“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 […]
Tag: FDA
FDA’s Patient Preference Initiative: … | FDA Voice
This should interest HME professionals: “Last week we announced FDA’s first-ever Patient Engagement Advisory Committee, which will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. We thought it would be good to step back and fill you in about our Patient […]
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 […]
Wholesale Distributor & Third-Party Logistics Providers Reporting – FDA Requirement
“The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015. FDA has issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and […]
Compound Pharmacies Complain FDA is Compounding Their Problems – Pharmalot – WSJ
“The stepped-up oversight was hastened by a new law that bolstered FDA authority. But compounders say the get-tough approach is a double-edged sword. Hospitals, doctors and patients may eventually have more confidence in compounded’ medicines, but in the meantime costs and red tape have increased. And a new batch of proposed guidelines issued by the […]
FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements – FDA Law Blog
“On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act (“DSCSA”) prior to May 2015. The guidance, states in relevant part:” . . . Read the full article: via FDA Law Blog: In Keeping With the […]