Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 226

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 226
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 drug candidates. The marketing and sale of those drug
candidates, FDA-approved drugs and compounded formulations are subject to and must comply with extensive state and federal statutes and
regulations governing those products and compounding pharmacies. These compounding statutes and regulations include, among other things,
restrictions on compounding for office use or in advance of receiving a patient-specific prescription or, for outsourcing facilities,
requirements regarding preparation, such as regular FDA inspections and cGMP requirements, prohibitions on compounding drugs that are
essentially copies of FDA-approved drugs, limitations on the volume of compounded formulations that may be sold across state lines, and
prohibitions on wholesaling or reselling. These and other restrictions on the activities of compounding pharmacies and outsourcing facilities
may significantly limit the market available for compounded formulations, compared to the market available for FDA-approved drugs.

Our pharmacy business is impacted
by federal and state laws and regulations governing the following: the purchase, distribution, management, compounding, dispensing, reimbursement,
marketing and labeling of prescription drugs and related services including: FDA and/or state regulation affecting the pharmacy and pharmaceutical
industries, including state pharmacy licensure and registration or permit standards; rules and regulations issued pursuant to HIPAA and
other state and federal laws related to the use, disclosure and transmission of health information; and state and federal controlled
substance laws. Our failure to comply with any of these laws and regulations could severely limit or curtail our pharmacy operations,
which would materially harm our business and prospects. Further, our business could be adversely affected by changes in these or any
newly enacted laws and regulations, and federal and state agency interpretations of the statutes and regulations. Statutory or regulatory
changes could require us to make changes to our business model and operations and/or could require us to incur significantly increased
costs to comply with such regulations.

On July 30, 2020, the FDA issued
a notice for comments related to certain bulk drug substances to be removed from the 503B Bulk’s List (or Category 1 List). Included
in this notice for comment were certain bulk drug substances which we currently use in some of our compounded products. In the event
one or more of these bulk substances are ultimately removed from the Category 1 List, we intend to utilize commercially available versions
of these substances or similar active pharmaceutical ingredients as replacements of the bulk powders contained in our sterile products.
In addition, nothing in the FDA’s notice affects the dispensing of bulk powder-containing products from our