PHARMACEUTICAL

LEGISLATION & HISTORY

Philippine Pharmaceutical
Regulatory Affairs, Laws & Ethics

Chapter 1
■ AGENDA
■ Fundamentals of the Law
■ Stalinon, Thalidomide & other Therapeutic
Disasters
■ History of Drug Regulation in the US
■ History of Drug Regulation in the UK
■ History of Drug Regulation in the Philippines
■ General Terminology Related to Pharmacy Law
■ Abbreviations in Pharmacy Law
■ References
■ The pharmacy laws in the Philippines are
regulated by 3 major government agencies
■ Food & Drug Authority (FDA)
■ This is where all the pharmaceuticals are regulated, this
includes drugs, food, cosmetics, medical device, and
household hazardous substances
■ Licensings, inspections, product registrations are
conducted by this bureau to ensure regulation
■ Dangerous Drugs Board (DDB)
■ This is the policy making body for the dangerous drugs
■ Philippine Drug Enforcement Agency (PDEA)
■ This is the implementing body of the DDB
■ The Legal System of the Philippines
■ Statutory Law
■ These are laws that have been passed by legislative bodies. In the
Philippines, this is mainly the senate and the congress
■ Regulatory Law
■ These are laws promulgated by the government agencies for the
enforcement and understanding of the law
■ Common Law
■ These are laws that encompasses those areas of law that have
evolved over hundred of years of judicial decisions
■ Cannon Law
■ These are the religious laws which are accepted in most countries –
the separation of church and state, mainly based on scriptures
■ Administrative Order
■ Enforceable order issued by a public authority (under the powers conferred
to it by one or more statutes) to an individual or an organization to take
certain corrective action, or to refrain from an activity
■ Bureau Circular
■ These are short notes sent to remind or inform people within FDA
■ Executive Order
■ These are legally binding orders given by the President, acting as the head
of the Executive Branch, to Federal Administrative Agencies. Executive
Orders are generally used to direct federal agencies and officials in their
execution of congressionally established laws or policies. However, in
many instances they have been used to guide agencies in directions contrary
to congressional intent
■ Memorandum Circular
■ These are short notes sent to remind or inform people
■ Presidential Decree
■ An edict or law made by the President of the Philippines
■ Republic Act
■ These are laws passed by the senate and congress which are later approved
by the President of the Philippines
■ In France, 102 people had died and 100 more
were affected by paraplegia in 1957 as a result
of the administration of Stalinon capsules for
the treatment of boils
■ The Stalinon episode had resulted from a
formulation error – Stalinon capsules for
marketing contained 15mg diiodoethylin and
100mg isolinoleic acid esters
■ Clinical trials were carried out with capsules
containing only 3mg diiodoethylin (one-fifth
of the marketed dose)
■ Subsequent studies in animals and in human
confirmed the neurotoxicity of diiodoethylin,
which was characterized by intramyelinic
vacuolation and astrocyte swelling with no
evidence of neuronal degeneration.
■ This tragedy, however, was a foretaste of an
ever greater disaster – that of thalidomide…
■ Thalidomide, is responsible for over 10,000 human birth
deformities such as phocomelia

