AmerisourceBergen to Buy PharMEDium for $2.6 Billion - WSJ

• People think highly of California Designated Representative training courses for:
        Wholesalers | 3PL | Reverse Distributors

Updated June 23, 2026

AmerisourceBergen does not own PharMEDium anymore because the drug compounding business was permanently shut down in 2020.

---  the original post follows below  ---

Read the full article: AmerisourceBergen to Buy PharMEDium for $2.6 Billion - WSJ:

"PharMEDium maintains four compounding facilities and serves more than 3,000 hospital clients, according to a news release."

'via Blog this'

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

FDA Establishes Public Docket on Drug Compounding - FDA.gov

Read the entire announcement: Compounding > FDA Establishes Public Docket on Drug Compounding - FDA.gov:

"However, stakeholders have expressed interest in providing comments and information to FDA on a variety of issues that are not related to the specific regulations, guidance documents or Federal Register notices that FDA has published. FDA has established this public docket so that stakeholders can share information, research, and ideas on any matters related to human drug compounding that are not specific to the documents or issues on which we have already sought public comment in other dockets."

'via Blog this'

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

Related articles

• Wholesale Distributor & Third-Party Logistics Providers Reporting - FDA Requirement

FDA issues new draft documents related to compounding of human drugs

Updated November 24, 2020

Links broke in the original post.

You'll be interested in:

Human Drug Compounding - FDA.gov

- - -  original post follows below  - - -

Read the full press release, and find links to the guidances:
Press Announcements > FDA issues new draft documents related to compounding of human drugs - FDA.gov:

"Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states"

'via Blog this'

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

14 Arrested in Meningitis Deaths Linked to New England Compounding Center - NYTimes.com

Read the full article: 14 Arrested in Meningitis Deaths Linked to New England Compounding Center - NYTimes.com:

"The arrests signal the beginning of criminal proceedings against the New England Compounding Center, whose contaminated drugs led to the deaths from fungal meningitis of 64 people in the fall of 2012. More than 680 people were sickened.

The contamination caused an uproar and prompted new legislation about compounding pharmacies, which make specialized formulations of drugs for patients with particular needs. Over the years, such companies have grown into mass manufacturers distributing medicine all over the country, virtually unregulated by the federal government."

'via Blog this'

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

Florida inspections reveal drug compounding health violations - South Florida Business Journal

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

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 - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Exam Prep Course

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

Violations also included improperly acting as a wholesaler.  For details, follow the link below . . .


Florida inspections reveal drug compounding health violations - South Florida Business Journal:

"Consumers often assume drugs are manufactured with the utmost care before injecting them into their veins or dropping them into their eyes, but Florida pharmacy inspectors have found that’s not always the case.
Since October 2012, 11 South Florida pharmacies have had their licenses revoked, relinquished or permanently suspended as compounders by the state Board of Pharmacy because of violations that directly impacted product safety. "

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

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

Related articles

• Florida inspections reveal drug compounding health violations (bizjournals.com)

What Are The FDA's CGMPs? Ramifications for Compounding Outsourcing Facilities

Updated February 4, 2026

Some of the links in the original post broke.

You might also be interested in:

• Board-approved California Designated Representative training courses for wholesalers, 3PL, reverse distributors
• FDA cGMP online training programs by SkillsPlus International Inc.

---  the original post follows below  ---

On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs. In the new law, a compounder can become an “outsourcing facility.” Outsourcing facilities must comply with CGMP requirements. (Source:  FDA.gov - Compounding Quality Act - Title I of the Drug Quality and Security Act of 2013)

The FDA (Food and Drug Administration) puts forth the cGMP regulations (current good manufacturing practice). The CGMPs are also commonly referred to as:

• GMP - good manufacturing practice, or
• CGMPR (current good manufacturing practices regulations)

If you're unfamiliar with the FDA cGMPs, then consider taking this online course:

21 CFR 211: Pure, Safe, and Effective - an introduction to the FDA cGMPs

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 > Registered Outsourcing Facilities - FDA.gov

Follow the FDA.gov link below for a list of the registered firms.

Compounding > Registered Outsourcing Facilities - FDA.gov:

"Firms Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)"

'via Blog this'


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

FDA Posts 3 New Draft Guidances RE: Human Drug Compounding

• FDA cGMP QSR GMP Online Training - by SkillsPlus International Inc.
  
• Purchase a California Designated Representative training course for:  
       Wholesalers | 3PL | Reverse Distributors

Updated June 18, 2025

All the links broke in the original post.

You'll be interested in:

• Human Drug Compounding - FDA.gov
• Compounding Research - FDA.gov
• Compounding Quality Center of Excellence On-demand Training - FDA.gov

- - -  original post follows below  - - -

The FDA just published 3 new draft guidances related to compounding. 


In a nutshell, they cover: earlier guidance prohibitions; "outsourcing facilities" (OF) voluntary registration; and how OF's should report their compounded drugs.

Category	Title	Type	Date
Procedural	Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB)	Draft Guidance	12/02/13
Procedural	Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB)	Draft Guidance	12/02/13
Procedural	Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB)	Draft Guidance	12/02/13

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

Obama signs Drug Quality and Security Act into law - SecuringIndustry.com

SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

Return Home:  The Designated Representative and Exemptee Blog

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

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

SkillsPlus Intl Info Blog

Breaking news: US Senate clears track-and-trace bill - SecuringIndustry.com

SecuringIndustry.com - Breaking news: US Senate clears track-and-trace bill:

"The US Senate passed H.R. 3204 by unanimous voice vote today, bringing a national track-and-trace system for medicines and new laws governing compounding pharmacies to the brink of fruition.

