Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 227

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 227
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 503A pharmacy. Nonetheless,
if all or some of the bulk drug substances we use are removed from the 503B Bulk’s List, this may result in a disruption in our
operations, revenues and cash flows.

On October
27, 2020, the FDA announced availability of a final Memorandum of Understanding, Addressing Certain Distributions of Compounded Human
Drug Products Between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration (the “Final
MOU”). The Final MOU describes the responsibilities of a state board of pharmacy, or other appropriate state agency that chooses
to sign the Final MOU, in investigating and responding to complaints related to drug products compounded in such state and distributed
outside such state and in addressing the interstate distribution of inordinate amounts of compounded human drug products. Additionally,
as part of the Final MOU, the FDA refined the definition of “inordinate amount,” a threshold for certain information identification
and sharing which does not place a limit on the distribution of compounded human drug products interstate by a pharmacy located in a
state that has entered into the Final MOU. Section 503A of the FDCA sets a 5% limit on compounded drugs distributed outside the state
by a pharmacist, pharmacy or physician located in a state that has not entered into the Final MOU.

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In February
2022, the FDA said it would suspend implementation of the Final MOU and engage in a formal rulemaking process. During the rulemaking
process, the agency will not enter into new agreements with states based on the Final MOU. The FDA does not expect states that have signed
the Final MOU to carry out the activities described in the Final MOU. Thus, there is no reporting requirement for any pharmacy concerning
interstate shipments pursuant to Section 503A and will 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