The professionals at Buderer Drug Co. recognize the importance of adherence to nationally-accepted standards. At Buderer Drug Co., all medications are compounded in compliance with established policies, procedures and industry standards, including the Ohio Board of Pharmacy, FDA, OSHA, USP, and newly developed 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 compounds assure uniformity and quality. The final preparation is examined to provide continuity of quality from batch to batch. We can always track each 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 are tested in-house using QI Medical products and at an independent laboratory as needed for endotoxins, potency, and sterility. Our sterile 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 to compound customized medications. Certificates of Analysis are available for these compounding chemicals.
To develop a customized preparation 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 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.
Tour our compounding lab.
Our ISO Class 7 Sterile Lab, Ante Area and Compounding Lab meet USP 795 and 797 requirements.
The preparation of medication is done in compliance with established policy and procedures and industry standards, including the Ohio Board of Pharmacy, FDA, OSHA, USP, and newly developed accreditation standards.
Powders are weighed on electronic scales with printers. The procedure is done in a flow hood, with technicians fully gowned.
Powders are blended using a V-blender to ensure even dispersement of active drug with the excipient.
Capsules are prepared in a flow hood. After the capsules are finished, they are weighed to determine variance in fill. If the capsules do not meet USP variance, they are rejected and not dispensed.
Creams are prepared using electronic mortar and pestles. The creams are then milled to reduce particle size so that the final product is both cosmetically elegant and improves absorption.
A formula is generated for each batch, assigned a lot number and expiration date, contains the printer tape from the electronic scale, and contains the lot numbers and expiration dates of the raw materials used. The final product is then checked by the pharmacist to ensure quality and accuracy.
Creams are dispensed in syringes so that the patient can dispense accurate amounts and are placed in light resistant containers.
Compounding laboratory for sterile preparations.
ISO Class 7 Cleanroom with ISO Class 5 Laminar flow hood and ISO Class 4 Glove-box. Autoclaves and Isotech barrier isolation unit optimize sterility of compounded preparations.
Preparation of an oil for injection in a Class 4 Glove-box.
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