In the light of the tremendous progress in the food and pharmaceutical industry, the late Department of Health (DOH) Secretary Francisco Duque, Sr. created a subcommittee on Food and Drugs in the year 1961-1962 to initiate an administration bill to Congress to enact a law that would ensure the safety, purity and quality of foods, drugs, and cosmetics being made available to the public. The Subcommittee on Food and Drug was chaired by the then Undersecretary for Special Health Services, Dr. Rodolfo Canos, with members Dr. Trinidad Pesigan, Director of the Bureau of Research and Laboratories, Mr. Emilio Espinosa of the Bureau of Health Services, Ms. Amor Cita M. Pallera, Pharmacy Adviser, Office of the Secretary of Health, also as Secretary and Liaison to Congress. Thus, on June 22, 1963, Republic Act No. 3720 was passed into law known as the "Food, Drug and Cosmetic Act".

To carry out the provisions of R.A. 3720, the Food and Drug Administration (FDA) was created and offices and laboratories werebconstructed in the DOH San Lazaro Compound, Sta. Cruz, Manila at a cost of about 2.5M. The Food and Drug Administration became operational with the appointment of its first FDA Administrator, Ms. Luzonica M. Pesigan on May 25, 1966 to Dec. 7, 1977 with Mr. Emilio Espinosa as her Deputy. By virtue of R.A. 3720, the powers, functions, and duties of the Division of Food and Drug Testing of the Bureau of Research and Laboratories and the Board of Food Inspection, all personnel together with all their equipment, supplies, records, files and balance of appropriations were transferred to the FDA.

After the retirement of the Deputy Administrator, Mr. Emilio Espinosa, Mr. Arsenio M. Regala took over as Deputy Administrator on June 1, 1972.

With the Integrated Reorganization Plan of 1973, the Narcotic Drugs Division, Bureau of Internal Revenue, Department of Finance was transferred to the Food and Drug Administration headed by Ms. Concepcion M. Fernandez who retired in 1975 with Ms. Rita V. Caoile as the next chief of the same. Mrs. Catalina C. Sanchez took over as the next chief of the Narcotic Drugs Division in 1976.

Mr. Arsenio M. Regala was appointed FDA Administrator on Dec. 13, 1977 upon the retirement of Ms. Luzonica M. Pesigan on Dec. 7, 1977. Ms. Catalina C. Sanchez was appointed Vice Mr. Arsenio M. Regala as Deputy Administrator on January 13, 1978. On his retirement, Mrs. Catalina C. Sanchez was designated Acting Administrator of FDA on April 5, 1982 to Feb. 19, 1984.

On December 2, 1982, Executive Order No. 851 by Section 4, under the Minister of Health Hon. Jesus M. Azurin, the FDA was abolished and created the Bureau of Food and Drugs (BFAD). Ms. Catalina C. Sanchez was appointed the first Director of the BFAD on Feb. 20, 1984 and took her oath on Feb 28, 1984

In 1987, the Bureau moved to its new site in Alabang, Muntinlupa City , and acquired new facilities including state-of-the-art analytical instruments and a modern experimental animal laboratory with the $12M grant from the Government of Japan through Japan International Cooperation Agency (JICA). This new BFAD in Alabang became operational on April 30, 1987.

In 1987, R.A. 3720 was amended by Executive Order 175 to the new title "Foods, Drugs, and Devices and Cosmetics Act."

It was also on the occasion of the inauguration of this new BFAD facility that President Corazon C. Aquino declared publicly the Philippine National Drug Policy (PNDP) together with its four pillars, i.e., Quality Assurance, Rational Use of Drugs, Self- Reliance, and Tailored Procurement. Based on the issuance of E.O. Nos. 174 and 175 amendments to R.A. 5921 "The Pharmacy Law" and R.A. 3720 "Food, Drug, and Cosmetic Act" respectively, the Philippine National Drug Policy Program was organized. Executive Order No. 851 was superseded by E.O. No. 119, s. 1987 under Hon. Alfredo R. A. Bengzon, Sec. of Health, that again reorganized the BFAD on the basis of Administrative Order (A.O.) No. 30, s. 1987, Provisions to Implement the Reorganization of the Department of Health.

Executive Order No. 102 dated May 24, 1999 was signed and redirected the functions and operations of the Department of Health, with then Hon. Alberto G. Romualdez, Sec. of Health, wherein BFAD was expanded with an added Division, the Policy, Planning, and Advocacy Division. The joining of the National Drug Policy workforce with that of BFAD in Alabang, further strengthened the Bureau to meet new challenges in serving the interests of the Filipino people consistent with the Philippine National Drug Policy and the National Health Policy.

On the retirement of Mrs. Catalina C. Sanchez on Feb. 1, 1989, Dr. Cecile P. Gonzales took over (Feb. 1, 1989 - Jan. 31,1991 ), followed by Dr. Quintin L. Kintanar (March 13, 1991 - January 4, 1999); Dr. William D. Torres (Jan. 5, 1999 - August 31, 2002), with Deputy Director for Drugs, Dr. Kenneth Hartigan-Go (June 1, 1999 - June 10, 2001) and the lateral transfer of Mrs. Adelisa C. Ramos, Director III of the DOH Nutrition Service as Deputy Director for Food pursuant to E.O. 102 (November 6, 2000 - Jan 2005). On September 1, 2002, Prof. Leticia Barbara B. Gutierrez was appointed new Director of the Bureau.