Most of my experience is in medical device. We have recently started adding an active ingredient to our product for a customer. We manufacture the product in bulk form and send it back to the customer who contracts a packager to produce the finished product and distribute to the end user. We do not hold the design and do not label. With past experiences, the customer would be considered the legal manufacturer. Does OTC drug regs differ in this situation? If we do not make the end product, are we still considered the manufacturer?