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,
Near the end of 2019, there were rumors that the Russian Federation would extend its regulatory deadlines for pharmaceutical serialization and traceability past its initial January 1, 2020 deadline, which called for full serialization using Russian Crypto Codes and government reporting...
Change is afoot, we are entering a new phase of activity within the pharmaceutical sector. The next stage of patient protection is starting to take shape across the industry, and it is a case of going back to the future. Though, no DeLorean, TARDIS or even a hot tub time machine are needed to make this change, we are not going to have hover boards or give cousin Chuck Berry a new sound. Instead of fighting Daleks we are going to wage war on counterfeiters and grey marketeers.
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.
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.
***For an UPDATE to the deadlines below please see this new post on Russian Deadlines***
The deadlines for the pharma labeling system (cryptographic serialization and tracing system) MDLP, in the Russian Federation are fast approaching. Companies marketing drugs in the Russia Federation targeting seven named nosologies must register with CRPT, the governments service provider, by July 8, 2019. Then on October 1, 2019, packages of drugs targeting those seven named nosologies...
On March 25, 2019 the Prescription Drug Security Alliance (PDSA) published the first of three white papers that describe their proposal for establishing a new, non-profit governance organization that would be responsible for ensuring interoperability of the Drug Supply Chain Security Act (DSCSA) solutions. This first paper is called “A Proposal: Governance for DSCSA Phase II Interoperability”. In addition, PDSA also published another paper called “An Overview: PDSA Vision for Phase II...
Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson. The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.
