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Pharmacy compounding traditionally involves pharmacists producing customized medications for patients whose medical needs cannot be met by commercially available medications approved by the Food and Drug Administration (FDA).
Since the early 1990s, many companies identifying themselves as compounding pharmacies greatly expanded their reach by engaging in large-scale production of unapproved drugs. Such companies often supply sterile drugs to hospitals and doctors’ offices across the U.S....
Pharmacy compounding traditionally involves pharmacists producing customized medications for patients whose medical needs cannot be met by commercially available medications approved by the Food and Drug Administration (FDA).
Since the early 1990s, many companies identifying themselves as compounding pharmacies greatly expanded their reach by engaging in large-scale production of unapproved drugs. Such companies often supply sterile drugs to hospitals and doctors’ offices across the U.S. Unlike FDA-approved products, compounded drugs have not been reviewed by the FDA to evaluate their safety, effectiveness or quality.
The public health danger posed by these poorly regulated companies became apparent in late 2012 to 2013 when an outbreak of fungal meningitis and other infections linked to contaminated injectable steroids made by the now-shuttered New England Compounding Center in Framingham, Mass., sickened more than 750 patients in 20 states, killing at least 64.[1],[2]
In an effort to prevent similar outbreaks from tainted compounded drugs, Congress in 2013 passed the Drug Quality and Security Act (DQSA).[3] The DQSA pushed companies that mass produce sterile compounded drugs for sale to hospitals and doctors’ offices to voluntarily register with the FDA under a newly created category of companies called “outsourcing facilities.” Once registered, these facilities must adhere to federally mandated quality standards for manufacturing drugs and undergo periodic FDA inspections.
The findings of a 2021 FDA inspection of an outsourcing facility operated by Edge Pharma in Colchester, Vt.,[4] reveal that the U.S. remains at risk of another large-scale infection outbreak caused by contaminated compounded drugs. Last fall, FDA inspectors documented numerous serious lapses at Edge Pharma’s facility, including the following:
- Failure to “ensure clean and sanitary conditions for the production of…[sterile] drugs.”
- Failure to “prevent the presence of vermin [including flying insects, ants and spiders] in the facility where [sterile] drug products…are prepared, and throughout the facility.”
- Failure to “investigate numerous instances of sterility samples [of drugs] contaminated with objects such as particles, fibers, and filaments.”
- Failure to “adequately investigate and remediate adverse mold trends in production clean rooms for drugs intended to be sterile.”
Because drugs produced under the type of unsanitary conditions found by FDA inspectors may not be sterile and thus pose a clear and present danger to patients, Edge Pharma in early December recalled all its drug products.[5]
The FDA’s inspection of Edge Pharma’s outsourcing facility is another stark reminder that compounded drugs continue to pose a greater risk to patients than FDA-approved medications.
References
[1] Centers for Disease Control and Prevention. Multistate outbreak of fungal meningitis and other infections –resources for clinicians. Updated October 30, 2015. https://www.cdc.gov/hai/outbreaks/clinicians/index.html. Accessed March 1, 2022.
[2] Centers for Disease Control and Prevention. Multistate outbreak of fungal meningitis and other infections. Updated October 30, 2015. https://www.cdc.gov/hai/outbreaks/meningitis.html. Accessed March 1, 2022.
[3] Congress.gov. H.R. 3204 – Drug Quality and Security Act. 113th Congress (2013-2014). https://www.congress.gov/bill/113th-congress/house-bill/3204/actions. Accessed March 1, 2022.
[4] Food and Drug Administration. Form FDA 483, inspection of Edge Pharma’s 503B outsourcing facility. December 1, 2021. https://www.fda.gov/media/156278/download. Accessed March 1, 2022.
[5] Food and Drug Administration. Company announcement: Edge Pharma, LLC issues voluntary nationwide recall of all drug products due to a lack of sterility assurance. December 4, 2021. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edge-pharma-llc-issues-voluntary-nationwide-recall-all-drug-products-due-lack-sterility-assurance#recall-announcement. Accessed March 1, 2022.
