FDA Consulting: Drug Shortages

A landmark FDA consulting article in Pharmaceutical Technology, “Linking Drug Shortages and Quality Metrics” provided information regarding the link between drug shortages including the enactment of the Food and Drug Administration Safety and Innovation Act,

FDA Drug Shortage List


FDA’s efforts to develop a common set of quality metrics for the pharmaceutical industry will help address the current drug shortage problem. Efforts from the industry to establish and maintain quality metrics capable of measuring the suitability of pharmaceutical products for the patient, and the capability of the manufacturer to consistently provide these products without delay will increase knowledge.
The Parenteral Drug Association (PDA) also published Technical Report No. 68 (TR68), “Risk-Based Approach for Prevention and Management of Drug Shortages,” which provides the bio/pharmaceutical industry with appropriate tools for preventing drug shortages.

FDA Drug Shortages


PDA technical reports, authored and peer-reviewed by PDA members, are intended to offer practical guidance on pertinent regulatory and scientific topics that affect the global pharmaceutical industry. Members with expertise in manufacturing and quality assurance for sterile biopharmaceutical and pharmaceutical products (the majority type of products subject to drug shortages) authored TR68.


Although PDA technical reports are not officially recognized guidance, they are often referenced by FDA consulting experts and regulators. Additionally, regulators may be involved in the writing or approving of the final report contents.


Product Shortages


TR68 addresses the drug shortage issue from a global perspective and offers relevant, proactive advice applicable to the global pharmaceutical industry. In addition, the paper recognizes several contributing factors potentially responsible for drug shortages: manufacturing issues, quality issues, and supply chain or distribution issues. This is important because TR68 recognizes that the issue of a potential drug shortage goes beyond the quality department within an organization.


Global Language for Global Issue


The document provides a common language for the industry to use when discussing drug shortages. It is this author’s opinion that it is always important when authoring potential global guidance to establish a common language for the readers. TR68 accomplishes this objective by placing a glossary at the beginning of the report and references, when possible, existing FDA consulting definitions from recognized, credible sources.


The definition for “harm” for example, is taken verbatim from the International Conference on Harmonization’s (ICH) Q9 guideline, Quality Risk Management. The definition of knowledge management is taken from ICH Q10 Pharmaceutical Quality Systems. Using previously established definitions helps the global users of TR68 understand the context and relationship of this document within the regulatory framework of the industry. 


FDA Shortage List


Once a common language is established, it is easier for a document user to relate the narrative portion of the document to the shortage list. The narrative of the technical report describes how the issue of drug shortages is global in nature and delineates current global regulatory and legal manufacturer reporting requirements when facing issues that may result in drug shortages. These issues are not limited to final product manufacturers but may involve suppliers of raw materials crucial for product formulation.


For example, TR68 describes how a supply-chain issue, a shortage of acetonitrile in 2008-2009, can prompt a drug shortage. The FDA consulting document discusses how multiple suppliers were unable to provide acetonitrile to the industry because of a series of unforeseen circumstances. This shortage impacted the ability of companies to manufacture APIs that then impacted the manufacture of the final drug product.


Drug Shortage List


The document is designed to guide bio/pharmaceutical companies in the assessment of the risk of experiencing a drug shortage. TR68 uses a risk triage model to collect and assess existing organizational information to determine drug-shortage risk. The model builds on the concepts of management responsibility, supply chain management, quality risk management, knowledge management, regulatory requirements and a company’s compliance history and treats them as integrated interrelated disciplines within an organization.


The examples included in the document provide templates to combine a company’s information into a comprehensive set of tools that not only measure the potential for a company to experience a drug shortage, but also delineate and identify gaps in organization structure that may exist in quality systems.


Medication Shortages


The document takes the aforementioned concepts and provides a framework for capturing the information in one inclusive document. This can help remedy issues with resolving medication shortages and patient wait times. The completed document can be used as a FDA consulting tool to share within an organization or with clients in determining potential process improvements or necessary resources required to address systemic process gaps.


TR68 can be used in part or in total by raw material and API suppliers, contract manufacturing organizations, and pharmaceutical companies to assess and manage organizational, manufacturing, and quality issues that could contribute to a drug shortage. The document provides tools to predict and hopefully prevent drug shortages in the future.


Article Details:


regulatory compliance


Pharmaceutical Technology
Vol. 39, Issue 3
Pages: 26–27 


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Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process. 


About RCA’s Pharmaceutical Consulting Services 


Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.


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pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:



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