Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 37

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 37
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, delayed or terminated, and we may not be able to commercialize
our formulations or advance our business.

If a compounded drug formulation provided through
our compounding services leads to patient injury or death or results in a product recall, we may be exposed to significant liabilities
and reputational harm.

The success of our business,
including our proprietary formulations and pharmacy operations, is highly dependent upon medical and patient perceptions of us and the
actual safety and quality of our products. We could be adversely affected if we, any other compounding pharmacies or our formulations
and technologies are subject to negative publicity. We could also be adversely affected if any of our formulations or other products
we sell, any similar products sold by other companies, or any products sold by other compounding pharmacies prove to be, or are asserted
to be, harmful to patients. For instance, if any of the components of approved drugs or other ingredients used to produce our compounded
formulations have quality or other problems that adversely affect the finished compounded preparations, our sales could be adversely
affected. Because of our dependence upon medical and patient perceptions, adverse publicity associated with illness or other adverse
effects resulting from the use or misuse of our products, any similar products sold by other companies, or any other compounded formulations
could have a material adverse impact on our business.

To assure compliance with USP
guidelines, we have a policy whereby 100% of all sterile compound batches produced by our ImprimisRx compounding pharmacies are tested
prior to their delivery to patients and physicians both in-house and externally by an FDA-registered laboratory that has represented
to us that it operates in compliance with current good laboratory practices. However, we could still become subject to product recalls
and termination or suspension of our state pharmacy licenses if we fail to fully implement this policy, if the laboratory testing does
not identify all contaminated products, or if our products otherwise cause or appear to have caused injury or harm to patients. In addition,
laboratory testing may produce false positives, which could harm our business and impact our pharmacy operations and licensure even if
the impacted formulations are ultimately found to be sterile and no patients are harmed by them. If adverse events or deaths or a product
recall, either voluntarily or as required by the FDA or a state board of pharmacy, were associated with one of our proprietary formulations
or any compounds prepared by our ImprimisRx compounding pharmacies or any pharmacy partner, our reputation could suffer, physicians may
be unwilling to prescribe our proprietary formulations or order