State Medical Boards Urged to Clarify Medication Compounding Proposal

February 7, 2018

ASCO provided comments to the Federation of State Medical Boards (FSMB) on a proposed position statement entitled “Compounding of Medications by Physicians.” The society appreciates FSMB’s efforts to ensure the safety of compounded medications, but believes that if finalized in its current form, the FSMB’s position statement would lead to confusion among cancer care providers and create barriers to providing chemotherapy to patients with cancer. ASCO urges FSMB to make clarifications and specific edits to the proposal, or to delay final approval of the position statement to allow time for refinements.

In a letter to FSMB, ASCO President Bruce E. Johnson, MD, FASCO, expressed the society’s deep commitment to safeguarding patients and professionals in the context of compounding medications and handling hazardous drugs. However, ASCO expressed concerned that “the current draft makes recommendations about the regulation of compounding without clarifying that the activities typically performed in oncology practices do not fall within the scope of compounding as used by Congress, the U.S. Food and Drug Administration (FDA), and as proposed for the next version of USP 797.”

ASCO urges FSMB to clarify that mixing and reconstituting drugs in accordance with the manufacturer’s instructions do not fit within the scope of compounding.

ASCO’s Task Force on Safe Handling of Chemotherapy is also working ensure the safety of compounded medications and would welcome the opportunity to work with FSMB toward their shared goals.

Keep an eye on ASCO in Action for breaking cancer policy news and updates as this issue unfolds.