The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning

EC logoWith the official publication of the European Union Delegated Act (EUDA), the clock starts for pharmaceutical manufacturers who supply drugs for the E. U. market to include two safety features on their drug packages.  One safety feature is some type of tamper evident seal, and the other is a “unique identifier”, also known as “serialisation” (see “The ‘Unique Identifier’ in the EU Delegated Act“). Continue reading The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning

U.S. Drug Wholesale Distributors Provide Direction To Manufacturers

Providing "direction"Over the next few years, the U.S. drug wholesale distributors are going to start dictating their specific requirements related to the Drug Supply Chain Security Act (DSCSA) to their suppliers.  For the “Big 3” U.S. wholesale distributors, those suppliers happen to be nearly every drug manufacturer who markets drugs in the United States.  The “Big 3” include McKesson, AmerisourceBergen and Cardinal Health, which together distribute about 85% of all drugs that pass through the domestic supply chain.

Of course, each segment has Continue reading U.S. Drug Wholesale Distributors Provide Direction To Manufacturers

FDA Considering A Delay Of A Small Part Of The UDI Rule

1622-468x60_AprilFor the second time this week, the FDA posted something related to the things I pay the most attention to.  Earlier this week it was about the DSCSA.  This time it was a draft guidance for comment on a proposed delay in enforcement of a small part of the Unique Device Identification (UDI) final rule.  I’ve seen a lot of mentions around the internet about this new FDA posting but none of them really explain it very well (including the FDA).  I’d like to take a stab.

Way back in around 1970 the FDA created a numbering system for drugs and one for devices.  The one for drugs Continue reading FDA Considering A Delay Of A Small Part Of The UDI Rule

FDA Announces OMB Approval Of One DSCSA Draft Guidance

omb-logoIt’s funny.  Here we are waiting for the FDA to publish four new Drug Supply Chain Security Act (DSCSA) guidance documents (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“), when an unexpected notice is published about an older draft DSCSA guidance document.  When I first looked at the title of the notice I had to read it four times before I could get myself to believe what I was seeing.

That’s right, this morning the FDA Continue reading FDA Announces OMB Approval Of One DSCSA Draft Guidance

Announcing: The Second Edition of The Drug Supply Chain Security Act Explained

DSCSA2ndEditionAdImageThis past week I have been on a vacation with my family in the Caribbean so I do not have a topical essay for you this week, except to announce the availability of the second edition of The Drug Supply Chain Security Act Explained.  The full title is “The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances”.  This time the book is available as a paperback and at the much more affordable price of only US$59.99.

I am working on Continue reading Announcing: The Second Edition of The Drug Supply Chain Security Act Explained

GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care

GS1_logoMedical device manufacturers have a choice of standards to use when identifying their products for the U.S. market.  The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose.  So far, three organizations have been FDA-accredited:  HIBCC, ICCBBA and GS1.

ICCBBA has a lock on the identification of Continue reading GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care

Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?

Happy Martin Luther King Day!

Congress set the calendar for many different kinds of requirements when it adopted the Drug Supply Chain Security Act, signed by the President back on November 27, 2013.  One of those dates was last November 27, 2015, two years after enactment, when the FDA was required to publish four new draft guidances.  So far, none of them have appeared (see “FDA DSCSA Deadline Passes Quietly”).  Continue reading Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?

India Posts New Deadlines (Again) For Serialization Of Drug Exports


Right now we are waiting for major new announcements regarding serialization and tracing requirements in the United States (4 overdue FDA guidance documents), the European Union (final publication of the Delegate Act related to the Falsified Medicines Act), Brazil (major redesign of their regulation), and Russia (first official publication of their regulation).  But last week, the India Directorate General of Foreign Trade (DGFT) published a new public notice containing details of the “Implementation of the Track and Trace System for Export of Pharmaceuticals and Drug Consignments”.  These details are for drugs made in India but exported to other markets. Continue reading India Posts New Deadlines (Again) For Serialization Of Drug Exports

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