AmerisourceBergen's compounding site still on ice despite beefed-up oversight - BioPharma Dive

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Updated June 13, 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's compounding site still on ice despite beefed-up oversight - BioPharma Dive

"PharMEDium, a drug compounder and subsidiary of AmerisourceBergen, received a series of Form 483s over the last year as regulators observed issues at several of its manufacturing plants. Some of the more common issues included failing to have procedures that adequately protect against contamination or ensure quality control."

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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"

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FDA > DSCSA > Are you ready for the Drug Supply Chain Security Act?

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Read the full article: Drug Supply Chain Security Act > Are you ready for the Drug Supply Chain Security Act? - FDA.gov:

"There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for product tracing will continue to be phased in over the next nine years. FDA will continue working with trading partners and other stakeholders to effectively implement the new requirements."

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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."

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2014 Fall Conference Season Preview - RxTrace

View Dirk Rodger's annotated list of upcoming supply chain conferences at: 2014 Fall Conference Season Preview - RxTrace:

"Here are the events that have caught my eye for one reason or another, in chronologic sequence:"

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The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace

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More great stuff that's clear and easy to understand from Dirk Rodgers. Follow the link below to read his full post.

The Differences Between The DSCSA, FDA Rules and Guidance - RxTrace:

"From reading the responses to the FDA docket requesting public feedback on standards for interoperable information exchange, I think it is time to review the difference between laws, FDA Rules and FDA guidance, like those stemming from the Drug Supply Chain Security Act (DSCSA).  It appears that some people might be confusing these a little."

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

Updated February 4, 2026

Some of the links in the original post broke.

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---  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

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FDA Posts 3 New Draft Guidances RE: Human Drug Compounding

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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

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

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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."

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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)."

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FDA - Hurricane Checklist - Medical Devices

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Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to: . . . "  (follow the link above to the FDA's checklist)

More specifically for medical devices:

Medical Devices

• If you have a "life-supporting" or "life-sustaining" device that depends on electricity, you should contact your healthcare provider for information on how to maintain function in the event of a loss of power.
• Keep your device and supplies clean and dry. If possible, notify your local Public Health Authority to request evacuation prior to adverse weather events.
• For more information, see FDA Offers Tips about Medical Devices and Hurricane Disasters¹⁵ (en Español¹⁶).

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Compounding A Crisis At FDA - Forbes Article

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Updated October 14, 2025

You might also be interested in:

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."

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FDA Considers Compounding Industry User Fees

Hamburg: User Fees Might be Solution for Funding Increasing Regulation of Compounding Industry:

Hamburg said in her blog posting that FDA "looks forward to working with Congress to explore funding mechanisms, which could include registration or other fees, as Congress has authorized and FDA has successfully implemented in other settings."

Such funding might be able to bridge the gap between agency goals and resource limitations. Left unclear, however, is whether the pharmaceutical compounding industry would be on board with the proposal. Past user fee proposals, such as the Prescription Drug User Fee Act, the Medical Device User Fee Act and the Generic Drug User Fee Act have all been passed with the explicit support of their respective industries.

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Hamburg Says FDA Needs New Authorities to Regulate Pharmacy Compounding

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Updated April 19, 2022

The original post didn't age well.

You can read more here:

• Compounding and the FDA: Questions and Answers - FDA.gov
• Compounding Quality Center of Excellence On-demand Training - FDA.gov

---  the original post follows below  ---

FDA Must Have New Authorities to Regulate Pharmacy Compounding | FDA Voice:

"In the new framework, FDA believes that certain high-risk sterile compounding facilities should be subject to federal oversight to ensure that the compounding of sterile drug products at those facilities can be done without putting patients at undue risk, including . . .

And for all pharmacy compounding, FDA believes certain basic protections should be in place. These include . . ."

'via Blog this'

New Framework:

• Require compliance with federal quality standards, appropriate for the compounding of riskier products & exposure of larger numbers of patients,
• Require federal registration of the compounding facilities that will be subject to federal quality standards so FDA knows where they are and what drug products they are making.
• Require those higher-risk compounding pharmacies to report to FDA serious adverse reactions to their drugs of which they become aware.

Basic Protections:

• Grant clear authority to examine a pharmacy’s records to more quickly locate the cause of an outbreak or other violations of the law.
• Prohibit compounding of the most complex and highest risk products—drugs and biologics that should only be made for patients by an FDA-registered drug manufacturer under an approved new drug application. 

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FDA Focus On cGMP Compliance By Compounders

Updated June 10, 2022

Some of the links broke.

You might also be interested in:

• Compounding Oversight and Compliance Actions - FDA.gov
• Human Drug Compounding - FDA.gov

---  the original post follows below  ---

The FDA continues to focus on pharmacy compounders.

This is evidenced by the growing number of the FDA's Form 483s (Inspectional Observations) that are being posted:  FDA - 2013 Pharmacy Inspections

Earlier this month, the FDA sent a "Warning Letter" to Medi-Fare Drug and Home Health Center 3/7/13.  It highlights the myriad touchpoint issues, including pharmacy regulations, and the FDA's regulations on current good manufacturing practices (i.e., the FDA's cGMPs).

