Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
API Sourcing Documentation: Certificates of Analysis
Section 503A conditions the compounding exemption on a valid Certificate of Analysis and Section 510 manufacturer registration for…
Anticipatory Compounding Limits
Federal law caps how much compounded drug a pharmacy can hold before a prescription arrives. What Section 503A requires and where…
Allergenic Extract Compounding Rules for Pharmacists
FDA's prescription-set framework and USP 797 Section 21 set separate rules for allergenic extract compounding, and state boards of…
Adverse Event Reporting for Compounded Preparations
Compounded-drug adverse events trigger different FDA reporting duties for 503A pharmacies and 503B outsourcing facilities, plus re…
USP 797 and 800 Inspections: The Compliance File Inspectors Ask For
USP 797 and 800 inspections turn on one thing: whether the pharmacy can produce the documentation file the chapters require on req…
State Board Compounding Inspections: Preparation and Response
State boards inspect compounding pharmacies under USP 797/800 standards, and a deficiency notice in one state can trigger multi-st…
Tirzepatide Compounding: Enforcement Risk After the Shortage List
Tirzepatide's shortage exemption closed in 2024. Eli Lilly's litigation campaign and FDA's Bulks List proposal now define compound…
Compounding Semaglutide After the Shortage Delisting: The Legal Landscape
FDA resolved the semaglutide shortage on February 21, 2025. What compounding pharmacies can still lawfully make now turns on docum…
Peptide Compounding: Regulatory Status and the Gray Market
Most peptides remain outside FDA's 503A Bulks List even as Category 2 status shifts, exposing compounding pharmacies to marketing…