The bill, which cleared the Senate without opposition, stops short of giving the F.D.A. complete authority over pharmacies that tailor-mix drugs for individual patients, a process known as compounding. But the bill still provides significant new safeguards, which have earned it the support of public health advocates around the country.
“It has very sharp teeth,” said Sarah Sellers, a drug safety consultant who has tracked the issue for years.
Just over a year ago, tainted injectable drugs from a compounding pharmacy in Massachusetts caused a meningitis outbreak that killed 64 people across the country, according to the Centers for Disease Control and Prevention. The bill, which took shape in the months after the outbreak, was designed to prevent such events.
“This bill will improve oversight of high-risk drug compounding,” said Senator Tom Harkin, Democrat of Iowa, who was one of the authors. President Obama is expected to sign the bill into law.
The practice of compounding has expanded drastically in recent decades, driven partly by the economics of hospitals, which now outsource large parts of their drug mixing. Some pharmacies moved beyond the business of mixing medicines for individual patients to become mini-manufacturers.
But while compounders were subject to state law, the federal authorities had limited power over them. Unlike drug makers, they were not subject to federal requirements that they report problems to the F.D.A. or open their records to federal inspectors.
Those regulatory gaps burst into public view last fall when the New England Compounding Center, a compounding pharmacy outside Boston, shipped tainted steroid medication around the country, sickening 751 people, according to the C.D.C. The F.D.A. said it lacked the authority to properly police such companies, though some analysts argued that the agency had not been aggressive enough with the powers it had.
The bill, the Drug Quality and Security Act, is an effort to clarify that regulatory confusion. It would allow compounders that mass-produce drugs to register with the F.D.A. as “outsourcing facilities.” Under the law, they would be subject to rules on quality control and oversight, not unlike large drug makers.
Companies that did not wish to make the switch would continue producing under a narrower definition of compounding: mixing medicines for individual patients on the basis of a prescription, or making limited quantities ahead of a prescription. Those companies would not be subject to any new federal oversight.
The bill would not force companies to register with the F.D.A. While that might seem like a loophole, many analysts argued that market forces would press most of the larger compounders into registering.
Eighty percent of hospitals outsource some part of their sterile compounding, said Allan Coukell, senior director of drugs and medical devices at the Pew Charitable Trusts. He argued that having the option of buying from a facility with an F.D.A. seal of approval would probably come as a relief for many.
“Hospitals and doctors would have to seriously consider the implications of buying from a facility that does not meet those quality standards,” he said. “This doesn’t necessarily preclude the risky practices we’ve seen in recent years. But it’s a big improvement.”
Another market pressure, said Ms. Sellers, who once worked on the issue of compounding for the F.D.A., is product liability insurance, which manufacturers that are F.D.A.-approved generally carry. The insurance helps when something goes wrong with a drug. Ordinary pharmacies do not have to have such insurance, Ms. Sellers said.
The F.D.A. said the bill was a step forward, but expressed disappointment that it fell short of giving the agency fuller regulatory power. Compounders that did not opt for the stricter standards, for example, would still not be required to open their records to federal inspectors. The F.D.A. has said it has to resort to asking for subpoenas to gain access to compounding facilities’ records, and the agency had sought additional powers to avoid that.
The compounding industry’s trade group, the International Academy of Compounding Pharmacists, strongly opposed the bill in its final form. It said in a statement that if the goal was to avoid another outbreak like the one last fall, “the American public must know that this bill will not accomplish that goal.”
The group said in another statement that the bill “will without question result in patients’ inability to obtain access to needed medications,” and expressed concern that it would grant the F.D.A. “sweeping, unprecedented authority in determining what pharmacies can compound.”
The bill also would set up a system for tracking drugs. The system, which the authors of the bill said would help ensure that counterfeit and stolen drugs stayed out of the drug supply, includes nationwide serial numbers for drugs and an electronic drug-tracing mechanism.
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