INTERNSHIP1 REVIEWER

EXERCISE 1: General Requirement

for the Issuance of LTO
ARTICLE IV PRACTICE OF
PHARMACY
Section 25 (Sales of Medicines,
Pharmaceuticals, Drugs, and
Devices)
-No MPDD shall be compounded,
dispensed, sold, resold to the
consuming public -> except through
Prescription Drugstore or Hospital
Pharmacy duly established in
accordance with the provision of this
Act
-Pharmaceutical, drug or biological
manufacturing establishments,
importers and wholesaler of DMBP ->
shall not sell their products for resale
->except only to Retail Drugstores,
Hospital Pharmacies or to other Drug
Wholesalers under the supervision of
registered pharmacists duly
established and licensed under the
RETAIL DRUG LAW (as amended by
P.D. 1363 on May 1, 1978)
Section 27 (Pharmacist Required
and Compensation)
-every pharmacy (drugstore or
hospital pharmacy) -> whether
government owned or private person
or firms shall at all times be under
the personal and immediate
supervision of a duly registered
pharmacist
Section 28 (Display of Certificate
Required)
-It shall be the duty every pharmacist
in practice to display his certificate of
registration (prominent and
conspicuous place in the pharmacy,

drugstore, hospital pharmacy, drug

establishment)
-No pharmacist shall, allow his
certificate of registration be displayed
in such establishments where he is not
employed in.
Section 33 (Inhibition Against Use
of Cipher or Unusual Terms in
Prescription and Prescription
Switching)
-No pharmacist shall compound or
dispense prescription, recipes, or
formulas which are written in ciphers,
codes or secret keys (not that of which
is used din PNDF
-No pharmacist dispensing or
compounding prescription shall
substitute the drugs or drugs called for
it the prescription with any other drug
substance or ingredient w/o prior
consultation and written consent of
the person prescribing
Section 39 (Requirements for
Opening and Operations of
Drugstores and Pharmacies)
-Minimum requirement necessary for
the opening and operation of
drugstores and pharmacies shall be in
accordance with the rules and
regulations prescribed by FDA.
-No application for opening of a retail
drugstore shall be approved unless it
is signed by a Filipino registered
pharmacist, either as owner or as
supervising pharmacist (as amended
by P.D. 1363 on May 1, 1978
DEFINITION OF TERMS
*PHARMACY
*DRUGS
1. Official in USP/NF
2. Mitigate, Prevent, Cure,

Diagnosis, Treat disease of human

and animals
3. Agents or substances that
alter/affect the function of human
body
Inactive dye, colorant
Active must not be <80%
Medicine dosage form
Drug natural form
4. Articles used as component of
such articles
RA 3720 product considered a drug
if found in PNDF
*repealed by RA 9711 any
formularies
RA 8203 counterfeit
*label is misleading, misbranded,
adulterated (any other ingredient
not stated)
*import of drug that is already
registered with FDA
*active ingredient <80%
*POISON
-drug that is dispensed w
prescription or recipe
*CODE/SECRET KEYS
-system of words arbitrarily to
present words
*BIOLOGIC PRODUCTS
*WHOLESALER
*DEVICES
-apparatus, equipment (same as
drug)
*CIPHER
-method of secret writing

