The passage of the Drug Supply Chain Security Act (DSCSA) in November 2013 led to a very busy 2014 as FDA and manufacturers, wholesale distributors, and dispensers began the statute’s complex 10-year implementation. 2015 promises to be equally bu…
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Tags: 3PL, CDER, Drug, Drug Dispenser, Drug Supply Chain Security Act, DSCSA, FDA, Interoperable Exchange, Prescription Drug, Repackager, Third-Party, Tish Eggleston Pahl, Wholesale Drug Distributor
In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA). FDA, the pharmaceutical supply chain, and other…
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Tags: 3PL, Congress, Drug, Drug Dispenser, Drug Supply Chain, Drug Supply Chain Security Act, DSCSA, Energy and Commerce, FDA, Guidance, Logistics Provider, Pre-emption, Preemption, Third-Party, Tish Eggleston Pahl, VAWD, Wholesale, Wholesale Drug Distributor
A Complimentary Webinar Presented by OFW Law’s Tish Pahl and the Food Marketing Institute Thursday, December 4th, 2014 3:00 pm – 4:00 pm US/Eastern Please join FMI on a webinar with Tish Pahl —Under the Drug Supply Chain Security Act (D…
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Tags: Drug, Drug Dispenser, Drug Supply Chain, DSCSA, FDA, FMI, Food Marketing Institute, OFW Law, Prescription Drug, Tish Eggleston Pahl, Transaction Data, Webinar, Wholesale, Wholesale Drug Distributor
In a time when internecine conflicts within the Congress and between the legislative and executive branch stymie so much important work, the easy passage of the bipartisan Drug Quality and Security Act (DQSA) (H.R. 3204) is cause for celebration. H…
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Tags: Compounding Pharmacies, Drug Dispenser, Drug Manufacturer, Drug Quality and Security Act, Food Drug and Cosmetic Act, HR 3204, Meningitis Outbreak, National Drug Code, Prescription Drug, Product Identifier, Standardized Numerical Identifier, Tish Eggleston Pahl, Wholesale Drug Distributor
