Section 657.20.20. Labeling for batch preparation compounding.  


Latest version.
  • Compounded preparations resulting from batch preparation compounding shall be labeled with the following information until such time as the preparations are labeled pursuant to rule 657—20.19(124,126,155A) for distribution to hospitals or practitioners or for dispensing or administration to patients:

                1.      The date that the preparation was compounded.

                2.      Compounded preparation name or formula.

                3.      Dosage form.

                4.      Strength.

                5.      Quantity per container.

                6.      Unique internal batch identification or control number.

                7.      Beyond-use date.

                8.      Special storage and handling instructions, if applicable.

    [ARC 2194C, IAB 10/14/15, effective 11/18/15]