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REGULATORY

AFFAIRS:
PHARMACY
ADVANCED HOSPITAL ADMINSTRATION
PREPARED BY: Ivy P. Ramirez RPh
INTRODUCTION
REGULATORY LAW OR ADMINISTRATIVE LAW
• Promulgated by government agencies for the
enforcement and understanding of the law.
• The government agencies are empowered by the
legislative body to make rules and regulations to
ensure implementation of the law
• Administrative orders, FDA circular, Bureau
Circular, FDA advisories
Government Regulatory Bodies
REGULATORY BODIES GOVERNING THE PRACTICE OF
PHARMACY
• DOH
• FDA
• PDEA
• DDB
• PRC
• *TESDA
DOH
• RA 6675- AO 62, AO 63
• RA 7875
• RA 8203
• RA 9165- 10064, BR no. 1
• RA 9502
• RA 7581
• RA 9994
• * RA 9211
RA 6675
GENERICS ACT OF 1988
• 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
• Mandates usage of generic terminology in prescribing and
dispensing
RA 6675
• To promote, encourage and require the use of generic
terminology in the importation, manufacture, distribution,
marketing, advertising and promotion, prescription and
dispensing of drugs;
• To ensure the adequate supply of drugs with generic names at
the lowest possible cost and endeavour to make them
available for free to indigent patients;
• To encourage the extensive use of drugs with generic names
through a rational system of procurement and distribution;
• To emphasize the scientific basis for the use of drugs, in order
that health professionals may become more aware and
cognizant of their therapeutic effectiveness; and
• To promote drug safety by minimizing duplication in
medications and/or use of drugs with potentially adverse drug
interactions.
PENALTY
(a) for the first conviction, he shall suffer the penalty of reprimand which shall
be officially recorded in the appropriate books of the Professional Regulation
Commission.

(b) for the second conviction, the penalty of fine in the amount of not less
than two thousand pesos (P2,000.00) but not exceeding five thousand pesos
(5,000.00) at the discretion of the court.

(c) for the third conviction, the penalty of fine in the amount of not less than
five thousand pesos (P5,000.00) but not exceeding then thousand pesos
(P10,000.00) and suspension of his license to practice his profession for thirty
(30) days at the discretion of the court.

(d) for the fourth and subsequent convictions, the penalty of fine of not less
than ten thousand pesos (P10,000.00) and suspension of his license to
practice his profession for one year or longer at the discretion of the court.

