Washington, DC—The FDA says it is backing off of a strict, 1-mile radius provision for distribution of compounded drugs by a hospital or health system.

The proposed policy received significant criticism, especially related to that restriction. The FDA was told that many health systems operate under a centralized compounding model and often service facilities at other sites much farther than a mile away.

“Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug,” said Donald D. Ashley, JD, director of the FDA’s Office of Compliance. “The FDA is continuing our efforts to help preserve access to compounded drugs for patients who have a medical need for them.”

The draft guidance was proposed in 2016 and has been altered to describe “certain flexibilities for hospital and health system pharmacies that distribute compounded drugs within their health system before receiving patient-specific prescriptions,” Dr. Ashley added.

In a proposed two-part compliance policy, the FDA says it 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.”

If hospital and health system pharmacies deviate from those circumstances, the revised draft guidance advises that the FDA would take a “a risk-based approach to enforcement.” Hospital and health system pharmacies would have the opportunity to assess their operations and determine if their practices were likely to be enforcement priorities.

The FDA points out that at this time, it would consider the following in prioritizing risk-based regulatory action:

• poor compounding practices or a lack of sterility assurance  
• nonpatient-specific compounded drugs that are not for emergency uses
• routine, large amounts of nonpatient-specific compounded drugs
• interstate distribution of large amounts of nonpatient-specific compounded drugs
• lack of a procedure to obtain nonpatient-specific compounded drugs from an outsourcing facility.

“Hospitals and health systems have varying distribution practices for drugs that have been compounded in their pharmacies,” Dr. Ashley said. “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 systems, such as to other hospitals, clinics, infusion centers or long-term care facilities within the health system.”

He notes that while additional flexibility is provided by the revised draft guidance, hospitals and health systems should have procedures in place to obtain non-patient-specific compounded drugs from outsourcing facilities and to consider registering their pharmacies as outsourcing facilities.

The revised draft guidance remains open for comments.

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