AmEx Pharmacy announced it has voluntarily registered with the US Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility under section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act. This new designation was created in November 2013 when President Obama signed Title 1 of the Drug Quality and Security Act (DQSA) referred to as the Compounding Quality Act into law.
The law, which calls for large-scale entities in the compounding industry to voluntarily register with the FDA and comply with guidelines, under the section 503B of the FD&C Act, has been recognized for the potential to improve patient safety as well as the protection that DQSA also affords hospitals/health systems and other healthcare providers.
As a 503B outsourcing facility, AmEx Pharmacy will be listed on the FDA’s approved list of compounding pharmacies. AmEx Pharmacy will therefore be able to compound and distribute medications to hospitals and clinics without patient-specific prescriptions provided that all requirements of Section 503B are met. With this new designation AmEx Pharmacy is implementing guidelines provided under Current Good Manufacturing Practice (CGMP) regulations. The CGMP will ensure that higher standards of quality and safety are met.
The fundamental regulation prior to the new Compounding Quality Act was USP 797. This regulation was used to govern sterile compounding pharmacies and guidance was provided by state boards of pharmacy. Due to the fungal meningitis outbreak in October 2012 caused by poor sterility assurance at New England Compounding Center in Massachusetts, federal legislators passed the new law. This law will expand the role of the FDA in providing guidance for compounding pharmacies.
Registration with the FDA is not mandatory under the current guidelines. If a compounding pharmacy is not registered as an outsourcing facility they will no longer be able to supply “office use” medications to clinics, hospitals and physician offices. AmEx Pharmacy prides itself on voluntarily registering with the FDA as a 503B Outsourcing facility and is committed to working together with the FDA and state authorities to supply patients with safe and high-quality drug products.
Compounding pharmacies are instrumental in the health and well-being of millions of individuals across the United States. Pharmacy compounding is the art and science of preparing medications for individual patients that are in need of a drug that is not readily available through traditional means.