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Pursuant to the powers vested in the Dangerous Drugs Board under Section 81(b), Article IX of Republic Act No. 9165 and incidental to its rule-making power, the following provisions are hereby prescribed governing the imposition of fines and other sanctions upon persons who are found and proven to have violated any of the following regulatory control measures of Board Regulation No. 3, Series of 2003, in case the Board decides under extraordinary circumstances not to pursue a criminal case against the violators:

SECTION 1.   Fine and Other Sanctions -

1. Violation of the terms and conditions of a license granted by the Philippine Drug Enforcement Agency (PDEA) in relation to Section 6 (1-a & b); (2-a & b), (3) and (6) of the said Regulation No. 3, Series of 2003:
   
   First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
   
   
2. Lack of PDEA permit in relation to first aid kits containing dangerous drugs and drug preparations in parenteral, tablet or capsule form for medical use in domestic or international flights or voyage or for medical missions sponsored by the Department of Health (DOH) or other government agencies or non-government civic organizations importing reasonable quantities of dangerous drugs or drug preparations in parenteral, tablet or capsule form containing Table 1 controlled chemicals as the only active medical ingredient or containing Table 1 controlled chemicals and therapeutically insignificant quantities of another active medicinal ingredient, needed during the mission but with export authorization from the country where the medical mission or medicine originated as provided under Section 13 (1-a & b), Art. III of the Regulation:
   
   
   1. First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
      
      
   2. If the drugs herein mentioned which were found in the test kits or brought in or imported by foreign medical mission were without export authorization from the country of origin, the same fine shall be imposed.
   
   
   
3. Violation of Section 20, Art. III of the Regulation – In addition to suspension or revocation of license, any person giving false or misleading information or who failed to report to the PDEA any material change and conditions not fulfilled shall be imposed of the following sanctions:
   
   First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
   
   
4. Any licensed operator found to be dealing with any unlicensed operator under any of the circumstances mentioned in Section 22 (1, 2, 3, 4, 6 and 7) of the Regulation shall be imposed the following sanctions:
   
   First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
   
   
5. Violation of Section 23 (1 & 2), Art. III of the Regulation - Any person found altering or breaking any package/container or the like containing any dangerous drugs or controlled chemicals while in lawful transit unless authorized shall be imposed the following sanctions:
   
   First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
   
   
6. Violation of Sec. 29, Art. III of the Regulation - The consignee or the consignor or both who are found to be using improper or undocumented consignment may be imposed the following sanctions:
   
   First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
   
   
7. Without prejudice to Section 19 and 32 of RA 9165, any person found to have prescribed dangerous drugs not in accordance with Section 32 (2, 3, 4, 5 (b), 6, 7(a), 8, 9, 10 and 11) of Board Regulation No. 3, Series of 2003, shall be imposed the following sanctions:
   
   First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
   
   
8. Failure to maintain Dangerous Drugs Registers under Sec. 38 and Controlled Chemical Registers under Sec. 39 and failure to keep records of sales, purchases, acquisitions and deliveries of drug preparation and/or to comply with requirements as mentioned in Sec. 40 of the Regulation:
   
   First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
   
   
9. Violation of Sec. 41 of the Regulation - Any person required to keep a register or any other record/documents under Sec. 38, 39 and 40 of the Regulation found to have made false or misleading entries or cancelled, obliterated or altered any entry, except to correct an error, shall be imposed the following sanctions:
   
   First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
   
   
10. Any person required to keep a registry who, in case of loss, destruction or discrepancy, failed to notify the PDEA upon discovery shall be imposed the following sanctions:
    
    First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
    
    
11. Any authorized person mentioned in Sec. 43 of the Regulation who failed to provide safekeeping of the dangerous drugs and controlled chemicals under his custody resulting in either loss or theft of any quantity of the dangerous drugs and controlled chemicals shall be imposed the following sanctions:
    
    First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
    
    If it is found that the loss or theft occurred through gross negligence of the person having custody of the dangerous drugs and/or controlled chemicals which were later traced to be used in the manufacture of dangerous drugs, the maximum fine of the penalty provided for under Section 32 of RA 9165 shall be imposed.
    
    
12. Any authorized supplier of controlled chemicals, whether manufacturer, importer or distributor, who failed to observe the required Material Safety Data Sheets and such other safety requirements mentioned under Sec. 45 of the said Regulation shall be imposed the following sanctions:
    
    First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.
    
    
13. Any person who obstruct, prevent, frustrate or delay any regulatory compliance officer in performing his/her duties shall be imposed the following sanctions:
    
    First offense – fine of P10,000.00 with a stern warning that repetition of the same offense shall be dealt with in accordance with Section 32, Article II of RA 9165 and other applicable penal laws.

SECTION 2.   Other Violations -  The penalty herein mentioned shall likewise be imposed upon persons who have committed any other violations of Board Regulation No. 3, S. 2003, other than those specified herein, whenever applicable as deemed by the Board.

SECTION 3. Where to Pay -  All fines herein mentioned imposed upon persons

found and proven to have violated any of the provisions of Board Regulation No. 3, Series of 2003, shall be paid to the Dangerous Drugs Board (DDB) cashier, who shall in return issue the corresponding receipt evidencing payment. The fine so paid shall form part of the Special Account of the Board.

SECTION 4. Effectivity -  This Regulation shall take effect fifteen (15) days after its publication in two (2) newspapers of general circulation and after its registration with the Office of the National Administrative Register (ONAR), UP Law Center, Quezon City.

Adopted: 6 Dec. 2007


(SGD.) Secretary ANSELMO S. AVENIDO, JR.
Chairman, Dangerous Drugs Board

Attested by:

(SGD.) Undersecretary EDGAR C. GALVANTE
Secretary of the Board