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Food and Drug Administration (FDA) Sends Warning Letters to Two Compounding Pharmacies for Issuing Drugs Without Patient-Specific Prescriptions

Earlier this month, FDA sent warning letters to two compounding pharmacies for issuing drugs without patient-specific prescriptions. The letters cite the Drug Quality and Security Act (DQSA), but are based on facility inspections that took place before the law was enacted. FDA’s actions seem to indicate that it will be taking a strong stance on interpreting existing law regarding anticipatory compounding that may be in conflict with individual states’ laws. These actions echo concerns raised by ASCRS and the ophthalmic community during the DQSA’s development that it did not adequately address office use and repackaging to ensure those drugs’ continued availability. The DQSA’s sponsors and others in Congress made statements for the record when it was considered that the intent of the legislation was not to disrupt access to these drugs. ASCRS and others in the ophthalmic community will continue to work with the FDA and Congress to ensure that compounded drugs for office use remain available.

We will keep you updated. 

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