B) Any juridical person who violates Section 6(c), 6(d), 7 or 8 shall suffer the
penalty of a fine of not less than five thousand pesos (P5,000.00) nor more
than ten thousand pesos (P10,000.00) and suspension or revocation of license
to operate such drug establishment or drug outlet at the discretion of the
Court
RA 7875 as amended by 9241
NATIONAL HEALTH INSURANCE ACT OF 1995
• An act instituting a national health insurance program for all
Filipinos and establishing the Philippine health insurance
corporation for the purpose
RA 7875 as amended by 9241
• provide all citizens of the Philippines with the mechanism to
gain financial access to health services;
• b) create the National Health Insurance Program, hereinafter
referred to as the Program, to serve as the means to help the
people pay for health care services;
• c) prioritize and accelerate the provision of health services to
all Filipinos, especially that segment of the population who
cannot afford such services; and
• d) establish the Philippine Health Insurance Corporation,
hereinafter referred to as the Corporation, that will administer
the Program at central and local levels.
RA 7875 as amended by 9241
• Excluded Personal Health Services.- The benefits granted
under this Act shall not cover expenses for the services
enumerated hereunder except when the Corporation, after
actuarial studies, recommends their inclusion subject to the
approval of the Board: (a) non-prescription drugs and devices;
(b) alcohol abuse or dependency treatment; (c) cosmetic
surgery; (d) optometric services; (e) fifth and subsequent
normal obstetrical deliveries; and (f) cost-ineffective
procedures, which shall be defined by the Corporation
PENALTY
• Where the violations consist of failure or refusal to deduct
contributions from the employees compensation or to remit
the same to the Corporation, the penalty shall be a fine of not
less than Five hundred pesos (P500) but not more than One
thousand pesos (P1,000) multiplied by the total number of
employees employed by the firm and imprisonment of not
less than six (6) months but not more than one (1) year.î
RA 8203
SPECIAL LAW ON COUNTERFEIT DRUGS
• An act prohibiting counterfeit drugs, providing penalties for
violations and appropriating funds therefore
• Prohibits the manufacture, sale or possession of any such
counterfeit drugs
• Prohibits forging, counterfeiting or falsely representing any
drug products
ADMINISTRATIVE SANCTIONS
a) permanent closure of the establishment concerned and the
revocation of its license to business;
b) a fine of not less than One hundred thousand pesos
(P100,000) but not more than Five hundred thousand pesos
(P500,000);
c) upon order of the Court, forfeiture, confiscation, and
destruction of products found to be counterfeited and the
equipment, instruments, and other articles used in violation of
this Act;
d) filing of an appropriate proceedings against the registered
pharmacist with the Professional Regulations Commission for
cancellation of professional license;
PENALTY
• a) imprisonment of not less than six (6) months and one (1)
day; but not more than six
• (6) years for more possession of counterfeit drugs as provided
for in Section 4(b) hereof; or
• b) imprisonment of six (6) years and one (1) day, but not more
than ten (10) years or a fine of not less than One hundred
thousand pesos (P100,000) but not more than Five hundred
thousand pesos (P500,000) or both such imprisonment and
fine at the discretion of the court in any other case mentioned
in Section 4 hereof; or
• c) imprisonment of not less than six (6) months and one (1)
day, but not more than two
RA 9165 as amended by 10064
• COMPREHENSIVE DANGEROUS DRUG ACT OF 2002
• An act instituting the amendments for RA 6425
• Prohibits unlawful and unnecessary prescription of dangerous
drug
• Mandates maintenance and keeping of original records of
transactions on dangerous drugs and controlled precursors
• Application for S licence for practitioner, manufacturers,
distributors, wholesalers and retailers
RA 9165 as amended by 10064
PHARMACIST
Shall maintain and keep an original records of sales, purchases,
acquisitions and deliveries of dangerous drugs:
a) License no. & address of pharmacist
b) Name, address & license of the manufacturer,
importer or wholesale.
c) Quantity and name of the dangerous drugs purchase
or acquired
d) Date of acquisition or purchase
e) Name, address & community tax certificate number of the buyer
f) Serial number of the Rx & name of the practitioner
g) Quantity & name of the dangerous drugs sold or delivered
h) Date of sale or delivery
PHYSICIAN, DENTIST, VETERINARIAN OR PRACTITIONER:
a) Rx must be issued in triplicate copies
b) One original & 2 duplicate copies
PENALTY
• DANGEROUS DRUG:
• Life imprisonment to death & a fine ranging from Php 500,000
to Php 10M (NOTE: Regardless of degree of purity) 10 grams or more
of:
• Opium
• Morphine, Heroin
• Cocaine or Cocaine HCL
• Marijuana Resin or Marijuana Resin Oil
• - 50 grams or more of Methamphetamine HCL or “Shabu”,
“Ice”, “Meth”
• - 500 grams or more of Marijuana
• -10 grams or more of other dangerous drugs such as, but not
limited
• MDMA – methylenedioxymethamphetamine or “Ecstacy”
• PMA – paramethoxyamphetamine
• TMA – trimethoxyamphetamine
• LSD – lysergic acid diethylamide
• GHB – gama hydroxybutyrate
RA 9502
UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES
ACT OF 2008
• An act providing for cheaper and quality medicines, amending
for the purpose republic act 8293, republic act 6675 and
republic act 5921 and for other purposes
• Drug and medicines price monitoring
• Recommendation of maximum retail price
• List of drugs subject to price regulation is listed
RA 9502
• Drugs and Medicines Price Regulation Authority of the
President of the Philippines. - The President of the
Philippines, upon recommendation of the Secretary of the
Department of Health, shall have the power to impose
maximum retail prices over any or all drugs and medicines as
enumerated in Section 23.
• The power to impose maximum retail prices 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
RA 9502
List of Drugs and Medicines that are Subject to Price Regulation. The
list of drugs and medicines that are subject to price regulation shall
include:
All drugs and medicines indicated for treatment of chronic illnesses
and life threatening conditions, such as, but not limited to,
• endocrine disorders, e.g., diabetes mellitus;
• gastrointestinal disorders, e.g., peptic ulcer;
• urologic disorders, e.g., benign prostatic hyperplasia (BPH);
• cardiovascular diseases, e.g., hypertension;
• pulmonary diseases, e.g., pulmonary tuberculosis (PTB), asthma;
• auto-immune diseases, e.g., systemic lupus erythematosus (SLE);
• skin diseases, e.g., psoriasis;
• neuro-psychiatric disorders;
RA 9502
other infectious diseases, e.g., human immunodeficiency virus-
acquired immune deficiency syndrome (HIV-AIDS); and
other conditions such as organ transplants and neoplasm;
a) Drugs and medicines indicated for prevention of diseases,
e.g., vaccines, immunoglobulin, anti-sera;
b) Drugs and medicines indicated for prevention of pregnancy,
e.g., oral contraceptives;
c) Anesthetic agents;
d) Intravenous fluids;
e) Drugs and medicines that are included in the Philippine
