Beruflich Dokumente
Kultur Dokumente
(Must know)
Republic Act No.
Common name
Year
RA 5921
Pharmacy Law
RA 3720
RA 6675
RA 8203
RA 6425
RA 9165
RA 7432
RA 9257
RA 9994
RA 7394
RA 7581
RA 9502
RA 9711
RA 8423
Amendments/
supplemental AOS
EO 174
RA 9502
EO 175
AO 55
AO 56
RA 9711
AO 62
AO 63
RA 9502
April 4, 1972
RA 9165
June 7, 2002
None
RA 9257
RA 9994
February 15 2010
April 13 1994
May 7, 1992
June 6, 2008
December 9, 1997
Definition
To do no harm
Duty to promote good
professional relationship
Respect for the individuals right to decide on issues that affect self
Right to be informed and to choose a course of action
right to give or refuse consent relative to release of privileged information
obligation to tell the truth, or honesty
8. A pharmacist in coordination with the government and other health professionals helps in the formulation and
implementation of health care policies, standards and programs designed for the benefit of the society.
Composition of
Council of
Pharmaceutical
Education
PRC Board of
Pharmacy
Candidacy for
Board
Examination
Ratings required
Practice of
pharmacy
Prerequisites for
the Practice of
Pharmacy
Codes
Secret keys
60 days
2
960 hours
10 days
-number of years of pharmacy practice for the pharmacist to comply as board examiner
the decision of board of pharmacy in administrative cases involving pharmacist becomes final
and executor
-members of the board and a chairman- composition of board of pharmacy
-times board exam is given in a year
complete pharmacy internship program
the BOP, upon receipt of formal complaint under oath against any pharmacist, shall furnish an
answer within
OBJECTIVES
BFAD Functions
BFAD Divisions
Adulterated Drugs
or Devices
Misbranded Drugs
and Devices
To issue certificate of compliance with technical requirements to serve basis for issuance of
license and spot-check for compliance with regulations
To levy, assess and collect fees for inspection, analysis and testing of products and materials
submitted in compliance with this Act
To certify batches of antibiotic and antibiotic preparations
Inspection and Licensing Division
Laboratory Division
If it consists in whole or part of any filthy, or decomposed substances
It has been manufactured, prepared or held under unsanitary conditions
It is composed of any poisonous or deleterious substances
It contains any color other than a permissible one
It purports to be an official drug and its strength differs from, or its safety, efficacy, quality or
purity falls below the standards set forth
It has been mixed or packed or substituted so as to reduce safety, efficacy, quality, strength or
purity
Methods, facilities or controls used do not conform to current good manufacturing practices
Labeling is false or misleading
It did not contain (1) the name and place of business of the manufacturer, importer, packer, or
distributor, and (2) an accurate statement of the quantity of contents in terms of weight,
measure or numerical count
If any word or information required is not prominently placed with conspicuousness
If it is for use of man and contains any quantity of narcotic or hypnotic substance
It is not designated solely by a name recognized in an official compendium
Unless its labeling bears (1) adequate directions for use, and (2) such adequate warnings
against use
It purports to be the drug the name of which is recognized in an official compendium
It has been found to be a drug liable to deterioration unless its label bears a statement of
precautions
Its container is so made, formed or filled as to be misleading
It is an imitation of another drug
It is offered for sale under the name of another drug
It is dangerous to health when used in dosage recommended or suggested in the labeling
If it purports to be, or is represented as a drug composed wholly or partly
A. Premises
A signboard in front of the place of the business bearing registered name of the drugstore
A well-ventilated area not less than 15 sq.m. in floor area with concrete tile or wooden flooring
A place suitable for compounding prescription and for washing and sterilizing bottles (compulsory only
for hospital pharmacy)
A suitable and proper place for the adequate storage of drugs and biological products as specified on the
label
A suitable cabinet for keeping poisons and/or dangerous drugs
An adequate water supply
B. References/Documents
Philippine National Drug Formulary (when available)
USP/NF (latest edition)
RA 3720, RA 6675, RA 5921
Remingtons Pharmaceutical Sciences (latest edition)
Goodman and Gilman-Pharmacological Basis of Therapeutics (latest edition)
C. Record Books duly registered with BFAD
Prescription Book
Dangerous Drug Book
Exempt Preparation Book
Poisons Book
Record Book for Selected Non-Prescription Drugs
D. A full-time validly registered pharmacist physically present while drugstore is open for business
E. Others
Invoices indicating the lot number or batch number of the manufacturers stock
REPUBLIC ACT
TITLE
Definition of terms
8423
AN ACT CREATING THE PHILIPPINE INSTITUTE OF TRADITIONAL AND
ALTERNATIVE HEALTH CARE (PITAHC) TO ACCELERATE THE DEVELOPMENT OF
TRADITIONAL AND ALTERNATIVE HEALTH CARE IN THE PHILIPPINES, PROVIDING
FOR A TRADITIONAL AND ALTERNATIVE HEALTH CARE DEVELOPMENT FUND AND
FOR OTHER PURPOSES
"Traditional and alternative health care" - the sum total of knowledge, skills and practices on
health care, other than those embodied in biomedicine, used in the prevention, diagnosis and
elimination of physical or mental disorder.
