From the U.S. Government Accountability Office, www.gao.gov Transcript for: FDA Oversight of Drug Compounding Description: Audio interview by GAO staff with Marcia Crosse, Director, Health Care Related GAO Work: GAO Work: GAO-13-702: Drug Compounding: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight Released: July 2013 [ Background Music ] [ Narrator: ] Welcome to GAO's Watchdog Report, your source for news and information from the U.S. Government Accountability Office. It's July, 2013. A pharmacist can compound drugs, combine, mix, or otherwise alter them to meet a customer's medical needs. In 2012, contaminants in compounded drugs let to an outbreak of fungal meningitis. A team led by Marcia Crosse, a director in GAO's Healthcare team, recently examined the federal government's role in overseeing drug compounding. GAO's Sarah Kaczmarek sat down with Marcia to talk about what they found. [ Sarah Kaczmarek: ] How would you describe the federal government's role in insuring the safety of drug compounding? [ Marcia Crosse: ] Well I think the federal government's role has been a little unclear. The oversight of pharmacies has traditionally been a responsibility for states and there had been some concern that pharmacies, or at least some pharmacies, were starting to produce drugs in large quantity. These compounded drugs where pharmacists actually mixes up a medication, and they weren't just doing it in larger quantities, they were also beginning to ship it interstate between different locations, and interstate commerce has normally been the responsibility of the federal government, so Congress enacted some legislation, but the courts have ruled differently on that. The federal responsibility has been a little muddled. [ Sarah Kaczmarek: ] Okay. So with that then, what's FDA doing now to oversee drug compounding? [ Marcia Crosse: ] Well, given the problems that occurred last year with the outbreak of meningitis from contaminated compounded drugs, FDA has stepped up its oversight and particularly for these larger compounders that have been producing sterile medications--injectable medications--where there's a high risk if the product is contaminated. FDA has begun to go in and do inspections in these facilities and try to point out problems, and this has actually resulted in a number of recalls of medications from a lot of different drug compounding pharmacies. However, there's still some question about what authority FDA has to oversee these pharmacies, and how long they can sustain this higher level of review. [ Sarah Kaczmarek: ] Now you mentioned that states have a role here. So what are states and pharmacy organizations doing to provide oversight as well? [ Marcia Crosse: ] Yes, states have also increased their oversight of pharmacies. They've been doing additional inspections and trying to get more information about the pharmacies that are located in their states. And some states have actually contracted with National Pharmacy Organization to do some inspections of pharmacies that are located in other states, and to provide them with additional information about the pharmacies that may be shipping drugs into their state. Because a state really only has oversight of the pharmacies that are located within their borders, and they need to understand the full picture of which pharmacies are shipping drugs to their state. [ Sarah Kaczmarek: ] And GAO is making recommendations to help insure appropriate oversight. Could you talk about those? [ Marcia Crosse: ] Yes, we are recommending that Congress should consider clarifying FDA's responsibility. As I said, the courts have had different rulings so that the rules in operation in different parts of the country have varied because different courts have made different rulings. We think that should be clarified and exactly where FDA's responsibility starts and ends should be cleared up. Right now, there seems to be some consensus that if you're making a medication--a pharmacist is making a medication for one patient with a prescription from a pharmacist, that's fine. That doesn't require FDA's oversight. If a pharmacy may be making, you know a dozen or 25 doses because they know they regularly get that many orders in a week or in a month that may be okay. What's not clear is where you cross the boundary from doing normal, traditional drug compounding into drug manufacturing. And when you're doing drug manufacturing, that's where FDA has had the responsibility, and we don't want to have a situation where drug manufacturers making thousands of doses that they ship interstate elude oversight and inspection responsibility from FDA by calling themselves compounders. [ Sarah Kaczmarek: ] So finally for consumers concerned about pharmaceutical drug safety, what's the bottom line here? [ Marcia Crosse: ] Most individuals are getting medications that are under regular drug manufacturing rules. When you go and you get a bottle of pills from a pharmacy, that's not the kind of drug we're talking about. A compounded drug is something that's made up especially for an individual patient, either because they may have some sensitivity to the ingredients or because they need a different form. They may need a liquid form of a medication, and normally it only comes in pills. Or for some kinds of hospital procedures or other source of medical procedures, they may need to have special drugs combined, things mixed, and that's where you get into compounding. So I think that if you're talking about something other than your sort of routine medications that you're obtaining all the time, you just want to ask some questions of your provider and of your pharmacy to understand what it is you're being given. [ Background Music ] [ Narrator: ] To learn more, visit gao.gov and be sure to tune in to the next episode of GAO's Watchdog Report for more from the Congressional Watchdog, the U.S. Government Accountability Office.