AdComm Recommends Adding Glutaraldehyde to Compounding Bulk Ingredients List

An FDA advisory committee has recommended adding one substance — glutaraldehyde — to the list of bulk ingredients used to compound products. Three other substances — alanyl-L-glutamine, glycyrrhizin, and domperidone — received  recommendations against their addition last week, one day after the committee recommended against five additional substances.

The FDA proposed that glutaraldehyde for topical use be placed on the 503A bulk list, the only one of the nine substances to receive the agency’s recommendation.

Last week, the committee recommended against adding methylsulfonylmethane, curcumin, germanium sesquioxide, rubidium chloride and deoxy-D-glucose.

The FDA issued draft guidance the day before saying that it reviews nominated substances based on factors such as safety concerns, efficiency of the evaluation process, and whether the substance was nominated by multiple parties.