FDA Issues Warning Letters to Two Compounders

Two more compounding pharmacies are in the FDA’s crosshairs, with one faulted for failing to maintain proper sterility while the other was accused of compounding without valid prescriptions.

PharmaLogic Holdings was cited over its handling and preparation standards, with the letter arguing that clean rooms at an outsourcing facility in Boca Raton, Fla., were unsanitary. The facility also was hit with several GMP citations, including failure to establish an adequate system for cleaning and disinfecting rooms and equipment, neglecting to set proper written procedures to prevent microbiological contamination of drug products and failing to withhold lots before testing and sampling.

The other letter went to Madison Drugs over the company’s compounding without prescriptions. The agency also contends that the company’s facility in Huntsville, Ala., misbranded its products because they lack sufficient directions for a layman to understand.