Stricter drug compounding regulations complicate ophthalmology care
In 2012, New England Compounding Center released a batch of methylprednisolone tainted with fungus that resulted in an outbreak of fungal meningitis. After it was confirmed that the outbreak was caused by the compounded drug, the FDA imposed new regulations on compounding pharmacies and how they produce drugs. According to some ophthalmologists and representatives in the pharmaceutical business, these regulations have made the procurement and production of several compounded drugs difficult. And that difficulty can affect practice.In 2013, Congress passed the Drug Quality and Security Act, which included the Compounding Quality Act. The act included several requirements for traditional compounders, which included the creation of a new section under the Federal Food, Drug and Cosmetic Act, according to an FDA release. This section, 503B, allowed a traditional 503A compounding pharmacy to become an outsourcing facility and create compounded drugs without a patient-specific prescription.
Original Article: Stricter drug compounding regulations complicate ophthalmology care
