Lawmakers in Pennsylvania and Hawaii are proposing legislation that would align state standards with federal laws to crack down on inflated prices for compound drugs in their workers compensation systems.
Pennsylvania S.B. 1215, introduced on Friday, and Hawaii H.B. 2164, which was passed to the Senate on March 10, both include references to U.S. Code Section 353.
The Hawaii bill would define a compound prescription drug as a medication compounded by a licensed pharmacist in a state-licensed pharmacy for an individual patient, based on a valid prescription. The bill would also require that the drug meet the requirements in Section 353a.
The bill’s language is similar to the federal law, which essentially requires compound drugs to be custom-formulated for specific patients. The federal law also includes a provision that prohibits compounding drugs that are essentially copies of a commercially available drug product.
The Pennsylvania bill includes a provision that would prohibit reimbursement for a compound drug that duplicates a commercially available product. The bill refers to Section 353b for determining equivalence.
Federal law defines an essential copy of an approved drug as a medication that is identical or nearly identical to an already approved drug, unless the approved drug is on the FDA shortage list.
The federal law also says a compound is essentially a copy if it uses a bulk drug that is a component of an approved drug, “unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug.”
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