Quality Assurance

A Commitment to Our Customers

The pharmacy compounding specialists at Buderer Drug Co. recognize the importance of adherence to nationally-accepted standards. At Buderer Drug Co., all prescriptions are compounded in compliance with established policies, procedures and industry standards, including the Ohio Board of Pharmacy, FDA, OSHA, USP, and newly developed PCAB accreditation standards.

We comply with USP Chapter 795 (Pharmaceutical Compounding – Nonsterile Preparations) and USP Chapter 797 (Pharmaceutical Compounding – Sterile Preparations) which establish practice standards and outline the responsibility of the compounder, selection and appropriate sources of ingredients, quality control, and considerations regarding the stability of compounded preparations. In addition, two additional USP informational chapters are in effect, including, USP Chapter 1075 – Good Compounding Practices, and USP Chapter 1160 – Pharmaceutical Calculations in Prescription Compounding.

Safety Policy and Procedures

Buderer Drug Co. adheres to OSHA standards for safety of our staff and patients.

Process Validation

Our strict guidelines for the preparation of compounded prescriptions assure uniformity and quality. The final preparation is examined to provide continuity of quality from batch to batch. We can always track each compounded prescription to determine when and by whom it was prepared, and the lot of chemical that was used. Preparations are randomly sent to an independent laboratory to ensure quality of oral, topical, and sterile compounds.

Compounded Sterile Preparations

Tested in-house using QI Medical products and at an independent laboratory as needed for endotoxin, potency, and sterility. Our sterile pharmacy compounding equipment is independently certified on a bi-annual basis. All personnel are certified in aseptic technique.

Finest Ingredients

We use only the highest grade of bulk drug powders and chemicals for custom compounded prescriptions. Certificates of Analysis are available for these pharmacy compounding chemicals.

To develop a custom compounded prescription that will meet a patient’s specific needs, Buderer Drug Co. will:

  • Research the medical literature for indications, dosing, stability data, and other information
  • Experiment and perform chemical analysis in the compounding laboratory
  • Network with colleagues, physicians, veterinarians, dentists, and other health care professionals to properly formulate a customized dosage form that will solve a patient’s medication problem