Compounding Controversies

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Recent product recalls from compounding pharmacies have been getting a lot of attention. Here are five things you need to know about compounding and why the recalls have been happening:

1. Compounding pharmacies are pharmacies that are able to make specific drugs for patients. This includes compounding of discontinued or unavailable medications, special formulations (suppositories, liquids, injections) of drugs that might not be sold that way commercially, specialty medications (hormonal treatments, some IV infusions) and other products that are not commercially available. All compounding is done by or under the supervision of a pharmacist, in community and hospital pharmacies.

2. The controversy: Late last year a number of doctor’s offices received spinal injections made by a compounding pharmacy that were contaminated by a fungus. This lead to numerous cases of fungal meningitis in patients that had received the injections, with several deaths reported. The pharmacy in question was closed down and the FDA initiated an investigation. There have been several other voluntary compounding pharmacy recalls in the months following.

3. What does this mean for you? For compounded medications that are used topically (creams, suppositories, ointments) or orally (liquid, capsules) the risk of contamination is generally low. The majority of compounding at your local pharmacy will be of these low risk medications. If you are receiving specialty drugs from a compounding pharmacy though, this may not be the case. The risk of contamination is higher for sterile products such as injections.

4. Check with your pharmacy or health care professional. If you are concerned about a compounded product, contact your pharmacy or your doctor with any questions you may have. Compounding pharmacies are expected to adhere to strict standards for preparing medications. Patients should be able to check on whether equipment, testing and other related procedures are up to date. You can also check the FDA Recalls page for listings of pharmacies and products that are involved in recalls or withdrawals.

5. The latest news: The outbreak of fungal meningitis has since been contained, and all patients that received a contaminated dose were informed and checked. Since then, increased regulation of compounding pharmacies has been proposed. Currently, a bill is being reviewed in the Senate to increase the FDA’s jurisdiction over compounding pharmacies. In addition, the FDA has increased audits and harsher penalties are being imposed on pharmacies that do not meet standards.

The GoodRx Pharmacist

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