“Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA”
On March 21, 2001 FDA classified Pharmacy Compounding Devices (PCDs) to Class II with exemption from the premarket notification requirements. Manufacturers that comply with the requirements of this guidance document need not provide 510(k) submissions. PCDs are often controlled by software. PCDs that are controlled by software are of concern to assure that the software performs safely. Software is mentioned in a number of locations in this guidance document as an element to be considered as a risk to the public health. This guidance document specifically requires design controls that address worse case operational conditions including stress on the system. It requires validation of old performance claims pertaining to potency, quantity, quality and purity, and uses software compatibility checks as an example of functionality needing to be validated.
It requires a variety of controls for software that relate to critical functions such as: weight and volume conversions, the effectiveness of sensors and detectors, user errors, and other items described in more detail. It also mentions use of the FDA software submission guidance for information on software design controls, as well as FDA recognized software standards.