“Compounding Clarity Act of 2013.” Here are the bullet points. How do you feel about these new proposals?
HR 3089 sets forth the following:
- Clear definitions that compounding within the patient-pharmacist-prescriber triad is legal and not subject to FDA oversight.
- Part of this definition is: “The drug product is compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician, for an identified individual patient based on the receipt of a valid prescription.”
- Allows for anticipatory compounding in limited quantities based on:
- “Historical demand for the drug product” and