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(NAR) VOL. 2 NO. 1/JANUARY-MARCH 1991

[ DOH ADMINISTRATIVE ORDER NO. 99, December 05, 1990 ]

REQUIREMENTS FOR LABELLING MATERIALS OF CATEGORIES OF PHARMACEUTICAL PRODUCTS CONTAINING FOUR OR MORE ACTIVE INGREDIENTS OUTSIDE THE COVERAGE OF A.O. 85, S. 1990



SECTION 1. Applicability of the Provisions of A.O. 55, s. 1990 — All pertinent provisions of A.O. 55, s. 1990 on general and specific requirements for labelling materials of pharmaceutical products shall apply to products containing four or more active ingredients covered by this A.O.

SECTION 2. Coverage — All multiactive-ingredient pharmaceutical products containing four or more ingredients not covered by A.O. 85, s. 1990, are covered by this A.O.

SECTION 3. Generic Labelling — For these multiactive-ingredient products covered by this A.O., the Generic Name for each active ingredient with the corresponding strength or concentration shall be printed within the outline box on the principal display panel with the Trade or Brand Name of the product printed in smaller letters than each generic name immediately below the box as shown in the example below:

3.1 Example 1

 
ORAL REHYDRATION SALT — 90
Per Liter
 
 
Sodium
90 mEq
  
 
Potassium
20 mEq
 
 
Chloride
80 mEq
 
 
Citrate
30 mEq
 
 
Dextrose
25 g
 

PEDIALYTE — 90

3.2           Example 2

 

DTP + IPV iNJ.
Per 5 ml Vial

 
 
Diphtheria Toxoid 
1 vac. dose:
  
 
Tetanus Toxoid
1 vac. dose:
  
 
Bordetella

 
 
Pertussis
min. int'l IU
 
 
Inactivated Polie Myelitis

 
 
Type 1 
1 vac. dose
 
 
Type 2
1 vac. dose
 
 
Type 3 
1 vac. dose
 

TETRACOQ

SECTION 4.       Procedure for Changing Over to New Labels —

4.1 All drug establishments that own registered drug products covered under this A.O. shall present their proposed generic labels in compliance with the above for review and approval by BFAD not later than March 31, 1991.

4.2  All satisfactory applications for new generic labels covered by this A.O. submitted within the March 31, 1991 deadline shall be approved by BFAD not later than May 31, 1991.

4.3 Starting sixty (60) days after approval but not later than August 1, 1991, only such approved generic labels shall be used for these products in new production.  The drug establishment is required to submit the last batch number bearing the new generic label before the start of actual production with the new label.

4.4 After October 31, 1991, all covered products with the old label shall be deemed misbranded and subject to seizure by BFAD.

4.5  It shall be the responsibility of the drug establishment to ascertain the coverage of this A.O. on its products.

4.6 Remedial generic labelling according to the provisions of A.O. 79, s. 1989 is available to products covered by the A.O.

4.7 Approval of the new label under this new A.O. should not be taken to mean that the present formula for the FDC is acceptable.  This formula will still be subject to review per A.O. 96, s. 1990.

SECTION 5. Separability Clause — In case any provision of the A.O. is declared contrary to law or unconstitutional, other provisions which are not affected thereby shall continue to be in force and in effect,

SECTION 6. Repealing Clause — All A.O.s, Rules and Regulations, and other Administrative issuances or parts thereof inconsistent with the provisions of this A.O. are thereby repealed and modified accordingly.

SECTION 7.  Effectivity — This A.O. shall take effect fifteen (15) days after its publication in two newspapers of general circulation.

Adopted: 3 Dec. 1990

(SGD.) ALFREDO R.A. BENGZON, M.D.
Secretary
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