Is That a Medical Device?
It’s a question on many IWLA members’ minds: Do I handle products considered “medical devices?” This is an even more important question now, as U.S. Rep. Fred Upton (R-MI), chairman […]
Tag Archives: licensing
This Week: FDA Releases More Guidance Focused on Reporting, Unveils New Web Portal System
The U.S. Food and Drug Administration has unveiled yet another guidance document outlining the information that needs to be reported to the FDA. This document covers timing, formatting and a […]
FDA Issues Guidance for Track-and-Trace of Pharmaceuticals, Two Important Takeaways for 3PLs by Jan. 1
The U.S. Food and Drug Administration issued guidance for the Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, and Prescription Drugs. The document establishes initial […]
IWLA Pushes for Uniform Federal Licensing Standards for Distribution of Medical Devices
IWLA has been working with others in the Device Distribution Group to develop uniform licensing of 3PLs in the medical device supply chain. This legislation is designed to mirror the […]
New Drafted Guidance Issued by FDA Raises More Questions About Federal/State Licensing of Pharmaceuticals
The U.S. Food and Drug Administration recently released recommendations in question-and-answer format for the purposes of clarifying the Drug Quality Security Act. However, several contradictions in the state and federal […]
Congressman Urges FDA Commissioner to Issue Statement Against States Imposing Licensing Standards
In a letter sent Sept. 9, U.S. Representative Fred Upton (R-Mich.), chairman of the House Committee on Energy and Commerce and author of the U.S. Food and Drug Administration (FDA) […]
IWLA Seeks Conformity in California/Federal Pharmaceutical Licensing Standards
IWLA has been closely engaging the California Board of Pharmacy after issuance of AB 2605, a statewide pharmaceutical licensing requirement on third-party logistics providers. IWLA members fully support licensing standards […]
Update: California Passes Pharmaceutical Licensing Legislation on 3PLs
The California Assembly Committee passed AB 2605 on April 29. The bill imposes a statewide licensing requirement on third-party logistics providers in the pharmaceutical supply chain. The legislation is inconsistent with […]
Understanding the Drug Quality and Security Act
The International Warehouse Logistics Association (IWLA) is following implementation of the Drug Quality and Security Act (DQSA) closely. The DQSA was signed into law on Nov. 27, 2013. According to […]
Drug Quality and Security Act Licensing Standards
Under the Drug Quality and Security Act, 3PLs will required to comply with national licensing standards (and/or potentially state licensing standards) including: Establish a process for third-party accreditation; provide for periodic inspection; prohibit a facility from […]
iwla1891 