Compounded Drug Guidance for Hospital and Health System Pharmacies | Clinical Pharmacy and Pharmacology | JAMA | JAMA Network
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News From the Food and Drug Administration
November 23/30, 2021

Compounded Drug Guidance for Hospital and Health System Pharmacies

JAMA. 2021;326(20):2003. doi:10.1001/jama.2021.20539

Some hospitalized patients’ medical needs can’t be met by an approved drug, so in 2016 the US Food and Drug Administration (FDA) issued a draft guidance about drug compounding. The agency recently revised the draft guidance, which contains nonbinding recommendations.

The original draft guidance noted that the FDA would allow a hospital or health system pharmacy to distribute compounded drugs to health care facilities owned and operated by the same entity that are within a 1-mile radius. The FDA received many comments about how the proposed geographic limit didn’t reflect the structure of health systems, many of which have a centralized compounding pharmacy serving facilities more than a mile away.

To help preserve access to compounded drugs, the FDA removed the 1-mile radius limit in the newly revised draft guidance and said it won’t take action against a hospital or health system pharmacy for compounding drugs as long as the medications are administered only to patients within the hospital or health system and used or discarded within 24 hours of leaving the pharmacy.

The FDA also outlined its plan to take a risk-based approach to enforcement of its compounding guidance, based on such factors as poor compounding practices or lack of sterility assurance and interstate distribution of large amounts of non–patient-specific compounded drugs.

The guidance doesn’t apply to human drug products compounded by outsourcing facilities, compounded drugs that aren’t distributed for use within a hospital or health system, or compounded drugs for animal use, according to the agency.

The document suggests that hospitals and health systems consider registering their compounding pharmacies as outsourcing facilities, which can compound and distribute drugs without receiving prescriptions for individually identified patients and ship unlimited quantities interstate.