■ Thalidomide was first marketed as a sedative in Europe in the

1950s. The German pharmaceutical company Gruuenthal
released the drug in 1957. Thalidomide's teratogenic properties
were not known at that time, and it was prescribed as a
sleeping pill and anti-nausea medication to treat morning
sickness in pregnant women
■ The impact in the United States was minimized when
pharmacologist and M.D. Frances Oldham Kelsey
refused Food and Drug Administration (FDA)
approval for an application from the
Richardson-Merrell company to market thalidomide,
saying further studies were needed
■ The FDA in the United States had reportedly refused
to approve the drug until further testing was done.
After the tragic discovery that the drug was more
harmful than beneficial, it was banned worldwide
■ The Australian obstetrician William McBride and the
German pediatrician Widukind Lenz suspected a link
between birth defects and the drug, and this was
proved by Lenz in 1961
■ The UK government set up in August 1962 the
joint Subcommittee of the English and Scottish
Standing Medical Advisory Committees, under
the chairmanship of Lorh Cohen of Birkenhead,
with the following terms of reference to advise
the Minister of Health and the Secretary of State
for Scotland on what measures are needed:
■ To secure adequate pharmacological and safety testing
and clinical trials of new drugs before their release for
general use;
■ To secure early detection of adverse effects arising
after their release for general use; and
■ To keep doctors informed of the experiences of such
drugs in clinical practice
■ Thalidomide is currently marketed by Celegen as Thalomid. It was initially
approved by the FDA in 1996 for limited distribution in experimental
testing of fatal diseases, but 1997 and 1998 saw its approval for other
diseases, including Hansen's Disease, leprosy, multiple myeloma, Behcet
Disease, Sjogren syndrome, lupus, and AIDS, among others
■ Examples in the Philippine Setting…
■ Unregistered Antimicrobial Drug
■ Ampicillin Sodium
■ Unasyn Powder for Injection
■ Carbamazepine
■ Unregistered Chinese “Natural” Medicine
■ Slimming Formulations
■ Antiperspirant
■ Hairdyes

■ On the other hand, polio has returned to several

nations where parents stopped vaccinating their
children in 2003, believing rumors that the vaccine
causes infertility and spreads HIV infection
■ Ampicillin Sodium Case
■ 10 cases of skin reactions
following administration
of Ampicillin Sodium
from Sultan Kudarat
■ Another 7 cases were
reported from Aurora
province
■ Batch not certified
■ FDA confiscated all
perenteral preparations
and issued a warning
■ Unasyn Powder for
Injection
■ Lot number: 239395
■ Manufacturing date:
01-2002
■ Expiry date: 01-2005
■ Complained reaction
was Dyspnea
■ Laboratory analysis
showed absence of
active ingredient
■ Carbamazepine 200mg tablet
■ Imported from India
■ Patient affected is 15 year old female,
hospitalized due to severe maculopapular
rashes all over the body which appeared on the
3rd day of drug intake
■ Oral / neck areas
■ Abdominal areas
■ Neck and chest areas
■ Extremities
■ Unregistered Chinese “Natural” Medicine
■ Claims to be effective for arthritis
■ Label claimed to contain natural ingredients
■ No report of any adverse effects following its use
■ Following analysis, it was found that the pills
contained phenylbutazone and an unspecified
steroid compound
■ Also, the product was not registered at FDA
■ Warnings to stop using the product were issued
■ 19 year old died following use of Power-up
capsules for slimming
■ Symptoms were:
■ Package insert of the product indicated
presence of ephedra, a regulated drug and
bladderwrack (possibly arsenic from kelp)
■ Warning were also issued to the public
■ Cosmetic products are consumer goods that are basically
conceived to make people feel comfortable and happy after
its use
■ But there are possibilties of an adverse event…
■ Allergic reaction to cosmetics such as a poorly formulated
antiperspirant may happen
■ BLONDE AMBITION
■ 2 cases of blindness as ADR reports were received for 2

different brands of hair dyes

■ BFAD M.C. No. 19-A s. 1992 sec. 4B-c then followed

which states that hair dyes shall bear the statement:

WARNING: “This product contains ingredients which
may cause skin irritation… Product must not be used for
dyeing the eyelashes or eyebrows, may cause blindness”
■ This warning must be

