Scrutinizing Drug Wholesaler Pricing

• California Board-approved training programs for license applicants. California Designated Representative training courses:  
• Wholesaler Training Course
• 3PL Training Course
• Reverse Distributor Training Course

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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- - -

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Senate Approves 21st Century Cures Act, Sending It to President Barack Obama's Desk | US News

Read the announcement: Senate Approves 21st Century Cures Act, Sending It to President Barack Obama's Desk | US News:

"Congress has approved a bill overhauling the development of medical treatments and cures that is likely to be one of the last pieces of legislation President Barack Obama will sign into law before he leaves office.

The Senate voted 94-5 on Wednesday to approve the bill, the 21st Century Cures Act, which will hasten how drugs and medical devices are reviewed and authorized by the Food and Drug Administration."

'via Blog this'

You might also be interested in:
Cures Act Headed To President - HME News

HMDR Exemptee Certification Class for Exemptee license applicants

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Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg:

"One lawmaker’s effort to alter Obamacare is holding up final action by Congress on legislation that would expand U.S. regulation of compounding pharmacies linked to meningitis deaths last year.

The Senate is poised to approve the measure to broaden the U.S. Food and Drug Administration’s oversight of compounding pharmacies. Ninety-nine senators have agreed to pass the legislation that the House passed without a roll call vote, Democratic and Republican lawmakers said.

Republican Senator David Vitter of Louisiana wants the vote on compounding pharmacies coupled with consideration of his proposal to deny lawmakers and their staffs employer contributions when they buy medical insurance on the exchanges set up under the new health-care law. As a result, senators may have to spend a week on work that could be done in minutes."

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

US Senate & House - Drug Quality and Security Act

• Recommended California Designated Representative online training programs, courses, and classes offered by SkillsPlus International Inc. | State-approved by the California State Board of Pharmacy.

Updated May 3, 2023

You might also be interested in:

Drug Supply Chain Security Act (DSCSA) - FDA.gov

---  the original post follows below  ---

This is promising news, cooperation and agreement between the House and Senate (and across the aisle), to converge on what could likely become final legislation. Stay tuned!

US Senate Committee on Health, Education, Labor, & Pensions: Newsroom - Press Releases:

" “This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards. This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution. I commend the bipartisan spirit that brought this compromise proposal together.” "

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- - -

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Share Your CMS Round 2 Concerns With Congress

• Buy now to enroll in California Exemptee Training Certification for home medical device retailers (HMDR)

AAHomecare Blog: Get a Bigger BANG for the August Recess Buck:

"Resources

For tips on how to talk to Congress and be more effective in the political process, download our 10 Step Guides in the AAHomecare Grassroots Toolbox.

For details about the bidding program and the reasonable alternative, the market pricing program, go to www.aahomecare.org/advocacy.

Find your Representative and Senators’ phone numbers and email addresses in our congressional directory."


Return Home:  The Designated Representative and Exemptee Blog

- - -

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace

Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace:

"Background

Both the Senate and House of Representatives have been working independently of one another to push forward measures on both compounding and track and trace. On the Senate side, the two measures have been combined into a single bill, the Pharmaceutical Quality, Security and Accountability Act (PQSA Act), while on the House side the measures are proceeding separately."

Follow this link to a draft of the Pharmaceutical Quality, Security and Accountability Act (PQSA Act) - PDF

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CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
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CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

SkillsPlus Intl Info Blog

Senate Bill S.959 - Text of Pharm Compounding Quality & Accountability Act

• The top choice for CDR training! California Designated Representative Training - for wholesalers, 3PL, reverse distributors. California Pharmacy Board approved. Earns a training affidavit suitable for your Designated Representative license application. More than 7,000 students have taken state license-related training programs taught by SkillsPlus International Inc. ... ... ... ... ... ... #CaliforniaDesRep #CaliforniaDesignatedRepresentative
  
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Updated October 13, 2021

You might also like:

Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry - FDA.gov

- - -  original post follows below  - - -

Here's a link to the bill's text as it progresses through Congress.

S.959 - 113th Congress (2013-2014) - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to compounding drugs. - Bill Text | Congress.gov | Library of Congress:

"A BILL - To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding drugs."

Return Home:  The Designated Representative and Exemptee Blog

- - -

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Draft Compounding Pharmacy Bill by the House

A nice article with the latest details . . .

FDA Law Blog: Proposed Draft of House Compounding Legislation Released, Comments Wanted by Thursday June 20, 2013:

"This bill does not define a “compounding pharmacy” or create a “compounding manufacturer” category, unlike the pending Senate Health, Education, Labor and Pensions Committee (“HELP”) legislation (S. 959)."

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Compounding A Crisis At FDA - Forbes Article

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Updated October 14, 2025

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Human Drug Compounding - FDA.gov

---  the original post follows below  ---

This is about legislative proceedings happening right now in Washington. Follow the link below to a short commentary.

Compounding A Crisis At FDA - Forbes:

"But all of this doesn’t change the fact that some “compounding” pharmacies are operating as drug makers under the guise of a pharmacy license, breaking existing law, and creating public risks. They are manufacturing drugs with none of the oversight that ensures that their processes are sterile and safe. FDA’s recent inspections of some of these facilities have surfaced widespread, and potentially dangerous biological contaminations of these products. Another tragedy is just a matter of time."

Return Home:  The Designated Representative and Exemptee Blog

- - -

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Group Letter - Repeal Medicare Competitive Bidding for HME and Services

• Purchase now, to take California Exemptee training certification for home medical device retailers (HMDR)

Updated July 26, 2021

The original link broke.

You can still read about this topic here:

INDUSTRY, PATIENT GROUPS CALL FOR NCB’S REPEAL - HME Business

---  the original post follows below  ---

Thought you'd be interested in this Medical News Today article, Nearly 60 Homecare And Patient Advocacy Groups Urge Congress To Repeal Medicare's "Competitive" Bidding For Home Medical Equipment And Services.

Tyler J. Wilson, president of the American Association for Homecare in the open letter to Congress says:

"Our national, state and local organizations believe that this program is fundamentally flawed and will create significant obstacles to patient care while threatening the homecare infrastructure for our nation's seniors and disabled."

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