GENERAL REQUIREMENTS FOR ISSUANCE OF LTO BY

FDA
Terms
PHARMACY
-a place or establishment where drugs, chemical
products, active principles of drugs,
pharmaceuticals, proprietary medicines or
pharmaceutical specialties, devices, and poisons
are sold at retail and where medical, dental and
veterinary prescriptions are compounded and
dispensed.
DRUGS
-Articles recognized in USP / NF
-articles used in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or
other animals
-articles (other than food) intended to affect the
structure or any function of the body of man
and animals
-articles intended for use as a component of any
article specified above but does not include
devices, or components, parts or accessories
POISON
any drug, active principle, or preparation of the
same, capable of destroying life or seriously
endangering health when applied externally to
the body or introduced internally in moderate
doses.
CODE
-a system of words or other symbols arbitrarily
used to represent words.
BIOLOGIC PRODUCTS
-viruses, sera, toxins and analogous products
used for the prevention or cure of human
diseases.
WHOLESALER
-means and includes every person who acts as a
jobber, merchant, broker or agent, who sells or
distributes for resale pharmaceuticals,
proprietary medicines or pharmaceutical
specialties.
DEVICE
-means instruments, apparatus or contrivances
including their components, parts and
accessories, intended (1) for use in the
diagnosis, cure, mitigation, treatment or
prevention of disease in man or animals; or
(2) to effect the structure or any function of the
body of man or animals.
CIPHER
-means a method of secret writing that
substitutes other letters or characters for the
letter intended or transposes the letter after
arranging them in blocks or squares.
SECRET KEYS
-means a characteristics style or symbols kept
from the knowledge of others or disclosed
confidentially to but one of few.
PHARMACEUTICAL MEDICINES
-means any drug, preparation or mixture of
drugs marked under a trade name and intended
for the cure, mitigation or prevention of disease
in man or animals.

REQUIREMENTS FOR OPENING A DRUGSTORE UNDER

PREMISES
Signboard
Well ventilated area nlt 15 sq.m.
Compounding area, sterilization area
Storage area for drugs
Cabinet ( poisons, DD)
Water supplies
REQUIREMENTS FOR OPENING A DRUGSTORE UNDER
UTENSILS, APPARATUS, & EQUIPMENT
Refrigerator
REQUIREMENTS FOR RENEWAL OF LTO
Standard Petition Form name, citizenship,
picture, proposed area
Proof of registration
Single proprietorship cert. of business
name registration (BDT of DTI)
Partnerships, corporations cert. of
registration (SEC) and 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 cert.
PRC-ID
valid PTR
ID picture
cert. of attendance to FDA seminar
Single proprietorship
Corporation
Contract of lease
Picture of drugstore with signboard
Location plan and floor plan with dimension
Opening fee ( A.O. 50 s. 2001)
REFERENCE BOOKS
PNDF
RA 3720
RA 6675
RA 5921
RA 8203
USP/NF
RPS
Goodman and Gilman Pharmacological Basis of
Therapeutics
RECORD BOOKS
Prescription Book
Dangerous Drug Book
Poison Book
Exempt Preparation Book
THE CONTROL OF PHARMACY PROFESSION
Terms
STATUTORY LAW
-laws enacted by any legislative body

COMMON LAW
-laws evolving from court decisions
ETHICS
-expected standards of moral behavior of a
particular group as described in the groups
formal code of professional ethics
REGULATORY LAW
- enforced by an administrative bodyfor
example, DOLE
JURISPRUDENCE
-science of philosophy of laws

STATUTORY LAWS AFFECTING PHARMACY PROFESSION

RA 5921 JUNE 22, 1969
RA 3720 JUNE 23, 1963
RA 8203 SEPT 4, 1996
RA 6675 SEPT 13, 1988
RA 9165 2002, repealing RA 6425
RA 9257 (2/26/04) RA 7432 (2/7/02), R.A.
9994 (2/15/10)
RA 7581 May 27, 1992
RA 7394 April 13,1992
THE PHARMACY LAW R.A. 5921
is an act regulating the practice of pharmacy and setting
standards of pharmaceutical education in the
Philippines and other purposes
THE FDDC ACT R.A. 3720
this is an act to ensure the safety and purity of foods
and cosmetics, and the purity, safety, efficacy, and
quality of drugs and devices being made available to the
public vesting the BFAD with authority to administer
and enforce the laws pertaining thereto
SPECIAL LAW ON COUNTERFEIT DRUGS R.A. 8203
It is an act prohibiting counterfeit drugs, providing
penalties for violations and appropriating funds. The
BFAD of the Department of Health is authorized to
administer and supervise the implementation of this Act
which was approved on September 4, 1996.
THE GENERICS ACT R.A. 6675
It is 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 R.A. 9165
It is an act instituting the Comprehensive Dangerous
Drugs Act of 2002, repealing Republic Act No. 6425,
otherwise known as the Dangerous Drugs Act of 1972
EXPANDED SENIOR CITIZEN ACT R.A. 9257
An act granting additional benefits and privileges to
senior citizens amending for the purpose RA No. 7432,
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 R.A. 7581
An act providing protection to consumers by stabilizing
the prices of basic necessities and prime commodities
and by prescribing measures against undue price

increases during emergency situations and like

occasions
CONSUMERS ACT R.A. 7394
It is 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
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