FDA Eases Compounding Rules for Hospitals: Ever So Slightly but Significantly
(Thursday, October 14, 2021)
Pharmacies located within hospitals are not required to register with the FDA as “Outsourcing Facilities” and are exempt from following GMP. However, there are strict conditions for the compounding operations performed at such hospital pharmacies some of which needed clarification and relaxation. This week, FDA did just that by relaxing the rules ever so slightly that should remove a nuisance issue and clarify some common questions about compounding drugs that are essentially copies of FDA-approved drugs. At the same time, the existing regulatory conditions for such operations and limitations on the scope of such compounded drugs were re-emphasized. First, FDA lifted the condition that the compounded drug be dispensed within 1 mile of a hospital or health system. It was deemed impractical since hospital systems may include other hospitals, clinics, infusion centers, or long-term care facilities that lack local pharmacy, and that are often located further than 1 mile from each other. The new guidance defines a “health system” as “an organization that includes at least one hospital and at least one group of physicians that provides comprehensive care (including primary and specialty care) who are connected with each other and with the hospital through common ownership or joint management.” So long as a facility meets this definition of health system, it can share the compounding pharmacies with its affiliates. This should allow large hospital systems that are geographically spread widely to consolidate their compounding operations. The hospital pharmacies can compound drugs only for the patients withing the system, only in small amounts that are administered to the patient within 24 hours of dispensing from the pharmacy and, must follow hygienic practices that assure sterility. Hospitals are encouraged to purchase compounded drugs from FDA-registered outsourcing facilities for non-emergency, non-patient-specific needs. The second relaxation is on the enforcement of restrictions on compounding drugs that the essentially copies of FDA-approved drugs. Hospital pharmacies are allowed to compound such copies of FDA-approved drugs provided it is done in small amounts for specific patients, and there is a documentation that the compounded drug contains a specific change from the commercially available drug product that would produce a significant difference from the commercially available drug product for that specific patient. FDA acknowledges that compounded drugs that are essentially copies of FDA-approved drugs may be cheaper but that as a policy it does not support wide use of such compounded products since they compete with the FDA-approved version. At the same time, FDA stated that it intends to follow enforcement discretion for hospital compounding pharmacies making copies of FDA-approved drugs, focusing on compounding operations that have other non-compliance issues as well. These ever so slight changes and clarifications of the FDA policies should offer relief to hospital pharmacies and patients alike, without rocking the status quo too much. This guidance also offers some creative ways for health systems to offer cheaper options to their patients.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC