Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 220

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 220
---
 and formulations could have a material adverse effect on our business, results of operations and
financial condition.

We have received multiple FDA
Forms 483, a MedWatch notice, warning letters and other regulatory notifications relating to issues at NJOF and our pharmacy RxNJ,
and have ongoing communications with the FDA about compliance and quality plans at NJOF. See “—We have been in discussions with the federal government regarding past FDA inspections of our 503B
facility, and to the extent we are unable to demonstrate compliance with cGMPs and other required regulations, the government could
pursue enforcement actions, the effects of which could be costly to us and could result in adverse consequences to our
business.” As a result of the MedWatch notice, warning letters and other regulatory notifications, some physicians may be
hesitant to prescribe and some patients may be hesitant to purchase and use non-FDA-approved compounded formulations, particularly
when an FDA-approved potential alternative is available. For other reasons, physicians may be unwilling to prescribe or patients may
be unwilling to use our proprietary compounded formulations, including, but not limited to, the following: 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. Any failure by physicians, patients and/or
third-party payors to accept and embrace compounded formulations could substantially limit our market and cause our operations to
suffer.

Our business and operations
could suffer in the event of cybersecurity or other system failures.

Despite the implementation of
security measures, our internal computer systems and those of any third parties with which we partner are vulnerable to damage from computer
viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced
any cybersecurity or system failure, accident or breach to date that has been determined to have had a material impact, if a significant
event were to occur, it could result in a material disruption of our operations, substantial costs to rectify or correct the failure,
if possible, and potentially violation of HIPAA and other privacy laws applicable to our operations. For example, the California Consumer
Privacy Act (the “CCPA”) became effective on January