Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 22

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 22
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 MOU would consider amounts shipped interstate by a compounder to be inordinate amounts if the
“number of prescriptions of compounded drugs distributed interstate during any calendar month is greater than 50 percent.”
Importantly, instead of that number serving as a “hard limit, for state action,” the 50% target would trigger certain additional
reporting requirements. On October 27, 2020, the FDA announced availability of a final MOU, Memorandum of Understanding Addressing
Certain Distributions of Compounded Human Drug Products Between the State Board of Pharmacy or Other Appropriate State Agency and the
U.S. 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. 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 there will not be one 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