Navigating the Quality Assurance and Regulatory Landscape in Compounding Pharmacy
May 10, 2017
By Washington M. Osiro

Contributors

Author:

1. Washington Osiro, M.B.A (cand.)

Reviewers:

1. Devin McElroy, Ph.D. (cand.), CSSGB, CQA
2. Sormeh Mahjouri, MPH

Introduction

This article provides an overview of the compounding pharmacy industry given reports of adverse events[1], some resulting in patient deaths, that has befallen it. The summary is designed to provide compounding pharmacy management a brief history and state-of-the-industry overview.

Between understanding the industry’s history and its current state, management will be better-positioned to formulate a strategy on how to navigate the quality assurance and regulatory landscape in the process assure patient safety by being compliant with relevant and related regulations.

Background / Problem

The compounding pharmacy industry has been in the news for host of adverse events including the tragic New England Compounding Center-related[2] outbreak of meningitis; an event whose root cause was traced to contaminated compounded injectable medication made by the Framingham, Massachusetts-based compounding pharmacy.

Such tragedies notwithstanding, few doubt the importance of the industry in fulfilling the demand for prescription drug formulation, manufacturing, distribution, and delivery of said drugs to the patient for use.

Unfortunately and surprisingly, the Food & Drug Administration (FDA) appears to lack the authority to force compounders to take recommended steps to comply with audit findings (described as “multiple egregious, life-threatening problems in the…..process for making sterile drugs.”): The foregoing is an inexplicable decision exemplified by the audited facility’s outright refusal to adhere to the agency’s “recommendation to halt production or issue a recall until the problems were fixed”.[3]

Additionally, there exists a spotty patchwork of (state) regulations[4] where some state regulations are not as stringent as others even as some are not portable across state lines.

Furthermore, few states require compounding pharmacies to comply with recognized quality standards including a systematic readily accessible repository for (all) serious adverse events and reactions related to sterile compounding.

The foregoing labyrinth of state and federal “Dos” and “Don’ts” have combined to raise questions about the industry’s ability to protect the public health at both the state and federal level. This has happened even as the International Academy of Compounding Pharmacists (IACA) recommends[5] that facilities adhere to quality standards recommended by the US Pharmacopeia Convention AND passage of the Drug Quality and Security Act (in 2013).

Discussion

The compounding pharmacy industry continues to evolve, as most businesses tend to BUT also because of the negative publicity that has befallen it.

The latter has also compelled state and federal governments to step up oversight.

Successful facilities will take a pro-active and holistic approach to quality and regulatory compliance.

Based on conversations with approximately twenty (20) compounding pharmacies over the last several months, including one out-of-state, I found just one pharmacy that was facing state sanctions and even then, this facility had been given ninety days to remediate the non-conformances.

The take-away from these conversations was that:

Rather than wait for an adverse event or visit from a (state or federal) regulatory agency to occur, there are viable, practical and less expensive options that do not include “lawyering up” as anecdotally appeared to be the consensus among a consortium of compounding pharm executives.

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Conclusion

Tighter regulation of the compounding pharmaceutical industry is here to stay: a reality underscored by a comparative study that revealed the need for “more robust safeguards….(especially) when compounding occurs on a larger scale.”[6]

And while the requirements may vary from state-to-state and frankly are still evolving at the federal level, there are some immediate steps the industry can take to implement a quality system that assures delivery of quality product that is safe and effective.

Beyond getting accredited by the Pharmacy Compounding Accreditation Board[7] (PCAB), compounding pharmacies can implement effective quality systems by borrowing from systems already in use across the med device, biotech and pharmaceutical industry. These include the following:

• Guidelines for Compounding Practices[8]
• ISO 9001 Quality Management System
• ISO 13485 Medical devices – Quality Management Systems –  Requirements for regulatory purposes
• cGMP Current Good Manufacturing Practices
• USP 795 Pharmaceutical Compounding – Nonsterile Preparations[9]
• USP 797 Pharmaceutical Compounding – Sterile Preparations
• USP 800 Hazardous Drugs Handling in Healthcare Settings

Rather than re-invent the wheel, Neozene will work with you to identify (any) gaps in your current system and work with you to bridge that gap – using your internal resources OR fully resourcing the project.

Neozene subject matter experts (SMEs) in quality systems across the biotech and pharmaceutical requirements can lead internal teams to assess and ensure a quality system program compliant with known and accepted standards.

References

[1] https://www.statnews.com/pharmalot/2016/04/08/compounding-pharmacy-drug-safety-fda/
[2] https://www.nytimes.com/2014/12/18/us/new-england-compounding-center-steroid-meningitis-arrests.html?_r=0
[3] https://www.statnews.com/pharmalot/2016/04/08/compounding-pharmacy-drug-safety-fda/
[4] https://www.statnews.com/pharmalot/2016/02/24/compounding-pharmacies-fda/
[5] http://www.iacprx.org/?page=100
[6] http://www.clinicaliq.com/images/stories/clinicaliq_compounding%20quality%20standards.pdf
[7] http://www.pcab.org/
[8] http://www.pharmacist.com/sites/default/files/files/Allen_%20Chap_%201_Art,%20Science%20and%20Technology%20of%20Pharmaceutical%20Compounding,%204e.pdf
[9] http://www.usp.org/sites/default/files/usp_pdf/EN/gc795.pdf