Drugs

FDA Eases Compounding for Neonatal Parenteral Nutrition Drugs

FDA has issued a guidance entitled Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates that is intended to help maintain supplies of starter parenteral nutrition drug products for newborns amid potential supply disruptions following the market exit of the predominant supplier.

Starter parenteral nutrition provides premature and other newborn infants with essential early nutrition, including dextrose and amino acids, and in some formulations calcium. FDA said there currently are no FDA-approved starter parenteral nutrition drug products specifically for neonates.

FDA says the guidance provides temporary regulatory flexibility for certain neonatal starter parenteral nutrition products compounded by state-licensed pharmacies, federal facilities and FDA-registered outsourcing facilities. The policies will remain in effect for 180 days, although they may be extended if necessary.

Under the guidance, FDA says that for state-licensed pharmacies and federal facilities that are not registered as outsourcing facilities, it generally does not intend to take regulatory action for providing specified compounded products to hospitals and health systems without first obtaining a patient-specific prescription, provided specified conditions are met. These include use of products listed in the guidance, appropriate beyond-use dating, single-use products without antimicrobial preservatives and notification of relevant state authorities.

For FDA-registered outsourcing facilities, the temporary policy allows certain flexibility involving the use of bulk drug substances and stability testing and expiration-date requirements. Among other conditions, facilities may use a default beyond-use date of no more than 30 hours at room temperature or nine days refrigerated when stability studies and sterility testing have not been completed before release.

The guidance identifies 20 eligible neonatal starter parenteral nutrition formulations, all supplied in 250-mL bags, containing varying concentrations of pediatric-specific amino acids and dextrose, with some formulations also containing calcium gluconate and heparin.

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