As FDA continues to issue more Risk Evaluation and Mitigation Strategies (REMS) for drug and biologic products, the instructive nature of these documents and requirements that they impose on health care professionals (HCPs) begin to encroach on the practice of medicine. For example, if a REMS directs that prescribers enroll in a particular training program on the risks associated with a product and make certain certifications upon completion, and should a prescriber then prescribe or dispense in a manner not in line with the REMS recommendations, there could be liability implications down the road. It is an interesting question likely to be resolved in future litigation as to whether a REMS establishes a standard of care to which practitioners may be bound.