Fensolvi is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty. 
USP General Chapter <800> considerations
USP General Chapter <800> does not apply to the mixing and administration of Fensolvi. USP Chapter <800> is only applicable in the context of compounding. Fensolvi is a conventionally manufactured product, and preparation in accordance with the approved labeling for administration to an individual patient is not considered compounding.
- Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.