The FDA released draft guidance for 503A compounding pharmacies in hospitals and health systems earlier this month. These updated documents remove the one-mile limit proposed in earlier versions and add a potential exemption to the prescription requirement (office use) for these entities — which does not exist for independent compounding pharmacies. The guidance states the FDA does not intend to act in the following circumstances:
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The compounded drug products are administered only to patients within the hospital or health system.
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The compounded drug products are used or discarded within 24 hours of transfer out of the pharmacy.
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The drug products are compounded in accordance following requirements 359 of the FD&C Act and FDA regulations (e.g., the drug products are not made under unsanitary conditions (section 501(a)(2)(A)) or misbranded (e.g., section 502(g)).
This guidance is still in draft form, and the FDA is currently accepting comments on the proposal. NCPA will continue advocating to prevent the implementation of different standards for 503A facilities based upon the pharmacy model.
