WASHINGTON—A bill to regulate so-called compounding pharmacies is headed to the president for his expected signature, a little more than a year after tainted steroid injections from one such enterprise caused more than 750 cases of spinal meningitis.
Compounding pharmacies mix drugs for patients, but some mix drugs for thousands of patients and perform more like drug makers than corner drugstores.
Compounding pharmacies grabbed headlines last fall when it was learned that the New England Compounding Center of Framingham, Mass., sold thousands of doses of the steroid methylprednisolone acetate tainted by fungus, the Food and Drug Administration found. The steroid shots led to fungal meningitis that caused 64 deaths and sickened hundreds of people in 20 states. The center suspended operations in October 2012.
The legislation, which cleared the Senate on a voice vote on Monday and already passed in the House of Representatives, allows compounding pharmacies to declare themselves to be manufacturers, or, as the bill describes them, "outsourcers." By doing this, the pharmacies would voluntarily place themselves under full FDA regulation, meaning the agency will perform inspections and possibly find problems before they cause illness and death.
But the legislation doesn't draw a clear line delineating which, if any, compounders must be regulated by the FDA. Those not regulated by the FDA are supposed to be monitored by state pharmacy boards.
The FDA said it is pleased that the bill creates a new pathway in which a compounder can register as an "outsourcing facility" subject to federal quality standards and oversight. "While this bill does not provide FDA with all the additional authorities it sought related to compounding pharmacies, it provides a regulatory framework for certain compounders who register with FDA," a spokesman said.
Some government officials said the measure is too watered down to prevent future disease outbreaks like the one last year.
The Senate and House held extensive hearings earlier this year in which lawmakers struggled to find a way to distinguish between small compounders filling prescriptions and larger multistate ones selling large batches to customers across the country, sometimes without prescriptions.
Allan Coukell, who oversees medical programs at the Pew Charitable Trusts, said the bill "is not as far-reaching as earlier versions, but it is a significant proposal." He and others who support the bill said compounders may come to see FDA regulation as a kind of mark of quality, and that compounders that sell to major hospitals may seek to attain such a status if this bill becomes law.
Groups representing compounding pharmacists differed on their views about the bill.
The National Community Pharmacists Association, in a letter to House Republican and Democratic leaders recently, said the bill "provides a balanced and effective approach."
But David G. Miller, executive vice president of the International Academy of Compounding Pharmacists, said the legislation "will not further the safety of compounding medication, which was its only purpose."
Rep. Morgan Griffith (R., Va.) a member of the House Energy and Commerce Committee, which held hearings on the topic, called the bill "a first step at clarifying current law."
Sen. Edward Markey (D. Mass.) said, "For the first time, hospitals and health-care facilities will have access to safer compounded drugs that are subject to rigorous FDA standards and oversight. This bill will go a long way to ensure that public health is protected and compounded drugs are safe."
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