DEA Responds to Concerns About Potential Shortages and Production Capabilities of Certain Injectable Drug Products – APhA submits compounding comments to FDA. – (866) 348-2889.
To prevent any pharmaceutical drug shortage that negatively impacts patients, DEA is working closely with FDA, drug manufacturers, wholesale distributors, and hospital associations to ensure that patients have access to necessary hospital-administered pain medications. These include certain injectable products that contain morphine, hydromorphone, meperidine, and fentanyl.
As indicated in a DEA news release, the largest US manufacturer of these injectable products has slowed production at one of their manufacturing facilities to perform necessary and required upgrades. As a result, this company voluntarily surrendered a portion of their quota allotment and DEA reallocated these amounts to three DEA-registered manufacturers of FDA-approved injectable products in accordance with DEA regulations. DEA indicates that an increase in DEA procurement quotas to various manufacturers alone cannot prevent future shortages as DEA does not control the quantity or the speed by which manufacturers produce these or any of their products.