Washington State Compounder Used Unapproved Ingredients, FDA Says

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 also violated those rules, the agency said.