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Applying Quality of Design Concepts to Pharmacy Compounding

Author(s):  Timko Robert J

Issue:  Nov/Dec 2015 - Volume 19, Number 6
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Note:  Electronic version includes supplemental material.

Abstract:  Compounding of medications is an important part of the practice of the pharmacy profession. Because compounded medications do not have U.S. Food and Drug Administration approval, a pharmacist has the responsibility to ensure that compounded medications are of suitable quality, safety, and efficacy. The Federal Government and numerous states have updated their laws and regulations regarding pharmacy compounding as a result of recent quality issues. Compounding pharmacists are expected to follow Current Good Compounding Practices in their compounding practices in much the same way pharmaceutical manufacturers are required to follow Current Good Manufacturing Procedures as detailed in the United States Code of Federal Regulations. Application of Quality by Design concepts to the preparation process for a compounded medication can help in understanding the potential pitfalls and the means to mitigate their impact. The goal is to build quality into the compounding process to ensure that the resultant compounded prescription meets the human or animal patients’ requirements.

Related Keywords: Robert J. Timko, RPh, PhD, quality assurance, drug safety, good compounding practices, U.S. federal pharmacy regulation, quality by design, pharmacy legislation, United States Pharmacopeial Convention, United States Pharmacopeia–National Formulary, U.S. Food and Drug Administration, quality standards, state boards of pharmacy, FDA guidance documents, outsourcing facilities, veterinary compounding, quality by design, process analytical technology, International Committee on Harmonization, Harmonized Tripartite Quality Guideline Documents, ICH, quality risk management, compounded product, control strategy


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