(1999; 168 pages) [Spanish]
5.4 Returned excipients
Returned excipients should be identified as such and kept. If the conditions under which the products have been stored and shipped or if the condition of the container itself casts doubt on the safety, quality or purity of the excipient, the product should be destroyed, unless thorough examination, testing, or other investigation shows that the product meets the appropriate predefined standards. If returned excipient containers are reused, all previous labelling should be removed or defaced. If the containers are used repeatedly solely for the same excipient, all previous batch numbers, or the entire label, should be removed or completely obliterated.