Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

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46 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Regulatory Guidance P harmaceutical compounding recalls the earliest days of medicine making, when the mortar and pestle, and vari- ability, were the rule. Since that time, and the establish- ment of the United States Pharmacopeia (USP) and FDA in the United States, the field has come a long way. Over the years, compounders have become an increasingly impor- tant, yet largely invisible, part of the pharmaceutical ecosystem. When a commercially available drug comes in a form that isn't suited to some patients (e.g., when they are allergic to ingredients or cannot swallow a tablet or capsule), compounders reformulate so that patients receive the treatments they need in a form they can tolerate, explains consultant Robert Dana, principal of Elkhorn Associates, who has worked in both Big Pharma and compounding. In 2020, he taught an extensive course in current good manufacturing practices (CGMPs) for compounders for the Parenteral Drug Association (PDA). Over the years, compounding has been profitable for pharmacies that have ridden short-lived commercial growth waves. During the early months of the COVID-19 pandemic in the US, for example, FDA eased rules to allow compounders to make drugs that were in short supply at most hospitals (e.g., hydroxychloroquine and workhorse muscle relax- ants and sedatives). The 1980s saw another example, with a compound that ultimately became a blockbuster, but was initially compounded to take advan- tage of a side effect. Physicians began to ask compounders to make topical formulations of the blood-pressure treatment, loniten, after noticing that it caused hair growth. The drug eventually became Rogaine, and compounders left the business when Upjohn Phar- POLINA - STOCK.ADOBE.COM Ending 'Magical Thinking' in Compounding Agnes Shanley Consistent product quality requires a clear understanding of the essence of CGMPs. Experts fear that the message is not always getting through to compounders.

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