Legal basis and amendment scope
- DDB Board Regulation No. 1 (s. 1994) is issued pursuant to powers under Section 36 of Republic Act No. 6425, as amended, specifically referencing Paragraphs (a) and (1).
- Board Regulation No. 4 (s. 1991) is amended to create updated registration and licensing requirements for dangerous drug dealing.
- The Regulation amends Section 2, Article II (Registration and Fees) of Board Regulation No. 4 (s. 1991).
- The Regulation amends Section 77, Article VII (Administrative Provisions) by adding a new sub-section (5) on fire extinguishers.
Coverage: where applications are filed
- All applications for registration and issuance of a license to deal in dangerous drugs and exempt dangerous drug preparations must be filed with the Dangerous Drugs Board.
- Applications may be filed with the Metro Manila office of the Dangerous Drugs Board.
- Persons or entities situated outside Metro Manila must file applications with special processing officers deputized for that purpose by the Board.
Registration and licensing requirements
- Section 2, Article II requires applicants to satisfy the “requirements for initial or renewal of registration and the issuance of the corresponding license” for dangerous drugs licenses and exempt dangerous drug preparations.
- The Regulation provides specific requirement sets for different S-licenses, including license holders, physician/practitioner licensees, and applicants for establishment and hospital pharmacy licenses.
Requirements for S-1, S-3, S-4, S-5-C, and S-5-I
- Applicants for S-1, S-3, S-4, S-5-C, and S-5-I must satisfy the requirements for License Holders covering renewal and/or issuance.
- Renewal requirements for operation must include “Renewal License to operate (current) for 19___ from BFAD”.
- Applicants must submit current Business Permit and current Mayor’s Permit.
Professional and authorization documents for license holders
- License-holder applicants must submit PRC requirements: Pharmacists (unexpired/updated).
- License-holder applicants must submit PTR requirements: PTR a 19 (current).
- Applicants must submit a letter from the owner of the applicant-establishment authorizing a pharmacist to apply for and secure the S-license from the Dangerous Drugs Board.
- If the authorized pharmacist cannot undertake follow-up, the owner must issue an authorization to a new designee who becomes the temporary representative of the applicant.
- License-holder applicants must submit SEC Registration.
Requirements for S-2 licenses (physicians and other practitioners)
- S-2 licenses must be issued to physicians and other authorized practitioners and require the following documents.
- Applicants must submit Privilege Tax Receipt (PTR) 19__ (current).
- Applicants must submit PRC Physician (unexpired/updated).
Authorization for physician/practitioner follow-up
- If the designee/designated representative cannot undertake follow-up, the applicant practitioner must issue another letter of authorization to a new designee.
Other requirements for establishments and hospital pharmacies
- All applicants for S-licenses of establishment and hospital pharmacy must comply with the “Other requirements” listed by the Regulation.
- Applicants must submit an NBI Clearance in favor of the applicant; if the applicant is a partnership, company, or corporation, the Head/Manager of the Establishment must secure the clearance.
- The NBI Clearance requirement applies required only for S-3, S-4, S-5-C- and S-5-I.
- Applicants must submit a Certificate of Integrity and Good Moral Character from the Barangay Chairman concerned for S-1 applicants.
- All applicants must submit a statement under oath attesting that the applicant has read and is familiar with RA 6425, as amended and its implementing rules and regulations, and other relevant laws including RA 3720, as amended, and assuring faithful compliance with laws and regulations.
Administrative requirement: fire extinguishers
- Section 77 is amended by adding a new sub-section (5) requiring safeguarding measures for dangerous drugs and exempt dangerous drug preparations.
- Establishments must install appropriate fire extinguishers in and around the premises where dangerous drugs and dangerous drug preparations are kept.
- Fire extinguishers must be adequate in number.
- Establishments must ensure maximum and intelligent utilization of fire extinguishers by requiring concerned personnel to undergo training on proper use and care of the equipment.
Enforcement and criminal consequence
- Any violation of the Regulation is a ground for the institution of criminal proceedings in the proper court.
Effectivity and publication rule
- DDB Board Regulation No. 1 (s. 1994) takes effect fifteen (15) days after its publication in a newspaper of general circulation.
- Publication must occur once a week for two (2) consecutive weeks.
- The Regulation is adopted on June 09, 1994 and becomes effective after compliance with the publication rule.