seen on the carton or

outer label and package
inserts
■ HISTORY OF DRUG REGULATION IN
THE US
■ U.S. Food and Drug Administration · 10903 New
Hampshire Ave.
Silver Spring, MD 20993 · 1-888-INFO-FDA
(1-888-463-6332)
■ HISTORY OF DRUG REGULATION IN
THE UK
■ Elaborately gilded
drug jar for
storing mithridate
■ Dr. William Heberden (1710-1801)
■ Best known for his description of “Herbeden’s nodes” in
osteoarthritis
■ Many physicians in the early 18th century had doubts as to
whether Mithridatium was the universal panacea of all
illness as claimed
■ Made the ultimate mortal attack of Mithridatium
■ “To produce it each batch had to be submitted to the
Medical Research Council (MRC) for approval before
marketing”
■ Perhaps in the final analysis, the contribution of
Mithridatium to modern medicine was that the
concerns about quality stimulated the earliest
concepts of medicine regulation
■ Medicines & Health Care Products Regulatory
Agency (MHRA) of UK
■ The Medicines Inspectorate was established within the
Medicines Division of the Department of Health and Social
Security (DHSS) in 1971 in accordance with the Medicines
Acts 1968 and 1971. It was set up to inspect and ensure
compliance with Standard Provisions (including GMP and
GDP) by all applicants for, and holders of, manufacturer's
and wholesale dealer's licences in the UK
■ Over the next few years it absorbed the functions of the
Department of Health (DH) Inspectorate under the repealed
Therapeutic Substances Act, which was only concerned
with biological products, and expanded to inspect
manufacturers in other countries exporting products to the
UK
■ Medicines & Health Care Products Regulatory Agency
(MHRA) of UK
■ In 1975 inspections of NHS manufacturing units were begun at the
behest of the then Secretary of State for Health. With the removal of
Crown Immunity in 1991 these units were required to hold licences and
became subject to statutory inspection
■ In April 1989 the MCA was established following the Cunliffe-Evans
report into the control of medicines. This brought two major changes.
Firstly, the Agency was organised into multi-disciplinary functional
groups. This has gradually evolved over the years to reach the present
organisation based on pre- and post-licensing activities. The
Inspectorate became part of the Inspection and Enforcement Division
responsible for inspection, licensing, testing and other activities
associated with manufacture and distribution. Secondly, the Agency
was to be entirely funded by licence holders on the basis of user fees
■ In 1991 requirements for manufacturing authorisations and GMP were
harmonised within the European Community. The UK no longer
inspected or exchanged Pharmaceutical Inspection Convention (PIC)
reports on manufacturers in other EC Member States
■ 151 Buckingham Palace Road
Victoria
London, SW1W 9SZ
■ Telephone (weekdays 9:00 -17:00): 020 3080 6000
Fax: 0203 118 9803
Email: [email protected]
■ HISTORY OF DRUG REGULATION IN THE
PHILIPPINES
■ In 1961-62, the late Department of Health (DOH) Secretary
Francisco Duque Sr. created a subcommittee on Food and
Drugs in order to get 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 Caños, 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
■ On June 22, 1963, Republic Act No. 3720, known as the
“Food, Drug and Cosmetic Act”, was passed into law
■ HISTORY OF DRUG REGULATION IN THE PHILIPPINES
■ The Food and Drug Administration (FDA) was created to carry out the
provisions of R.A. 3720. 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
■ Offices and laboratories were constructed in the DOH San Lazaro
Compound in Sta. Cruz, Manila
■ The FDA's first Administrator, Ms. Luzonica M. Pesigan was instated
on May 25, 1966 and continued until Dec. 7, 1977
■ Mr. Emilio Espinosa was Deputy Director. After his retirement, Mr.
Arsenio M. Regala took over on June 1, 1972
■ HISTORY OF DRUG REGULATION IN THE
PHILIPPINES
■ 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. Conception M.
Fernandez. She retired in 1975 and was succeeded by Ms.
Rita V. Caoile, and then by Mrs. Catalina C. Sanchez in
1976
■ On December 2, 1982, Executive Order No. 851 by Section
4, under the Minister of Health Hon. Jesus M. Azurin,
abolished the FDA and created the Bureau of Food and
Drugs (BFAD). Mrs. Catalina C. Sanchez was appointed
the first Director of the BFAD on Feb. 20, 1984 and took
her oath on Feb. 28, 1984
■ HISTORY OF DRUG REGULATION IN
THE PHILIPPINES
■ In 1987, R.A. 3720 was amended by Executive
Order 175 to the new title “Foods, Drugs, Devices
and Cosmetics Act”. 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 the Japan
International Cooperation Agency (JICA). This
new BFAD in Alabang became operational on
April 30, 1987
■ HISTORY OF DRUG REGULATION IN THE PHILIPPINES
■ It was also on the same occasion of the inauguration of this new BFAD
facility that Pres. 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 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".
■ HISTORY OF DRUG REGULATION IN THE
PHILIPPINES
■ Executive Order No. 102 was signed on May 24, 1999. It
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
■ HISTORY OF DRUG REGULATION IN THE
PHILIPPINES
■ 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 – Jan. 4, 1999);
■ Dr. William D. Torres (January 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 Ramos, Director III of the DOH Nutrition
Service as Deputy Director for Food pursuant to E.O. 102
(November 6, 2000 – January 2,2005)
■ On September 1, 2002, Prof. Leticia Barbara B. Gutierrez
was appointed new Director of the Bureau
■ Quintin L. Kintanar (4th Director)
■ Leticia Barbara B. Gutierrez (5th Director)
■ HISTORY OF DRUG REGULATION IN
THE PHILIPPINES
■ Nazarita T. Tacandong, a pharmacist assumed
office as Acting Director IV last June 2009 and
became Acting Director III under temporary status
due to CESO (Career Executive Service Officer)
examination requirements of the government
■ Suzette H. Lazo, a medical doctor became Acting
Director IV on November 2010
■ These two officials are currently running the Food
& Drug Administration of the Philippines
■ Nazarita T. Tacandong (6th Director)
■ Suzette H. Lazo (7th Director)
■ Civic Drive, Filinvest Corporate City, Alabang,
Muntinlupa City, 1781,Philippines
■ GENERAL TERMINOLOGY RELATED TO
PHARMACY LAW
■ Bioethics
■ This is the study of controversial ethics brought

