FDA WARNING_LETTER - Foothills Professional Pharmacy, LTD - October 24, 2018

The FDA inspected Foothills Professional Pharmacy, Ltd. from July to October 2018, identifying serious deficiencies in drug production and violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The firm failed to meet Section 503A conditions for exemption from certain FDCA provisions, specifically by not receiving valid prescriptions for individually-identified patients for products like Lidocaine/Tetracaine/Phenylepherine Gel and Benzocaine/Lidocaine/Tetracaine/Phenylephrine.

This rendered their drug products ineligible for exemptions from CGMP, adequate labeling, and FDA approval requirements. The inspection revealed adulterated drug products due to insanitary conditions, including loose powder, dried product splatter, damaged and discolored equipment, and inadequate deactivation agents. Significant CGMP violations were also cited, such as failure to maintain defined production areas, perform final product testing, establish process controls, use appropriate equipment, conduct stability testing, implement adequate laboratory controls, and ensure quality control unit review of records.

The firm also produced unapproved new drugs and misbranded drug products lacking adequate directions for use. Compounding of domperidone, a substance with significant safety risks and not eligible for 503A exemptions, was also noted. While some corrective actions were acknowledged, the FDA found the firm's response regarding cleaning agents insufficient and recommended a comprehensive assessment by a third-party consultant. The firm must correct all violations within 15 working days to avoid legal