"Traditional medicine" - the sum total of knowledge, skills, and practice on health care, not
necessarily explicable in the context of modern, scientific philosophical framework, but recognized
by the people to help maintain and improve their health towards the wholeness of their being, the
community and society, and their interrelations based on culture, history, heritage, and
consciousness.
"Biomedicine" - that discipline of medical care advocating therapy with remedies that produce
effects differing from those of the diseases treated. It is also called "allopathy","western medicine",
"orthodox medicine", or "cosmopolitan medicine".
"Alternative health care modalities" other forms of non-allopathic, occasionally non-indigenous
or imported healing methods, though not necessarily practiced for centuries nor handed down from
one generation to another. Some alternative health care modalities include reflexology,
acupressure, chiropractics, nutritional therapy, and other similar methods.
"Herbal medicines" - finished, labelled, medicinal products that contain as active ingredient/s serial
or underground part/s of plant or other materials or combination thereof, whether in the crude state
or as plant preparations.
"Natural product" - those foods that grow spontaneously in nature whether or not they are tended
by man. It also refers to foods that have been prepared from grains, vegetables, fruits, nuts, meats,
fish, eggs, honey, raw milk, and the like, without the use or addition of additives, preservatives,
artificial colors and flavors, or manufactured chemicals of any sort after harvest or slaughter.
"Traditional healers" - the relatively old, highly respected people with a profound knowledge of
traditional remedies.
Governing Body
"Intellectual property rights" - is the legal basis by which the indigenous communities exercise
their rights to have access to, protect, control over their cultural knowledge and product, including,
but not limited to, traditional medicines, and includes the right to receive compensation for it.
Philippine Institute of Traditional and Alternative Health Care. - There is hereby established a
body corporate to be known as the Philippine Institute of Traditional and Alternative Health Care,
hereinafter referred to as the Institute. The Institute shall be attached to the Department of Health.
Its principal flag office shall be in Metro Manila, but it may establish other branches or offices
elsewhere in the Philippines as may be necessary or proper for the accomplishment of its purposes
and objectives.
D. FDA ACT
REPUBLIC ACT
TITLE
objectives
RA 9711
AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF
THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING
LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTING
ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS
INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING
CERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED, AND
APPROPRIATING FUNDS THEREOF
(a) To enhance and strengthen the administrative and technical capacity of the FDA in the
regulation of establishments and products under its jurisdiction;
(b) To ensure the FDA's monitoring and regulatory coverage over establishments and products
under its jurisdiction; and
Director General
(c) To provide coherence in the FDA's regulatory system for establishments and products under its
jurisdiction.
(1) To hold in direct or indirect contempt any person who disregards orders or writs he or she
issues and impose the appropriate penalties following the same procedures and penalties provided
in the Rules of Court;
(2) To administer oaths and affirmations and issue subpoena duces tecum and subpoena ad
testificandumrequiring the production of such books, contracts, correspondence, records, statement
of accounts and other documents and/or the attendance and testimony of parties and witnesses as
may be material to the investigation conducted by the FDA;
(3) To obtain information from any officer or office of the national or local governments,
government agencies and its instrumentalities;
(4) To issue orders of seizure, to seize and hold in custody any article or articles of food, device,
cosmetics, household hazardous substances and health products that is adulterated, counterfeited,
misbranded or unregistered, or drug, in-vitro diagnostic reagent, biologicals, and vaccine that is
adulterated or misbranded, when introduced into domestic commerce pending the authorized
hearing under Republic Act No. 3720, as amended, Executive Order No. 175 (1987), and Republic
Act No. 7394, otherwise known as the Consumers Act of the Philippines;
(5) To call on the assistance of any department, office or agency and deputize members of the
Philippine National Police or any law enforcement agency for the effective implementation of this
Act; and
organization
(6) To exercise such powers and functions as may be necessary for the effective implementation of
this Act."
