FDA Commissioner Scott Gottlieb, M.D., announced that the agency was “taking a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. Among other things, these provisions limit the bulk drug substances that outsourcing facilities can use in compounding. It directs the FDA to develop a list of bulk drug substances for which there is a clinical need—the 503B bulks list.”
The March 23, 2018 statement looks at how that list will be formulated, and what bulk drug substances the outsourcing facilities can use to compound drugs. Some key points:
• Compounding can be critical for advancing the health of patients who have specific medical needs that cannot be met by FDA-approved drugs.
• Compounded drugs are not FDA-approved and do not undergo premarket review by the FDA for safety, effectiveness and quality; they also present a greater risk to patients than FDA-approved drugs.
• The draft guidance is one part of a comprehensive policy framework. In January, FDA released its compounding policy priorities plan, which lays out how during 2018 the agency will implement certain key provisions of DQSA and other requirements of the law relevant to compounders. The plan includes draft and final guidance documents, proposed and final rules, and a revised draft memorandum of understanding (MOU) between the FDA and states.
• The draft guidance represents “a significant milestone in our work to implement that compounding priorities plan,” says Gottlieb. The new draft guidance (“Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act”), issued for public comment, discusses the FDA’s interpretation of the statutory phrase “bulk drug substances for which there is a clinical need,” as well as the factors and processes that the FDA proposes to use when evaluating whether to include a bulk drug substance on the list of bulk drug substances that outsourcing facilities may use in compounding drugs.
• Outsourcing facilities are subject to more stringent FDA oversight than traditional pharmacy compounders and can compound drugs in one of two ways. First, by starting from an FDA-approved drug product, the outsourcing facilities may prepare compounded drugs by altering the FDA-approved drug. The second way is by starting from a bulk drug substance. An outsourcing facility may do this because an attribute of the alternative, FDA-approved drug product makes it inappropriate or unsafe for the patient.