The Food and Drug Administration issued three draft guidance documents last week that clarify the amount of drugs that providers can compound without a prescription, set requirements for health system compounding pharmacies and clarify how large-scale compounding sites known as “outsourcing facilities” may be set up. The guidance follows two reports from Pew Charitable Trusts that found compounding oversight is largely left up to the states and varies widely.
Since 1997, pharmacists or physicians have been able to compound a “limited quantity” of drugs to keep on hand for established patients. The guidance clarifies that providers meet this requirement if they produce enough drugs for a typical 30-day supply, based on patient patterns.
The guidance further explains that the FDA won't take action against a hospital pharmacy distributing compounded products if the drugs are distributed only to facilities owned and controlled by the entity or health system in which the pharmacy exists, pursuant to a patient-specific prescription or order, and that are within a one-mile radius of the compounding pharmacy.
That distance distinguishes the dispensing of medicine within a hospital campus from a larger health system, according to the FDA. A health system that wants to use a compounding pharmacy to distribute non-patient-specific compounded drugs to facilities across its service area will need to register as an outsourcing facility. These facilities can compound drugs without a prescription if they register with the FDA, but they're subject to the agency's stricter standards.
Elizabeth Jungman, director of public health at Pew Charitable Trusts, lauded the agency for moving forward with compounding oversight.
“The FDA draft guidance documents are an important step for the stability of the compounding industry,” she said in a statement. “The (earlier) federal law was a sea change in compounding oversight, and people need to know what the rules are.” The guidance is open for public comment for the next 90 days.