FDA WARNING_LETTER - Total Pharmacy Services, Inc. - May 22, 2013

On February 28, 2014, the FDA issued a Warning Letter to Total Pharmacy Services, Inc. following a May 13-22, 2013 inspection. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and compounding domperidone, which lacks an applicable USP/NF monograph, FDA approval, or inclusion on a Secretary-developed list.

Serious deficiencies in sterile drug production were observed, including failure to demonstrate adequate ISO 5 area protection, operators not sanitizing components transferred into the ISO 5 area, and operators wearing non-sterile gowning while performing aseptic operations with arms resting on the ISO 5 work surface. These issues were noted on a Form FDA 483.

The FDA cited violations of the Federal Food, Drug, and Cosmetic Act (FDCA). Drugs compounded without individual patient prescriptions and domperidone products are not exempt under FDCA Section 503A and are considered misbranded under Section 502(f)(1). Sterile drug products were deemed adulterated under Section 501(a)(2)(A) due to insanitary conditions. Furthermore, drugs produced without individual prescriptions are subject to Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), and significant CGMP violations were observed, rendering these products adulterated under Section 501(a)(2)(B).