The government of Brazil is trying to recover from the poor design of their first attempt at a pharma serialization and tracing regulation, RDC-54/2013. That first regulation was at least partially suspended (see “Brazil Suspends Pharma Serialization And Tracing Requirements” and “The Official Suspension of the Three-Lot Pilot in Brazil”). Everyone seems to be operating under the assumption that the entire RDC-54-2013 will be replaced with a new regulation. Legislation to do exactly that has been slowly churning its way through the Legislature for the last 9 months. Word came last week that Continue reading Proposed Pharma Serialization Regulation Progresses in Brazil
All posts by Dirk Rodgers
The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations
The Healthcare Distribution Alliance (HDA) (formerly HDMA) published their highly anticipated “Guidelines for Bar Coding in the Pharmaceutical Supply Chain, Quick Start Guide” a few weeks ago. Do yourself a favor and stop reading this essay right now, click on the link and download your copy and read it. It is free, and it is essential reading for manufacturers and solution providers who expect to develop and deploy solutions that ship serialized units and cases of prescription drugs to U.S. wholesale distributors. This includes solutions that Continue reading The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations
Product Identification And National Registration Codes
There is a long-running tug-of-war going on between GS1 and national governments around the world over how exactly to identify medical products, whether devices or pharmaceuticals. National governments regulate those products to maximize the health of their citizens and so they take a natural interest in how they are identified. They want to eliminate all ambiguity between products within their market. They need to be able to tightly grant market authorization, revoke it and oversee recalls when warranted. To do that effectively, they need a way of clearly and concisely referencing a given product. That same way of referencing the product should also be used for patient education and for healthcare professional prescribing. Bad things happen when mistakes are made in the identification of healthcare products.
GS1 offers a global standard way of identifying Continue reading Product Identification And National Registration Codes
FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected
Last week the US FDA Center for Drug Evaluation and Research (CDER) published an update to their guidance agenda for calendar 2016. Originally published in January, this is the mid-year update, when the CDER has a shorter window to think about and, presumably, can be more accurate. What has changed since January? The number of Drug Supply Chain Security Act (DSCSA)-related draft guidance they expect to publish by year end remains the same, as reported by our friends at the Regulatory Affairs Professionals Society (RAPS).
In fact, according to RAPS, those same six draft guidances were Continue reading FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected
Who Will Enforce The DSCSA 2017 Serialization Mandate?
Last week I listened in on a Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 U.S. wholesale distributors. It was a well-run call that included several presentations and a Q&A session. Several times the question was discussed about whether or not the wholesale distributor would accept non-serialized product in the time between November 27, 2017 and November 27, 2019. Continue reading Who Will Enforce The DSCSA 2017 Serialization Mandate?
China Adds Traceability Requirement To CFDA Drug Quality Management Specification
Everyone who markets drugs in China has been watching for the publication of revised requirements for tracing drugs there since the government apparently suspended their previous requirements earlier this year. Interpreting Chinese government announcements is very hard to do. Even knowing for sure exactly what has been suspended about the previous regulation is very difficult. Google Translate does a poor job of making Chinese understandable enough to provide me with confidence.
With all that said, a few weeks ago a notice appeared Continue reading China Adds Traceability Requirement To CFDA Drug Quality Management Specification
Decommissioning Under the FMD/EUDR
It is a little surprising that the European Union Delegated Regulation (EUDR) uses a form of the word “decommission” 67 times, but not even once uses the opposite term, “commission”. Article 3.2(c) of the EUDR defines the term ‘decommissioning of a unique identifier’ as:
“… the operation changing the active status of a unique identifier stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful verification of the authenticity of that unique identifier;”
It is a striking omission to define how to change the active status of a drug to impede successful verification, but to fail to define the opposite operation that sets the active status to enable successful verification in the first place. Continue reading Decommissioning Under the FMD/EUDR
Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again
This week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids. Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA. Here it is again.
Regulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet. When allowed, grandfathering allows Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again
