CHA News

FDA Revises Draft Guidance on Hospital and Health System Drug Compounding

For COOs, pharmacy staff, licensing & certification staff

The Food and Drug Administration (FDA) has issued revised draft guidance on hospital and health system compounding under section 503A, updating draft guidance released in 2016. As advocated for by CHA, the FDA has revised the 2016 guidance to remove a requirement that would have limited the distribution of compounded drugs to health care facilities located within a one-mile radius of the compounding pharmacy. 

The draft guidance describes how the FDA intends to prioritize enforcement of the requirement to obtain a prescription for an individual patient for compounded drugs. Under the revised draft guidance, the FDA would not take action if the compounded drugs are administered only to patients within the hospital or health system, the drugs are used or discarded within 24 hours of leaving the pharmacy, and compounding is done in compliance with provisions of FDA law and regulation.  

The FDA also proposes a risk-based approach for other circumstance to prioritize enforcement of 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, and lack of a procedure to obtain non-patient-specific compounded drugs from an outsourcing facility.  

The FDA also proposes that it would generally not take action against a hospital or health system pharmacy that is not an outsourcing facility for compounding a drug product regularly or in inordinate amounts that is essentially a copy of a commercially available drug product.  

Comments on the draft guidance are due Dec. 6.