National Drug Formulary (PNDF) Essential Drug List; and
f) All other drugs and medicines which, from time to time, the
Secretary of the Department of Health determines to be in
need of price regulation.
PENALTY
• Any person or entity who commits any act of illegal price
manipulation of any drug and medicine subject to price
regulation shall suffer the penalty of imprisonment for a
period of not less than five (5) years nor more than fifteen
(15) years or shall be imposed a fine of not less than One
hundred thousand pesos (Php100,000.00) nor more than Ten
million pesos (Php10,000,000.00), at the discretion of the
court. The court may also order the suspension or revocation
of its license to operate (LTO), professional or business license.
RA 7581
THE PRICE ACT
• 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
• Mandated price ceiling
• Automatic price control
• Prohibits illegal acts of price manipulation
RA 7581
Automatic Price Control
a) That area is proclaimed or declared a disaster area or under a
state of calamity;
b) That area is declared under an emergency;
c) The privilege of the writ of habeas corpus is suspended in that
area;
d) That area is placed under martial law;
e) That area is declared to be in a state of rebellion; or
f) A state of war is declared in that area.
Mandated Price Ceiling
a) The impendency, existence, or effects of a calamity;
b) The threat, existence, or effect of an emergency;
c) The prevalence or widespread acts of illegal price manipulation:
d) The impendency, existence, or effect of any event that causes
artificial and unreasonable increase in the price of the basic
necessity or prime-commodity; and
e) Whenever the prevailing price of any basic necessity or prime
commodity has risen to unreasonable levels.
PENALTY
• Penalty for Acts of Illegal Price Manipulation. - Any person
who commits any act of illegal price manipulation of any basic
necessity or prime commodity under Section 5 hereof shall
suffer the penalty of imprisonment for a period of not less
than five (5) years nor more than Fifteen (15) years, and shall
be imposed a fine of not less than Five thousand pesos
(P5,000) nor more than Two million pesos (P2,000,000)
• Penalty for Violation of Price Ceiling. - Any person who
violates Section 6 or 7 of this Act shall suffer the penalty of
imprisonment for a period of not less than one (1) year nor
more than ten (10) years of a fine of note less than Five
thousand pesos (P5,000) nor more than One million pesos
(P1,000,000), or both, at the discretion of the court.
RA 9994
EXPANDED SENIOR CITIZEN ACT OF 2010
• An act granting additional benefits and privileges to senior
citizens, amending RA 7423
• Provides discount privilege to prescribed drugs for senior
citizens
• The grant of twenty percent (20%) discount and exemption
from the value -added tax (VAT)
PENALTY
a) For the first violation, imprisonment of not less than two (2)
years but not more than six (6) years and a fine of not less
than Fifty thousand pesos (Php50,000.00) but not exceeding
One hundred thousand pesos (Php100,000.00);
b) For any subsequent violation, imprisonment of not less
than two (2) years but not more than six (6) years and a fine
of not less than One Hundred thousand pesos
(Php100,000.00) but not exceeding Two hundred thousand
pesos (Php200,000.00); and
c) Any person who abuses the privileges granted herein shall
be punished with imprisonment of not less than six (6)
months and a fine of not less than Fifty thousand pesos
(Php50,000.00) but not more than One hundred thousand
pesos (Php100,000.00).
DOH
SUMMARY
• Generic prescribing for all physicians
• PHILHEALTH for all Filipinos, list of drugs is provided
• Law against sale or distribution of counterfeit drugs
• Law on sale or consumption of dangerous drug
• Accessible cheaper and quality medicines
• Protection for consumers
• Rights of senior citizens in medicine discounts
FDA
• RA 10918
• RA 5921
• RA 3720- ao 56, ao-2016-003
• RA 9711
• RA 8203
• RA 6675
RA 5921 as amended by RA
10918
THE PHARMACY LAW
• An Act Regulating the Practice of Pharmacy and Setting
Standards of Pharmaceutical Education in the Philippines and
for Other Purposes
• Registered pharmacist render services, such as clinical
pharmacy services, drug information services, regulatory
services, pharmaceutical marketing, medication management,
or whenever the expertise and technical knowledge of the
pharmacist is required;
• Engage in teaching scientific, technical, or professional
pharmacy courses in a school or college of pharmacy
• Dispense pharmaceutical products in situations where
supervision is required
PENALTY
a) Grounds for Reprimand, Suspension or Revocation of
Registration of Certificate
b) In case of suspension – NMT 6 months
c) If revoked-after 6 months, may apply for a new certificate of
registration
d) BOP shall furnish the RPh a copy of complaint which RPh
shall answer within 10 days
e) After 30 days from notice, the decision of the BOP shall
automatically become final
RA 3720
FOOD, DRUG, DEVICES AND COSMETICS ACT
• An act to ensure the safety and purity of food and cosmetics
and the purity, safety and efficacy of drugs and devices
available to the public, vesting the BFAD with authority to
administer and enforce the laws pertaining thereto, and for
other purposes
• Prohibits the sale of adulterated and misbranded drugs
• AO 55- requirements for labelling pharmaceutical products
RA 9711
FOOD AND DRUG ADMINISTRATION ACT OF 2009
• An act strengthening and rationalizing the regulatory capacity
of the bureau of food and drugs 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 FDA amending sections of
RA 3720
AOs, EOs, MCs, PDs, BCS under
DOH AND FDA
EO 119
• REORGANIZING THE BUREU OF FOOD AND DRUGS, DOH
AO 43 1999
• CURRENT GOOD MANUFACTURING PRACTICE FOR DRUGS
AO 42 1982
• DRUG REGISTRATION OF HERBAL AND TRADITIONAL DRUGS
EO 302
• ADOPTING THE PHILIPPINE PHARMACOPEIA AS THE OFFICIAL
BOOK OF STANDARDS
AO 55
• REQUIREMENTS FOR LABELLING MATERIALS
AOs, EOs, MCs, PDs, BCS under
FDA
AO 64
• AMENDMENTS OF AO 55, LIST A AND LIST B
AO 107 1991
• GUIDELINES ON DISPENSING MULTIACTIVE-INGREDIENT FIXED
DOSE COMBINATION PRODUCTS
MC 17 1989
• MONITORING OF DRUGSTORE PHARMACIST HOURS
AO 62
• PRESCRIBING GUIDELINES
AO 63
• DISPENSING GUIDELINES
AO 56 1989
REVISED REGULATIONS FOR THE LICENSING OF DRUG
ESTABLISHMENTS
• This order prescribes the activities involving drug products
that need to be covered by a license from BFAD. Identifying
these activities, the regulations provide for the general
requirements applicable to all categories or activities and the
specific requirements applicable for each category. The order
further provides for the conditions for renewal and sanctions
for deficiencies or failure to comply with the requirements.
AO 56 1989
GENERAL REQUIREMENTS
• A standard petition form
• Proof of Registration
• COR of the Pharmacist issued by the PRC and Current PTR
• Certificate of Attendance to a BFAD sponsored/accredited seminar on
licensing DE/DO
• Affidavit of undertaking
• List of product to be manufactured pr distributed, tentative list of
products intended to be sold.
• Authenticated photocopy of contract of lease for the space to be
occupied if the applicant does not own it.

