In the FDA Voice, the official blog of the FDA, Capt. Valerie Jensen, RPh, Associate Director of the Drug Shortages Program in FDA’s Center for Drug Evaluation and Research describes the process of identifying manufacturers willing to help with shortages of parenteral nutrition components and to ensure that imported products are quality drugs that would not pose undue risk to patients in the United States.
Capt. Jensen stated that the FDA reviewed many aspects of the companies’ processes and operations, including:
- the manufacturing practices at the manufacturing facilities, as well as at the facilities where the active pharmaceutical
ingredients, or APIs, are produced;
- the history of inspections of those facilities from our own inspections or those of our regulatory counterparts; and
- the sterilization methods used for injectable drug products to ensure they met FDA standards.
We then met with manufacturers to determine:
- a distribution and shipping plan;
- how adverse events will be reported to FDA;
- how an outline for a Dear Health Care Provider letter, which highlights important information for doctors and pharmacists, will be structured; and
- product labeling.
Capt. Jensen commented, “While this might seem like a long road to take in resolving a shortage, it is an important process to protect the health of patients during a shortage. We expect these importations to address the current supply disruption over the coming weeks and we will remain vigilant in monitoring the supplies of these drugs until patient needs are fully met.”