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24 Pharmaceutical Technology ® Quality and Regulatory Sourcebook March eBook 2023 PharmTech.com TYYANG - STOCK.ADOBE.COM D rug compounding gives doctors and patients an alternative option for treat- ment. But these products come with some risk because of the nature of how they are manufactured. FDA states, "Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facilit y, a person under the supervision of a licensed pharmacist, com- bines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients" (1). Pharmaceutical Technology® spoke with Susan J. Schniepp, distinguished fellow, and Steven Lynn, executive principal consultant, Pharma and Biolog- ics, at Regulatory Compliance Associates (RCA), and Purushottam Singnurkar PhD, VP and Head, Formu- lation Development, Syngene International Limited about quality measures that should be considered in the manufacture of compounded drugs. Compounding versus traditional drug manufacture PharmTech: What are some of the processes that go into manufacturing compounded dr ugs? How do t hese d i f fer f rom s t a nd a rd ph a r m ace ut ic a l manufacturing? Singnurkar (Syngene): Drug compounding is a practice in which a trained and licensed pharmacist or physician at the hospital or clinical site does the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an in- dividual patient. Quality Considerations for the Manufacture of Compounded Drugs Susan Haigney, managing editor Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.