Oct. 21, 2021 - MILWAUKEE
The FDA has introduced updated Guidance to 503A Compounders, removing the one-mile radius rule that required compound medications be used within one-mile of their production.
When announced, the one-mile radius provision was met with skepticism. The primary fear was that placing geographic limits on the use of compounded drugs could lead to operational challenges and ultimately lead to negative patient outcomes.
Many industry partners argued that the one-mile requirement was drafted without considering the structural realities of modern-day health systems, many of which operate under a centralized compounding model that may serve many facilities outside of the one-mile requirement.
The FDA has since agreed that the one-mile provision limited access to necessary medications and has introduced a new two-part compliance policy.
The updated Guidance, according to the FDA, “describes circumstances under which the agency generally does not intend to act 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.”
Additionally, the revised Guidance details the FDA’s risk-based approach to enforcement. The FDA generally intends to consider the following factors for prioritizing risk-based regulatory action1:
Despite this additional flexibility that the FDA is allowing, the agency continues to encourage 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.
Stay tuned to the ConsortiEX Blog for future compliance updates, and please contact us today if you have any concerns about your compliance standing.