This section allowed licensed pharmacies and physician offices to engage in compounding activities; however, they could do so based only on a patient-specific prescription. All compounders were exempted from passing the product premarket approval process, labeling directions for use on the compounded drug, and complying with the Current Good Manufacturing Practices (CGMP) safety and cleanliness requirements. Although Section 503A initially also restricted the level of product advertisement allowed for compounding facilities, this limit was deemed unconstitutional, giving compounders the legal platform to promote their products. Smaller pharmacies, which fall under Section 503A guidelines, complained that they were allowed to deliver compounded drugs based only on an individual patient’s prescription, making it impossible for physicians to keep stock of specially compounded medications. Thus, smaller pharmacies claimed that it was nearly impossible for patients to receive compounded medication in emergency situations.

Source: CNN September 14, 2023 13:37 UTC