資料來源：https://www.reuters.com/article/us-usa-fda-pharmacies-exclusive/exclusive-fda-plans-new-compounding-pharmacy-policy-agency-head-says-idUSKCN1BQ2RV

The head of the U.S. Food and Drug Administration said on Friday the agency is working on a new policy that would encourage more compounding pharmacies to register under a law enacted in the wake of a deadly 2012 meningitis outbreak linked to one such company.

FDA Commissioner Scott Gottlieb made the comments in an interview with Reuters as federal prosecutors in Boston prepare for the second criminal trial over contaminated steroids manufactured by the now-defunct New England Compounding Center (NECC).

That meningitis outbreak sickened 778 patients nationwide, including 76 who died, after receiving contaminated steroids, prosecutors said.

After the outbreak, Congress in 2013 passed the Drug Quality and Security Act, which aimed to bring more compounding pharmacies, which make custom medications, under the authority of the FDA rather than state pharmacy boards.

The law created a category of “outsourcing facilities” that could register with the FDA, allowing them to sell products in bulk to hospitals and physician practices without prescriptions for individual patients.

In exchange, those compounders would have to follow federal manufacturing standards and subject themselves to routine inspections. Today, around 70 firms have registered as outsourcing facilities.

According to the American Pharmacists Association, there are about 7,500 pharmacies that specialize in compounding services.

Under the 2013 law, compounders that did not register with the FDA would remain under state oversight, and according to the agency, could only compound drugs based on prescriptions for specific patients.

Gottlieb said that in order to encourage more compounders to register, the FDA would release draft guidance in the next two months reflecting its intention to adjust its enforcement priorities based on the size of registered compounders and the riskiness of their products.

“We’re looking at ways we can provide more of a gradation in our regulatory architecture so we don’t have a one-size-fits-all approach,” Gottlieb said.

Pharmacists have long mixed tailored medications for patients based on individual prescriptions. By 2013, the practice had mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures for physicians to keep for future use.

Gottlieb’s comments came ahead of next week’s trial in Boston of Glenn Chin, a former supervisory pharmacist at NECC who is accused of second-degree murder and fraud. He has pleaded not guilty.

NECC’s co-founder, Barry Cadden, was sentenced in June to nine years in prison after he was convicted on racketeering and fraud charges. Prosecutors said he directed the production of drugs in unsanitary and dangerous ways to boost profits.

The FDA has been criticized by groups like the American Pharmacists Association, which has said the federal agency has been overstepping its authority to regulate state-licensed pharmacies.

That criticism has focused on the FDA’s position that the 2013 law requires prescriptions for specific patients, restricting pharmacies from distributing drugs to stock doctors’ offices for their uses, even if allowed under state law.

Gottlieb said he stood by the FDA’s interpretation of the law and that he expected no slowdown in terms of its enforcement.

But he said the new guidance would help address concerns from smaller pharmacies that want to do just that but have resisted registering as outsourcing facilities because of the expense of regulatory compliance.

The draft guidance, he said, would allow smaller firms creating low-risk drugs to be subject to less onerous requirements than larger outsourcing facilities.

Doing so, he said, would help ensure more pharmacies are in compliance with manufacturing standards, potentially creating more access to compounded medications.

“I want to move more of them into a compliant space, and I‘m willing to work with compounders and the broader community to find some regulatory accommodation that gets more of them into a compliant space,” he said.