Quality Considerations for the Manufacture of Compounded Drugs

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Drug compounding gives doctors and patients an alternative option for treatment. 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 facility, a person under the supervision of a licensed pharmacist, combines, 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 Biologics, at Regulatory Compliance Associates (RCA), and Purushottam Singnurkar PhD, VP and Head, Formulation Development, Syngene International Limited about quality measures that should be considered in the manufacture of compounded drugs.

Read this article in Pharmaceutical Technology’s Quality and Regulatory Sourcebook eBook.

About the author

Susan Haigney is managing editor of Pharmaceutical Technology.

Article details

Pharmaceutical Technology
eBook: Quality and Regulatory Sourcebook
March 2023
Pages: 24–29

Citation

When referring to this article, please cite it as Haigney, S. Quality Considerations for the Manufacture of Compounded Drugs. Pharmaceutical Technology Quality and Regulatory Sourcebook eBook. March 2023.