Package Level Under News Today

Last week, the FDA issued three pieces of guidance for pharmacies. The first, entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, updated and finalized a June 2021 draft guidance. In this guidance, FDA emphasized that pharmacies (known as “dispensers” in the DSCSA) and other trading partners’ product tracing information should be true, accurate, and complete.

Last week, the FDA issued three pieces of guidance for pharmacies. The first, entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, updated and finalized a June 2021 draft guidance. In this guidance, FDA emphasized that pharmacies (known as “dispensers” in the DSCSA) and other trading partners’ product tracing information should be true, accurate, and complete.

The U.S. Food and Drug Administration (FDA) recently published a guidance for immediate implementation, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1), that...

The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into...

With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate...

With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate...

This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug...

Last week, the FDA authorized the booster doses for both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines and mix and match booster doses. The FDA also proposed a new rule for...

This week, the Department of Health and Human Services announced $100 million in American Rescue Plan funding for state programs supporting primary health care workers in underserved communities.

Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances By Madeleine Giaquinto, Manager of Regulatory Affairs, Greenleaf Health, Inc. In its seventh year of implementation, trading partners involved in manufacturing, distributing, and dispensing prescription drugs in the U.S. (Industry) continue to grapple with requirements of the Drug Supply Chain Security Act (DSCSA), working to set up a fully interoperable electronic system for securing and tracing products across Industry se...