Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 99)
The order sets the requirements for labelling materials of pharmaceutical products containing four or more active ingredients that are outside the coverage of A.O. 85, s. 1990.
It applies to all multiactive-ingredient pharmaceutical products containing four or more active ingredients that are not covered by A.O. 85, s. 1990.
All pertinent provisions of A.O. 55, s. 1990 relating to labelling are applicable to these products.
The generic name for each active ingredient with the corresponding strength or concentration must be printed within the outline box on the principal display panel, with the trade or brand name printed in smaller letters immediately below the box.
Example 1 is Oral Rehydration Salt with ingredients and strength listed inside a box and brand name 'PEDIALYTE' below. Example 2 is DTP + IPV Inj. with each active ingredient and its dose inside the box and brand name 'TETRACOQ' below.
Proposals must be submitted not later than March 31, 1991.
Approvals must be made not later than May 31, 1991.
Approved labels must be used starting sixty (60) days after BFAD approval but not later than August 1, 1991.
Products with old labels shall be deemed misbranded and are subject to seizure by BFAD.
The drug establishment is responsible for ascertaining coverage of this A.O. on its products.
No. The formula of the fixed dose combination remains subject to review under A.O. 96, s. 1990 despite label approval.
It repeals, modifies, or supersedes all previous A.O.s, rules, regulations, or administrative issuances inconsistent with this order.
It took effect fifteen (15) days after its publication in two newspapers of general circulation.
Other provisions not affected by such declaration shall continue to be in force and effect (Separability Clause).
Yes, remedial generic labelling is available under the provisions of A.O. 79, s. 1989.