Labeling Rules for Multi-Ingredient Drugs

This Order covers all multi-active-ingredient pharmaceutical products containing four or more active ingredients.
These products are not covered by Administrative Order No. 85, series of 1990.

Each active ingredient's Generic Name and its corresponding strength or concentration must be printed within the outlined box on the principal display panel.
The Trade or Brand Name must be printed immediately below the box, in smaller letters than the Generic Names.
Provided examples demonstrate the required format for oral and injectable pharmaceutical products.

All drug establishments owning covered products must submit their proposed generic labels for BFAD review and approval by March 31, 1991.
BFAD shall approve satisfactory applications not later than May 31, 1991.
Starting sixty days after approval but not later than August 1, 1991, only approved generic labels may be used for new production batches.
Establishments must submit the last batch number with the new label before commencing production.
After October 31, 1991, all products with old labels are considered misbranded and subject to seizure.
Drug establishments bear responsibility to determine if their products fall under this Order's coverage.
Remedial labelling under Administrative Order No. 79, series of 1989, is allowed for covered products.
Label approval does not imply acceptance of the fixed-dose combination formula, which remains subject to further review.

If any provision is declared unconstitutional or contrary to law, the remaining provisions remain effective and enforceable.

All previous Administrative Orders, rules, regulations, and issuances inconsistent with this Order are hereby repealed or modified accordingly.

This Order takes effect fifteen days after publication in two newspapers of general circulation.