пятница, 26 февраля 2016 г.

FDA Addresses ASHP Concerns in Pre-Published Guidance

FDA Addresses ASHP Concerns in Pre-Published Guidance


The Food and Drug Administration (FDA) today announced the availability of a guidance for industry entitled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy.” The guidance specifically addresses concerns raised by ASHP and its members over the ability of hospitals to supply first responders with medications in anticipation of emergent use or specific patient need. On February 5 of this year, ASHP sent a letter to then-FDA Commissioner Stephen Ostroff, M.D., outlining these concerns and the need for further guidance on Drug Quality and Security Act (DQSA) requirements. DQSA was signed into law in 2013. Title II of DQSA creates a pharmaceutical tracking system to account for medications throughout the supply chain. Under this new framework, pharmacies (dispensers) must collect and store certain drug information for up to six years. Originally these requirements were set to go into effect on July 1, 2015, but they have twice been delayed by FDA and are now scheduled to go into effect on Tuesday, March 1. “ASHP is eager to see the full guidance and evaluate the impact on patient care and the practice of pharmacy in hospitals and clinics”, said ASHP Senior Vice President and Interim Chief Operating Officer Kasey Thompson, Pharm.D., M.S., M.B.A. “We are pleased to see that FDA has addressed this concern, and we look forward to continued collaboration to ensure that the U.S. supply chain is the safest in the world.”  The guidance, due to be published on Monday, February 29, is a final guidance. Although FDA will accept public comments, this final guidance will go into effect upon official publication:

ASHP Health-System Pharmacy Press Releases and Announcements

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