Welcome to the Director's Corner, an audio podcast series featuring the director of FDA’s Center for Drug Evaluation and Research (CDER).

 

Anne Rowzee: Hi, I'm Anne Rowzee from the Office of Communications, and once again, I'm joined by CDER's director, Dr. Janet Woodcock for the Director's Corner. In this session Dr. Woodcock and I will be discussing a topic that might be unfamiliar to some of our listeners and that's drug compounding. Hi Dr. Woodcock, thanks for joining me.

 

Dr. Woodcock: Hi.

 

Anne Rowzee: All right, so let's begin with sort of a general question. What is drug compounding and can give you an example of compounding for the individual consumer and of compounding in the hospital setting?

 

Dr. Woodcock: Sure, compounding is something pharmacists have been doing for a very long time and that is mixing up a drug for a specific patient. Often a drug, that a patient needs may not be in the right form for them where they need, may need a drug that doesn't have some ingredient in it that is in the regular pill or whatever that you might get at the pharmacy, and so the compounding pharmacist can mix up a special preparation for an individual patient who has a need. As for examples, when I was practicing there were drugs that could be used for allergy and were very good but they didn't have an eye drop form. And so, I for my allergy patients, I would write a prescription and they could take it to the pharmacy and the pharmacist could turn the medicine into an eye drop form that helped them during allergy season.

 

Anne Rowzee: Okay. So then, seeing that compounding results in drugs that are combinations or maybe alterations of FDA approved drug ingredients, what are some of the regulatory and safety concerns relating specifically to compounding?

 

Dr. Woodcock: Well, there are a couple different issues that could raise safety problems. The first one is if you're trying to make a sterile preparation, and that would be something say that would be injected into the person or even eye drops and so forth, you don't want to introduce bacteria that way and we've had a number of different outbreaks where people have been harmed because there's been bacteria or fungus or other contamination in what was supposed to be a sterile product, and so that requires an extra level of care. And then even beyond sterile, of course there's the issue is it the right amount in there, is it made right, and pharmaceutical manufacturers, regular drug manufacturers are regulated very strictly, and so their limits that they must test every batch to make sure it has the right amounts in it and, and so forth, and there are very strict controls over how they do that in mass production. So that drug supply is quite safe, but if a, a pharmacy compounding operation is making large amounts of a various compound products then you have to be very careful that No. 1, it's made correctly and then it doesn't get contaminated.

 

Anne Rowzee: Interesting. So, then what is FDA doing to address some of these concerns?

 

Dr. Woodcock: Well, after the very large outbreak of fungal meningitis a number of years ago, where a lot of people were harmed and a number of people died from an injection of a non-sterile product, the congress took some action, passed some additional legislation, and FDA has been implementing that and that legislation gave FDA some additional tools to regulate compounding, and so we're in the process of setting up an entire framework for this. Then a new category of compounding has been established by congress and that's the outsourcers and the outsourcing facilities can make sterile products but they must make them under GMP conditions and GMP means good manufacturing practices, the regulations that FDA has to ensure that the products are made correctly and that they're sterile.

 

Anne Rowzee: Okay, so just to wrap up, why it is important that drug compounding remain an option for the healthcare system?

 

Dr. Woodcock: Well, we know that one size doesn't fit all, right, and people are all different and so, for example, there will remain people who need a special form of a drug that's available widely, but not in the form that's right for them. And then, hospitals, clinics, and so forth really look to these outsourcers to make special forms of the drug that they may use all the time, but might not be available commercially. And that often can be safer when it's done correctly than a clinic say that nowadays might be located in an office building making their own syringes full of drugs and so forth, so this provides a source and for some special populations like kids, we're still in the era where doses must be adjusted for children and special formulas must be made and so forth. So, all those special populations do need medicines.

 

Anne Rowzee: Mm hmm.

 

Dr. Woodcock: But they need to be made correctly.

 

Anne Rowzee: Dr. Woodcock, thank you so much for sitting down and helping to clarify drug compounding for our listeners.

 

Dr. Woodcock: Most welcome.

 

Thanks for listening. For more information about what you heard today please visit our web site at FDA.gov/drugs.