As of October 10, 2024, pursuant to section 319(a) of the Public Health Service Act (PHS Act), Department of Health and Human Services (DHHS) Secretary Becerra has determined that public health emergencies (PHEs) resulted from the devastation caused by hurricanes Helene and Milton. Because of the disruption to the availability of certain parenteral products, the FDA has issued a guidance titled, Temporary Policies for Compounding Certain Parenteral Drug Products (here) that explains the FDA’s temporary enforcement activity as it relates to the compounding of certain parenteral products by 503A and 503B compounders.
The guidance outlines specific requirements for each class of compounders as far as stability and sterility are concerned. It also addresses beyond-use dates depending on the method of manufacture, whether the product contains a preservative, and whether the compounder is a 503A or 503B facility. It is essential for compounders to carefully review and evaluate the requirements under this guidance to ensure compliance is achieved in accordance with the provisions outlined. There are also state requirements that the FDA outlines that must be met to permit 503A pharmacies to compound the products without first obtaining a patient-specific prescription.
The list of parenteral products that fall under this temporary guidance is limited to include:
- Dextrose 5% IV solution
- Dextrose 10% IV Solution
- Dextrose 70% IV solution
- Lactated Ringers 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
Remember, this guidance focuses on a narrow and limited number of products and is temporary in nature. To take advantage of the provisions outlined in the guidance, compliance with its requirements is essential.
