FDA Issues Exemptions from Nov. 27, Compliance Deadline for Updated DSCSA Requirements

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Sunflower Health Network Board Meeting - Jan. 9

The Sunflower Health Network is a not-for-profit organization that consists of 26 counties located primarily in North Central and North West Kansas. Sunflower Health Network's (SHN) specific purpose is to improve the population's health status. The 26 member hospitals, in conjunction with their medical staff, have developed a network that fosters cooperation and coordination. The priority has been to enhance the integration of health-related services among the SHN member communities.

Quality Corner Call - Jan. 10

Quality Corner Calls are offered by the Kansas Department of Health and Environment and Healthworks and focus on quality improvement activities consistent with the Medicare Rural Hospital Flexibility Grant Program.

KHA Board Meeting - Jan. 22

KHA has a 21-member board of directors. They meet at least five times a year. Each board member holds three-year terms, with a two-term limit. The board has a composition of members from all geographic areas of Kansas all sizes and types of member hospitals are represented. The board also includes two hospital trustees and two physician members. Other participants include American Hospital Association delegate.

KHA's Advocacy Day - Jan. 23

Advocacy is at the heart of every service KHA provides for our members. Whether we are educating, advocating or relationship-building, we look for ways to assist policymakers at the federal, state and local levels in understanding the implications of the policies being discussed.

KHSC Board Meeting - Jan. 28

KHSC is a wholly owned subsidiary of KHA. Therefore, a secondary objective of KHSC is to support KHA in meeting its mission of serving hospitals. Its mission is to provide enhanced value to KHA members by evaluating and endorsing selected vendors of services needed by the KHA membership. KHSC will be a valuable resource to Kansas healthcare facilities and the Kansas Hospital Association as they serve their constituents.

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FDA Issues Exemptions from Nov. 27, Compliance Deadline for Updated DSCSA Requirements

FDALogo (Oct. 18, 2024) – On Oct. 9, the Food and Drug Administration issued exemptions from the upcoming Nov. 27, 2024, compliance deadline for the U.S. Drug Supply Chain Security Act requirements. The updated exemptions from the FDA do NOT change the following requirements for pharmacies:

Know your drug suppliers and ensure they are authorized trading partners.
Know where your product tracing or transaction information (data) is stored and how to access it.
Know what the suspect product is, how to identify and investigate it and what to do if it is deemed illegitimate.
Policies and procedures for prescription drug purchasing and investigations for suspect or illegitimate products.

According to the FDA's announcement this week, the FDA continues receiving feedback from trading partners regarding readiness to adequately meet the Food Drug and Cosmetic Act requirements by the Nov. 27, 2024, compliance deadline. The FDA recognizes that trading partners who have initiated their systems and processes and have established electronic DSCSA data connections with their trading partners may need additional time beyond Nov. 27, 2024, when the stabilization period ends, to strengthen capabilities to mitigate data issues associated with electronic DSCSA transaction information and transaction statements and to ensure uninterrupted product distribution. The FDA's notification outlines exemptions for manufacturers, repackagers, wholesale distributors and dispensers with 26 or more full-time employees.

Review the FDA's Oct. 9 notice of exemptions to the DSCSA for detailed information about exemptions. KHA will monitor compliance requirements and exemptions and their impact on hospital pharmacies, communicate with the Board of Pharmacy and continue to provide updates to KHA members.
--Karen Braman

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