Statement From:Donald D. Ashley, J.D.
Director – Office of Compliance
Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA is continuing our efforts to help preserve access to compounded drugs for patients who have a medical need for them.
We understand that compounded drugs can serve an important role for patients in hospitals and other healthcare settings whose medical needs cannot be met by an FDA-approved product, and that hospital care raises unique considerations and needs. Recognizing this, in 2016 the agency proposed a policy in draft guidance, that described certain flexibilities for hospital and health system pharmacies that distribute compounded drugs within their health system before receiving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.
Since that time, the agency has received many comments on this proposed policy, including regarding 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. Stakeholders commented that the proposed 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After considering these comments, to help preserve access to compounded drugs, today, the FDA is revising our draft guidance to, among other things, remove the one-mile radius provision. We are proposing a two-part compliance policy. The policy 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.
With respect to hospital and health system pharmacies that deviate from these circumstances, the revised draft guidance outlines the FDA’s intention to take a risk-based approach to enforcement.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 and based on the agency’s current understanding of the risks, the FDA generally 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.
Hospitals and health systems have varying distribution practices for drugs that have been compounded in their pharmacies. The agency understands the size of operations and resources available to hospital and health system pharmacies varies widely. For example, small rural hospitals may differ from large multi-state health systems. Some pharmacies compound drugs only for use in the same hospital where the pharmacy is located, (e.g., for the treatment of patients during a hospital admission, or for use in the hospital emergency room). Other health system pharmacies distribute compounded drugs to other facilities within their health system, such as to other hospitals, clinics, infusion centers or long-term care facilities within the health system.
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.
We believe the revised policy being proposed today will assist hospitals and health systems in their approach to appropriate medical treatments for patients. 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 remains committed to our compounding policy efforts as we continue to promote opportunities to improve health and provide appropriate medications for patients who rely on compounded drugs.