Compounding

Question 1

What are the state-specific compounding requirements that differ from federal requirements?

Answer 1

• The current edition of USP Compendium must be available
• Must have a separate storage area, appropriate materials and references for compounding.
• Compounded drugs dispensed to patients must have an appropriate label and auxiliary labels.
• Records, including purchase records and patient profiles, must be maintained for 5 years, readily retrievable in a format that provides enforcement agents an accurate and comprehensive method of monitoring distribution.

Question 2

What requirements must be met before an out-of-state pharmacy can compound drugs for dispensing to patients in this state (e.g., inspections, permits, fees)?

Answer 2

• The non-resident pharmacy must file an application with the IDFPR and pay required fees
• Application must include certification of compliance with requirements and license in the state where the dispensing facility is located.
• A toll-free number is available to nonresident pharmacies at least 6 days per week for a minimum of 40 hours per week.

Question 3

What are the additional label requirements for compounded products?

Answer 3

• The name, address and 24-hour telephone number of the compounding pharmacy must be included on the prescription label of sterile compounded drugs
• Date dispensed and prescription number
• Patient’s name
• The name, strength, quantity and dosage form of the compounded product
• Directions for use and/or infusion rate
• Prescriber’s name
• The pharmacy’s lot number and beyond-use date
• The appropriate ancillary and storage instructions, cautionary statements and hazardous drug warning labels
• Must have on the label “This prescription was specifically compounded in our pharmacy for you at the direction of your prescriber.”