Transitioning a compounding pharmacy to a compliant 503b outsourcing facility is challenging. Our cleanroom consultants specialize in conversion to and maintaining compliance for outsourcing facilities. Following the Drug Quality and Security Act made effective November 27, 2013, the 503b section in the FDCA applies. Under this 503B section a sterile compounding pharmacy must register as an outsourcing facility. For FDA approval, your facility must comply with all of the 503b requirements.
503b Compliance Requirements
Sterile compounded pharmaceuticals from an outsourcing facility can qualify for FDA exemptions and the requirement to label products with adequate directions for use. However, due to the sensitive nature of effective drugs, a 503b outsourcing facility must strictly adhere to current good manufacturing practices, also known as cGMP, and include but are not limited to :
- FDA inspections according to a risk-based schedule
- Reporting adverse events
- Providing the FDA with certain information about the products they compound
- Maintaining a truly sterile environment through the use of clean and sterile cleanroom apparel, cleaning supplies, sterility testing products etc.
503b, cGMP, & Sterile Cleanroom Products
Cleanroom Connection offers the most complete and comprehensive selection of 503b and cGMP compatible cleanroom apparel, cleaning supplies, sterility testing products and quality assurance items for sterile compounding pharmacies. We work very closely with our sterile compounding pharmacy clients that are seeking to become a 503b outsourcing facility to make sure they are using the correct sterile cleanroom products. We have invested years of effort in working alongside the FDA, PCAB, and other pharmaceutical associations to evaluate and come up with a hand-picked selection of cGMP compatible apparel and other cleanroom supplies. As the only focused sterile compounding pharmacy cleanroom supplier in the USA we offer a tailored supply chain program for medium and large-scale compounding facilities.
503b Compliance Assistance
It can be very daunting and confusing when it comes to compliance for your sterile compounding pharmacy for USP 797, USP 800, cGMP, and especially 503b. Cleanroom Connection offers proven consulting programs and inventory supply programs to ensure you are always prepared for audits, inspections and problems when they arise. Our consulting partners have over 40 years of experience in compounding compliance with all USP chapters and FDA requirements. Our personal customer service and special relationships with key people, suppliers and organizations make us the best choice to be your sterile compounding pharmacy partner. Cleanroom Connection establishes long-term relationships with clients, many over 15 years and running strong. Cleanroom Connection is more than just a supplier, we consider ourselves part of your clean room team and bring to the table years of experience in 503b compliance.
As the leading supplier of sterile cleanroom apparel, cleaning products, critical environment cleaning and disinfecting chemicals, and related compounding pharmacy cleanroom supplies, Cleanroom Connection has deep, long-term relationships with the nation’s leading pharmacy consulting firms. Contact us for compounding pharmacy and healthcare cleanroom consulting.
To learn more, give us a call at 800.616.5319.