REQUIREMENTS FOR OPENING A

DRUGSTORE UNDER PREMISES
-Signboard
-Well ventilated area nlt 15 sq.m.
-Compounding area, Sterilization Are
-Storage are for drugs
-Cabinet (poisons, dangerous drugs)
-Water Supplies
REQUIREMENTS FOR OPENING A
DRUGSTORE UNDER UTENSILS,
APPARATUS, EQUIPMENT
-Refrigerator for biologicals and other
drug products
-Full-time registered pharmacist
*HOSPITAL PHARMACY
-Prescription balance (1cg sensitivity)
& set-up weights
-Glass volumetric measures (a set of
not less than 6 pieces from 15ml
1000ml capacity)
-Mortar and Pestle (a set of not less
than 3 pieces of assorted sizes)
Others
-Invoices indicating the lot & batch
number of manufacturers stock
pursuant to BFAD Memorandum
Circular No. 001, S. 1983
REQUIREMENTS OF RENEWAL OF
LICENSE TO OPERATE (LTO)
*Standard Petition form name,
citizenship, picture, proposed area
*Proof of Registration
-Single Proprietorship (Certificate of
Business Name Registration -> BDT or
DTI)
-Partnerships, corporations (Certificate
of Registration -> SEC & Articles of
Incorporation or Partnership
REQUIREMENTS FOR
DRUGSTORE/RETAIL OUTLET FOR
NON-RX DRUGS
*Notarized Petition/Joint Affidavit

*Tentative list of Products

*Floor Area (nlt 15 sq.m.)
*Generic white and red labels
*Rubber stamp of outlets
*Pharmacist
-Registration Certificate
-PRC-ID
-Valid PTR
-ID Picture
-Certificate of Attendance to BFAD
Seminar
-Single Proprietorship or Corporation
-Contract of Lease
-Picture of Drugstore w/ Signboard
-Location Plan and Floor Plan with
Dimension
-Opening fee (A.O. 50 S. 2001)
REFERENCE BOOKS
-Philippine National Drug Formulary
(PNDF)
-United States Pharmacopoeia,
National Drug Formulary (USP, NF)
-Remingtons Pharmaceutical Sciences
-Goodman and Gilman
Pharmacological Basis of Therapeutics
-RA 3720 (Food, Drugs, Devices, and
Cosmetics Act)
-RA 6675 (Generics Act of 1968)
-RA 5921 (Pharmacy Law)
-RA 8203 (Special Law on Counterfeit
Drugs)
RECORD BOOKS
-Prescription Book
Date
Name of
Physician
Drug

-Dangerous Drug Book

-Exempt Preparation Book
-Poison Book

INTERNSHIP1 REVIEWER
EXERCISE 2: Control of the
Pharmacy Profession
Pharmacy Profession regulated by
State Laws
Pharmacy Laws promulgated to
define and regulate the Pharmacy
Profession and delimit its practice
Ethics
Jurisprudence
LEGAL PRINCIPLES THAT GOVERN
THE MANNER IN WHICH
PROFESSIONAL PRACTICE
3 Basic Categories
1. Statutory Law
- Laws that have been passed by
the Senate and the Congress
Statutes
-dictate the activities of persons
subject to the law

-enable regulatory agencies to

function pursuant to the mandate
of the legislative body
-provides penalties for those who
fail to comply with the law.
2. Regulatory Law
- Promulgated by GOVERNMENT
AGENCIES for the enforcement
and understanding of the law.
- To make rules and regulations to
ensure full and proper
implementation of the law.
3. Common Law
- Encompasses those areas of law
that have evolved over
hundreds of years of JUDICIAL
DECISIONS
- Based on the PRINCIPLE OF
STATE DECISIVE -> the policy of
courts to stand by precedent
- Entails the intricacies by which
courts interpret statutes and its
application to fact situations
STATUTORY LAWS THAT AFFECT
THE PHARMACY PROFESSION AND
IT PRACTICE
The Pharmacy Law (RA 5921) ->
P5
-An act regulating the Practice of
Pharmacy and Setting Standards of
Pharmaceutical Education in the
Philippines and for other Purposes
The Food, Drugs, Devices, and
Cosmetics Act (RA 3720) ->FDDC3
-An act to ensure the Safety and Purity
of Food, Drugs, and Cosmetics being
made available to the public by
creating the Food and Drug
Administration which shall administer
and enforce the Laws pertaining
thereto
The Food and Drug Administration
Act of 2009 (RA 9711) -> FDA9

