Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 51

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 51
---
 deviations from cGMP and impose reporting and documentation requirements upon the sponsor
and any third-party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money,
and effort in the area of production and quality control to maintain cGMP compliance.

Once an approval is granted, the FDA may withdraw
the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches
the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency,
or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling
to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution
or other restrictions under a REMS program. Other potential consequences include, among other things:

    ●
    restrictions on the marketing or manufacturing of the product, complete
    withdrawal of the product from the market or product recalls;

    ●
    fines, warning letters or holds on post-approval clinical trials;

    ●
    refusal of the FDA to approve pending NDAs or supplements to approved
    NDAs, or suspension or revocation of product license approvals;

    ●
    product seizure or detention, or refusal to permit the import or export
    of products; or

    ●
    injunctions or the imposition of civil or criminal penalties.

The FDA strictly regulates the marketing, labeling,
advertising and promotion of prescription drug products placed on the market. This regulation includes, among other things, standards
and regulations for direct-to-consumer advertising, communications regarding unapproved uses, industry-sponsored scientific and educational
activities, and promotional activities involving the Internet and social media. Promotional claims about a drug’s safety or effectiveness
are prohibited before the drug is approved. After approval, a drug product generally may not be promoted for uses that are not approved
by the FDA, as reflected in the product’s prescribing information. In the United States, healthcare professionals are generally
permitted to prescribe drugs for such uses not described in the drug’s labeling, known as off-label uses, because the FDA does
not regulate the practice of medicine. However, the FDA’s regulations impose rigorous restrictions on manufacturers’ communications,
prohibiting the promotion of off-label uses. It may be permissible, under very specific, narrow conditions, for a manufacturer to engage
in nonpromotional, non-misleading communication regarding off-label information, such as distributing scientific