(1) Center for Drug Regulation and Research (to include veterinary medicine, vaccines and
biologicals);
(2) Center for Food Regulation and Research;
(3) Center for Cosmetics Regulation and Research (to include household hazardous/urban
substances); and
Division per
center
Other divisions
(3) Laboratory Support Division, which shall be responsible for the conduct of research and
appropriate testa and calibration, analyses and trials of products including, but not limited to,
assays, and the conduct of oversight and/or audit of centers conducting bioavailability and
bioequivalence tests and other tests as covered by this Act. It shall likewise provide direct line
support to the centers which shall be separate and distinct per major product category that is
regulated
(a) The Administration and Finance Office headed by the deputy director-general for
administration and finance shall have, at least, the following divisions: the Human Resource
Development Division; Property and Logistics Management Division; Human Resource
Management Division; Assets and Financial Management Division; and the Information and
Communication Technology Management Division.
(b) The Policy and Planning Office which shall be under the Office of the Director-General shall
have, at least, a training, advocacy and communications division and shall monitor the performance
of the centers for product research and evaluation and standards development.
(c) The Field Regulatory Operations Office headed by the deputy director-general for field
regulatory operations shall include, among others, all the field offices, field or satellite laboratories
and the regulatory enforcement units.
(d) The Legal Services Support Center shall provide legal services to the entire FDA and shall be
directly under the Office of the Director-General
(e) The FDA shall establish a Regulatory Enforcement Unit (REU) for a period not exceeding five
(5) years from the effectivity of this Act. It shall be composed of at least five (5) qualified
personnel in every region who shall be directly under the control and supervision of the Deputy
Director-General for Field Regulatory Operations and shall be administratively supported by the
field offices.
Bear arms, wear official uniforms and insignias and shall be classified as law enforcement
agents;
Serve and execute rulings, orders, and decisions of the Director-General of the FDA; and
Execute and serve search warrants and arrest warrants issued by the courts in connection
with violations under this Act and related laws concerning the regulation of health
products.
(f) testing laboratory each in Luzon, Visayas and Mindanao, which shall have the necessary and
appropriate state-of-the-art laboratory equipment and personnel complement.
- The main testing laboratories at the central office shall be maintained and shall serve as a support
unit to the centers
- The existing laboratories in Cebu and Davao will be upgraded and transformed as quality
assurance laboratories, while another one will be established in Subic, Zambales
(g) Field Offices- The field offices shall be comprised of the following: (a) licensing, inspection
and compliance division, which shall have charge of the inspection of food, drugs and cosmetic
establishments engaged in their manufacture, importation, distribution, and sale; (b) satellite
laboratory division; and (c) administrative division.
Regulation
Division I
(Outlets)
Regulation
Division II
(Manufacturers)
c. drug producer
d. drug department
a. importer/exporter in bulk
b. distributor/importer/exporter, which is at the same time a manufacturer or producer
e. food and food products manufacturer/processor
f. household hazardous substance manufacturer
F. ASEAN Harmonisation
In 2015, the ten countries which form ASEAN ("Association of Southeast Asian Nations") will implement the
ASEAN Economic Community ("AEC") with the goal of creating a common economic community in Southeast Asia,
characterized by a single market and production base. The establishment of this community has the potential to
substantially change the way we do business and interact with our neighboring countries.
In order to achieve the ASEAN's objectives, there is a need to eliminate the barrier of having different laws,
regulations and standards governing goods and services. Thirteen sectors have been identified as areas of importance,
where efforts to achieve harmonization should be concentrated. The Healthcare industry, including pharmaceuticals and
other relevant products, has been particularly identified as one of these 13 sectors.
The ASEAN Pharmaceutical Product Working Group ("PPWG"), the regulatory body responsible for overseeing the
ASEAN harmonization efforts, has formally stated the following objective:
"To develop harmonization schemes of pharmaceutical regulations of the ASEAN member countries to
complement and facilitate the objective of AFTA, particularly, the elimination of technical barriers to trade posed
by these regulations, without compromising drug quality, safety and efficacy."
In terms of the registration of pharmaceutical facilities, compliance with the Pharmaceutical Inspection Cooperation
Scheme ("PIC/S") standards is the end goal of the ASEAN harmonization. Although some countries have already
enforced this, not all countries have fully adopted the PIC/S compliance requirement.
Components of the
National Drug
Policy
AO 62 s 1989
If the brand name is written on the prescription, it should be in parentheses and be written
under the generic name.
