The U.S. Food and Drug Administration (FDA) has officially released a proposed rule to amend the list of bulk drug substances that can be used to compound drug products with the addition of five new substances to the list. If approved, glutaraldehyde, glycolic acid, L-citrulline, pyruvic acid and trichloroacetic acid (TCA) will be placed on the 503A Bulks List, which is a list of bulk drug substances under section 503A of the FD&C Act that are permissible to be used in the compounding of drug products, subject to the conditions laid out in section 503A. The FDA’s full proposed rule can be read here.
The significance of this proposal lays in the fact that, if successful, it would mark the first addition the list has seen since the FDA published a final ruling in February of this year, which outlined the criteria substances must satisfy in order to be used to compound drug products. The parameters that the substances are measured against are based on their physical and chemical characterization, potential safety issues, any available evidence of effectiveness, as well as information regarding the historical use of the substance in compounded drug products. The FDA`s final rule discussing the above criteria further can be read here.
The new proposed rule came just shortly after the FDA categorized nine other bulk drug substances as not permitted to be compounded by outsourcing facilities. The FDA declared that these substances, which included dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue and vecuronium bromide, were already “present in one or more FDA-approved drugs and the nominators did not offer valid reasons for why the FDA-approved drugs could not be used or adapted”. For this reason, the FDA concluded there was “no clinical need for outsourcing facilities to compound them”.
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