Among other highlights, the legislation:
- Distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
- Defines the Food and Drug Administration’s (FDA’s) role in oversight of outsourcing facilities. Outsourcing facilities would be subject to FDA oversight in much the same way as traditional manufacturers. FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections. The legislation will give providers and patients the option of purchasing product from outsourcing facilities that comply with FDA quality standards.
- Offers providers and patients better information about compounded drugs. The legislation directs FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requires detailed labeling on compounded drugs, and prohibits false and misleading advertising.
- Clarifies current federal law regarding pharmacy compounding. The legislation strikes unconstitutional provisions in current law, resolving the patchwork of current federal regulation and applying a uniform standard nationwide.
quoted from here
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