How Compounding Pharmacies Fill Critical Gaps in Pediatric Drug Development Processes: Suggested Regulatory Changes to Meet Future Challenges.
Level 5 - mechanism / opinion, no new human data
Expert opinion and narrative regulatory review
PubMed 36553327 · doi:10.3390/children9121885
What was done
This opinion article reviews the United States regulatory framework governing pediatric drug approvals and compounding pathways (under 503A pharmacies and 503B outsourcing facilities). The authors describe existing hurdles in pediatric drug development and outline proposed regulatory modifications to improve drug availability.
What was found
The abstract reports no empirical numbers or quantitative data. It qualitatively notes that the majority of pediatric drug use is off-label, requiring compounding from FDA-approved dosage forms or bulk active pharmaceutical ingredients to address critical gaps in commercially available finished dosage forms.
Why it matters
Pediatric patients frequently lack age-appropriate finished dosage forms from commercial manufacturers. Highlighting regulatory gaps in compounding and manufacturing pathways provides context for policy solutions aimed at improving safe access to pediatric medications.
Limits
This is a non-systematic narrative opinion paper with no experimental data, patient outcomes, sample size, or quantitative analysis. The discussion is specific to United States FDA regulations.
Cited by
- supports Under FDA compounding rules, compounded medications can be prepared either during an official shortage or to meet a unique clinical need of an individual patient.