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# FDA Cites 2 Pharmacy Compounding Operations
- URL: https://www.fdaweb.com/fda-cites-2-pharmacy-compounding-operations/
- Published: 2016-11-30T12:00:00.000Z
- Updated: 2026-09-14T21:51:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137459

Prescription Lab Compounding Pharmacy and Stonegate Pharmacy have been cited in two recent Warning Letters as part of FDA’s increased scrutiny of drug compounding operations. In a [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm530474.htm?ref=fdaweb.com) to Prescription Lab, the agency said it observed a serious deficiency in its practices for producing sterile drug products. Specifically, it said glass beakers used to mix non-sterile drug product solutions prior to the sterilization step are not protected from contamination after they are processed through a dry oven.

In a separate [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm530525.htm?ref=fdaweb.com) to Stonegate, FDA investigators noted that the firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products produced. The investigators also noted that it produces domperidone products, which are not on a list recognized by the agency as approved for compounding. Additionally, they observed serious deficiencies in Stonegates’practices for producing sterile drug products. For example, the investigators noted the use of non-sterile wipes and non-sterile disinfectants in the ISO 5 area in which sterile products are processed.