CONCEPT #79 OF 100 · Medical, Dental & Clinical Practices · LAYOUT: clinical_box_grid
Compounding Pharmacy Master Formulation Record & USP <797>/<800> Sterile Batch Log
Standard / Reference: USP General Chapters <797> & <800> · FD&C Act § 503A / § 503B (21 U.S.C. § 353a/b)
Why professionals use this template: 13,900/mo search demand: 503A sterile compounding pharmacies and 503B outsourcing facilities requiring USP <797>/<800> master formulation records with ISO Class 5 hood certs, bubble-point tests, and BUD calculations.
144-DPI VECTOR PREVIEW · PAGE 1 OF 1
ACROFORM READY
Included Financial Metrics & Line-Item Schedule
Target Roles: Compounding Pharmacists (PharmD), 503A/503B Outsourcing Facilities & Cleanroom Directors · Search Keywords: compounding pharmacy master formulation and batch record template pdf, usp 797 sterile compounding log, 503b outsourcing facility batch record, bubble point filter integrity test log
STERILE PREPARATION
Bupivacaine HCl 0.25% (100 mL)
PRIMARY PEC ENVIRONMENT
ISO Class 5 LAFW (+0.04" WC)
FILTER BUBBLE POINT
48.5 PSI (Min Spec 45.0 PSI)
BEYOND-USE DATE (BUD)
45 Days Refrigerated (2–8°C)
| CODE | DESCRIPTION & TECHNICAL SPECIFICATION | BASIS / QTY | AMOUNT / DELTA |
|---|---|---|---|
| API-BUP | Bupivacaine Hydrochloride USP Powder (Certificate Lot #BUP-26-411 · 99.8%) | 12.50 g Weighed | $680.00 Batch |
| VEH-SAL | 0.9% Sodium Chloride for Injection USP Sterile Preservative-Free Vehicle | 5,000 mL Q.S. | $420.00 Batch |
| FLT-PES | 0.22-Micron Sterile Hydrophilic PES Membrane Capsule Filter (Post-Run 48.5 PSI) | 1 Capsule Lot | $195.00 Batch |
| QC-LAL | USP <85> Bacterial Endotoxins (< 0.2 EU/mL) & USP <71> 14-Day Sterility Release | 50 x 100 mL Bags | $3,355.00 Total |
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