QuestionsQuestions (DDB BOARD REGULATION NO. 1)
It is adopted pursuant to the powers under Paragraphs (a) and (l), Section 36 of Republic Act (RA) No. 6425, as amended.
Board Regulation No. 4, Series of 1991.
Section 2, Article II (Registration and Fees) and Section 77, Article VII (Administrative Provisions), by adding Subsection 5.
Applications must be filed with the Dangerous Drugs Board, or with the Metro Manila area. Those outside Metro Manila file with special processing officers deputized by the Board.
The regulation lists: (1) Renewal License to operate (current) for 19___ from BFAD; (2) Business Permit (current); (3) Mayor’s Permit (current); (4) PRC pharmacist (unexpired/updated); (5) PTR 19__ (current); (6) Letter from owner authorizing a pharmacist; (7) SEC registration.
It authorizes a pharmacist to apply for and secure the S-license from the Dangerous Drugs Board. It also provides a mechanism for substitution if the authorized pharmacist cannot follow up.
The owner of the establishment must issue an authorization to a new designee who will be the temporary representative of the applicant.
The regulation lists: (1) PTR 19__ (current); (2) PRC physician (unexpired/updated); and (3) if the designee/designated representative cannot undertake follow-up, the applicant must issue another letter of authorization to a new designee.
NBI clearance in favor of the applicant is required only for S-3, S-4, S-5-C, and S-5-I. If the applicant is a partnership, company, or corporation, the head/manager of the establishment shall secure it.
No. It is required for the S-1 applicant from the Barangay Chairman concerned.
A statement under oath attesting that the applicant has read and is familiar with the pertinent provisions of RA 6425 (as amended) and its implementing rules and regulations, as well as other relevant laws (i.e., RA 3720), and assuring faithful compliance.
The addition of Subsection 5 requiring the installation of appropriate fire extinguishers adequate in number in and around premises where dangerous drugs are kept, and requiring training of concerned personnel on proper use and care.
Any violation is ground for the institution of criminal proceedings in the proper court.
It takes effect fifteen (15) days after its publication in a newspaper of general circulation once a week for two (2) consecutive weeks.
It strengthens administrative safeguards for the keeping of dangerous drugs and exempt dangerous drug preparations by requiring adequate fire extinguishers and training so personnel can properly use and care for them.