Drugs

Draft Guide on Bulk Substances for Drug Compounding

FDA has issued a draft guidance on “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act” that discusses the agency’s interpretation of the statutory phrase “bulk drug substances for which there is a clinical need.” It also addresses the factors and processes that FDA proposes to use when evaluating whether to include a bulk drug substance on its list of bulk drug substances that outsourcing facilities may use in compounding drugs.

According to an agency release, the agency proposes to use a two-step analysis when evaluating bulk drug substances. The first step “involves the agency considering whether attributes of the approved drug may make it unsuitable to treat certain patients for particular conditions – and whether the compounded drug is intended to address that attribute,” the release says. The second step involves a “balancing test under which the FDA would weigh certain factors for each substance being proposed for use in a compounded drug product – specifically, its physical and chemical characterization, possible or known safety issues, evidence or lack of thereof of effectiveness, and historical use,” it says.

The guidance is mandated under the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. DQSA was enacted following the 2012 nationwide fungal meningitis outbreak that led to more than 750 illnesses and 64 deaths from a compounded drug for injection that was supposed to be sterile, but became contaminated. The document is also part of FDA’s January-announced compounding policy priorities plan for implementing key provisions of DQSA during 2018, and other requirements of the law relevant to compounders. The plan comprises several draft and final guidance documents, proposed and final rules, and a revised draft memorandum of understanding between the agency and states.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome