The bill gives the Food and Drug Administration more power to “police” compounding pharmacies in an attempt to make the drug supply safer. Compounders were previously subject to state law with limited federal oversight.
Under the Drug Quality and Security Act, compounders would register with the FDA as “outsourcing facilities” and be subject to quality control and oversight rules. Companies that mix medications for individual patients based on prescriptions would not be subject to the new federal oversights, according to the report. Companies that mixed limited quantities “ahead of prescription” would also fall between the cracks.
Finally, the bill would set up a drug tracking system.
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