FDA has proposed a revised draft guidance for industry which will clarify exactly which cGMP requirements an outsourcing facility must follow until the FDA issues regulations specific to outsourcing facilities. In developing these policies, the FDA seeks to recognize the differences between outsourcing facilities and conventional drug manufacturers and to develop policies that reflect the specific compounding operations conducted by outsourcing facilities. The draft proposes a risk-based approach to enforcement of CGMP requirements, tailored to the size and scope of outsourcing facilities’ operations. The policies are aimed at making it more feasible for entities to register as outsourcing facilities to compound drugs for office stock in accordance with CGMP requirements, while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.
In the revised draft guidance, FDA made a number of revisions to address comments submitted on the 2014 draft, which are listed below:
- It differentiates between CGMP requirements applicable to sterile drug products and nonsterile drug products where appropriate. This is the first guidance that speaks to nonsterile drug products and identifies specific regulations for those drug products
- It provides clarification to identify the specifications of a complete stability test and use of a BUD as an expiration date.
- It provides a clear definition of “in-use time,” distinguishing it from “BUD” and “expiration date”
- It defines exactly what testing is required for batch release, which is defined by the type of product compounded, as well as the batch size compounded and identifies the specific tests that need to be performed prior to batch release.
- It clarifies the specific regulations regarding the collection and use of samples retained from distributed batches, known as reserve samples.
For a more comprehensive discussion of the policies proposed in the revised draft guidance, please see the revised draft guidance (available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov)
The FDA had also recently met with practitioners and medical specialty groups regarding these revisions.
