Administrative Code of 1987
Section 15. Office for Standards and Regulations. - The Office for Standards and Regulations, headed by an Undersecretary and supported by an Assistant Secretary, shall include three (3) bureaus and one (1) national office that shall be responsible for the formulation of regulatory policies and standards over the various areas of concern in the health sector, whose implementation shall be the general responsibility of the Department's regional field offices. The same bureaus shall also be responsible for those areas of activity covered by regulatory policy to provide the Secretary with current information on the status of these regulated areas of activity and to provide the Secretary with a basis for preliminary evaluation of the efficiency of the Department's field offices in performing their regulatory functions. The same bureaus shall conduct studies and research pertinent to their areas of responsibility . In certain instances the bureaus may also perform consultative, training and advisory services to the practitioners and institutions in the area of regulated activity. The same bureaus and national office are the following:
(1) Bureau of Research and Laboratories which shall develop and formulate plans, standards and policies for the establishment and accreditation and licensing of laboratories; blood banks and entities handling biological products, provide consultative, training and advisory services to public and private laboratories; and conduct studies and research related to laboratory procedures and operations;
(2) Bureau of Food and Drugs which shall act as the policy formulation and sector monitoring arm of the Secretary on matters pertaining to foods, drugs, traditional medicines, cosmetics and household products containing hazardous substances, and the formulation of rules, regulations and standards in accordance with Republic Act 3720 (1963), as amended by Executive Order No. 175, s. 1987, and other pertinent laws for their proper enforcement; prescribe general standards and guidelines with respect to the veracity of nutritional and medicinal claims in the advertisement of food, drugs and cosmetics in the various media, to monitor such advertisements; advise the Department's field offices to call upon any erring manufacturer, distributor, or advertiser to desist from such inaccurate or misleading nutritional or medicinal claims in their advertising; should such manufacturer, distributor, or advertiser refuse or fail to obey the desistance order issued by the Bureau, he shall be subject to the applicable penalties as may be prescribed by law and regulations; the Bureau shall provide consultative, training and advisory services to all agencies and organizations involved in food and drug manufacturing and distribution with respect to assuring safety and efficacy of food and drugs; conduct studies and research related to food and drug safety; maintain a corps of specially trained food and drugs inspectors for assignment to the various field offices of the Department; while these inspectors shall be under the technical supervision and guidance of the Bureau, they shall be under the administrative supervision of the head of the field office to which they shall be assigned, the latter being responsible for regulatory program implementation within the geographic area of his jurisdiction;
(3) Bureau of Licensing and Regulation which shall formulate policies and establish the standards for the licensing and regulation of hospitals, clinics and other health facilities; establish standards that shall be the basis of inspections and licensure procedures of the Department's field offices; and provide consultative, training and advisory services to field offices on the conduct of licensing and regulatory functions over hospitals, clinics and other health facilities.
(4) National Quarantine Office which shall formulate and implement quarantine laws and regulations and, through its field offices, exercise supervision over rat-proof zones in designated international ports and airports and over medical examination of aliens for immigration purposes.