FDA Singles Out 9 More Drug Substances Not for Compounding

FDA Singles Out 9 More Drug Substances Not for Compounding

Following a court win late last month to keep one such drug substance out of the hands of compounders, the US Food and Drug Administration (FDA) pointed to nine more bulk drug substances for which it has concluded that there is no clinical need for outsourcing facilities to compound them.

For the nominated substances — dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue and vecuronium bromide — FDA said in its preliminary analysis that all ingredients are 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.

Similarly, FDA last August pointed to three other bulk drug substances that should not be compounded because of a lack of clinical need. And FDA won a court case in the US District Court for the District of Columbia related to the compounding of vasopressin.

In determining whether there is a “clinical need” for the 503B Bulks List to include a bulk drug substance, FDA looks at whether an attribute of the approved version “makes it medically unsuitable to treat certain patients for a condition” and whether the drug proposed to be compounded is intended to address that attribute. Similarly, FDA considers whether there is a basis to conclude that the drug proposed to be compounded must be produced from a bulk drug substance rather than from an FDA-approved drug, the agency said in the Federal Register.

FDA also said that supply issues and the cost of the compounded drug, which is often a fraction of the price of an FDA-approved version, are not considered when determining “clinical need.”

Currently, FDA has not placed any bulk drug substances on the 503B bulks list. Nicardipine hydrochloride and vasopressin are the only two substances determined to not be included on the list.

03 September 2019


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