Due to problems with compounded medications—including the 2012 fungal meningitis outbreak that led to 64 deaths—FDA is releasing a draft guidance that will determine which bulk drug substances outsourcing facilities can use to compound drugs.
“…Compounding from bulk drug substances generally presents greater risk to patients than compounding from FDA-approved drugs,” FDA Commissioner Scott Gottlieb, MD, said in a statement about the new draft guidance. “Compounding from bulk drug substances also involves more numerous and complex steps than compounding from approved drugs. This process can introduce increased risk for compounding errors or contamination.”
In addition, compounding drugs using bulk drug substances—when the use of an FDA-approved drug or a drug compounded using an FDA-approved drug would meet patients’ medical needs—can undermine the drug approval process by “reducing the incentive for drug manufacturers to seek approval of brand or generic drugs,” Gottlieb said.
As a result, FDA proposes interpreting the statutory language, “bulk drug substances for which there is a clinical need”, to mean there is a clinical need, or reason, for an outsourcing facility to compound a drug product using a bulk drug substance (instead of the FDA-approved drug as the source).
In addition, when FDA is assessing the clinical need for a drug to be compounded from bulk substance, the first step of the FDA’s analysis 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 FDA also intends to consider whether the drug product to be compounded must be produced from a bulk drug substance rather than an approved drug,” Gottlieb said.
“For example, if an approved drug contains peanut oil, the FDA would consider whether there was information indicating that patients with a peanut allergy need a drug product compounded without the allergen,” Gottlieb said. “The FDA would further consider whether there was information suggesting that the drug product needs to be compounded using a bulk drug substance, rather than the approved drug, because the type and number of manipulations necessary to remove the peanut oil from the approved product would adversely impact the overall quality of the drug.”
Submit electronic comments on the draft guidance by May 23 to: https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.