VIOLATIVE PRESCRIPTIONS
Where the generic name is not written
Where the generic name is not legible and a brand name which is legible is written
When the brand name is indicated and instructions added (such as No substitution) which
tend to obstruct, hinder, or prevent proper generic dispensing
What to do with VIOLATIVE PRESCRIPTIONS?
Do not fill.
Keep and report to the nearest DOH office for appropriate action
Pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the
proper prescription.
ERRONEOUS PRESCRIPTIONS
Where the brand name precedes the generic name
Where the generic name is the one in parentheses
Where the brand name is not in parentheses
What to do with ERRONEOUS PRESCRIPTIONS?
Shall be filled
Keep and report to the nearest DOH office for appropriate action
AO 63 s 1989
IMPOSSIBLE PRESCRIPTIONS
When only the generic name is written but is not legible
When the generic name does not correspond to the brand name
When both the generic name and the brand name are not legible
When the drug product prescribed is not registered with BFAD
What to do with IMPOSSIBLE PRESCRIPTIONS?
Shall not be filled
Keep and report to the nearest DOH Office for appropriate action
Pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the
proper prescription.
RULES AND REGULATIONS TO IMPLEMENT DISPENSING REQUIREMENTS UNDER
THE GENERICS ACT OF 1988
Generic dispensing: dispensing the patients choice from among generic equivalents (same
API, dosage form and strength)
Inform the patient of all available drug products generically equivalent to th prescribed drug.
All drug outlets shall post in a conspicuous place in their establishment a list of drug products
using generic names with their brand names.
REPUBLIC ACT
TITLE
Additional
Benefits to senior
citizens
Expanded
coverage of
discounts
Compulsory License is a license issued by the Director General of the Intellectual Property
Office to exploit a patented invention without the permission of the patent holder, either by
manufacture or through parallel importation;
Drug outlet refers to drugstores, pharmacies, and any other business establishments which sell
drugs and medicines;
Essential drugs list or national drug formulary refers to a list of drugs prepared and periodically
updated by the Department of Health on the basis of health conditions obtaining in the Philippines
as well as on internationally accepted criteria
Multisource pharmaceutical products refers to pharmaceutically equivalent or pharmaceutically
alternative products that may or may not be therapeutically equivalent. Multisource pharmaceutical
products that are therapeutically equivalent are interchangeable
TRIPS Agreement or Agreement on Trade-Related Aspects of Intellectual Property Rights refers
to the international agreement administered by the WTO that sets down minimum standards for
many forms of intellectual property regulation; and
Amendment in the
definition of drugs
or medicine
Drugs and medicines refers to any chemical compound or biological substance, other than food,
intended for use in the treatment, prevention or diagnosis of disease in humans or animals,
including but not limited to:
(1) any article recognized in the official United States Pharmacopoeia-National Formulary
(USP-NF), official Homeopathic Pharmacopoeia of the United States, Philippine
Pharmacopoeia, Philippine National Drug Formulary, British Pharmacopoeia, European
Pharmacopoeia, Japanese Pharmacopoeia, Indian Pharmacopoeia, any national
compendium or any supplement to any of them;
(2) any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease in humans or animals;
(3) any article other than food intended to affect the structure or any function of the human
body or animals;
(4) any article intended for use as a component of any articles specified in clauses (1), (2),
and (3) not including devices or their components, parts, or accessories; and
(5) herbal and/or traditional drugs which are articles of plant or animal origin used in folk
medicine which are:
(i) recognized in the Philippine National Drug Formulary;
(ii) intended for use in the treatment or cure or mitigation of disease symptoms, injury or body
defects in humans;
(iii) other than food, intended to affect the structure or any function of the human body;
(iv) in finished or ready-to-use dosage form; and
(v) intended for use as a component of any of the articles specified in clauses (i), (ii), (iii), and
(iv);
AMENDMENTS
TO REPUBLIC
ACT NO. 8293,
OTHERWISE
KNOWN AS THE
INTELLECTUAL
PROPERTY
CODE OF THE
PHILIPPINES
>President have the power to impose maximum retail prices over any or all drugs and medicines as
enumerated in Section 23, upon recommendation of the Secretary of the Department of Health
MAXIMUM
RETAIL PRICE
DURATION :
power to impose MRP over drugs and medicines shall be exercised within such period of time as
the situation may warrant as determined by the President of the Philippines. (17)
>. Drugs and Medicines Price Monitoring and Regulation Authority of the Secretary of the
Department of Health.
>Functions and Responsibilities of the Secretary of the Department of Health.
