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The US Food and Drug Administration (FDA) has issued a guidance on facility definition for outsourcing plants. Indian pharma which has chipped in a lot of manufacturing capability to global drug majors sees the need for this regulation which could provide specific requirements for manufacturing units as the way forward in outsourcing services.
The global regulatory authority now seeks the comments from the industry before July 30, 2016. Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines an outsourcing facility, at each geographic location.
India has 584 US FDA approved facilities. The norms are now drafted primarily because the FDA has received questions from outsourcing facilities. The queries are related on whether multiple locations used for compounding human drugs at a single street address constitute one or multiple facilities. Another clarification was on whether a single location where human drugs are compounded could be subdivided into separate operations, compounding under different standards.
Section 503B, added to the FD&C Act by the Drug Quality and Security Act in 2013, created a new category of compounders called outsourcing facilities. Section 503B describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility. This would enable to qualify for exemptions from three sections of the FD&C Act: section 502(f)(1) concerning labeling requirements; section 505 on drug approval requirements; and section 582 related to Drug Supply Chain Security Act.
Section 503B(d)(4) of the FD&C Act defines an outsourcing facility as a facility at one geographic location engaged in the compounding of sterile drugs. This would be the registered facility complying with all the requirements. In addition, an outsourcing facility is not required to be a licensed pharmacy, and it may or may not obtain prescriptions for identified individual patients. Outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements.
Industry observers state that there is need for facility definition going by the FDA warnings that have been imposed on units here. If the production plants have a set of systems as the norms, then approvals would be easier.
Some outsourcing facilities compound drugs both according to patient-specific prescriptions as well as in response to orders that are not patient-specific, as section 503B permits them to do. FDA has been asked whether an outsourcing facility can create a separate area within its facility for compounding according to patient specific prescriptions under section 503A, and not follow CGMP requirements in that area.
The CGMP regulations contain requirements for facility design, staff training and competency testing, control of incoming components, aseptic processing, air quality, environmental monitoring, and related requirements designed to ensure the quality of the finished product.
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