In an effort to make it easier for first responders to supply necessary medications to their patients, leaders from the American Society of Health-System Pharmacists (ASHP) recently sent a letter to FDA Commissioner Stephen Ostross, asking for more clarification on the mandates set forth in the Drug Quality and Security Act (DQSA).
The DQSA became law in 2013. Under the act, a pharmaceutical tracking system was put in place for medications used in hospitals and other health care facilities. The act requires that some drug information remain stored for as long as six years.
After several delays, the act finally went into effect on March 1.
The FDA’s response was a set of guidelines titled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy,” which was released Feb. 29.
“ASHP is eager to see the full guidance and evaluate the impact on patient care and the practice of pharmacy in hospitals and clinics,” ASHP Senior Vice President Kasey Thompson said. “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.”
FDA officials have stated that the organization is aware of the potential challenges and prepared to meet them.
“To minimize possible disruptions to the activities of first responders, FDA does not intend to take action against certain trading partners and first responders as described in the guidance,” the officials said. “This compliance policy is in effect until further notice by FDA.”
