UPDATED: May 15, 2019
In early 2018, Congress held an important and timely hearing on compounded drugs. The hearing brought stakeholders together to reflect on a law enacted nearly five years before in response to serious public health incidents. In 2012, a nationwide fungal meningitis outbreak originating from contaminated injectable compounded sterile drugs sickened over 750 individuals and resulted in the deaths of more than 70. This is just one example of several tragedies that prompted Congress to enact the Drug Quality and Security Act (DQSA). Also in response, Federal and state regulators adopted reforms directed at protecting patient safety and helping to ensure safe, quality compounded drugs. We commend Congress for its attention to this critical public health issue and support the ongoing efforts of the U.S. Food and Drug Administration (FDA), states, providers, and practitioners to advance efforts to promote quality in compounded sterile drugs.
As Congress conducts its oversight of the implementation of DQSA, it is useful to reflect on this law that established a new paradigm promoting the protection of patients while helping to maintain access to needed medicines. The practice of compounding has a longstanding presence—before the advent of manufactured medicines, essentially all medicines were compounded. Today, compounding continues to play an important role by providing patients who have specific medical needs with tailored medicines when a suitable product is not otherwise available. As with all medicines, it is essential to safeguard against potential risks, including problems that can occur with sterility (e.g., microorganisms such as bacteria, fungus, or virus), purity (e.g., the drug contains unintended contaminants that could be harmful), and potency (e.g., the dosage is inaccurate, either too strong or too weak).
Congress continues to set forth requirements, integrated with state law, to support the safety, quality, and availability of compounded medicines for patients who need them, regardless of healthcare setting. Successful implementation of the law depends on ongoing collaborative efforts of the FDA, states, providers, practitioners, and other stakeholders, to advance quality compounded products.
USP standards contribute to a framework designed to support quality
USP standards for compounding are part of a quality framework designed to protect patients. Federal law specifically references and mandates USP standards for compounding. A compounder must use bulk drug substances and ingredients that comply with the standards of an applicable USP monograph, if a monograph exists, and the USP chapter on pharmacy compounding.
USP compounding standards are developed based on the expertise of the Compounding Expert Committee and facilitate consistency and quality in the medicines prepared for patients. USP develops and updates its quality standards through independent experts in a transparent scientific process, incorporating perspectives from practitioners from all disciplines and specialties, public interest groups representing various patient populations, Federal agencies such as the FDA and the Centers for Disease Control and Prevention (CDC), as well as state regulators. Public input is an important part of this process and helps to ensure that USP’s public standards reflect a balanced approach—one that protects patients while facilitating access to needed therapies. USP is committed to being a resource and working in partnership with FDA, state regulators, providers, practitioners, and others as standards evolve to reflect public health needs and advances in science.
Empowering a healthy tomorrow
USP supports efforts by Congress, regulators, providers, practitioners, and other stakeholders to address this critical public health issue and ensure that quality compounded preparations are available for patients. Efforts such as these are essential to helping prevent additional tragedies like those that prompted the law’s enactment and to ensuring patient access to quality compounded medicines.
Jaap Venema, Ph.D., is Executive Vice President and Chief Science Officer (CSO) for USP.