Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 100

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 100
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 guidance. Under Section 503B, outsourcing facilities are prohibited from compounding a drug that is “essentially a copy” of an FDA-approved drug, unless the drug is on the FDA’s Drug Shortage List at the time of compounding, distribution, and dispensing. A drug is essentially a copy of an FDA-approved drug if it is identical or nearly identical to the FDA-approved drug, which the FDA has interpreted to mean that it has the same active ingredient(s), route of administration, dosage form, dosage strength and excipients as the approved drug, or if it has the same active ingredient as an approved drug and there is not a change from the approved drug that produces a clinical difference for an individual patient, as determined by the prescribing practitioner. Outsourcing facilities may only compound using bulk drug substances that either appear on a list established by the FDA of bulk drug substances for which there is a clinical need or drug products on FDA's Drug Shortage List. Although the FDA has not yet finalized its list of bulk drug substances for which there is a clinical need, the FDA has announced an interim policy pursuant to which bulk drug substances may be nominated for inclusion on such list and, provided certain conditions are met, outsourcing facilities may compound with such bulk drug substances pending evaluation of the substances for inclusion on the FDA’s list of bulk drug substances for which there is a clinical need. Sildenafil citrate is currently listed in FDA's interim Category 1 List of bulk substances that have been nominated, reviewed by FDA, and may be compounded by outsourcing facilities pending FDA’s final evaluation. In December 2023, the FDA issued Guidance for Industry addressing the criteria by which the FDA intends to evaluate whether there exists a clinical need for compounding with a bulk drug substance.Under such guidance, the FDA intends to use a two-part analysis if the bulk drug substance is a component of an FDA-approved product, and if the bulk drug substance is not a component of an FDA-approved product, then the FDA intends to use only part 2 of such analysis. Under part 1 of the analysis, the FDA intends to evaluate whether there is a basis for the FDA to conclude that (a) an attribute of the FDA-approved drug that makes it medically unsuitable to treat certain patients; and the drug proposed to be compounded is intended to address that attribute; and (b) the drug proposed to be compounded must be produced from a bulk drug substance rather than from the FDA-approved drug product. If the answer to either of such questions is "no," then the FDA