Compounding Pharmacies As Outsourcing Facilities
Big Horn Safety provides services for compounding pharmacies designated as 503(b). Compounding Pharmacies are divided into two categories designated as 503(a) and 503(b). 503(b) pharmacies are unique in that they provide bulk sterile products that are shipped interstate (outsourced) mainly for medical clinic use.
503(b) designation for certain compounding pharmacies came as a result of unsafe practices by New England Compounding Center in 2012. 64 deaths resulted from fungal contamination of a compounded product by this outsourcing pharmacy (See this link). Subsequently, compounding pharmacies that provide outsourced sterile products are required to register with FDA as a 503(b) facility and now come under additional strict federal standards.
503(b) compounding pharmacies must now operate under current Good Manufacturing Practices (cGMPs) for finished pharmaceuticals. They are subject to FDA inspection under 21 CFR part 211. See this link for FDA's compliance program and how your 503(b) pharmacy would be inspected.
Big Horn Safety can provide an FDA compliance assessment for your compounding pharmacy. We can assist you with a mock-FDA inspection to assess if your compounded sterile products are in cGMP compliance. We can assist you to create batch records, SOP's, data security, and audit trails as required by the FDA. See this link
for the FDA Implementation of the Compounding Quality Act and more information on these new requirements.
