Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 157

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 157
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 may be used in compounding by outsourcing facilities.

The source of any bulk substance active ingredient used in compounding must be a Section 510 registered manufacturer, and the bulk substance must be accompanied by a Certificate of Analysis.

Section 503A of the FDCA exempts licensed pharmacists or licensed physicians who compound drugs for identified, individual patients, based on the receipt of a valid prescription order, from the FDCA’s new drug approval requirements, cGMP requirements, and the requirement to label products with adequate directions for use, provided 

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certain conditions are met. These conditions include that the pharmacist or physician does not compound regularly or inordinate amounts any drug that is essentially a copy of an FDA-approved drug. The framework for assessing if a drug is essentially a copy of an FDA-approved drug under Section 503A is different than the framework under Section 503B described above. For instance, a Section 503A pharmacy may compound a formulation that is greater than 10% in dosage strength than the commercially available drug product, if that formulation is accompanied by a statement of significant difference. In addition, the substances that may be used in compounding under Section 503A are much broader than under Section 503B, because Section 503A pharmacies may compound from bulk substances that are components of FDA-approved drug products and substances that are the subject of a USP/NF monograph.

Sections 503A and 503B also prohibit compounding of drugs that present “demonstrable difficulties for compounding.” The FDA must publish a list of such drugs, through notice and comment rulemaking, before implementing the prohibition, and FDA has not yet finalized any such lists for publication.

Data Privacy and the Protection of Personal Information

We are subject to numerous laws and regulations governing data privacy and the protection of personal information of patients, clinical investigators, employees, and vendors/business contacts including in relation to medical records and other health information, credit card data and financial information. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues which will continue to affect our business. In the United States, we may be subject to state security breach notification laws, state laws protecting the privacy of health and personal information and federal and state consumer protections laws that regulate the collection, use, disclosure and transmission of personal information. These laws overlap and often conflict and each of these laws is subject to varying interpretations by courts and government agencies, creating complex compliance issues. If we fail to comply