FDA Affirms Office-Use Compounding Restrictions In Letter To Lawmakers

September 19, 2014 at 1:39 PM
FDA affirms that traditional compounders must obtain patient-specific prescriptions, laying out the policy in a Sept. 15 letter responding to lawmakers' questions about whether the agency would allow compounding for physicians to use in their practice without having patient-specific prescriptions. Compounders worry the agency's stance against office-use compounding will prompt states to also restrict the practice, and hope lawmakers will change the policy through clarifying legislation as soon as possible. FDA's regulation of office-use compounding has been a highly watched...


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