Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
Bulk Drug Substance Sourcing and the Section 503A Lists
How the FDA 503A Bulks List nomination process works, the sourcing paperwork pharmacies need, and the enforcement exposure an unli…
Peptides & 503A Compounders: FDA PCAC Meeting and Beyond
A PCAC meeting with close to 2000 comments on the public docket and a recommendation that goes against FDA staff recommendations!…
Billing and NDC Assignment for Compounded Preparations
How ingredient-level billing and NDC assignment for compounded preparations turn into PBM audit findings and federal enforcement c…
Bioidentical Hormone Compounding After the NASEM Report
The 2020 NASEM report reshaped cBHT prescribing limits, and 2025-2026 FDA enforcement shows compounders how those limits get read…
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…