Hurricanes Helene and Milton have both had devastating impacts on the United States. Late last week, the Department of Health and Human Services (HHS) determined that public health emergencies (PHEs) in North Carolina, Florida, Georgia, Tennessee, and South Carolina exist as a result of these hurricanes. 

To increase supply and reduce the risk of new shortages of critical drug products, FDA announced the availability of a final guidance entitled “Temporary Policies for Compounding Certain Parenteral Drug Products.” This guidance describes that FDA does not intend to take action against State-licensed pharmacies not registered as outsourcing facilities, including hospitals or health system pharmacies, that provide certain compounded parenteral drugs to a hospital without first obtaining a patient-specific prescription, provided certain conditions are met. This guidance also provides that FDA does not intend to take action against an outsourcing facility for "compounding [specific parenteral drug products] that are essentially a copy of an approved drug, for using a bulk drug substance that is not on FDA’s 503B Bulks List, or for not meeting [current good manufacturing practice (CGMP)] requirements with regard to [guidance described] product stability testing and the establishment of an expiration date,” provided certain conditions are met.

FDA has identified the following list of parenteral drug products to which this temporary policy applies:

• 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

Moreover, FDA makes clear this policy is intended to remain in effect only for the duration of the supply disruption related to the PHEs, “or for another period of time as FDA may announce.”