Compulsory Law, FDA Rules, and FDA Guidance : Know The Difference with the DSCSA

sharon roberts attorney tallahasseeAs many of you know, in the world of pharmaceutical compliance, the Drug Supply Chain Security Act (or DSCSA) is an act that was set forth by the US Food and Drug Administration in November of 2013. The purpose of the act is to strengthen the security measures surrounding the drug distribution supply chain through adding more levels of control such as a national pharmaceutical track and trace system, as well as establishing national standards for licensing of prescription drug wholesale distributors and third-party logistics providers (3PLs).

The planned implementation of the Act will take place over a period of ten years.

What’s important to note is that a new set of requirements were slated to go into effect on November 1, 2015, however the FDA has announced a delay in enforcing these new requirements for four more months. With that in mind, these new rulings can be somewhat confusing as there are distinctions among compulsory law compliance, compliance with FDA rules, and FDA guidance.

When considering the value or relative importance of each of these types of rulings, it’s important to understand the differences between each type.

The DSCSA was an act signed by President Obama making this an act of congress. This fact means that compliance with these rules is mandated by Federal Law. This also means that non-compliance will result in fines and other penalties no matter where you are located in the country.

In addition to those provisions from the DSCSA, rules set forth by the FDA are in fact regulations backed by US law. Therefore, compliance is necessary in order to avoid penalties.

However, FDA guidances are not backed by law. These regulatory suggestions are strongly encouraged by the FDA, but they are not backed by the law. Numerous publications regarding FDA guidance have surfaced since the DSCSA was passed back in 2013, however, these are not in fact laws. These are suggestions or guidelines endorsed by the FDA, however it is up to individual companies whether or not they follow these suggestions. The FDA’s website claims that these guidance documents reflect the “current thinking” of the FDA on any particular topic, however they are non-binding as long as you meet the actual requirements of the underlying law.

While it is likely a wise idea to follow the FDA guidance documents when you can, compliance with the rules from the DSCSA and the FDA is critical in order to stay in line with the law.


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