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Pharmaceuticals / Inspections and Audits

FDA Plans to Exclude Nine Substances From the Bulks List

Sept. 11, 2019
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The FDA is proposing to exclude nine substances from its 503B Bulks List of substances outsourcing facilities may use in drug compounding.

The agency proposes to exclude dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue and vecuronium bromide from the list — on the grounds that there are approved alternatives and there is no clinical need for compounded products.

The arguments for inclusion of the nine substances on the list didn’t convince the agency that the products “could not be used, adapted, or diluted rather than compounded from bulk drug substances.” For example, the nomination for dipyridamole, a drug for prevention of blood clots, didn’t explain why existing, approved medications are unsuitable.

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