Company: HROW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001493152-25-021562
Chunk: 114

Company: HARROW, INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Item 3
Chunk 114
---
;

●we
                                            may not be able to satisfy applicable federal licensing, state board of pharmacy licensing
                                            and other requirements for any of our pharmacy businesses in a timely manner or at all;

●changes
                                            to federal and state pharmacy regulations may restrict compounding operations or make them
                                            more costly;

●we
                                            may be unable to achieve or maintain a sufficient physician and patient customer base to
                                            sustain our pharmacy operations;

●market
                                            acceptance of compounding pharmacies generally may be curtailed or delayed; and 

●We
                                            may not be able to enter into licensing or other arrangements with third-party pharmacies
                                            or outsourcing facilities when desired, on acceptable terms, or at all.

Our
ImprimisRx subsidiary completed an in-person meeting with the FDA in October 2025 regarding its efforts to remediate certain deficiencies
at its New Jersey site. At the FDA meeting, ImprimisRx presented, among other data, its safety record, which includes an
adverse event (ADE) rate of approximately 2 per million units, which is meaningfully better than known ADE rates for FDA-approved products.
FDA ultimately decided to allow ImprimisRx to continue with its remediation efforts on a voluntary basis. Additionally, Imprimis is currently
subject to an administrative accusation by the California State Board of Pharmacy relating to certain alleged regulatory compliance matters.
ImprimisRx is actively engaged in discussions with the California Board of Pharmacy regarding a resolution to the administrative action
and the potential denial of ImprimisRx’s 503B out-of-state outsourcing facility renewal application. Although the loss of the California
nonresident outsourcing facility pharmacy license would restrict sales and dispensing of our compounded products in that state and would
reduce revenues from the affected state, we believe that, based on our current concentration of sales and geographic diversification,
such loss would not be material to our consolidated statement of operations. Nevertheless, if additional states were to take similar
actions, or if broader or longer-term restrictions were imposed, the cumulative effect could be material.

Moreover,
all our efforts to expand pharmacy operations will involve significant costs and other resources, which we may not be able to afford
and may disrupt our other operations and distract management and employees from the other aspects of our business. As a result, our business
could materially suffer if we are unable to further develop a group of unified compounding facilities and, even if we are successful,
we may be unable to generate sufficient revenue to recover our costs.

The
federal