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(NAR) VOL. 5 NO. 4 / OCTOBER - DECEMBER 1994

[ DDB BOARD REGULATION NO. 1, s. 1994, June 09, 1994 ]

AMENDING BOARD REGULATION NO. 4, SERIES OF 1991 BY PROVIDING ADDITIONAL REQUIREMENTS FOR THE REGISTRATION AND ISSUANCE OF S - LICENSES TO DRUG ESTABLISHMENTS, HOSPITALS, PRACTITIONERS, AND OTHER QUALIFIED APPLICANTS



Pursuant to its powers under Paragraphs (a) and (1), Section 36 of RA 6425, as amended, Board Regulation No. 4, Series of 1991, is hereby amended to read as follows:

SECTION 1. Section 2, ARTICLE II, REGISTRATION AND FEES, is hereby amended thus:

"Section 2. Registration — All applications for registration and for the issuance of a license to deal in dangerous drugs and exempt dangerous drug preparations shall be filed with the Dangerous Drugs Board, or with the Metro Manila area. Persons or entities situated outside of the Metro Manila area shall file their applications with the special processing officers deputized as such by the Board.

The requirements for initial or renewal of registration and the issuance of the corresponding license to deal in Dangerous Drugs Licenses or Exempt Dangerous Drugs:

A. Requirements for S-1, S-3, S-4, S-5-C-and S-5-I (License Holders)

1. Renewal License to operate (current) for 19___ from BFAD
2. Business Permit (Current)
3. Mayor's Permit (Current)
4. PRC — Pharmacists (Unexpired/Updated)
5. PTR — 19 (Current)
6. Letter from the owner of the applicant-establishment authorizing a pharmacist to apply for and secure the S-license from the Dangerous Drugs Board. In the event that the authorized Pharmacist is unable to undertake the follow-up, the owner of the establishment shall issue an authorization to a new designee who shall be the temporary representative of the applicant.
7. SEC Registration

B. Requirements for the issuance of S-2 Licenses (to Physicians/ other authorized practitioners)

1. Privilege Tax Receipt (PTR) 19__ (current)
2. PRC — Physician (unexpired/Updated)
3. If the designee/designated representative is unable to undertake the follow-up, the applicant practitioner must issue another letter of authorization to a new designee.

C. Other requirements (for all applicants for S-Licenses of establishment and hospital pharmacy):

1. NBI Clearance in favor of the applicant. If the applicant is a partnership, Company or Corporation, the Head/Manager of the Establishment shall secure the clearance. (Required only for S-3, S-4, S-5-C- and S-5-I)
2. Certificate of Integrity and Good Moral Character from the Barangay Chairman concerned is required for S-1 applicant.
3. A statement under oath attesting to the fact that the applicant for S-License 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, as amended) and assuring that such laws, rules and regulations shall be faithfully complied with."

SECTION 2. SECTION 77 — Safeguarding of dangerous drugs and exempt dangerous drug preparations, ARTICLE VII, Administrative Provisions, is hereby amended by the addition of sub-section 5 after sub-section 4. (A), to read as follows:

"5. Fire Extinguishers. Appropriate fire extinguishers adequate in number shall be installed in and around the premises where the dangerous drugs and dangerous drug preparations are kept. To ensure maximum and intelligent utilization of the fire extinguishers, the establishment shall see to it that concerned personnel are made to undergo training on the proper use and care of the said equipment."

SECTION 3. Any violation hereof shall be ground for the institution of criminal proceedings in the proper court.

SECTION 4. Effectivity — This Regulation shall take effect fifteen (15) days after its publication in a newspaper of general circulation once a week for two (2) consecutive weeks.

Adopted: 9 June 1994

(SGD.) MANUEL G. ROXAS, M.D., M.P.H.
(Undersecretary of Health for Public Health Services)
Vice-Chairman and Presiding Officer

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