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Author: Admin | 2025-04-28
(gabapentin, baclofen, cyclobenzaprine, diclofenac, ketamine, lidocaine, bupivacaine, flurbiprofen) or hormone replacement (progesterone, estradiol, estriol, testosterone).12 Compounded medications are also commonly used in dermatology to help achieve better therapeutic effects through the tailored actions of a specific combination of ingredients.13 In addition, compounded medications provide a source of pharmaceutical during times of national drug shortages. Drug shortages have created a tremendous strain on the ability to provide adequate care. In 2011, it was estimated that up to 11% of all FDA-approved and marketed drugs, vaccines, and biologics were in short supply.14 National drug shortages worsened during the COVID-19 pandemic as foreign countries that provided America’s drug supply limited the amount of medication that they would export to retain adequate supplies for their own citizens. This was exacerbated by manufacturing plant closures and limitations on transportation.15 Compounding pharmacies helped meet the pharmaceutical need during this critical time.16 Cons of Compounding Serious patient illnesses and death have been linked to poor-quality compounding drugs.17 In 2012, New England Compounding Center (NEC) distributed compounded preservative-free methylprednisolone acetate solution that was contaminated with Exserohilum rostratum and Aspergillus fumigatus, resulting in 753 cases of fungal infections and 63 deaths.18 This has not been the only incident. There is a database of compounding recalls, inspections, and other actions on the FDA’s website.19 Incidents have involved contamination resulting in infection or improper doses.1 In 2013, in response to the NEC tragedy, Congress amended the FD&C Act by enacting the Drug Quality and Security Act (DQSA). Part of DQSA is the Compounding Quality Act, which provides the FDA with more authority to regulate and monitor the manufacturing of compounded drugs.20 However, the FDA does not routinely inspect compounding pharmacies; nor do they determine the quality of compounded pharmaceuticals.9 Additionally, in the past the reporting of adverse drug events involving compounded
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