FDA is aware that there are drugs being marketed that have not received FDA approval but are medically necessary and have been marketed for many years. When shortages occur for these drugs, FDA addresses these shortages through our normal processes and works with the companies to ensure patient needs are being met while also ensuring there is not any significant risk associated with the drug due to quality, safety, or efficacy that could result in harm to patients. FDA encourages the companies making these drugs to notify us of any changes in supply and also encourages the firms to seek FDA approval to help ensure ongoing quality and safety of these drugs for US patients.
