A congressional committee is proposing an amendment to a spending bill that may intensify the debate over the safety of compounded medicines.
The House Appropriations Committee has introduced language that would alter a key requirement for pharmacists to make and dispense compounded medicines, which are generally customized for specific patient needs. And the language runs counter to a draft guidance that the US Food and Drug Administration released just last week that would govern compounding practices.
Specifically, the amendment would allow pharmacists to compound medicines without needing prescriptions for individual patients (see page 66). This has been a contentious issue in the wake of the 2012 outbreak of fungal meningitis that was tied to a compounding pharmacy and led to 64 deaths. The episode underscored confusion between federal and state oversight of compounders.
In the aftermath, a law called the Drug Quality and Security Act went into effect to sort out enforcement authority. And it also created two classes of compounders — traditional compounders who make medicines for individual patients, and others who resemble drug makers by making large amounts of a drug. These compounders must register with the FDA and are subject to greater federal oversight.
The law says that traditional compounders need a prescription before dispensing a medicine, and can also make limited quantities in anticipation of additional orders. As a practical matter, this means the traditional compounding pharmacist would generally be expected to know which patients are receiving the compounded medicine.
But there has been lingering debate about when a compounder must have a prescription in hand before being able to make batches of medicines, which can then be shipped to doctors’ offices or hospitals. This is called “office-use compounding.” Some have argued that the law does permit larger compounding pharmacies to ship large quantities of medicines to their customers.
For its part, the FDA has consistently maintained that traditional compounders should not be allowed to make and distribute large batches of medicines, in order to draw clear distinctions between small and large compounding businesses. And its draft guidance is an attempt to memorialize that distinction by noting that compounders should have prescriptions before proceeding to make and ship medicines.
However, The Pew Charitable Trusts, a nonprofit that studies health care issues and has closely tracked the debate over compound pharmacies, argued that the language proposed by the House committee would blur that distinction. And the nonprofit contended the change could jeopardize public safety.
“The intent of the law was to make the lines between these different types of compounders more clear,” said Elizabeth Jungman, director of public health at Pew.
“The purpose is to have the folks who stock and sell large supplies of compounded drugs come up to the same standards as the companies that manufacture drugs,” she said. “But this language would undermine the law and puts us back where we were in 2012, when it was not clear which standards applied to which type of compounder and who should enforce them.”
An FDA spokeswoman said the agency would not comment on proposed or pending legislation.
A spokeswoman for the International Academy of Compounding Pharmacists sent us a statement from John Voliva, an executive vice president at the trade group: “The FDA continues to ignore clear congressional intent where the states have clearly indicated pathways in which pharmacies can participate in office-use compounding. The 2017 appropriations bill reinforces this intent.”
The trade group also criticized the agency over its draft guidance, arguing the FDA issued contradictory views on traditional compounders. The group maintained the agency’s draft guidance would allow hospital pharmacies to dispense larger batches of compounded medicines. “FDA’s draft guidance on anticipatory compounding is confusing at best and may ignore the clear language of bill when it comes to defining this practice,” the IACP spokeswoman wrote.