The U.S. Food and Drug Administration announced that it is taking action to help address a potential supply gap of neonatal starter parenteral nutrition (PN). These products provide essential nutrients through an IV to premature and critically ill newborns who cannot receive nutrition by mouth or through a feeding tube. The FDA has issued an immediately effective guidance (here) titled Temporary Policies for Compounding Certain Starter Parenteral Nutrition (PN) Drug Products for Neonates.
The guidance comes on the heel of hospital complaints regarding the inability to obtain total neonatal starter PN products. The concerns were based on the discontinuation of certain standardized neonatal starter PN products made by two outsourcing facilities that are permanently shutting down.
The FDA guidance recommends that hospitals engage other outsourcing facilities to meet the needs of neonatal patients; however, the guidance is also providing a 180-day period of the enforcement policies in this guidance for Federal and State 503A compounders to provide temporary flexibility to meet supply needs.
FDA says: “Generally, to the extent that hospitals and health systems have a need for compounded drug products, FDA encourages them to obtain such products from outsourcing facilities…Outsourcing facilities register with FDA, are subject to CGMP requirements, and are inspected by FDA according to a risk-based schedule. This helps to mitigate the risk that their drug products will be contaminated or otherwise made under substandard conditions. However, at this time there are no FDA-approved starter parenteral nutrition drug products for neonates and hospitals and health systems may have difficulty obtaining adequate supplies of certain starter parenteral nutrition drug products for neonates made by an outsourcing facility.”
“Therefore, as a temporary measure for 180 days after the publication date of this guidance, until March 8, 2027, FDA does not intend to take action against a State-licensed pharmacy or Federal facility that is not registered as an outsourcing facility, including a hospital or health system pharmacy, for providing a compounded drug to a hospital or health system without obtaining a patient-specific prescription, if all of the following circumstances are present.
(1) The compounded drug product appears on the list of drugs in Appendix A of this guidance.
(2) The compounded drug product is labeled with a default beyond use date (BUD) in accordance with the table in Appendix B.
(3) The compounded drug product is for single-use only and does not contain antimicrobial preservatives, due to safety concerns with the use of antimicrobial preservatives in drug products for neonates.
(4) The State authorities that regulate pharmacy compounding in the State where the pharmacy is located (and, if different, the state where the hospital or health system is located) are aware that the pharmacy is compounding these products for the hospital or health system before the compounded drug product is provided to the hospital or health system, and the State authority(ies) do not object to the pharmacy providing the compounded drug product to the hospital or health system without first obtaining a patient-specific prescription.
(5) Other conditions of section 503A and other requirements in the FD&C Act are met. In particular, a drug is deemed to be adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.” Drug products prepared, packed, or held under insanitary conditions could become contaminated and cause serious adverse events, including death.”
The guidance provides a complete outline of the enforcement policy and emphasizes that it is a temporary measure to address a serious shortage that could impact neonatal patients. It also has some helpful appendices that outline further what is permitted for compounding purposes as well as outlining proposed Starter Neonatal Parenteral Nutrition Formulations, beyond use dates for non-outsourcing facilities, and Stability Program and Beyond Use Dating for outsourcing facilities, as well as additional information on FDA intent regarding enforcement action relative to stability for outsourcing facilities.
