AG/FDA Blog

May 19 Webinar on the Drug Supply Chain Security Act

May 15th, 2015
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 for D… Read More
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Categories: Health Care, OFW Law News, Public Policy
Tags: Dispenser, Drug, Drug Supply Chain Security Act, DSCSA, HDMA, Hospital, Pharmacy, Tish Eggleston Pahl, Wholesale Drug Distributor

Drug Supply Chain Security Act – What’s Next? A whole lot.

February 26th, 2015
Contributor: Tish Eggleston Pahl
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 busy… Read More
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Categories: FDA, Health Care, Public Policy
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

FDA’s Draft Guidance On DSCSA Preemption Misses The Mark

December 15th, 2014
Contributor: Tish Eggleston Pahl
In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA).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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Categories: FDA, Health Care, Public Policy
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

Webinar Tomorrow: What Dispensers Need to Know About the Drug Supply Chain Security Act

December 3rd, 2014
Contributor: Tish Eggleston Pahl
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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Categories: FDA, Health Care, Public Policy
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

FDA Opens Portal For Wholesale Distributor and 3PL Reporting

December 1st, 2014
Contributor: Tish Eggleston Pahl
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 advice… Read More
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Categories: FDA
Tags: 3PL, CDER, Center for Drug Evaluation and Research, Direct Electronic Submissions Portal, Drug, Drug Supply Chain, DSCSA, FDA, Logistics Provider, Third-Party, Tish Eggleston Pahl, Wholesale, Wholesale Drug Distributor

The DSCSA Standards Guidance is here!

November 26th, 2014
Contributor: Tish Eggleston Pahl
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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Categories: FDA, Health Care, Public Policy
Tags: Drug, Drug Supply Chain, Drug Supply Chain Security Act, DSCSA, FDA, Interoperable Exchange, Prescription Drug, Tish Eggleston Pahl, Wholesale Drug Distributor

26 Years, With 9 To Go.... 35 Years to Prescription Drug Traceability

November 10th, 2014
Contributor: Tish Eggleston Pahl
OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part IV) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are tak… Read More
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Categories: FDA, Health Care, OFW Law News, Public Policy
Tags: Congress, Drug, Drug Quality and Security Act, Drug Sample, Drug Supply Chain, Drug Supply Chain Security Act, DSCSA, FDA, OFW Law, PDMA, Prescription Drug, Prescription Drug Marketing Act, Tish Eggleston Pahl, Traceability, Wholesale, Wholesale Drug Distributor

Achievement Unlocked! Senate Passes Drug Quality and Security Act for a Safer, More Secure Pharmaceutical Supply Chain

November 18th, 2013
Contributor: Tish Eggleston Pahl
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. Hav… Read More
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Categories: FDA, Public Policy
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

Veterinary Drug Distribution

October 1st, 2012
Contributor: Tish Eggleston Pahl
As I write this, my Labrador is gutting a stuffed mouse at my feet. I’ll need to take the toy from her shortly to avoid her enthusiastic consumption of the squeaker within (and what I know, from experience, can be a very costly aftermath of emergen… Read More
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Categories: FDA
Tags: Consumers, FDA Compliance, FTC, FTC Enforcement, Generic Drug, Pet Medication, Prescription Drug, Proposed Regulation, Social Media, Tish Eggleston Pahl, Veterinarian, Wholesale Drug Distributor

OFW Law Drug and Health Care Privacy Practices

October 1st, 2012
OFW Law’s Drug and Health Care Privacy Practices focus on advising our clients regarding every aspect of the regulatory process related to bringing a product to market, post-marketing compliance, and issues central to the privacy of personal health… Read More
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Categories: FDA, Health Care
Tags: Advertising, Congress, Cosmetics, DEA, Drug, Drug Approval, Drug Marketing, FDA Compliance, FDA Enforcement, Food Drug and Cosmetic Act, Healthcare, Jonathan M. Weinrieb, Labeling, New Drug Application, OTC Drugs, Prescription Drug, Privacy, Public Policy, State Law, Wholesale Drug Distributor

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