Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 51

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 51
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 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 adverse actions by other state boards of pharmacy. FDA inspection of a facility to determine compliance with the FDCA,
if not successful, may result in the loss of FDCA exemptions provided under Sections 503A and 503B, warning letters, injunctions, prosecution,
fines and loss of required government licenses, certifications and approvals, any of which could involve significant costs and could
cause us to be unable to realize the expected benefits of these pharmacies’ operations. Additionally, the permanent injunction
entered on July 22, 2019, by the U.S. District Court of the Central District of California (the “Court”) in the Allergan
litigation (also referenced in Item. 3 Legal Proceedings), enjoins the Company from engaging in activities that are inconsistent with
current FDA guidelines for 503A and 503B operations.

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If we market any of our drug candidates in
a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil
or criminal penalties. 

The FDA enforces laws and regulations
which require that the promotion of pharmaceutical products be consistent with the approved prescribing information. While physicians
may prescribe an approved product for a so-called “off label” use, it is unlawful for a pharmaceutical company to promote
its products in a manner that is inconsistent with its approved label, and any company which engages in such conduct can subject that
company to significant liability. Similarly, industry codes in the EU and other foreign jurisdictions prohibit companies from engaging
in off-label promotion, and regulatory agencies in various countries enforce violations of the code with civil penalties. While we intend
to ensure that our promotional materials are consistent with our label, regulatory agencies may disagree with our assessment and may
issue untitled letters, warning letters or may institute other civil or criminal enforcement proceedings.