Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 242

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 242
---
 to market under Section 503B will subject us to a variety of new regulations and related potential liability.

We plan to enter into arrangements with one or more outsourcing facility(ies) to produce and distribute our proprietary Sildenafil Cream formulation under Section 503B. An outsourcing facility must meet certain conditions under Section 503B, including registering with the FDA, operating in compliance with the FDA’s cGMP regulations and guidance, and is subject to FDA inspection. Outsourcing facilities have been subject to increased scrutiny of their compounding activities by the FDA and state governmental agencies. Governmental inquiries or actions or litigation brought against us or any of our suppliers or outsourcing facilities relating to our proprietary Sildenafil Cream formulation, whether or not such inquiry, action or litigation ultimately results in penalties, changes to our business practices or other consequences, could have an adverse effect on our reputation, business and financial condition.

We or any outsourcing facility with which we have a business relationship may also face allegations, litigation, and regulatory investigations under federal or state laws related to the promotion, advertising, fulfillment, distribution, and/or sale of our proprietary Sildenafil Cream formulation under Section 503B. Litigation and regulatory proceedings, and particularly the healthcare, pharmaceutical-related, consumer protection, data privacy and/or class action matters we could face, may be protracted and expensive, and the results are difficult to predict. Such litigation or regulatory proceedings and investigations, unexpected side effects or safety or efficacy concerns with our proprietary Sildenafil Cream formulation or related negative 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