The Food and Drug Administration hopes hospitals and clinics will vote with their pocketbooks, buying supplies from pharmacies regulated under new powers just given to the agency.
Congress passed a law last month giving the FDA authority to regulate some so-called compounding pharmacies. The aim is to have some oversight over operations that are far bigger than the small pharmacies that make medicines to order.
FDA demanded the changes after a fungal meningitis outbreak last year that killed 64 people and sickened more than 750 others across the country. The outbreak was traced to contaminated drugs sold by a single pharmacy – the New England Compounding Center in Massachusetts.
NECC was an example of a new type of compounding pharmacy – one that made specialized drugs on a large scale and shipped them all over the country. States are supposed to regulate compounding pharmacies, but the laws were written to cover small, mom-and-pop-type operations. The new compounders more closely resemble drug manufacturers, but were not subject to the same FDA oversight as manufacturers.
The new law gives the compounders some leeway but the FDA hopes the marketplace will eventually bring them into line.
“If compounders register with FDA as outsourcers, hospitals and other health care providers will be able to provide their patients with drugs that were compounded in facilities that are subject to FDA oversight and federal requirements for current good manufacturing practice, among others,” FDA commissioner Dr. Margaret Hamburg writes in a blog post discussing the new powers.
“To that end, we will be encouraging health care providers and health networks to consider purchasing compounded products from facilities that are registered with FDA and subject to risk-based inspections.”
"The more that register, the less need there would be to buy from facilities that are not registered," Jane Axelrad, associate director for policy for the FDA's Center for Drug Evaluation and Research, told reporters in a conference call.
The law isn’t perfect, in FDA's eyes. "It will be difficult for us to identify compounding pharmacies that choose not to register with us," Axelrad said. "We will not be able to do proactive inspections and will have to wait until we have a complaint."
State boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state licensed pharmacies, including traditional pharmacy compounding.
The law also provides for labeling of certain prescription drugs so they can be traced more easily.
“Starting four years after enactment of the law, manufacturers, followed by repackagers, will be required to affix a unique product identifier to each drug package that contains the drug’s national drug code (NDC), serial number, lot number, and expiration date,” Hamburg wrote.
The FDA doesn't know how many compounding pharmacies there are, but estimates anywhere between 700 and 1,000 are in business.
Some of the people infected in the fungal meningitis outbreak are still ill, and several state prosecutors are considering legal action against NECC and its owners.
FDA investigators have found vials of steroids used for back and joint pain injections were contaminated with at least two species of fungus, as well as bacteria. Patients being treated for back pain had these contaminated drugs injected right into their spines, where the fungus grew slowly, eventually spreading into spinal fluid and causing vague symptoms such as headache and fever.
A federal grand jury in Boston has been investigating the New England Compounding Center for more than a year. FDA inspections since the outbreak have turned up cleanliness problems at several other pharmacies.
Reuters contributed to this story
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First published December 3 2013, 7:48 AM