Amendment ID: S1899-14

Amendment 14

Compounding Requirements

Mr. Tarr moves to amend the amendment by striking lines 242-250 in its entirety.

Moves to further amend by inserting in section 39F of SECTION 18 the following new subsection:-

“(f) Compounding does not include the preparation of commercially available, federal Food and Drug Administration-approved drug preparations or drug preparations banned by the federal Food and Drug Administration because of safety concerns. Compounded preparations that produce, for the patient, a significant difference between the compounded drug and the comparable commercially available drug preparation as determined, by the prescriber, as necessary for the medical best interest of the patient, are not copies of commercially available preparations. A significant difference may include, but is not limited to, the removal of a dye for medical reasons, a change in strength, dosage form or delivery mechanism. A price difference is not a significant difference to justify compounding.”

Moves to further amend by inserting in section 39G of SECTION 18 the following new subsection:-

“(f) Compounding does not include the preparation of commercially available, federal Food and Drug Administration-approved drug preparations or drug preparations banned by the federal Food and Drug Administration because of safety concerns. Compounded preparations that produce, for the patient, a significant difference between the compounded drug and the comparable commercially available drug preparation as determined, by the prescriber, as necessary for the medical best interest of the patient, are not copies of commercially available preparations. A significant difference may include, but is not limited to, the removal of a dye for medical reasons, a change in strength, dosage form or delivery mechanism. A price difference is not a significant difference to justify compounding.”