FDA WARNING_LETTER - McGuff Compounding Pharmacy Services, Inc. - December 31, 2014

On November 13, 2015, the FDA issued a Warning Letter to McGuff Compounding Pharmacy Services following an inspection from December 15-31, 2014. The inspection revealed the firm was producing drug products without receiving valid prescriptions for individually-identified patients, a condition necessary for exemptions under Section 503A of the FDCA.

The FDA determined that drugs compounded without individual patient prescriptions are not entitled to exemptions from CGMP, adequate directions for use labeling, and FDA approval prior to marketing. Specifically, these drug products are considered misbranded under Section 502(f)(1) of the FDCA because they are intended for conditions not amenable to self-diagnosis, and adequate directions for lay use cannot be provided. This constitutes a prohibited act under Section 301(k) of the FDCA.

The FDA acknowledged the firm's April 28, 2015, response indicating a "conversion to 100% Patient Prescription Orders" and cessation of "office use" orders. However, the letter warns that continued manufacturing and distribution without valid individual patient prescriptions would subject the firm to FDA's drug CGMP regulations (21 CFR Parts 210 and 211).

McGuff Compounding Pharmacy Services was required to respond within fifteen working days with specific corrective actions, an explanation of recurrence prevention, and supporting documentation. Failure to comply could result in legal