Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 186

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 186
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 publicity could have an adverse effect on our reputation, business and financial condition. Achieving and maintaining market acceptance of our proprietary Sildenafil Cream formulation produced and distributed under Section 503B could be negatively impacted by perceived risks associated with compounded drugs. Compounded drugs are not FDA-approved products; lawfully compounded drugs are specifically exempt from FDA approval pursuant to Section 503B(a). Some physicians may be hesitant to prescribe, and some patients may be hesitant to purchase and use, a compounded drug for a variety of reasons, including because it is not required to be, and has not been, approved for marketing and sale by the FDA. In addition, certain outsourcing facilities have experienced both facility and product quality issues and been the subject of negative media coverage and litigation, and the actions of these facilities have resulted in increased scrutiny of compounding activities. Our ability to generate revenue from sales of our proprietary Sildenafil Cream formulation produced and distributed under Section 503B will be adversely impacted if we are unable to achieve and maintain market acceptance for it. Sildenafil citrate 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