Draft Guidances Seek to Simplify Compounding Rules

The FDA is looking to shed light on the sometimes murky rules governing compounding operations to distinguish heavily regulated outsourcing facilities from tiny compounding operations that are lightly regulated.

A trio of draft guidances issued last week address multiple facets of the compounding industry, including what constitutes a large-scale compounding facility and associated GMP requirements, the standards for hospital compounding and the requirements for compounding without a prescription.

Paramount among these guidances is one that imposes a set definition for “outsourcing facility,” which is a large-scale compounder that can produce compounded drugs without patient prescriptions, but are heavily regulated.