Yesterday the FDA published a preview of two announcements related to the Drug Supply Chain Security Act (DSCSA). One was announcing a new pilot program, “…to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States.” That is, the system that will comprise the “Enhanced Drug Distribution Security” (EDDS) system in 2023. The other announcement was for a series of DSCSA public meetings—also intended to work on the system in 2023. Both announcements include a docket for use by stakeholders and the public to submit written comments to the FDA. Continue reading FDA Announces New DSCSA Pilot Program and Public Meeting Series
I recently wrote about several letters sent to the FDA by the Pharmaceutical Distribution Security Alliance (PDSA) regarding the overdue guidance documents (see “In Absence Of FDA Guidance, Follow PDSA Recommendations”). I highly recommend that you read those letters. But there was one letter from the PDSA to the FDA that I did not reference in that essay because it is not related to missing guidance. Instead, it’s about PDSA’s fear about the potential inability of some manufacturers to verify, in the DSCSA sense, certain drugs between now and November of 2019. To be exact, the type of verification they are worried about is the kind that will be based on a drug’s Standardized Numerical Identifier (SNI). Continue reading Will Manufacturers Have Trouble Verifying Some Drugs Next Year?
The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future. Today I want to take a closer look at the results of the Saleable Returns Pilots conducted by the HDA last year to figure out the most efficient way to verify saleable returns. I discussed the overall project in my report of the Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”) but today I want to focus in on just two of the approaches piloted. These are:
- Manufacturer sends to wholesale distributor product identifiers for only the units purchased by that wholesale distributor, and,
- Verification Router Service (VRS).
Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing. My mother and my mother-in-law both suffered from heart failure during their decline. Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”. At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect. Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition. The NDC won’t last long now, and there is no longer any excuse for inaction. The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’
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
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
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
A revolution occurred last week. Not by guns—by referendum. Like most revolutions, it caught a lot of people by surprise. The most laughable surprise comes from those who voted for the UK to leave the European Union as a kind of protest vote, but immediately became sorry they voted that way after learning that they had “won”, because they really didn’t mean it! It’s also laughable to hear the cries of the people who didn’t bother to vote because they felt confident that the referendum would go their way. Now they would like to go back in time so they can cast their vote. Whoops, too late.
What these people didn’t realize is that revolutions are serious business, whether executed with guns or with votes. One of the reasons Continue reading How Brexit Might Impact The Pharma Supply Chain