Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

Version 1 : Received: 3 March 2022 / Approved: 8 March 2022 / Online: 8 March 2022 (08:24:35 CET)
Version 2 : Received: 9 March 2022 / Approved: 10 March 2022 / Online: 10 March 2022 (08:26:21 CET)
Version 3 : Received: 4 April 2022 / Approved: 5 April 2022 / Online: 5 April 2022 (10:17:10 CEST)

How to cite: Parrish, R.; Ashworth, L.D.; Löbenberg, R.; Benavides, S.; Cies, J.J.; MacArthur, R.B. Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update. Preprints 2022, 2022030117 (doi: 10.20944/preprints202203.0117.v1). Parrish, R.; Ashworth, L.D.; Löbenberg, R.; Benavides, S.; Cies, J.J.; MacArthur, R.B. Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update. Preprints 2022, 2022030117 (doi: 10.20944/preprints202203.0117.v1).

Abstract

The purpose of this work was to evaluate the suitability of recently US Food and Drug Administration (US-FDA) approved and marketed oral liquid, powder, or granule products for children in North America, to identify the next group of Active Pharmaceutical Ingredients (APIs) that have high potential for development as commercially available FDA-approved finished liquid dosage forms , and to propose lists of compounded nonsterile preparations (CNSPs) that should developed as commercially available FDA-approved finished liquid dosage forms as well as those that pharmacists should continue to compound extemporaneously. Through this identification and categorization process, the pharmaceutical industry, government, and the professions are encouraged to continue to work together to improve the likelihood that patients will receive high quality standardized extemporaneous CNSPs and US-FDA-approved products.

Keywords

active pharmaceutical ingredient; compounded drug; compounding; extemporaneous formulation; manufactured material; medication; monograph; pediatric; reference standards

Subject

MEDICINE & PHARMACOLOGY, Pharmacology & Toxicology

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