A Washington state pharmacy used ingredients that are not covered by a designated monograph in compounding drugs, meaning it lost its exemption for labeling requirements, and also failed to maintain sanitary conditions for drug production, the FDA said in a warning letter.
Without the labeling exemption, the compounder — Riverpoint Pharmacy, of Spokane — landed in hot water as a producer of misbranded drugs, the FDA said.
FDA rules for sanitary production apply with or without the exemption, and Riverpoint violated them as well, the agency said.
The warning letter listed Peruvian balsam and zinc picolinate as the forbidden ingredients, given that neither is addressed in a monograph provided by either the U.S. Pharmacopeia or the National Formulary.
In a December inspection, an FDA inspector saw that an isolation area for sterile production was in a prep room that was not supplied with adequately filtered air and which contained a sink. “Sinks are sources of microbial contamination,” the letter said.