AG/FDA Blog

EPA Hazardous Waste Pharmaceuticals Rule Begins Circulating: Proposal Applies To Dietary Supplements, 503B Outsourcing Facilities, And Any OTC Retailers

On Tuesday, the Environmental Protection Agency (EPA) announced that its Administrator signed the proposed rule: Management Standards for Hazardous Waste Pharmaceuticals Rule.  The announcement and EPA blog post are here.   The summary of the pre-… Read More
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FDA Drug Promotion Enforcement Update

It has been an interesting week from the perspective of an FDA drug promotion attorney. On the one hand, we have a federal district court expanding how drug companies can promote drugs; on the other, we have FDA’s Office of Prescription Drug Promot… Read More
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FDA Releases Draft Guidance on Compounding Animal Drugs

Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance).  The Federal Register notice accompanying the Draft Guidance can be found here.  The agency also withdrew its previous Com… Read More
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May 19 Webinar on the Drug Supply Chain Security Act

Tish Eggleston Pahl will be speaking on May 19 at a webinar on dispenser obligations under the Drug Supply Chain Security Act (DSCSA).  The webinar is sponsored by the Healthcare Distribution Management Association (HDMA).  This “DSCSA Overview… Read More
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Webinar: Drug Supply Chain Security Act Overview for Dispensers

On April 21, OFW Law’s Tish Eggleston Pahl will participate in a webinar being held by the Healthcare Distribution Management Association (HDMA) for dispensers on implementation of the Drug Supply Chain Security Act (DSCSA) Register Today!… Read More
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Drug Supply Chain Security Act – What’s Next? A whole lot.

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… Read More
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FDA’s Draft Guidance On DSCSA Preemption Misses The Mark

In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA).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… Read More
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Webinar Tomorrow: What Dispensers Need to Know About the Drug Supply Chain Security Act

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… Read More
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FDA Opens Portal For Wholesale Distributor and 3PL Reporting

While you were sitting in traffic, making pie crust, or absorbing the menu and vending labeling rules… FDA Opens Portal For Wholesale Distributor and 3PL Reporting At OFW Law, we hope you all had a terrific Thanksgiving.  (If you followed the advi… Read More
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The DSCSA Standards Guidance is here!

This morning, FDA met another of its milestones in implementing the Drug Supply Chain Security Act (DSCSA) and posted a Draft Guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription… Read More
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