A congressional committee is proposing an amendment to a spending bill that may intensify the debate over the safety of compounded medicines.
The House Appropriations Committee has introduced language that would alter a key requirement for pharmacists to make and dispense compounded medicines, which are generally customized for specific patient needs. And the language runs counter to a draft guidance that the US Food and Drug Administration released just last week that would govern compounding practices.
Specifically, the amendment would allow pharmacists to compound medicines without needing prescriptions for individual patients (see page 66). This has been a contentious issue in the wake of the 2012 outbreak of fungal meningitis that was tied to a compounding pharmacy and led to 64 deaths. The episode underscored confusion between federal and state oversight of compounders.
As a victim of the 2012 fungal meningitis outbreak of 2012 I think the laws should be stricter. This will only happen again because compounders and doctors value profit over the safety of patients. Whoever started this bill profited already which has been shared widely. It’s a disgrace!
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