“On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule.” Read the full article: Source: FDA Law Blog: New Draft Guidance Clarifies UDI Exceptions for Convenience Kits Go […]
Tag: Traceability
Prescription drug scheme: Miami Beach prescription drug supplier pleads guilty – South Florida Business Journal
“Prescription drug diversion compromises the integrity of America’s drug supply chain,” Principal Deputy Assistant Attorney General Benjamin Mizer said in a new release. “This Miami-based supplier sold tens of millions of dollars of illegally diverted drugs, which ended up on the shelves of pharmacies and in the medicine cabinets of American consumers.” Read the full […]
FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review
“Users either can query the database when searching for a particular company here or download the entire data set as an Excel file from this page. Although technically the law only requires a public wholesale distributor database, FDA determined that making the 3PL information public as well served the law’s goals, and it stated in a December […]
NEW: 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors – Drug Channels
“This year’s report—our sixth edition—has been updated, revised, reorganized, and expanded. It contains the latest industry and financial data, along with detailed information about the strategies and market positions of the largest public companies: AmerisourceBergen, McKesson, and Cardinal Health. It also includes many new elements.” Read the full article: Source: Drug Channels: NEW: 2015-16 Economic […]
With One Day Remaining Before July 1 Compliance Date, FDA Exercises Enforcement Discretion of DSCSA’s Product-Tracing Requirements for Dispensers – FDA Law Blog
“Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for failure to comply with the DSCSA’s two major product-tracing requirements for dispensers until November […]
New California Licenses Required For Third-Party Logistics Providers (3PLs)
This announcement was just sent by the California Board of Pharmacy: “Companies that do not own, but receive, store and ship prescription drugs and prescription devices into or within California need to obtain a third-party logistics provider (3PL) license immediately with the California State Board of Pharmacy. Formerly, these entities were licensed as wholesalers or nonresident wholesalers by […]