FDA Revises Guidance on Hospital and Health System Compounding
October 2021 - The Food & Drug Administration (FDA) published a statement that revised its proposed guidance on compounded drugs to help preserve patient access to those medications whose medical needs cannot be met by an FDA-approved drug.
In 2016 the agency proposed a policy in draft guidance, that described certain flexibilities for hospital and health system pharmacies that distribute compounded drugs within their health system before receiving patient-specific prescriptions. One such policy in the original guidance included a provision about FDA’s intent not to take action if a hospital or health system pharmacy distributes compounded drugs to healthcare facilities within a one-mile radius, that are owned and controlled by the same entity that owns and controls the pharmacy.
The agency received numerous comments on the proposed policy, including stakeholders claiming the the one-mile policy was not reflective of the structure of health systems, many of which operate under a centralized compounding model and may service facilities at other sites located outside a one-mile radius without similar compounding capabilities.
After consideration of the submitted comments, in an effort to help preserve access to compounded drugs, the FDA is revising the draft guidance to, among other things, remove the one-mile radius provision. The agency is proposing a two-part compliance policy that describes circumstances under which the agency generally does not intend to take action against a hospital or health system pharmacy, that is not an outsourcing facility, that compounds and distributes a drug without first receiving a valid prescription or order for an individual patient. These circumstances include that compounded drugs be administered only to patients within the hospital or health system and the drugs are used or discarded within 24 hours of leaving the pharmacy.
Hospital and health system pharmacies that deviate from these circumstances, the revised draft guidance outlines the FDA’s intention to take a risk-based approach to enforcement. Hospital and health system pharmacies can measure their operations against certain factors to assess whether their practices are likely to be an enforcement priority. At this time, the FDA intends to consider the following factors for prioritizing risk-based regulatory action:
poor compounding practices or a lack of sterility assurance
non-patient-specific compounded drugs that are not for emergency uses
routine, large amounts of non-patient-specific compounded drugs
interstate distribution of large amounts of non-patient-specific compounded drugs
lack of a procedure to obtain non-patient-specific compounded drugs from an outsourcing facility.
While the revised draft guidance provides additional flexibility, the agency encourages hospitals and health systems to have procedures in place to obtain non-patient-specific compounded drugs from outsourcing facilities and to consider registering their pharmacies as outsourcing facilities.
The agency will further consider the policy based on any comments received in response to this revised draft guidance before it is finalized. The FDA stated “We believe the revised policy being proposed will assist hospitals and health systems in their approach to appropriate medical treatments for patients.”