Search Results for: H.R. 3204

FDA Guidance

Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?

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Last week I wrote about the recent FDA DSCSA Public Meeting where the FDA asked for reports on the progress of the industry toward meeting the November 27, 2017 serialization requirements contained in the Drug Supply Chain Security Act (DSCSA) (see “FDA Forfeits Opportunity To Guide Industry”).  In that essay I expressed a view that … Continue reading Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance? →

FDA Guidance

FDA DSCSA Deadline Passes Quietly

Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”).  The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, … Continue reading FDA DSCSA Deadline Passes Quietly →

Healthcare Legislation

RAPS Explains The 21st Century Cures Act

Alexander Gaffney, RAC, Manager, Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS) is right on top of any new proposed legislation related to FDA and other health-related federal government agencies.  Last week he reported on the contents of a discussion draft of the “21st Century Cures” Act that was made public by the House … Continue reading RAPS Explains The 21st Century Cures Act →

FDA Guidance

FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting

The FDA posted new draft guidance for pharma wholesale distributors and third-party logistics providers to follow to meet their obligation to register their licensing information annually.  The new requirement is from the Drug Supply Chain Security Act (DSCSA) that was enacted last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“).  The … Continue reading FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting →

DSCSA, NDC

The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys

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Until the Drug Supply Chain Security Act (DSCSA) was passed as part of the Drug Quality and Security Act (DQSA) last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), companies could use whatever code they wanted to refer to the prescription drug products in supply chain operations and for their own … Continue reading The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys →

DSCSA

Will The FDA Delay The DSCSA?

More and more people are asking if the FDA will delay the January 1, 2015 requirements of the Drug Supply Chain Security Act (DSCSA).  On that day, drug manufacturers, repackagers and wholesale distributors must begin exchanging Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), (dispensers join them next July) and the FDA is … Continue reading Will The FDA Delay The DSCSA? →

DSCSA, exemptions

Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited

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I am working this week, but I know this is a popular time for vacations, especially for those who do not have children in school.  I typically write my Monday essays over the weekend, but because it was a holiday weekend and my wife and I did some leisure traveling, I decided to re-post a … Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited →