US FDA Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry:
As of October 10, 2024, under section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)), HHS Secretary Becerra has declared public health emergencies (PHEs) in North Carolina, Florida, Georgia, Tennessee, and South Carolina due to the impacts of Hurricane Helene, as well as in Florida because of Hurricane Milton. In late September 2024, Hurricane Helene severely affected one of the largest manufacturers of specific intravenous and peritoneal dialysis solutions in the U.S. The FDA is collaborating with this manufacturer and alternative suppliers to enhance the supply and mitigate the risk of shortages of essential drug products.
This guidance outlines the FDA’s regulatory and enforcement priorities regarding the compounding of certain parenteral drug products by outsourcing facilities, State-licensed pharmacies, and Federal facilities not registered with the FDA as outsourcing facilities. This policy will be in effect only for the duration of the supply disruption associated with the aforementioned PHEs or for another period as the FDA may announce. As needs and circumstances change, the FDA plans to update, adjust, or withdraw the policies in this guidance and the specific drug products covered by this policy.
The document details the requirements for each class of compounders concerning stability and sterility, including considerations for beyond-use dates based on the manufacturing method, the presence of preservatives, and whether the compounder is classified as a 503A or 503B facility. It’s crucial for compounders to thoroughly review these requirements to ensure compliance with the outlined provisions. Additionally, the FDA has specified state requirements that must be met for 503A pharmacies to compound products without a patient-specific prescription.
The FDA has identified several parenteral drug products included under this temporary policy, such as:- Dextrose 5% IV solution
- Dextrose 10% IV solution
- Dextrose 70% IV solution
- Lactated Ringer’s IV solution
- Peritoneal dialysis solution
- Sodium Chloride 0.9% IV solution (normal saline)
- Sodium Chloride 0.9% for irrigation
- Sterile water for injection
- Sterile water for irrigation
It’s important to note that This policy is designed to remain in effect only for the duration of the supply disruptions linked to the public health emergencies mentioned above, or for any additional period as determined by the FDA. This initiative underscores the FDA’s commitment to ensuring access to vital medications during challenging times.
Masuu Global provides a comprehensive service to support regulatory affairs in various ways, which include white paper preparation, pre-submission meetings, scientific package preparation, submission gap analysis, and dossier compilation with lifecycle management.