Monthly Archives: June 2019

Reimportation

Here We Go Again. Florida Flirts With Opening Door To Counterfeits

Earlier this month, the state of Florida (population:  21 million) passed a law that seeks to enable the importation of drugs from Canada (population:  37 million).  The goal is to carve out some way for Florida residents to take advantage of the lower drug prices that Canadian citizens enjoy.  Canada is a “single payer” healthcare country, except for prescription drugs, which are not covered by the Canadian universal public health insurance system.  The reason some drugs are cheaper in Canada than they are here in the US is because the government is allowed to negotiate with drug companies to set pricing for their citizens.  But in the US, Congress has specifically denied that option for itself, except for Medicare.

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DSCSA

Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?

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On November 27, 2019 the Drug Supply Chain Security Act (DSCSA) requires wholesale distributors to step up their supply chain security activities another notch.  They are required to:

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GS1, UDI

Meet The Latest GS1 Key: The Global Model Number (GMN)

GS1 makes modifications and additions to their General Specifications every year—sometimes even twice a year.  The latest is version 19 and was published in January 2019.  The “GenSpecs” contain the full detailed definitions of every GS1 “key” and every GS1 barcode.  While it doesn’t contain the definitions of every GS1 standard, it is the catch-all specification for their traditional core—mostly barcode related—standards.  This is where GS1’s keys are defined, included the Global Trade Item Number (GTIN, Application Identifier, or AI = 01), Global Location Number (GLN), Serial Shipping Container Code (SSCC, AI = 00), Global Returnable Asset Identifier (GRAI, AI = 8003) and all the others.  Last year (GenSpecs version 18) GS1 introduced their latest key, the Global Model Number (GMN, AI = 8013).  It’s an important addition, particularly for healthcare.  Let me explain.

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China

China: NMPA Drug Traceability Guidance

Most RxTrace readers will recall that China was an early adopter of drug traceability.  Back in 2007, companies were required to begin printing unique identifiers in linear barcodes on certain drug packages.  The unique identifiers had to be purchased from a government contractor.  The list of drugs grew each year to the point where all drugs were effectively covered by early 2016.  But shortly after that, the whole requirement was suspended (see “China’s Retreat From Pharma Serialization: Will This Become A Global Trend?” and “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”).  Then last summer, a new government agency, the National Medical Products Administration (NMPA), posted three draft guidance documents for review and comments (see “China Posts New Draft Pharma Serialization Guidelines”).  Finally, last month, the NMPA published two of those documents in final form, “Implemented on April 19, 2019”. 

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