With the House having given its blessing to H.R. 3204- also known as the Drug Quality and Security Act (DQSA) - at the end of September, all that remains now is for the bill to be passed to President Obama for signature."

Return Home:  The Designated Representative and Exemptee Blog

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

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

SkillsPlus Intl Info Blog

All Eyes On The U.S. Senate Tonight - RxTrace

• California Board of Pharmacy Approved Designated Representative Training Courses
• Wholesaler Training Course
• 3PL Training Course
• Reverse Distributor Training Course


• Trusted FDA GMP online training courses and programs sold by SkillsPlus International Inc.

Updated November 24, 2025

The original post didn't age well.

You might also be interested in:

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

---  the original post follows below  ---

Hold your breath. Let's see if the U.S. Senate will pass this bill, H.R. 3204 (An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.)

All Eyes On The U.S. Senate Tonight - RxTrace:

"There are lots of things that would be triggered by passage of the law. No doubt, the most important one is that the California pedigree law would immediately become inoperative. That is, all of the “clocks” in that law—like January 1, 2015 for 50% of all drugs being serialized and pedigreed, etc.—would stop and disintegrate into irrelevance along with those of all other state pedigree laws."

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

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

New CA Law - SB 294 Requires A Special License For Sterile Compounders

• People also look for Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.
  
• Register now to take a Board-approved California Designated Representative training course for:
     Wholesalers | 3PL | Reverse Distributors

Updated June 26, 2023:

The original link broke.

You might also be interested in:

Sterile Compounding/Nonresident Sterile Compounding/Hospital In-Patient Sterile Compounding Pharmacy/Hospital Satellite Compounding Pharmacy License - California State Board of Pharmacy

---  the original post follows below  ---

Governor Jerry Brown signed Senate Bill 294 into law. SB 294 will go into effect in July of 2014.

Highland News > Archives > News > Bill Increasing Oversight Of Sterile Compounding Pharmacies Signed Into Law:

"Specifically, SB 294 requires both in-state and out-of-state pharmacies that compound sterile drug products for California patients that will be inhaled, injected, or administered into the eye to apply for a special, additional license from the California State Board of Pharmacy. Under this new law, the board is required to inspect these facilities annually to provide consistent oversight and ensure compliance with pharmacy law."

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

Congress Clarifies Drug Compounding, Tracking Policies

Updated 12/12/2022

The links in the original post broke.

You might also be interested in:

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

---  the original link follows below  ---

Congress Clarifies Drug Compounding, Tracking Policies:

"After months of public hearings and negotiations, Democrat and Republican leaders of the House Energy & Commerce Committee and the Senate Health, Education, Labor and Pensions Committee unveiled a compromise bill last week. No one gets all they wanted from H.R. 3204, the Drug Quality and Security Act, but it provides more clarity and predictability to drug oversight programs and moves forward initiatives designed to enhance the safety and quality of medicines in the US."

Follow this link to the draft bill, Drug Quality and Security Act (PDF)

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.” "

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

Survey Finds S.B. 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession

New Poll Finds Senate Bill 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession | Business Wire:

"A recent poll of independent compounding pharmacies by PCCA shows that 4 in 10 of the pharmacies surveyed would be required to abandon the pharmacy profession under the terms of Senate Bill 959, The Pharmaceutical Quality, Security, and Accountability Act."

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

House Version of Compounding Legislation Emerges, Contrasts With Senate Approach

Updated November 22, 2025

You might also like:

Human Drug Compounding - FDA.gov:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding

---  the original post follows below  ---

House Version of Compounding Legislation Emerges, Contrasting Sharply With Senate Approach:

"Now legislators will be tasked with negotiating out differences in their legislative approaches. The PQSA is significantly more rigorous toward the compounding industry than the Compounding Clarity Act, and also includes track and trace legislative measures. The significant differences and approaches between the two pieces of legislation mean it could be months before any legislation stands a chance of reaching President Barack Obama's desk."

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

The US House Finally Introduces A Compounding Pharmacy Bill | Pharmalot

Updated October 2, 2025

The original link broke.

You might also be interested in:

Compounding and the FDA: Questions and Answers - FDA.gov
https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

---  the original post follows below  ---

The US House Finally Introduces A Compounding Pharmacy Bill | Pharmalot:

"A long-awaited compounding pharmacy bill from the US House of Representatives has finally been introduced and, like a Senate bill introduced earlier this year, offers greater authority to the FDA. But while a key organization representing pharmacists is backing the effort, consumer advocacy groups remain concerned that both bills create loopholes that may create dangers for patients."

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

Shrinking - Insurance Coverage Of Some Compounded Meds

• The recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.
  

Updated November 15, 2023

The original link broke.

You might also be interested in:

Compounding: Inspections, Recalls, and other Actions - FDA.gov

---  the original post follows below  ---

It appears that health insurers are getting concerned about the safety and quality of compounded meds.

Compounding Problems: Anthem Restricts Coverage Of Some Compounded Meds | Pharmalot:

"More fallout from the compounding controversy. Anthem Blue Cross Blue Shield, one of the nation's largest insurers, has decided to end reimbursement of certain compounded medications as of November 1. Specifically, the insurer will not pay for compounded bulk powders or pharmaceutical adjuvants that are not approved by the FDA, according to a mailing that were sent to pharmacists."

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

FDA - Pharmacy Alert - Front Range Laboratories - Testing Concerns

Updated November 18, 2025

The original post didn't age well.

You might also be interested in:

Compounding: Inspections, Recalls, and other Actions - FDA.gov

https://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions

---  the original post follows below  ---

Drug Safety and Availability > CDER Statement: FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories:

"In a recent inspection, FDA investigators observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this 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