Category Archives: FDA

DSCSA, FDA

FDA Posts Wholesale Distributor and 3PL License Database

1 Comment

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 →

DSCSA, FDA

FDA Looking For Consulting Org To Run DSCSA Pilots

2 Comments

FDALogoLast week the FDA quietly posted a Request For Proposal (RFP) on the FedBizOpps.gov government bidding site for a consulting organization to design and implement a program of pilot projects that explore and evaluate methods to enhance the safety and security of the pharma supply chain.  The scope of work is: Continue reading FDA Looking For Consulting Org To Run DSCSA Pilots →

DSCSA, FDA, HDMA

HDMA Expresses Concerns About Industry Readiness for DSCSA

HDMA LogoLast week the Healthcare Distribution Management Association (HDMA), the industry association for the U.S. primary healthcare distributors, published a letter from HDMA President and CEO John M. Gray to the FDA expressing concerns that not all members of the supply chain will be ready to exchange the transaction data mandated by the Drug Supply Chain Security Act (DSCSA) by the January 1 deadline.

The letter expresses concern about the potential that complexities of implementing the law across the entire supply chain… Continue reading HDMA Expresses Concerns About Industry Readiness for DSCSA →

DSCSA, FDA

FDA Publishes Draft Guidance For DSCSA Data Exchange

As expected, the FDA has published the draft guidance on standards for paper and electronic data exchange that was mandated by the U.S. Drug Supply Chain Security Act (DSCSA).  And the guidance is early–by one day–fulfilling the intent of the FDA as expressed in the DSCSA Data Exchange workshop held last spring (see “The 2014 FDA DSCSA Workshop“).

The new guidance document can be found on the FDA website at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM424895.pdf

I will provide my full analysis in Continue reading FDA Publishes Draft Guidance For DSCSA Data Exchange →

DSCSA, FDA

The 2014 FDA DSCSA Workshop

WorkshopThe U.S. FDA held their first industry workshop focusing on the new Federal Drug Supply Chain Security Act (DSCSA) last Thursday and Friday at FDA Headquarters in Silver Spring, MD.  The goal of the workshop was to help the FDA collect ideas and preferences from industry stakeholders and technology providers for meeting the January 1, 2015 DSCSA requirement to exchange Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS).  The FDA must publish a draft guidance document on the same topic before November 27, 2014, so this workshop, plus the responses to the recent docket, will help them write that draft.

The workshop was held in a large room with eleven big tables, each with about 18 chairs around them.  The FDA had Continue reading The 2014 FDA DSCSA Workshop →

DSCSA, FDA

DSCSA: Many Questions, Few Answers

Jung_ConnieConnie T. Jung, RPh, PhD, Acting Associate Director of Policy and Communications, Office of Drug Security, Integrity and Recalls, in the Office of Compliance within the U.S. FDA Center for Drug Evaluation and Research (CDER) delivered an overview of the new Drug Supply Chain Security Act (DSCSA) during a webinar last Monday.  The title of the webinar was “FDA Perspectives on Implementation of the Drug Supply Chain Security Act”.  The webinar is one of a series that the Healthcare Distribution Management Association (HDMA) plans to offer on related topics through the remainder of the year.  If you missed it, don’t worry, they will post the recording and the slides on the HDMA event web page.

I have to give credit to Dr. Jung and the FDA in general for being willing to make presentations like this at this time.  The material they cover is a good overview of the new law at a high level.  The tough part for the speaker comes at the end when the floor is opened up for Q&A.  There were a number of very good questions asked by participants on this one, but most were answered with simple reference to future guidance.  Here is Dr. Jung’s answer to Continue reading DSCSA: Many Questions, Few Answers →

DSCSA, FDA

Decoding The FDA’s DSCSA Timeline

2 Comments

FDA DSCSA Implementation Plan.shrunkMany RxTrace readers probably saw the FDA press release last week that included the timeline chart called “Summary of Planned Implementation Timeframes for the Drug Supply Chain Security Act”.  If you did not see it, here is the link.  I found the text to be too small so I reproduced the chart using a larger font size.  See that version below.  Click on it to enlarge the image.  You might find this version better for inclusion in Powerpoint slides.

This is the FDA’s interpretation of their obligations under the Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA) that was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  There really are not any surprises in their interpretation, but there are a few interesting things to notice in this timeline and the associated table of target dates that accompanied it.  I have also reproduced the FDA’s deliverable table, but my version is sorted by the estimated target date column to make it easier to see what they plan to do in time sequence.

The first thing to notice about the timeline is Continue reading Decoding The FDA’s DSCSA Timeline →

FDA

InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13

1 Comment

PSM mug logoDr. Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), delivered the keynote address at yesterday’s Partnership for Safe Medicines (PSM) Interchange 2013 event (see “Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange”).

Her presentation covered the full range of activities that the FDA is currently pursuing to improve the security of the U.S. pharmaceutical supply chain, including their efforts to implement the new powers they were given by Congress in last year’s FDA Safety and Innovation Act (FDASIA).  Continue reading InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13 →