When a product is prepared in a licensed establishment for export in large multiple-dose containers as provided in §112.8(d) or (e) of this subchapter or for further manufacturing purposes as provided in §114.3(d) of this subchapter, samples of the bulk material shall be subjected to all required tests prescribed in the filed Outline of Production or Standard Requirements for the product. Samples of concentrated liquid product shall be diluted to a volume equal to the contents of the sample times the concentration factor prior to initiating potency tests.

[49 FR 45846, Nov. 21, 1984]