Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 156

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 156
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 the FDA has announced an interim policy pursuant to which bulk drug substances may be nominated for inclusion on such list and, provided certain conditions are met, outsourcing facilities may compound with such bulk drug substances pending evaluation of the substances for inclusion on the FDA’s list of bulk drug substances for which there is a clinical need. Sildenafil citrate is currently listed in FDA's interim Category 1 List of bulk substances that have been nominated, reviewed by FDA, and may be compounded by outsourcing facilities pending FDA’s final evaluation. 

In December 2023, the FDA issued Guidance for Industry addressing the criteria by which the FDA intends to evaluate whether there exists a clinical need for compounding with a bulk drug substance.Under such guidance, the FDA intends to use a two-part analysis if the bulk drug substance is a component of an FDA-approved product, and if the bulk drug substance is not a component of an FDA-approved product, then the FDA intends to use only part 2 of such analysis. Under part 1 of the analysis, the FDA intends to evaluate whether there is a basis for the FDA to conclude that (a) an attribute of the FDA-approved drug that makes it medically unsuitable to treat certain patients; and the drug proposed to be compounded is intended to address that attribute; and (b) the drug proposed to be compounded must be produced from a bulk drug substance rather than from the FDA-approved drug product. If the answer to either of such questions is "no," then the FDA could determine that there is no clinical need for compounding with the bulk drug substance. If the answer to both such questions is "yes," then the FDA intends to proceed to part 2 of the analysis. Under part 2 of the analysis, the FDA intends to conduct a balancing test under which FDA would consider each of the following factors: (i) the physical and chemical characterization of the bulk drug substance; (ii) any safety issues raised by the use of the bulk drug substance in compounding; (iii) the available evidence of effectiveness or lack of effectiveness of a drug product compounded with the bulk drug substance, if any such evidence exists; and (iv) current and historical use of the bulk drug substance in compounded drug products, including information about medical condition(s) that the substance has been used to treat and any references in peer-reviewed medical literature. FDA has not announced when it will complete its analysis of nominated bulk substances and make a determination of substances that will be placed, after notice and a comment period, on FDA's final list of bulk substances that