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.
In 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.
Remember, the law is the law. So the Saleable Returns Verifcation did become a requirement of the law this past November 27th 2020.
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→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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