FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document

Last week the FDA posted final versions of two DSCSA guidance documents, and, a new draft Product Identifier Q&A document.  The two final guidance documents include the grandfathering policy and the product identifier compliance policy that delayed enforcement of the product identifier and verification requirements until November 27, 2018.  These documents are companions to each other, which is to say that they are pretty tightly related, and that’s why FDA Continue reading FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document

Sponsored: From Serialization to Full Traceability: 2018 Outlook On Compliance

In just two months, pharmaceuticals entering the US pharma supply chain through drug manufacturers will be serialized according to the Drug Supply Chain Security Act (DSCSA).  It’s already been a long journey, but this is only the beginning.  Companies can’t even take a break.  In just one year the wholesale distributor saleable returns requirement will force manufacturers to either capture aggregation data or connect to a Verification Router Service (VRS)—or both!  The year after that, Continue reading Sponsored: From Serialization to Full Traceability: 2018 Outlook On Compliance

Sponsored: IQPC: The Biggest Challenges Preparing For The DSCSA

Kevan MacKenzie, Director of Serialization Technology at McKesson

Kevan MacKenzie, Director of Serialization Technology at McKesson, is arguably the leading expert on the Drug Supply Chain Security Act (DSCSA) requirements for wholesale distributors, and interactions with their trading partners.  IQPC recently interviewed Mr. MacKenzie to get his perspectives on the biggest challenges companies face when preparing for the DSCSA.

MacKenzie’s insights will Continue reading Sponsored: IQPC: The Biggest Challenges Preparing For The DSCSA

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As I was preparing today’s RxTrace essay on Friday I received notice from GS1 Healthcare that China had posted draft guidance for comment for a new pharmaceutical traceability system.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