Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy – FDA Warning Letter, Dec 16, 2016

On September 20, 2017, the FDA issued Warning Letter WL # 537129 to Loop Plaza Pharmacy, Co. dba Loop Pharmacy & Home Medical, following an inspection from December 12-16, 2016. The inspection revealed that compounded drug products failed to meet Section 503A of the FDCA exemptions and identified serious deficiencies in sterile drug product production, posing patient risks.

Violations included: 1. **Failure to meet Section 503A conditions:** The firm did not receive valid prescriptions for individually-identified patients for a portion of products. Additionally, drug products were compounded using bulk drug substances (domperidone, saw palmetto, melatonin, short chain fatty acid, zinc picolinate) not eligible for 503A exemptions, as they lack USP/NF monographs, are not FDA-approved drug components, and are not on the 503A bulks list. This renders these products subject to FDA approval, adequate labeling, and CGMP requirements. 2. **Adulterated Drug Products (Section 501(a)(2)(A) & (B) FDCA):** Sterile products were prepared under insanitary conditions, including a pharmacist blocking first pass air in the ISO 5 hood, inadequate pressure differentials between the cleanroom and anteroom, and failure to use a sporicidal agent for ISO 5 hood