Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 101

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 101
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 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 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 49

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