FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Store Club Card Not a Valid Drugmaking Tool, FDA Warns Compounder

Nov. 22, 2017

A worker at an Idaho compounding pharmacy used “a worn plastic store club card” to scoop a powdered drug into empty gelatin capsules, in violation of federal regulations, the FDA said in a warning letter.

The club card was “not intended for pharmaceutical or laboratory use,” the agency observed in the letter to Ladd Family Pharmacy, of Boise.

The pharmacy produced drug products for which it did not receive prescriptions for individual patients, and it compounded products with acidophilus lactobacillus, coenzyme Q10 and melatonin, none of which appear in qualifying monographs or on lists of approved substances, the letter said. Either of those actions would render Ladd ineligible for the regulatory exemptions that are extended to compounders in compliance.

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