Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 230

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 230
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 to
regularly update the FDA regarding our compliance and quality activities.

These regulatory actions
could increase further scrutiny and could create negative publicity on us as a company. As part of our commitment to actively work
with regulators, at times, we have become aware of concerns related to certain formulations, and as a result, discontinued
compounding certain drug formulations in an attempt to help mitigate potential regulatory risk. For other reasons, including, but
not limited to, the following, physicians may be unwilling to prescribe or patients may be unwilling to use our compounded
formulations: legal prohibitions on our ability to discuss the efficacy or safety of our formulations with potential users to the
extent applicable data is available; our pharmacy operations are primarily operating on a cash-pay basis and reimbursement may or
may not be available from third-party payors, including the government Medicare and Medicaid programs; and certain formulations are
not required to be prepared and are not presently being prepared in a manufacturing facility governed by cGMP requirements. These
factors and any future regulatory action could continue to limit our production, and our ability to dispense and distribute our
compounded products, which would negatively affect sales of our compounded products.

If we or our partner
facilities fail to comply with the Controlled Substances Act, FDCA, or similar state statutes and regulations, the pharmacy facilities
could be required to cease operations or become subject to restrictions that could adversely affect our business. 

State pharmacy laws require pharmacy
locations in those states to be licensed as an in-state pharmacy to dispense pharmaceuticals. In addition, state controlled substance
laws require registration and compliance with state pharmacy licensure, registration or permit standards promulgated by the state’s
pharmacy licensing authority. Pharmacy and controlled substance laws often address the qualification of an applicant’s personnel,
the adequacy of its prescription fulfillment and inventory control practices and the adequacy of its facilities. These laws also subject
pharmacies to oversight by state boards of pharmacy and other regulators that could impose burdensome requirements or restrictions on
operations if a pharmacy is found not in compliance with these laws. We believe that our compounding pharmacies are in material compliance
with applicable regulatory requirements. Further, if any of our compounding pharmacies fail to comply with regulatory requirements, they
could be forced to permanently or temporarily cease or limit their compounding operations, which would severely limit our ability to
market and sell our proprietary formulations and would materially harm our operations and prospects. Any noncompliance could also result
in complaints or