Does the DSCSA Have A ‘Spirit’

I was on an industry call a few weeks ago when someone from a technology vendor suggested that the industry should take some particular action because, it was aligned with “the spirit of the Drug Supply Chain Security Act (DSCSA)”.  That got me to thinking… Continue reading Does the DSCSA Have A ‘Spirit’

China Posts New Draft Pharma Serialization Guidelines

As I was preparing today’s RxTrace essay on Friday I received notice from GS1 Healthcare that China had posted draft guidance for comment for a new pharmaceutical traceability system.  I dropped everything and translated the three documents into English for RxTrace subscribers and GS1 Healthcare members to use.

The explanation provided by the China Office of the State Drug Administration for the drafts translates to: Continue reading China Posts New Draft Pharma Serialization Guidelines

EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored

The EU Delegated Regulation (EUDR) of the Falsified Medicines Directive (FMD) mandates that all serial numbers placed on non-exempt drugs entering the EU supply chain after February 9, 2019 must be ‘sufficiently randomised’.  What is sufficient randomisation?  The regulation says one thing, and the European Medicines Verification Organization (EMVO), the operator of the EU Hub, says something beyond that.  What should drug manufacturers do?  The EMVO recently updated their messaging.  Let’s take another look at this important topic. Continue reading EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored

FDA Seeks Input On The Future Format of the National Drug Code

Last week the FDA published a notice of a public hearing and request for comments regarding the impact of any future changes made to the length and format of the National Drug Code (NDC).  The current format of the NDC has been around since the early 1970s (see “Anatomy Of The National Drug Code”).  It has served the FDA, healthcare professionals and patients well since that time, but it is showing its age.  I call its affliction, “Identifier Failure” and I point out all of the symptoms for the aging NDC system in my essay “NDC Nearing Its End, Afflicted by ‘Identifier Failure’”.

It appears that the FDA recognizes these problems Continue reading FDA Seeks Input On The Future Format of the National Drug Code

Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation

View of a layer of drug cartons inside a case. Photo courtesy of Omega Design. Click image to enlarge.

Neither the Drug Supply Chain Security Act (DSCSA) in the United States, nor the Falsified Medicines Directive (FMD) in the European Union explicitly mandates the capture or use of aggregation data (see “Aggregation –> Chargeback Accuracy –> ROI” and “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary“).   In this instance, “aggregation data” is data that documents the serialized packaging containment hierarchy of drug products—also known as “parent-child relationships”.  It is well established that companies are not required by law to capture it, but for the smooth operation of pharma supply chains under a serialization, tracing and/or verification regulation, high quality aggregation data will be necessary.  But there are warning signs that a significant percentage of drug manufacturers are not going to meet that bar by the deadlines. Continue reading Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation

Personalized Medicines In A Serialized World

3d render of T cells attacking cancer cells

The era of personalized medicines has begun.  These are medicines that are tailored specifically for a single patient, using that patient’s specific DNA or other blood characteristic as a guide or actual source component.  The new chimeric antigen receptor T-cells (CAR-T) is an exciting example.  It results in the conversion of a patient’s own T-cells into cells that are able to recognize the specific type of cancer cells that the patient has, and thus able to attack them in the same way that normal T-cells attack normal infectious cells.  In short, it’s a way of manipulating a person’s own immune system to attack cancer cells that it would normally be blind to.  When it works, the results can be breathtaking.  The question is, how are these drugs treated under today’s serialization and tracing regulations?  Let’s take a look. Continue reading Personalized Medicines In A Serialized World

New Direction For Pharma Serialization In The Russian Federation

Click image to enlarge. Image from www.GreenwichMeanTime.com

Over the last 18 months or so, the Ministry of Health in the Russian Federation has been conducting a pilot to learn what works and what doesn’t work for pharma serialization and tracing (see “Russia Begins Its Pharma Supply Chain Pilot” and “The Russia Serialization Pilot Guideline”).  They were due to publish a report on their findings in February of this year, but we are still watching for that.  As we’ve learned over the years, it’s not uncommon for governments to miss their deadlines, at the same time, making tough statements about the industry needing to meet theirs, followed by caving on those deadlines too (See US, China, Brazil, US, India, Pakistan…).  That pattern is repeating in Russia. Continue reading New Direction For Pharma Serialization In The Russian Federation

HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

Unlike the implication of this drawing, FDA does hear and care about submitted comments.

The Healthcare Distribution Alliance (HDA) recently posted their response to the latest draft Drug Supply Chain Security Act (DSCSA) guidance published by the FDA.  That draft guidance explains how, when and why companies in the US pharma supply chain can apply for waivers, exemptions and exceptions to provisions in the DSCSA (see “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”).  As usual, the HDA took close to the full sixty day comment period to respond.  The comment period closed last Monday. Continue reading HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than Dirk Rodgers.

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