Quality Assurance Standards

Bellevue Pharmacy = High Quality

The following is a summary of our operations and procurement and quality control processes. We are committed to complying with applicable laws and regulations and to ensuring high quality care for our patients.

Bellevue Pharmacy operates as a compounding pharmacy in the State of Missouri. Traditionally, the Food and Drug Administration (FDA) regulates the manufacture of drugs and the State Boards of Pharmacy regulates the practice of pharmacy compounding. Compounding differs from manufacturing in that compounded medication is prepared and dispensed pursuant to a valid prescription order from a physician for a specific patient. Manufactured drugs are mass-marketed, distributed through wholesalers, and eventually dispensed through pharmacies to patients unknown to the manufacturer.

Bellevue Pharmacy is a state of the art compounding pharmacy, and we strive to provide high quality compounded prescriptions. We are active members of the following organizations:

• Professional Compounding Centers of America (PCCA) (www.pccarx.com)
  
• International Academy of Compounding Pharmacists (IACP) (www.iacprx.org)
  
• American Pharmaceutical Association (APhA) (www.alphanet.org)
  
• National Community Pharmacists Association (NCPA) (www.ncpanet.org)
  
• Missouri Pharmacy Association (MPA) (www.morx.com)
  

Our compounding lab is compliant with USP/NF 795 (non-sterile products) and USP/NF 797 (sterile products). We operate a class 100 clean room under American Society of Health-System Pharmacies guidelines. We perform sterile product testing using an independent laboratory to ensure each vial meets our stringent quality requirements. We perform random sampling of all prescriptions compounded by our pharmacy as an additional measure of product quality. We calibrate our scales daily prior to the start of operations, and throughout the day, as necessary. Our laminar flow hood is certified every six months by an outside agency. Our pharmacists and pharmacy technician staff are trained and certified in aseptic technique.

We purchase all ingredients used in compounding prescriptions from an FDA-approved distributor. All hormones come with a certificate of analysis (generally 99.8%-99.9% purity) from the distributor. Each prescription undergoes an internal check process that ensures accurate preparation. Each ingredient of the prescription is calculated based on the prescription, individually weighed, and lot numbers and weights are recorded on a compounding record sheet. The scale tapes (ingredient weights) are attached to the record sheet. We comply with USP/NF 795, which requires a potency of plus or minus 10%. Records are maintained for the life of the prescription in accordance with pharmacy law.

Each prescription undergoes four internal checks of lot numbers, weights, and calculations by our technical staff, and by a compounding and dispensing pharmacist prior to shipment. Injectable preparations also undergo a second final dispensing check prior to shipment.

Our goal is to prepare the highest quality compounded prescriptions for our patients.

Please contact us for additional information regarding our quality standards.