Food and Drug Regulations

C.04.131 Notwithstanding sections C.04.129 and C.04.130, a fabricator may manufacture other drugs in an area in which polio-virus vaccine, live, oral is manufactured at times when that vaccine is not being manufactured, if

• (a) both prior to and following each manufacture the area is cleaned and disinfected by methods acceptable to the Director; and

• (b) the fabricator has received written permission from the Director to carry out such manufacture.