FDA WARNING_LETTER - Steven's Pharmacy - June 25, 2008

On November 12, 2008, the FDA issued a Warning Letter to Steven's Pharmacy following a June 23-25, 2008 inspection. The FDA determined that Steven's Pharmacy's operations exceeded traditional compounding and were akin to a drug manufacturer.

Violations included manufacturing large volumes of "new drugs" like "Profound Gel" and "Profound Gel Light" in anticipation of prescriptions, and producing copies of FDA-approved drugs without patient-specific medical need. The firm also compounded drugs containing [(b)(4)], an ingredient not part of FDA-approved drugs and lacking demonstrated safety and efficacy. These products were introduced into interstate commerce without FDA approval, violating Sections 505(a) and 301(d) of the FDCA.

The products were also misbranded under Section 502(f)(1) for lacking adequate directions for use, and under Section 502(o) because the facility was not registered and products were not listed as required by Section 510. Additionally, topical anesthetic products were misbranded under Section 502(a) due to inadequate safety information, limited dosing, and unclear indications, posing public health risks, especially concerning high concentrations of local anesthetics and the use of [(b)(4)].

Steven's Pharmacy was required to respond within fifteen working days with specific corrective actions, an explanation of steps to prevent recurrence,