You might also be interested in:
21 CFR 211: Pure, Safe, and Effective - Online training - An orientation to the FDA's cGMPs

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"The Politic" Interviews Margaret Hamburg (FDA)

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The Woman in Charge: Margaret Hamburg | The Politic:

". . . The Politic: Let’s move on to the recent meningitis outbreak. Was the FDA in this case supposed to have prevented the outbreak, or was the role of the FDA more in the response portion?

Sadly, the current regulatory framework for these so-called compounding pharmacies is inadequate and ambiguous as to the state role and the federal role, and we need to address that concern. I hope we can work with Congress to craft new legislation that will strengthen and clarify existing law. Within the existing legal framework, we are in a much more reactive posture rather than a preventive one.

As a public health official and the head of the FDA, I would really like to be able to see a system that could help us prevent this type of tragedy going forward. As we've seen the industry and healthcare system evolve, I think what has always been a concern about a lack of clarity between state and federal responsibilities has gotten more pronounced and more dangerous. More and more health care systems are relying on sort of hybrid  compounding pharmacy/manufacturer in order to produce products they need. These facilities are in a gray area in between state and FDA regulations. . . . "

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FDA Seizes Illegal Dietary Supplements in FL

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Updated March 9, 2026:

The link in the original post broke.

You might also be interested in:  FDA Seizes Illegal Dietary Supplements In Florida

- - -  the original post follows below  - - -

WASHINGTON: FDA seizes illegal dietary supplements in Florida - Business Breaking News - MiamiHerald.com:

"Several of the supplements from Globe All Wellness LLC contain the active ingredient in Meridia, a weight loss drug that was withdrawn from the market in 2010. The drug was pulled after studies showed it could increase the risk of heart attack and stroke.

Among other problems, the Hollywood, Florida-based company made unsubstantiated claims about the benefits of its products and did not comply with manufacturing standards."

'via Blog this'

For additional details:
FDA Warning Letters - Globe All Wellness, LLC 2/6/12

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FDA and States Meet On Regulation of Drug Compounders

F.D.A. and States Meet About Regulation of Drug Compounders - NYTimes.com:

"Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how the states see the federal role. Some states said they would prefer to see the F.D.A. handle large-scale compounders like the New England Compounding Center, or N.E.C.C., the Massachusetts pharmacy that was the source of the outbreak.

“The consensus in our group was that there is a role for the F.D.A. to be involved in facilities like N.E.C.C.,” said Cody Wiberg, the executive director of the Minnesota Board of Pharmacy. “If you’re talking about compounding, most states have the authority and resources to handle that. If you’re talking about nontraditional compounding,” he said, referring to large-scale enterprises like N.E.C.C., “fewer states may have the resources to do that.”"

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Public Citizen to FDA - RE: Compounding Pharmacies

Updated June 6, 2024

Links in the original post broke.

You might also be interested in:

Compounding and the FDA: Questions and Answers - FDA.gov

---  the original post follows below  ---

This is interesting reading for those of you who are following the role of the FDA in compounding pharmacy oversight.

Public Citizen to FDA: Reinspect Compounding Pharmacies Across the Country | The Legal Examiner Cleveland:

"In an 11-page letter to FDA Commissioner Margaret Hamburg, consumer watchdog group Public Citizen asked the agency to follow up on warning letters it issued to compounding pharmacies committing NECC-like violations.

Since 2003, the FDA has sent at least 18 warning letters to 16 compounding pharmacies, Public Citizen’s letter stated. In light of the 2012 fungal meningitis outbreak, the group would like the FDA to either reinspect those pharmacies or to verify that recent reinspections confirmed that those pharmacies cleaned up their act."

'via Blog this'

You might be interested in:
Public Citizen's Letter to the FDA re:  Compounding Pharmacies (PDF)

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     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

ASHP's Sterile Compounding Checklist

Updated December 6, 2025

You might also be interested in:

• ASHP STERILE COMPOUNDING COMPETENCY LIBRARY
• Compounding Quality Center of Excellence On-demand Training - FDA.gov

= = =
Updated September 2, 2019

The link in the original post below is broken.  You might also be interested in:

• ASHP - Sterile Compounding Resource Center
• ASHP Guidelines on Outsourcing Sterile Compounding Services (2015 PDF)

= = = original post below = = =

The American Society of Health-System Pharmacists (ASHP) just published this document:
     Eight Critical Steps Related to Sterile Compounding Services - Member Action Check List

In the checklist, ASHP says:

"ASHP strongly encourages you to review this list, even if your pharmacy department does not have a contract with an external compounding facility. This is important because off-site clinics or affiliated entities within your health system may have developed independent contracts that the pharmacy department was not involved in securing."

Return Home:  The Designated Representative and Exemptee Blog

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The largest selection of Board-approved California Designated Representative training programs. 3 distinct courses for wholesalers, 3PL, reversed distributors. Earns a Board-accepted training affidavit.

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