-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 RA
3720, as amended and appropriating
funds thereof
Special Law on Counterfeit Drugs
(RA 8203) -> C8
-An act prohibiting counterfeit drugs,
providing penalties for violations and
appropriating funds therefor

The Generics Act of 1988 (RA

6675) -> G6
-An act to promote, require, and
ensure the production of an adequate
supply, distribution, use, and
acceptance of drugs and medicines
identified by their Generic Names
Comprehensive Dangerous Drug Act of
2002 (RA 9165)
-An act instituting the Comprehensive
Dangerous Drug Act of 2002, repealing
RA of 1972, as amended, providing
funs therefor and for other purposes
The Expanded Senior Citizens Act
of 2010 (RA 9994) -> SC9
-An act granting additional benefits
and privileges, to Senior Citizens,
further amending RA 7432, as
amended, otherwise, known as An Act
to Maximize the Contribution of Senior
Citizens to Nation Building, Grant

Benefits and Special Privileges and for

other purposes.
The Price Act (RA 7394) -> P7
-An act providing protection to
consumers by stabilizing the prices of
basic necessities and prime
commodities and by prescribing
measures against undue price
increase during emergency situations
and like occasions
The Consumers Act (RA 7394) ->
C7
-An act to protect the interest of the
consumer, promote his general
welfare and to establish standards of
conduct for business and industry

PRINCIPLES OF PROFESSIONAL
CONDUCT
-Service to others
-Integrity and Objectivity
-Professional Competence
-Solidarity and Teamwork
-Social and Civic Responsibility
-Global Competitiveness
-Equality of all Professions

CODE OF ETHICS FOR

PHARMACISTS
-prepared by the PHILIPPINE
PHARMACEUTICAL ASSOCATION
-latest version was approved on
November 2002.
*Importance
-States publicly the principles that
form the fundamental basis of
pharmacists roles and responsibilities
-Guides them in their relationship with
patients, health professionals and
society

Planning
Personal
Management
Finance
Purchasing

Management
Financial Analysis
Quantitative
Models
Fiscal
Management
Operations

2. Sole Proprietorship Drugstores

and Chain Drugstores
-operate with branches or franchises
all over the country
-drug outlets -> situated in strategic
business centers -> converted into
self-service stores or superstores
*Superstores carry not only
pharmaceutical products from
accredited drug firms but also
assorted grocery items.
Drugstores
-carry in conspicuous spaces of their
stores, product posters, mobiles, and
other merchandising paraphernalia
-constantly in search of Competitive
Market Strategies

INTERNSHIP1 REVIEWER
EXERCISE 3: The Community
Pharmacy Profile
CLASSIFICATION OF COMMUNITY
DRUGSTORE
1. Independent
-owned by pharmacist or operated by
entrepreneurs
-typical community pharmacy
-Management Process
*involves a group of similar functions
performed by pharmacy managers
regardless of type of system
Organization
Sales

Strategies
-lifeblood of successful business
endeavors
-competition is increasingly stiff and
sophisticated towards greatly
improving customer satisfaction
WAYS OF DEVELOPING
COMPETITIVE ADVANTAGES IN
COMMUNITY PHARMACY
1. Product Line Assortment
2. Leader Price Strategy
3. Innovation of Operation
4. Customer Services
5. Equipment/ Facilities
COMPARISON OF COMMUNITY
PHARMACY
1. Location
2. Signboard

3.
4.
5.
6.
7.
8.
9.

Store Front and Interiors

Staffing Pattern
Pharmacist
Communication
Store Facilities
Capitalization
Transportation

THE 1ST OF MERCURY DRUGSTORE

*24 Hour Service
*Motorized Customer Delivery
*Computerized Temperature
Controlled Warehouse
*Community Pharmacy inside
Shopping Malls and Supermarkets

*Modernize Store Front, Interiors

Warehouse and Layout
*Medical-Pharmacy Outreach Mission
*Drugstore Chain to Expand
Throughout
*Professionalize its Personnel