Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 39

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 39
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 able to satisfy applicable federal and state 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.

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.

We are dependent on market acceptance of compounding
pharmacies and compounded formulations, and physicians may be unwilling to prescribe, and patients may be unwilling to use, our proprietary
customizable compounded formulations.

We currently
distribute our proprietary formulations through compounding pharmacies and an outsourcing facility. Formulations prepared and dispensed
by compounding pharmacies contain FDA-approved ingredients, but are not themselves approved by the FDA. Thus, our compounded formulations
have not undergone the FDA approval process and only limited data, if any, may be available about the safety and efficacy of our formulations
for any particular indication. Certain compounding pharmacies have been subject to widespread negative media coverage in recent years,
and the actions of these pharmacies have resulted in increased scrutiny of compounding pharmacy activities from the FDA and state governmental
agencies. For example, the FDA has issued formal requests to compounding pharmacies and outsourcing facilities to conduct a recall of
all non-expired, purportedly sterile drug products and to cease sterile compounding operations due to lack of sterility assurance. As
a result, some health care providers may be reluctant to purchase and use compounded drugs. Our growth and future sales depend not only
on our ability to demonstrate in the face of increased scrutiny the quality and safety of our pharmacies and outsourcing facilities and
our compliance with more stringent regulatory standards at the federal and state levels, but also on the continued acceptance of compounded