FDA WARNING_LETTER - VP Pharmacy Partners LLC - February 03, 2015

On December 18, 2015, the FDA issued a Warning Letter to Spoonamore Drug Co. Inc., dba Louisville Pharmacy and Custom Script, following an inspection from January 13 to February 3, 2015. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and had serious deficiencies in sterile drug production, posing contamination risks.

Key violations include: 1. **Compounded Drugs:** The firm did not receive valid prescriptions for individually-identified patients for a portion of its drug products, thus not qualifying for exemptions under FDCA Section 503A. Domperidone products, which are not eligible for 503A exemptions, were also produced. 2. **Unapproved New Drugs:** Drugs compounded without individual prescriptions lacked FDA approval, violating FDCA Sections 505(a) and 301(d). 3. **Misbranded Drugs:** Products compounded without individual prescriptions were misbranded under FDCA Section 502(f)(1) because they lacked adequate directions for layperson use. 4. **Adulterated Drug Products:** Sterile drug products were prepared under insanitary conditions, violating FDCA Section 501(a)(2)(A). Specific issues included not using a sporicidal agent in the cleanroom/ISO 5 area and failing to monitor pressure differential between ISO 7 and ISO 8 areas. 5