FDA’s March 1998 draft GMP guidance for API manufacturing defined for antibiotics the use of expiry date. Q7A does not have this recommendation, is this difference existing or not?

FDA’s March 1998 draft GMP guidance for API manufacturing tried to reflect the then current
practice of assigning expirations dates for many antibiotics. FDAMA (FDA Modernization Act)
essentially eliminated the regulations that required expiration dates for many antibiotics. Q7A
came along post-FDAMA, so you don’t see that language. But there’s no conflict between Q7A
and national laws. National laws still would prevail in this international agreement if they exist.