Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 243

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 243
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 must remain on the list of bulk substances that may be used in compounding under Section 503B, and if it were to be removed, we would be unable to offer our proprietary Sildenafil Cream formulation under Section 503B.

Sildenafil citrate is currently listed among those nominated substances for which bulk drug substance may be used in compounding by Section 503B-registered outsourcing facilities; the so-called "Category 1" list pending FDA’s evaluation. However, we have no control over whether sildenafil citrate will remain on the list of bulk drug substance that may be used in compounding by outsourcing facilities or for how long. If sildenafil citrate is removed from the list, we would be unable to offer our proprietary Sildenafil Cream formulation via a Section 503B-registered outsourcing facility, and it could harm our reputation, business and financial condition.

In addition, a third party could request that the FDA remove sildenafil citrate from the list of bulk substances that may be used in compounding by Section 503B-registered outsourcing facilities. If removed from such list, outsourcing facilities would be prohibited from producing any compounded drug that includes sildenafil citrate, including our proprietary Sildenafil Cream formulation. For information regarding how the FDA intends to evaluate whether there exists a clinical need for compounding with a bulk drug substance, see "Regulation of Compounded Drugs," below.

If a compounded drug formulation provided by an outsourcing facility leads to patient injury or death, or results in a product recall, we may be exposed to significant liability and reputational harm.

The success of our proprietary Sildenafil Cream formulation produced and distributed under Section 503B will depend to a significant extent upon perceptions of product quality. We could be adversely affected if the formulation is 

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subject to negative publicity. We could also be adversely affected if it or similar products sold by other companies, or any products sold by outsourcing facilities that produce our proprietary Sildenafil Cream formulation, prove to be, or are alleged or asserted to be, harmful to patients. There are a number of factors that could result in the injury or death of a patient who takes a compounded drug, including quality issues, manufacturing or labeling flaws, improper packaging or unanticipated or improper distribution or other uses of the compounded drug, any of which could result from human or other error. Any of these situations could lead to a recall of, or safety alert relating to, the compounded drug. Similarly, to the extent any of the ingredients used to produce a compounded drug have quality or other problems that adversely affect the finished compounded