Increase in Outsourcing of Bio Pharmaceutical Labeling and Packaging to 3PL & 4PL

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Read the full news release:  Global Bio Pharma Logistics Market 2015-2019 - Increase in Outsourcing of Bio Pharmaceutical Labeling and Packaging... -- DUBLIN, Oct. 28, 2015 /PRNewswire/ --:

"The market is witnessing certain trends that are expected to contribute to its growth during the forecast period. One of these trends is the increase in outsourcing of bio pharma labeling and packaging activities to 3PL and 4PL companies. This helps the manufacturing companies to focus on core activities like the procurement of raw materials and distribution of the products."

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US Senate & House - Drug Quality and Security Act

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Updated May 3, 2023

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

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

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Updated October 13, 2021

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

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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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Compounding A Crisis At FDA - Forbes Article

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Updated October 14, 2025

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Human Drug Compounding - FDA.gov

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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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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

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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 . . ."

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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.

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

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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).

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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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Public Citizen to FDA - RE: Compounding Pharmacies

Updated June 6, 2024

Links in the original post broke.

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

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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."

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Public Citizen's Letter to the FDA re:  Compounding Pharmacies (PDF)

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