about by advances in biology and medicine

■ Jurisprudence
■ This is defined as a system of laws. It is the science of
philosophy of laws
■ Legislation
■ This is the act or process of law making
■ Parliament
■ A Parliament is the supreme legislative (law-making) body
of a democratic nation
■ ABBREVIATIONS IN PHARMACY LAW
■ Philippine Abbreviations
■ BAI Bureau of Animal Industry
■ BFAD Bureau of Food & Drugs (now FDA)
■ BHDT Bureau of Health Device & Technology (now Center for
Health Device Regulation, Radiation Health, and Research)
■ BIR Bureau of Internal Revenue
■ BnB Botika ng Barangay
■ BoC Bureau of Customs
■ CLIDP Certificate of Listing of Identical Drug Product
■ CPR Certificate of Product Registration
■ CSP Compassionate Special Permit
■ DDB Dangerous Drugs Board
■ DOLE Department of Labor and Employment
■ DOH Department of Health
■ DSAP Drugstores Association of the Philippines
■ DTI Department of Trade & Industry
■ e-EDPMS Electronic Essential Drug Price Monitoring System
(now EDPMS)
■ EDPMS Essential Drug Price Monitoring System
■ FDRO Food & Drug Regulatory Officer
■ Philippine Abbreviations (continued)
■ IPAP Industrial Pharmacist Association of the Philippines
■ LICD Legal Information & Compliance Division
■ LTH License to Handle
■ LTO License to Operate
■ JPPhA Junior Philippine Pharmaceutical Association
■ NDIC National drug Information Center
■ NFC National Formulary Committee
■ PACOP Philippine Association of Colleges of Pharmacy
■ PCPI Philippine Chamber of the Pharmaceutical Industry
■ PDEA Philippine Drug Enforcement Agency
■ PNDF Philippine National Drug Formulary
■ PNDP Philippine National Drug Policy
■ PPAD Policy Planning & Advocacy Division
■ PPhA Philippine Pharmacists Association
■ PRC Professional Regulations Commissions
■ PSD Product Services Division
■ PSHP Philippine Society of Hospital Pharmacists
■ SEC Securities & Exchange Commision
■ REFERENCES
■ Books
■ Pharmacy Terminology, 2010, Jahangir Moini MD
■ Pharmacy Management, Leadership, Marketing, and Finance, 2011,
Marie A. Chrisholm-Burns et al
■ Pharmaceutical Jurisprudence & Ethics, 6th Edition, 2009, Olivia
M. Limuaco PhD & Mary Jane C. Cruz MS
■ Philippine National Drug Formulary, Volume 1 / 7th Edition, 2008,
BFAD
■ The Textbook of Pharmaceutical Medicine, 6th Edition, 2009, John
P. Griffin
■ Notes
■ Training / Workshop for Regulatory Affairs Officers Handling
Cosmetics, 2006, Cynthia C. Diza MD
■ Electronic
■ FDA Website
■ MHRA Website