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 […]
Category: Designated Representative
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 […]
Proposed Regulations for 3PL Providers – CA Board of Pharmacy
Here’s an update on the status of California Board of Pharmacy sponsored legislation to enact provisions to license third-party logistic (3PL) providers as a separate class, and not as the Board had previously done under the category of wholesaler. According to the December 17, 2014 meeting minutes of the Enforcement and Compounding Committee: Legislation was […]
New Pharmacy Laws for 2015 – California Board of Pharmacy
Just posted, the CA Board of Pharmacy – California Law Changes for 2015 (PDF). It covers all code sections that were added or amended during the 2014 Legislative Session. Unless otherwise indicated, all of the provisions go into effect on January 1, 2015. Go to DREprof.com: The Designated Representative and Exemptee Training Website CA Designated […]
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 […]
FDA > Are you ready for the Drug Supply Chain Security Act?
Become familiar with the law There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for […]