Scope: covered violations and trigger
- The regulation applies when persons are found and proven to have violated designated regulatory control measures in Board Regulation No. 3, Series of 2003.
- The sanctions are imposed when the Board decides, under extraordinary circumstances, not to pursue a criminal case against the violators.
- It covers license-related violations involving terms and conditions of a license granted by the Philippine Drug Enforcement Agency (PDEA).
- It covers violations tied to documentation and reporting obligations under Board Regulation No. 3, Series of 2003, including false entries and failures to notify.
- It covers operational violations such as dealing with unlicensed operators, improper handling of packages in transit, improper consignment documentation, and regulatory recordkeeping violations.
Fines and sanctions for specified violations
- Section 1 imposes the following fines and sanctions for the enumerated violations of Board Regulation No. 3, Series of 2003, with all first offenses carrying a fine of PHP 10,000.00 and a stern warning that repetition shall be handled under Section 32, Article II of RA 9165 and other applicable penal laws.
- For violation of license terms and conditions in relation to Section 6 (1-a & b), (2-a & b), (3) and (6) of Board Regulation No. 3, Series of 2003, the penalty for first offense is PHP 10,000.00 plus a stern warning.
- For lack of a PDEA permit relating to first aid kits containing dangerous drugs and drug preparations in parenteral, tablet or capsule form for specified purposes including domestic or international flights or voyage or medical missions sponsored by the Department of Health (DOH) or other government agencies or non-government civic organizations, importing reasonable quantities containing specified Table 1 controlled chemicals for medical use, the penalty for first offense is PHP 10,000.00 plus a stern warning.
- If the dangerous drugs in test kits or brought in or imported by foreign medical missions were found without export authorization from the country of origin, the same fine is imposed.
- For violation of Section 20, Article III of Board Regulation No. 3, Series of 2003, any person giving false or misleading information or failing to report to the PDEA any material change and conditions not fulfilled is subject to sanctions that include suspension or revocation of license, and the fine for first offense is PHP 10,000.00 plus a stern warning.
Dealing, handling in transit, and consignment rules
- Any licensed operator found to be dealing with an unlicensed operator under circumstances covered by Section 22 (1, 2, 3, 4, 6 and 7) of Board Regulation No. 3, Series of 2003 is subject to PHP 10,000.00 for first offense plus a stern warning.
- For violation of Section 23 (1 & 2), Article III of Board Regulation No. 3, Series of 2003—altering or breaking any package/container containing dangerous drugs or controlled chemicals while in lawful transit unless authorized—the penalty for first offense is PHP 10,000.00 plus a stern warning.
- For violation of Section 29, Article III of Board Regulation No. 3, Series of 2003—using improper or undocumented consignment—the penalty for first offense is PHP 10,000.00 plus a stern warning against the consignee, consignor, or both found liable.
- For prescribing violations involving Section 32 (2, 3, 4, 5 (b), 6, 7(a), 8, 9, 10 and 11) of Board Regulation No. 3, Series of 2003 (without prejudice to Section 19 and 32 of RA 9165), the penalty for first offense is PHP 10,000.00 plus a stern warning.
Recordkeeping, entries, safekeeping, and compliance
- Failure to maintain Dangerous Drugs Registers under Section 38 and Controlled Chemical Registers under Section 39, and failure to keep records of sales, purchases, acquisitions and deliveries of drug preparations or to comply with requirements under Section 40 of Board Regulation No. 3, Series of 2003, results in a penalty for first offense of PHP 10,000.00 plus a stern warning.
- For violation of Section 41 of Board Regulation No. 3, Series of 2003—making false or misleading entries in required registers/records/documents, or cancelling, obliterating, or altering any entry except to correct an error—the penalty for first offense is PHP 10,000.00 plus a stern warning.
- For any person required to keep a registry who, upon loss, destruction or discrepancy, failed to notify the PDEA upon discovery, the penalty for first offense is PHP 10,000.00 plus a stern warning.
- For violation involving authorized persons under Section 43 of Board Regulation No. 3, Series of 2003—failure to provide safekeeping of dangerous drugs and controlled chemicals in custody resulting in loss or theft—the penalty for first offense is PHP 10,000.00 plus a stern warning.
- If loss or theft occurred through gross negligence of the person having custody and was 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 is imposed.
- Any authorized supplier of controlled chemicals, whether manufacturer, importer, or distributor, who failed to observe required Material Safety Data Sheets and other safety requirements under Section 45 of Board Regulation No. 3, Series of 2003, is penalized for first offense with PHP 10,000.00 plus a stern warning.
- Any person who obstructs, prevents, frustrates, or delays a regulatory compliance officer in performing duties is penalized for first offense with PHP 10,000.00 plus a stern warning.
Additional violations and enforcement mechanics
- Section 2 extends the applicable penalty scheme to persons who commit other violations of Board Regulation No. 3, S. 2003 not specifically enumerated in Section 1, whenever applicable as deemed by the Board.
- Section 3 requires payment of all fines imposed for violations of Board Regulation No. 3, Series of 2003 to the DDB cashier, which issues a receipt evidencing payment.
- Section 3 provides that fines paid under the regulation form part of the Special Account of the Board.
Penalty escalation principle
- Every first offense fine expressly carries a stern warning that repetition of the same offense shall be dealt with under Section 32, Article II of RA 9165 and other applicable penal laws.
- For cases involving loss or theft caused by gross negligence and traced to manufacture of dangerous drugs, the regulation authorizes imposition of the maximum fine under Section 32 of RA 9165.