STANDARD POLICY ON LABELED POTENCY OF PHARMACEUTICAL PRODUCTS
disapproval/denial of initial and renewal registration is due to its
failure to meet potency specifications.
For example, in the case of Amoxicillin preparations, the amount of
Amoxicillin trihydrate used must be equivalent to the amoxicillin base
that will provide the required dosage strength (e.g. 500 mg Amoxicillin
base requires 574 mg of the trihydrate form).
Henceforth and effective immediately, it is hereby reiterated that
all formulations of pharmaceutical products registered with this Office
must be in accordance with the potency requirements of the monograph of
the product as officially listed in USP, BP and EP pursuant to AO 67, s.
1989 and in such other official compendia as may be recognized by BFAD.
Adopted: 03 Aug. 2000
(SGD.) WILLIAM D. TORRES, Ph.D.
Director
Noted:
(SGD.) ALBERTO G. ROMUALDEZ, JR. M.D.
Secretary of Health