FDA Issues Warning Letter to Drug Compounder

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The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.

FDA sent a warning letter on June 6, 2016 to People’s Custom Rx and Clinical Care, LLC in Memphis, TN. The drug compounder was cited for not receiving valid prescriptions for individually identified patients and for deficiencies in the production of sterile drug products.

FDA stated in the letter that the company’s products may be produced in an environment that poses a significant contamination risk. During a July 2015 FDA inspection, investigators found that the company failed to use a sporicidal agent and the used non-sterile disinfectants for daily cleaning of the ISO 5 hoods and cleanroom. Personnel were seen not sanitizing syringes, needles, compounding solution, or other components prior to placing them inside the aseptic areas. The company also failed to assure the sterility of multi-use solutions used to produce injectable drug products without a subsequent sterilization step. The company also failed “to demonstrate through appropriate studies that your hoods are able to provide adequate protection of the ISO 5 area in which sterile products are processed.” 

The company was also found in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). FDA states that the company manufactured and distributed product without valid prescriptions for individually-identified patients, which makes the products unapproved new drugs and misbranded drugs in violation of Sections 505(a) and 502(f)(1) of the FDCA. FDA stated, "... should you continue to manufacture and distribute drug products, including non-sterile drug products, without valid prescriptions for individually-identified patients, the manufacture of such drugs would be subject to FDA’s drug CGMP regulations (21 CFR 210 and 211), among other requirements described above, and, before doing so, you should fully implement the minimum requirements of 21 CFR 211 in order to provide assurance that the drug product(s) produced by your firm conform to the basic quality standards regarding safety, identity, strength, quality, and purity.” FDA also noted that “Section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether the drugs are compounded and distributed after receipt of a prescription for an identified individual patient.”


Source: FDA