Tag 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

Sponsored: RxTrace to Sponsor the 2017 UDI Conference – June 7 & 8 in Baltimore, MD!

One of my favorite conferences each year is the annual Unique Device Identification (UDI) Conference put on by the Clarion Group on behalf of the Food and Drug Administration (FDA).  I am happy to sponsor the event each year, and I try to attend when I can.  

As an educational authority on UDI, the 9th annual UDI Conference will Continue reading Sponsored: RxTrace to Sponsor the 2017 UDI Conference – June 7 & 8 in Baltimore, MD!

HDA’s 2016 Serialization Readiness Survey

Because of all the major news and developments over the last six months, it has taken me way too long to fully cover the Healthcare Distribution Alliance’s (HDA’s) 2016 Serialization Readiness Survey of drug manufacturers.  In my defense, I did cover it partially in my report of the HDA 2016 Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”), but the other news from that event seemed to overshadow the survey results.  The HDA survey executive summary was so well done, and the results so important that it deserves closer scrutiny.  So here is my coverage, better late than never. Continue reading HDA’s 2016 Serialization Readiness Survey

Serializing Product Groupings Under Global Regulations

A “product grouping” is any collection of saleable units of products that are bound together in some way.  They can be “bundles”, homogeneous or non-homogeneous cases, totes, pallets or something like these.  The pharma serialization regulations in some markets call out some of these groupings for special treatment, and some do not.  I’ll try to catalog what we know about product groupings in each of the current, known regulations. Continue reading Serializing Product Groupings Under Global Regulations

First Meeting of the HDA Verification Router Service Task Force

Happy Martin Luther King Jr. Day!

As someone who often attempts to explain truth and reality through writing, I can really appreciate the writing skill of Rev. Dr. Martin Luther King Jr. (see “Celebrating Martin Luther King Jr.”).  I’ve learned that the best writing has to come from your heart just as much as it does from your head, but I still make mistakes that I don’t expect to see in Dr. King’s writing.  Last week is an example.  By attending the Healthcare Distribution Alliance’s (HDA’s) Verification Router Services (VRS) Task Force meeting in Crystal City, Virginia, I learned more about HDA’s intentions for the design of the VRS. Continue reading First Meeting of the HDA Verification Router Service Task Force

NDC Nearing Its End, Afflicted by ‘Identifier Failure’

business-executive-and-his-energy-level-concept-vector-cartoon-i-507717540_4911x3472Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing.  My mother and my mother-in-law both suffered from heart failure during their decline.  Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”.  At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect.  Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition.  The NDC won’t last long now, and there is no longer any excuse for inaction.  The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’

FDA Finalizes Guidance On Suspect Product

suspect-product-final-guidanceHere we are, waiting for the FDA to publish new draft guidance related to the Drug Supply Chain Security Act (DSCSA) after a deadline that passed more than a year ago, and what do we get?  A final version of a guidance document that was originally published in draft form two and a half years ago:  “Identification of Suspect Product and Notification”.  Well, OK, thanks. 

I have to say, this is important guidance.  In fact, it is probably the most important DSCSA guidance that the FDA has published yet, whether in draft or final forms.  And, unfortunately, Continue reading FDA Finalizes Guidance On Suspect Product

HDA Delivers Home Run To Record-Breaking Audience

HDA logoLast week the Healthcare Distribution Alliance (HDA) (formerly the HDMA) held their annual Traceability Seminar in Washington DC.  More than 450 people registered, shattering the previous record set just last year (see “Aggregation –> Chargeback Accuracy –> ROI”) and nearly equaling the record set in March for their 2016 Distribution Management Conference and Expo (see “HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil”).  This year’s event was executed nearly flawlessly with presentations by the FDA and wholesale distributors, and various panel discussions with thought-leaders from drug manufacturers, 3PLs, contract manufacturers, wholesale distributors, repackages, hospitals and chain pharmacies.  Here are some of my notes from the event. Continue reading HDA Delivers Home Run To Record-Breaking Audience