Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 20

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 20
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(b)(2) applicant is relying on the FDA’s conclusions regarding studies conducted for an already approved product, the applicant
is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Approved Drug Products with
Therapeutic Equivalence Evaluations, or Orange Book. Specifically, the applicant must certify that: (i) the required patent information
has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired, but will expire on a particular date
and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the new product. The
Section 505(b)(2) application also will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval
of a new chemical entity, listed in the Orange Book for the referenced product has expired. Thus, the Section 505(b)(2) applicant may
invest a significant amount of time and expense in the development of its products only to be subject to significant delay and patent
litigation before its products may be commercialized.

 14 

Pharmacy Regulation

Our pharmacy operations are regulated
by both individual states and the federal government. Every state has laws and regulations addressing pharmacy operations, including
regulations relating specifically to compounding pharmacy operations. These regulations generally include licensing requirements for
pharmacists, pharmacy technicians and pharmacies, as well as regulations related to compounding processes, safety protocols, purity,
sterility, storage, controlled substances, recordkeeping and regular inspections, among other things. State rules and regulations are
updated periodically, generally under the jurisdiction of individual state boards of pharmacy. Failure to comply with the state pharmacy
regulations of a particular state could result in a pharmacy being prohibited from operating in that state, financial penalties and/or
becoming subject to additional oversight from that state’s board of pharmacy. In addition, many states are considering imposing,
or have already begun to impose, more stringent requirements on compounding pharmacies. If our pharmacy operations become subject to
additional licensure requirements, are unable to maintain their required licenses or if states place burdensome restrictions or limitations
on pharmacies, our ability to operate in some states could be limited.

Federal law limits compounding
pharmacies from engaging in the practice of anticipatory compounding, which involves preparing compounded medications before the actual
receipt of a prescription or practitioner’s order, unless the compounding pharmacy has a history of filling certain prescriptions