Deadline will not be extended
As reported by the Regulatory Focus, the FDA will not delay the interoperability deadline for the DSCSA 2023 deadline. You can for sure group the saleable returns requirements as well. The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to have a full interoperable electronic track and trace system in place by 2023.
Continue reading FDA Official Will not extend the 2023 deadline
As the premier regulatory body for ingestible products in the United States, the FDA (Food and Drug Administration) is responsible for safeguarding public health through safety measures, guidance, and regulations. The importance of the FDA’s job cannot be stressed enough, and in the current global health crisis we find ourselves in, this responsibility is even more critical.
The FDA’s annual guidance schedule is often more aspirational than strictly practical, but it does a good job in providing useful insights into what areas the FDA’s CDER (Center for Drug Evaluation and Research) has given priority for that particular year.
You can find updated lists for the FDA’s guidance for 2021 here. In this article, we’ll focus on the guidance as it relates to the DSCSA (Drug Supply Chain Security Act).
Continue reading The FDA’s New Guidance for 2021 Explained
One of the most important things for a country to safeguard is the health and safety of its residents. Hazards don’t always arrive in plain sight and are most often hidden in things we trust and consume on a daily basis. The biggest example of this is the food we eat.
Food has the ability to nourish us and provide us with the energy to thrive in our existence, but it can also severely damage our health if not mandated properly. This is the main reason why the FDA’s Food Safety Modernization Act (FSMA) was enacted in 2011 by President Obama.
The specifics of the act are complicated, and the nature of the subject matter requires extensive regulations to be upheld. In this article, we’ll give you an overview of everything worth knowing about the FSMA guidelines. We’ll show you the importance of food regulation standards, we’ll get into each aspect of the FSMA in more detail and we’ll end with what’s changed for 2021.
Continue reading FDA’s Food Safety Modernization Act (FSMA), ExplainedIn 2020, most things did not go as planned. Considering the overwhelming impact of the worldwide pandemic, the pharmaceutical industry was far from immune to last year’s instability.
One of the major changes came with the Saleable Returns Verification’s extension. Despite being originally scheduled for a 2020 enactment, the FDA recently announced their plan to extend, yet again, the Saleable Returns Verification enforcement until 2023.
What does this really mean? Well the FDA won’t enforce it. So should you not care? It’s not that simple.
Legal liability
Remember, the law is the law. So the Saleable Returns Verifcation did become a requirement of the law this past November 27th 2020.
Continue reading Why the FDA Extended The Saleable Returns Verification from 2020 to 2023
Happy New Year, 2018 is here! Last year, the FDA announced a series of three Drug Supply Chain Security Act (DSCSA) Public Meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). So far they have held two (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “FDA DSCSA Public Meeting #2, Still A Gulf”). One more is left in that series, to be held on February 28, 2018. Continue reading 2018: The Year of FDA DSCSA Public Meetings
The gulf in expectations and goals exposed in the first FDA Drug Supply Chain Security Act (DSCSA) Public Meeting back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “HDA Schools FDA On DSCSA”) was still visible in the second meeting last week. There is still one more announced meeting scheduled for February 28, 2018 for the FDA and the industry to align (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). Based on my observations at these first two meetings, I’m not going to hold my breath. The FDA is likely to announce more meetings in 2018.
The FDA did adjust their position on at least one thing after the August meeting. Continue reading FDA DSCSA Public Meeting #2, Still A Gulf
Last week, Dr. Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spoke last week at the Healthcare Distribution Alliance (HDA) Traceability Seminar (see “HDA Traceability Seminar: RxTrace Future Topic List Explodes“). Her presentation went beyond the simple, tight-lipped, high-level review of the Drug Supply Chain Security Act (DSCSA) that is typical of recent FDA presentations at conferences. It was a refreshing change.
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
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