Getting Listed on the FDA’s Approved List of Compounding Pharmacies as an 503B Outsourcing Facility

MediStat Specialized Pharmacy based in Foley, Alabama became the first facility in Alabama to voluntarily register with the FDA as a Human Drug Compounding Outsourcing Facility under section 503B of the Federal Food, Drug, and Cosmetic Act. As an 503B outsourcing facility, this will allow Medistat to be listed on the FDA’s approved list of compounding pharmacies. This will allow MediStat to be able to compound and distribute medications to hospitals and clinics without patient-specific prescriptions provided that all requirements of Section 503B are met. The new designation was created in November 2013 when President Obama signed the Drug Quality and Security Act, referred to as the Compounding Quality Act into law. The new law creates a new section 503B in the FDCA. Under section 503B, a compounder can become an “outsourcing facility.” An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP requirements. If compounders register with the FDA as outsourcing facilities, hospitals and other health care providers can provide their patients with drugs that were compounded in outsourcing facilities that are subject to CGMP requirements and federal oversight. The law, which calls for large-scale entities in the compounding industry to voluntarily register with the FDA and comply with guidelines, has been recognized for the potential to improve patient safety as well as the protection that the act also affords hospitals/health systems and other healthcare providers.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.

If you are a compounding pharmacy…… what should you do? Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.

Bob Miller
11/16/2014


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