When is an exemption to licensure allowed for drug distributors?

An exemption to licensure for drug distributors is allowed when they supply drugs in emergencies to a licensed distributor. This provision recognizes the need for flexibility in certain urgent situations, such as natural disasters, public health crises, or shortages of essential medications, where timely access to medications is critical. In these cases, the law acknowledges that a licensed distributor may need to quickly receive supplies without undergoing the normal licensure process, ensuring that patient care and safety are prioritized.

Other scenarios, such as distributing to retail pharmacies, providing samples to healthcare professionals, or partnering with local hospitals, do not typically fall under the same urgent circumstances that justify an exemption to licensure. These activities generally require compliance with licensing regulations to ensure appropriate oversight and accountability in the distribution of pharmaceutical products.