For pharmaceutical industry veterans, November 2023 marks the end of a decade-long journey to “achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.” This milestone will come with little fanfare, but with gigantic impact to the pharmaceutical supply chain.
Many major wholesalers are leading the charge for receiving aggregated data—requiring that manufacturers be able to digitally send pallet identifiers with corresponding digital details of all shipments sent to them. Without this data being aggregated, wholesale staff would have to open each pallet and manually scan each serialized product.
Preface: In this blog I’m going to assert that “the data associated with the drug and its supply chain transactions is just as important as the drug itself.” Disclaimer: The drug is certainly the most important part in the patient healthcare equation—data has nothing to do with that. BUT… there is a comprehensive data collection and integration reality that is required to get these drugs through the supply chain and eventually to the patients who need them. Ultimately, regulations like the...
Pharmaceutical serialization has been looked upon as a panacea for the rampant global issue of counterfeiting. Now that enforcement data has become available on the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD), it’s time to analyze the results. Has serialization put an end to counterfeiting?
Spoiler alert. According to the EU IP Office, pharmaceutical counterfeiting has not slowed down but is a growing threat.
Updated Sept 24 2020.
As of September 24, 2020 Class I medical devices needed to meet the FDA’s Unique Device Identification Final Rule. However, that date was postponed by the FDA in July with the publication of a new Policy Guideline document. That means the FDA will not begin enforcing the UDA Final Rule on these devices until September 24, 2022. By this new date,
It is one thing to mandate the printing of serialized barcodes on pharmaceutical packaging, and quite another to properly print these barcodes on said packaging to meet compliance.
Indonesia is a country that is a collection of many islands in Southeast Asia. You may not think of Indonesia very often, but you should. Indonesia is the fourth largest country on Earth by population, behind China, India and the United States. It is the 14th largest by land area and the 7th largest when you consider land and water surface. It’s big, and it has been doing well economically for the last decade or so since the government stabilized. And they have a government-run universal health...
The US pharmaceutical industry has been all abuzz about the upcoming VRS Mandate on November 27, 2019. If this is news to you, you may want to start here.
China’s National Medical Products Administration (NMPA) has been very active in the last year, producing documents that address various aspects of their planned pharma traceability mandate. It has been several years since the previous pharma serialization and tracing regulation was suspended. The future system described in the new final guidance documents is significantly different from that old suspended system. Where the old system avoided the use of global standards—and thus it was a...
The Drug Supply Chain Security Act (DSCSA) contains a series of escalating mandates for companies in the pharmaceutical supply chain. Each deadline falls on the anniversary date of the law’s adoption on November 27, 2013. For 2019, one of the new requirements is for wholesale distributors to begin verifying saleable returns using the Standardized Numerical Identifier (SNI) before they can redistribute them.
