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Ellen Klepac
Ellen Klepac
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FDA Director Spoke to Senate Re: Compounding Pharmacies Long Before Meningitis Outbreak

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In the wake of the recent fungal meningitis outbreak, it’s worth taking another look at an October 2003 speech by Steven Galston, then-Acting Director of the Food and Drug Administration’s Center for Drug Evaluation and Evaluation. Galston spoke to the Senate Committee on Health, Education, Labor, and Pensions about the FDA’s responsibility regarding compounding pharmacies.

He noted the importance of compounding pharmacies, a growing business at the time, which could tailor FDA-approved drugs to meet the specific need of a patient by altering the drug or mixing it with another.

He also discussed the rise of compounded drugs that were of “substandard quality” and compounding pharmacies that marketed compounded drugs on a large scale or marketed drugs that were mere copies of FDA-approved drugs.

Galston said some pharmacies may lack the equipment or know-how to properly compound a drug and some of the drugs themselves may not be suitable for mixing or altering in any way, which could lead to potential health risks for patients. Though the majority of compounding pharmacies were “well-trained and well-equipped,” those that were not or chose to improperly market a large number of unapproved drugs could pose a threat to a great number of people. Thanks to NECC’s contaminated epidural steroid, this is a chance we are now all too familiar with.

Because compounding pharmacies could potentially wreak havoc if they went beyond what constitutes traditional compounding, the FDA issued guidelines that outlined the sort of behavior that could get pharmacies in trouble, including:

  • Compounding drugs (in unreasonably large amounts) before receiving prescription requests for those drugs;
  • Sending large amounts of drugs out of state;
  • Mixing ingredients that had not been properly approved;
  • Using commercial-scale manufacturing facilities; and
  • Making and selling copies of FDA-approved drugs.

Though compounding pharmacies do a lot of good for a lot of patients, this year’s fungal meningitis outbreak shows they are also capable of doing a tremendous amount of harm.