OC also reviews or, if necessary, provides a health hazard risk evaluation that outlines the risk of the defective product in the market. In addition, OC also helps manage any drug shortages that may result from a recall or other regulatory action.
OC serves as the liaison and facilitator among regulatory, field and medical personnel, as needed, to resolve or minimize the impact of a drug shortage. A drug shortage is when a product has been deemed medically necessary and is not available to the public due to an inadequate supply.
A medically necessary drug is defined as a product used to prevent or treat a serious or life-threatening disease or medical condition for which there is no other available source of that product, alternative drug or therapy. FDA - and not a company - determines if a product is medically necessary. When necessary, FDA can use regulatory discretion to allow violative or unapproved drug products to remain on or enter the market to alleviate potential drug shortages of a medically necessary product.