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

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 10
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 of our compounded formulations in accordance with cGMP standards and our other formulations are produced according to the standards
provided by U.S. Pharmacopoeia (USP) Chapter <795> (“USP 795”) and USP Chapter <797> (“USP 797”)
and applicable state and federal law, our compounded formulations are not required to be, and have not been, approved for marketing and
sale by the FDA. As a result, some physicians may be unwilling to prescribe, and some patients may be unwilling to use, our compounded
formulations. Additionally, under federal and state laws applicable to our current compounding pharmacy operations operating under Section
503A of the FDCA, we are not permitted to prepare significant amounts of a specific formulation in advance of a prescription, compound
quantities for office use or utilize a wholesaler for distribution of our formulations; instead, our compounded formulations must be
prepared and dispensed in connection with a physician prescription for an individually identified patient. Pharmaceutical companies,
on the other hand, are able to sell their FDA-approved products to large pharmaceutical wholesalers, who can in turn sell to and supply
hospitals and retail pharmacies. Even though we have registered NJOF with the FDA, our compounding business may not be scalable on the
scope available to our competitors that produce FDA-approved drugs, which may limit our potential for profitable operations. These facets
of our operations may subject our business to limitations our competitors offering only FDA-approved drugs may not face.

 9 

Biotechnology and related pharmaceutical
technologies are subject to rapid and significant change. Our future success will depend in large part on our ability to maintain a competitive
position with respect to these technologies. Products developed by our competitors, including FDA-approved drugs and compounded formulations
created by other pharmacies, could render our products and technologies obsolete or unable to compete. Any products that we develop may
become obsolete before we recover expenses incurred in developing the products, which may require that we seek additional funds that
may or may not be available to continue our operations. The competitive environment requires an ongoing, extensive search for medical
and technological innovations and the ability to develop and market these innovations effectively, and we may not be competitive with
respect to these factors. Other competitive factors include the safety and efficacy of a product, the size of the market for a product,
the timing of market entry relative to competitive products, the availability of alternative compounded formulations or approved drugs,
the price of a product relative to alternative products, the availability