UM School of Pharmacy-led Team to Aid FDA in Examining Clinical Need for Compounding Using Bulk Drug Substances
A three-year grant from the U.S. Food and Drug Administration will enable researchers to evaluate more than 200 nominated bulk drug substances in a review that includes outreach to medical specialty groups.
Newswise — BALTIMORE, MD — University of Maryland School of Pharmacy (UMSOP) researchers will lead a nationwide effort in cooperation with the U.S. Food and Drug Administration (FDA) to evaluate more than 200 bulk drug substances used in compounding drugs. Findings of the research team will inform FDA’s efforts to develop a list of bulk drug substances for use in compounding by outsourcing facilities -- a newly-established category of drug compounders under Federal law.
Ashlee Mattingly, PharmD, BCPS, assistant professor in the Department of Pharmacy Practice and Science at UMSOP, has been awarded a three-year, $2.2 million federal grant to investigate the use in clinical practice of drugs including certain bulk drug substances (active ingredients) nominated for use in compounding by outsourcing facilities.
“Compounded drugs serve an important role for patients whose medication needs cannot be met by an FDA-approved drug product, such as patients who have an allergy and need a medication to be made without a certain dye,” says Mattingly. In 2012, contaminated injectable drugs that a state-licensed compounding pharmacy shipped across the country caused an outbreak of fungal meningitis that led to more than 60 deaths and 750 cases of infection across the nation. In response to this outbreak, Congress enacted the Drug Quality and Security Act (DQSA) that amended the Federal Food, Drug, and Cosmetic Act to strengthen the FDA’s authority to regulate and monitor compounded drugs.
The legislation, among other things, established a new category of compounders known as outsourcing facilities, which are registered with the FDA and operate under the direct supervision of a licensed pharmacist. These facilities can only compound using bulk drug substances if the substance is used to compound a drug on the FDA’s drug shortage list or appears on a list that will be developed by the FDA of bulk drug substances for which there is a clinical need.
Stephen Hoag, PhD, professor in the Department of Pharmaceutical Sciences and director of the Applied Pharmaceutics Lab at UMSOP, joins Mattingly as a collaborator. Hoag explains: “It’s a difficult balancing act with which the FDA has been tasked. The FDA wants to make compounded medications available for the patients who need them, but it must also take certain precautions to help ensure that the medications are compounded properly and not otherwise harmful to patients. We will help the FDA collect information that it will use to make informed decisions about which substances should be used in compounding, as well as which substances should not be used in compounding.”
The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) grant is part of an ongoing partnership between the University of Maryland, Baltimore; the University of Maryland, College Park; and the FDA. M-CERSI focuses on modernizing and improving the ways drugs and medical devices are evaluated. James Polli, PhD, co-principal investigator for M-CERSI, will also collaborate on the project.
“The goal of M-CERSI is to bring together researchers from across the University of Maryland to assist the FDA with a wide range of regulatory science issues. We want its scientists to be best informed when making decisions that will affect patients, providers, researchers, and manufacturers across the country,” says Polli, who is the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at UMSOP. “Through our involvement in this project, we are helping to support FDA’s efforts in identifying bulk drug substances for which there is a clinical need.”
Mattingly explains that the broad scope of the inquiry will require a review of both present and past usage. “Our research will examine how drugs compounded with certain bulk drug substances have been used historically, as well as how they are currently used in clinical practice, which will help the FDA determine whether these substances should be included on its list of bulk drug substances that outsourcing facilities can use in compounding.”
The project will include an in-depth review of clinical practice guidelines, published literature, and other relevant sources regarding the clinical use of drugs containing certain bulk drug substances. The project also will involve outreach to medical specialty groups, medical experts, and specialists in the relevant fields. Examples of substances to be evaluated are alpha lipoic acid, which is a supplement often used by individuals with diabetes and peripheral neuropathy, and glycolic acid, which is a substance used to treat skin conditions such as scarring and hyperpigmentation.
Mattingly and collaborators will leverage their individual expertise in pharmacy practice and pharmaceutical sciences, as well as their extensive outreach to medical experts, to understand use in clinical practice of more than 200 substances. Their findings will inform the FDA in its decisions regarding each substance.
“This project is really about learning as much as we can about each substance that has been nominated for inclusion on FDA’s list of bulk drug substances for which there is a clinical need,” says Mattingly. “Our goal is to support FDA’s efforts to preserve access to compounded drug products that meet individual patients’ medical needs.”
About the University of Maryland School of Pharmacy
Established in 1841, the University of Maryland School of Pharmacy is ranked as one of the top ten schools of pharmacy in the United States. The School is a thriving center for professional and graduate education, pharmaceutical care, research, and community service. Its faculty create the future of pharmacy by pioneering new roles for pharmacists in advanced clinical practice and conducting cutting-edge research in drug discovery and development, comparative effectiveness and patient-centered outcomes, and disease management. A contemporary curriculum, innovative educational experiences, and strategic professional relationships help to inspire excellence in the School’s more than 800 students, residents, and postdoctoral fellows. Together, we are critical thinkers, lifelong learners, and leaders who are sought for our expertise.