Question of the Day February 26, 2015 Is the following a deal breaker or soura huge incentive for compounding pharmacies who do sterile compounds to register as 503B outsourcing facilities? FDA guidance on outsourcing facilities indicates "If you do not intend to compound all drugs at your facility in accordance with section 503B and 101 comply with CGMP requirements, you should not register as an outsourcing facility under section 503B"

The draft guidance also states:

If a facility compounds sterile human drugs and otherwise meets the definition of an outsourcing 131 facility, any non-sterile human drugs compounded by the facility would also be eligible for the 132 exemptions from sections 505, 502(f)(1), and 582 if the drugs are compounded in accordance 133 with the provisions of section 503B. However, if a facility that meets the definition of an 134 outsourcing facility repackages certain human drugs, or mixes, dilutes, or repackages biological 135 products outside the scope of an approved BLA, FDA does not intend to take action against 136 those products for violations of certain provisions of the FD&C Act or the PHS Act, if 137 applicable, provided those products satisfy the conditions described in the two guidances on 138 biological products and repackaging, referenced above.

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