the bots from IAM Robotics do the full job of a picker.  One can only ask, what might this company be worth as the technology matures?"

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

Training program for California Designated Representative (including 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):

Wednesday, August 30, 2017

How Many California Designated Reps Do I Need?

Several California Designated Representatives Might Be Needed - Consider These Reasons

California Pharmacy Law

According to the California Board of Pharmacy website:

"Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations." Specifically, the California Wholesaler license application says (in boldface), "There must be one designated representative on the premises at all times during business operation."

"Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider's customer specifications, except where the customer's specifications conflict with state or federal laws. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager." Specifically, the California Third-Party Logistics Provider license application says (in boldface), "There must be one licensed designated representative-3PL on the premises at all times during business operation."
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When the business operations and staffing model are taken into consideration, some companies will need more than one designated representative. In other words, when the business is operating, there must be at least one designated representative there. Scheduling designated representative coverage starts to get tricky when you figure in vacations, days off, multiple shifts, etc. To reiterate the Board, there must be one licensed designated representative on the premises at all times during business operation.

Good Business Practice

And just when you think you've got it all covered ...

It's not unusual for some businesses to manage with just one designated representative, or keep the bare minimum of licensed designated representatives on staff.  However, these companies can run into a situation that can affect the company's business financial health. In the event the company loses a licensed designated representative, for example, the designated rep quits, and cross-coverage by another licensed designated representative isn't possible, then the business operation could get into trouble with the Board, or just as bad, must shut down (until a licensed designated rep can be on premise).

It's a difficult scenario, to be left scrambling, trying to find, hire, and get a new employee properly licensed as a designated rep.  Therefore, consider the risks, and keep just the "right" number of licensed designated representatives.

Return Home:  The Designated Representative and Exemptee Blog

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Training programs for California Designated Representative (including 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):

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):

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