Power to Recommend the Maximum Retail Price of Drugs and Medicines Subject to Price
Regulation,
Power to Include Other Drugs and Medicines in the List Subject to Price Regulation,
Power to Implement Cost-Containment and Other Measures,
Power to Impose Administrative Fines and Penalties,
Power to Deputize Government Entities, or
Other Powers Necessary to Implement Provisions of this Chapter, shall be immediately
operative
COVERAGE:
the imposition of the MRP will be at all levels of the supply chains i.e manufacturers price,
traders price, distributors price, wholesalers price and retailers price.
DISCOUNTS:
Senior Citizens Discount and Discount for People with Disability shall continue to be honored
even if
the drug and medicines are subject to MRP (n)
Display of Maximum Retail Price Fixed and Approved by Order of the President of the Philippines
for Drugs and Medicines Subject to Price Regulation.
- manufacturer, importer, distributor, wholesaler, trader, or retailer of a drug and medicine
intended for sale.
- printed on the label of the immediate container of the drug and medicine and the
minimum pack thereof offered for retail sale with the words RETAIL PRICE NOT TO
EXCEED preceding it, and UNDER DRUG PRICE REGULATION on a red strip
F. Price Act
REPUBLIC ACT
TITLE
Definition of terms
7581
It is the act providing protection to consumers by stabilizing the prices of basic necessities and
prime commodities.
Basic necessities- includes rice, corn, bread, fish and drug classified essential by the DOH
Buffer fund- it is a contingent fund in the budget of the implementing agency which shall
not be used in normal or regular operations
Price ceiling- maximum price at which any basic necessities or prime commodities may be
sold to the general public
AT a (declared state of rebellion, martial law, state of calamity) otherwise declared by
the president, prices of basic commodities shall be automatically be frozen at their
prevailing price or automatic price control
Prohibited acts
Profiteering- the sale or offering for sale of any basic necessity or prime commodity at a
price grossly in excess of its true worth
Cartel- it is a combination of agreement between two or more persons engaged in the
activity of any basic commodity designed to artificially and unreasonably increase or
manipulate the price
Panic buying- abnormal phenomenon where consumers buy basic necessities and prime
commodities grossly in excess of their normal requirement resulting in undue shortages of
such goods to the prejudice of less previledge
Hoarding- it is the undue accumulation by a person or combination of persons of any basic
necessity or prime commodity beyond his or their normal inventory levels
Records Required
of Pharmacists
Composition of
the Dangerous
Drugs Board
RA 6425
THE DANGEROUS DRUGS ACT
a. Prohibited Drug
- including opium and its active components and derivatives, such heroin and morphine; coca
leaf and its derivatives principally cocaine; alpha and beta eucaine; hallucinogenic drugs such
as mescaline, lysergic acid diethlamide (LSD) and other substances producing similar effects;
Indian hemp and its derivatives; all preparations made from any of the foregoing; and other
drugs and chmical preparations, whether natural or synthetic, with the physiological effects of
a narcotic or a hallucinogenic drug.
b. Regulated Drug
- which includes self-inducing sedatives, such as secobarbital, Phenobarbital, pentobarbital,
barbital, amobarbital ad other drug which contains a salt of a derivative of a salt of barbituric
acid; any salt, isomeror salt of an isomer, of amphetamine, such as Benzedrine or Dexedrine, or
any drug which produces a physiological actions similar to amphetamine; and hypnotic drug,
such as methaqualone, nitrazepam; or any other compound producing similar effects.
Every pharmacist dealing in dangerous drugs shall maintain and keep an original record of sales,
purchases, acquisitions and deliveries of dangerous drugs, indicating therein the license number
and address of the pharmacist; the name, address, and license number of the manufacturer, importer
or wholesaler from whom dangerous drugs have been purchased or acquired; the date of
acquisition or purchase; the name, address and class A residence certificate number of the buyer;
the serial number of the prescription and the name of the doctor, dentist, veterinarian or practitioner
issuing the same; and the date of sale or delivery.
A certified true copy of such record covering a period of six calendar months, duly signed by the
pharmacist or owner of the drugstore or pharmacy, shall be forwarded to the Board within fifteen
days following the last day of every June and December of each year, copy furnished the city or
municipal health officer concerned
a. DOH Secretary or representative
b. DOH Undersecretary or representative
c. Executive Director of the Dangerous Drugs Board
d. DOJ Secretary or representative
e. Department of National Defense or representative
f. DepEd Secretary or representative
Important numbers
and facts to
remember
Possession will
result to maximum
penalty
Authorities