Category Archives: FDA

One Immediate Impact of President Trump On The FDA

Most RxTrace subscribers are aware that the FDA is way overdue to publish four guidance documents mandated by the Drug Supply Chain Security Act (DSCSA) (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?” and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?” for a list of the missing documents).  Two of those four documents could impact how some drug manufacturers deal with the November 27, 2017 deadline for full serialization of prescription drug products, depending on what the FDA says in them. 

Every day since the original due date of those documents (November 27, 2015) I have Continue reading One Immediate Impact of President Trump On The FDA

FDA Forfeits Opportunity To Guide Industry

fda-building-2016-10-14-16-38-20I hope you were able to attend last Friday’s FDA DSCSA Public Meeting at FDA’s White Oak, Maryland campus (see “FDA To Hold DSCSA Public Meeting”).  If you missed it, make sure you listen in on the recording that the FDA will provide on the event webpage.  You can also submit written comments through that page as well.  The event was called “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (DSCSA)” and it consisted of very brief introductory comments by the FDA followed by presentations made by attendees who applied for a speaking slot.  Presentations covering progress toward the November 27, 2017 DSCSA serialization requirements were made by: Continue reading FDA Forfeits Opportunity To Guide Industry

FDA To Hold DSCSA Public Meeting

2016-04-05 14.11.09.reducedThe FDA is almost 10 months behind in the release of guidance documents for the Drug Supply Chain Security Act (DSCSA) as scheduled by Congress (see “FDA DSCSA Deadline Passes Quietly”, “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “FDA Speaks At GS1 Connect”, and “FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected”).  So far this year the FDA has held one public meeting to collect public and stakeholder input on the pilot that the law mandates (see “FDA To Hold DSCSA Pilots Workshop”, and “The 2016 FDA Pilots Workshop”).  The DSCSA requires the FDA to hold at least five public meetings “…to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment.”

This morning, the FDA announced Continue reading FDA To Hold DSCSA Public Meeting

FDA Speaks At GS1 Connect

Jung_ConnieLast week, Connie Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity, & Recalls, U.S. Food and Drug Administration, spoke about the Drug Supply Chain Security Act (DSCSA) at the GS1 US Connect event in Washington DC.  This was our latest opportunity to get a glimpse of what the FDA is thinking and what they are doing.  Dr. Jung spoke for about 50 minutes and then answered questions from the audience. Continue reading FDA Speaks At GS1 Connect

HDMA Responds To FDA Pilots RFC

iStock_000023623347_SmallerA few months ago the FDA opened two “dockets”, or Requests for Comments (RFC) to collect ideas and experiences about technology pilots related to the Drug Supply Chain Security Act (DSCSA).  The first docket was associated with the FDA Public Meeting held on April 5 and 6 (see “The 2016 FDA Pilots Workshop”).  The second docket was opened shortly after the Public Meeting to continue collecting the same kind of information from anyone who had already conducted their own pilots or was planning future pilots.  Both dockets are now closed so here is a look at the responses. Continue reading HDMA Responds To FDA Pilots RFC

Sponsored: The Many Faces Of The FDA

MultiFacesWhy is there such a wide gap between the actions of the UDI face of the FDA and the DSCSA face?

The U.S. Food and Drug Administration (FDA) is an agency of the U.S. government that falls under the Department of Health and Human Services, which is under the leadership of the current Presidential Administration through a cabinet seat.  But it is also a concept, and the concept has been conceived, modified, adjusted, influenced and expanded—especially expanded—by many thousands of members of Congress that have served from 1906 to 2016.  It started as a nearly powerless monitoring agency in 1906 with the passage of the Federal Food and Drugs Act.  But in the aftermath of a number of widely-reported incidents of harm and deaths caused by cosmetics and medicines, the Congress passed the original Food, Drug and Cosmetics Act (FD&C) in 1938 and President Franklin D. Roosevelt signed it into law.

Right from the beginning you had an agency with at least three faces:  foods, drugs and cosmetics.  Continue reading Sponsored: The Many Faces Of The FDA

More Thoughts On FDA and ANVISA

More ThoughtsOne of the problems with trying to respond overnight to big announcements made by regulators is that it’s easy to leave something significant out.  And in the ensuing days you find out what you should have included in those original essays.  That’s what happened with my two essays from last week:  “Brazil Suspends Pharma Serialization And Tracing Requirements” and “FDA Posts Wholesale Distributor and 3PL License Database“.

So let me add a few more thoughts and observations regarding Continue reading More Thoughts On FDA and ANVISA

FDA Posts Wholesale Distributor and 3PL License Database

FDALogoYesterday the U.S. FDA posted the first issue of the wholesale distributor and third-party logistics provider (3PL) database as mandated by the Drug Supply Chain Security Act (DSCSA).  Through this webpage, you can either download the entire database (in .XLS form), or enter a specific query and then download that result set if desired.  I couldn’t get the result set download to work, so there are obviously some bugs that need to get worked out, but this is still an important step in the implementation of the DSCSA.

With this posting, anyone who buys drugs Continue reading FDA Posts Wholesale Distributor and 3PL License Database