The Drug Quality Security Act and creation of section 503B, allowing for compounding pharmacies to voluntarily register as an “outsourcing facility”, presents interesting challenges and opportunities for these specialized pharmacies. 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.
Registered outsourcing facilities must comply with CGMP requirements, will be inspected by FDA according to a risk-based schedule, and must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
If a compounder chooses not to register as an outsourcing facility and qualify for the exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, under section 503B, the compounder could also qualify for the CGMP requirements exemptions under section 503A of the FDCA. Otherwise, it would be subject to all of the requirements in the FDCA applicable to conventional manufacturers.
Should you wish to discuss your compounding pharmacy’s situation and how section 503B will impact your business, EAS has experts in the field who are able to assist. Should you choose to register with FDA as an outsourcing facility, EAS is able to assist or complete the registration on your behalf. We are also able to provide mock-FDA audit assistance, help with SOPs and GMP compliance procedures and tracking of adverse events reporting.