Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 23

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 23
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 that do not sign the Final MOU for the duration of the rulemaking
process.

 15 

Certain provisions of the FDCA
govern the preparation, handling, storage, marketing and distribution of pharmaceutical products. The DQSA clarifies and strengthens
the federal regulatory framework governing compounding pharmacies. Title 1 of the DQSA, the Compounding Quality Act, modified provisions
of the Section 503A of the FDCA that were found to be unconstitutional by the U.S. Supreme Court in 2002. In general, Section 503A provides
that pharmacies are exempt from the provisions of the FDCA requiring compliance with cGMPs, labeling with adequate directions for use
and FDA approval prior to marketing if the pharmacy complies with certain other requirements. Among other things, to comply with Section
503A, a compounded drug must be compounded by a licensed pharmacist for an identified individual patient on the basis of a valid prescription.
Pharmacies may only compound in limited quantities before receipt of a prescription for an individual patient and are subject to limitations
on anticipatory compounding for distribution, which generally permit anticipatory compounding only based on historical prescription volumes.

The DQSA also contained new Section
503B of the FDCA, which established an outsourcing facility as a new form of entity that is permitted to compound larger quantities of
drug formulations without a prescription, thus permitting the practice of anticipatory compounding, and distributing them out of state
without limitation, if the drug formulations appear on the FDA’s drug shortage list or the bulk drug substances contained in the
formulations appear on a “clinical need” list to be established by the FDA. In January 2017, the FDA issued Interim Policy
on Compounding Using Bulk Drug Substances Under Section 503B of the FFDCA (“Interim Policy”) which informs stakeholders
about how the FDA intends to exercise its enforcement discretion for compounding with those substances on a “Category 1 list”
while the agency compiles and evaluates its clinical needs list, and in March 2019 the FDA issued Evaluation of Bulk Substances Nominated
for Use in Compounding Under Section 503B of the Federal Food, Drug and Cosmetic Act which provides further guidance as to the FDA’s
policy for evaluating bulk drug substances nominated for use in compounding by outsourcing facilities. Entities voluntarily registering
as outsourcing facilities are subject to cGMP requirements and regular FDA inspection, among other requirements. As described above,
our current pharmacy operations in New