California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) – Approved by the California State Board of Pharmacy “Many years ago, I worked for a very insightful CIO who mastered communications to senior executive management. Often, when he received pressure regarding systems maintenance budgets associated with mission critical business systems such as order fulfillment, he […]
Tag: Supply chain
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 FDA has issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and […]
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 […]
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 […]
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 […]