Enhanced Safety and Oversight for Compounded Drugs and Pharmacies.
This law tightens regulations on compounding pharmacies and large outsourcing facilities that create custom medications. It limits the mass production of drugs that are essentially copies of commercial products and mandates stricter, more frequent safety inspections for high-volume facilities. These changes aim to ensure that custom-made drugs are safe, necessary, and tailored specifically to individual patient needs.
Key points
Pharmacies are restricted from mass-producing drugs that are essentially copies of commercially available medications (limited to 20 times per month).
Large-scale compounding facilities (producing over 100 drugs annually) must undergo mandatory, more frequent safety inspections (at least biennially).
New reporting requirements are established for facilities that ship compounded drugs across state lines, increasing federal oversight.
Status:
Introduced
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