Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 48

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 48
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 not be until the Final MOU is finalized through the rulemaking process, which
will include the engagement of a notice-and-comment and rulemaking period to implement certain provisions of Section 503A. The agency
indicated that the process may take “several years” to complete. In the same announcement, the FDA stated it does not intend
to enforce the statutory 5% limit on the distribution of compounded drugs out of the state in which they are compounded by compounders
located in states that do not sign the Final MOU for the duration of the rulemaking process.

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.

In August 2017, the FDA issued
a MedWatch notification regarding a curcumin emulsion and two adverse events that had been associated with the use of these emulsions
by prescribing physicians. We issued a press release on August 7, 2017, clarifying certain facts regarding the notice which outlined
our belief that the adverse events associated with the two patients occurred due to an allergic reaction caused by the products being
inappropriately administered and obtained by the prescribing physician, and our use of curcumin and excipients in our curcumin emulsion
formulation met regulatory standards required for dispensing of the curcumin emulsion. In September 2017, the FDA released a letter confirming
that the alleged misuse of certain ingredients in our curcumin emulsions was due to mislabeling by the underlying supplier and not of
our own misdoing. We no longer compound curcumin emulsion products. 

Separately, in December 2017,
we were issued a warning letter from the FDA alleging that, in its interpretation of our public communications, we had made false or
misleading claims and omitted risk and side effect information regarding certain of our ophthalmology-focused compounded medications.
We immediately performed a full review of our public communications referenced in the warning letter and responded to the FDA in January
2018; notwithstanding our continued belief that our public communications were not, in fact, false and misleading, we remained in communication
with the FDA and took steps to address the items outlined in the FDA letter. The Company received another warning letter from