Specific Requirements for Opening of Drugstores (PREMISES)


• Signboard
• Well ventilated area – nlt 15 square in floor area (concrete, tile or
wooden floorings)
• Compounding area for Rx
• An adequate water supply
• A cabinet for storage of poisons and DD
AO 2016-004
AO 67 1989
REVISED RULES AND REGULATIONS OF REGISTRATION
• This order gives comprehensive guidelines on the registration
of pharmaceutical products and to be consistent with R.A.
6675 known as “GENERICS Act of 1988”
AO 67 1989
1. Application
2. Evaluation by review of submitted data by BFAD
3. Evaluation by Testing of Submitted Samples BFAD
4. Assessment of Findings

* Requirements are found in ANNEX I


AO 2016-019
FDA
SUMMARY
• Pharmaceutical companies and outlets should have a
pharmacist who will fulfil regulatory requirements
• Pharmacists are responsible for reporting ADRs or ADEs
• Sale and distribution of adulterated and misbranded drugs are
prohibited
• FDA is the regulatory government body for pharmaceutical
companies and outlets
• Sale and distribution of counterfeit drugs are prohibited
• Reporting of prescriptions without generic name
• Generic labelling of drugs
• Pharmaceutical companies and their representatives should
adhere to ethical principles
PDEA
• RA 9165
• RA 10640
RA 10640
AMMENDMENTS TO RA 9165
• An act to further strengthen the anti-drug campaign of the
government, amending for the purpose section 21 of republic
act no. 9165, otherwise known as the “Comprehensive
Dangerous Drugs Act Of 2002″
• The PDEA shall take charge and have custody of all dangerous
drugs, plant sources of dangerous drugs, controlled precursors
and essential chemicals, as well as instruments/paraphernalia
and/or laboratory equipment so confiscated, seized and/or
surrendered, for proper disposition in the following manner:
PRC, TESDA
• RA 10918
• RA 5921
• RA 8981
• RA 10912
• RA 7796
RA 8981
PRC MODERNIZATION ACT OF 2000
• An act modernizing the professional regulation commission,
repealing for the purpose presidential decree numbered two
hundred and twenty-three, entitled "creating the professional
regulation commission and prescribing its powers and
functions," and for other purposes
• Administer, implement and enforce the regulatory policies of
the national government with respect to the regulation and
licensing of the various professions and occupations under its
jurisdiction including the enhancement and maintenance of
professional and occupational standards and ethics and the
enforcement of the rules and regulation
RA 10912
CONTINUING PROFESSIONAL DEVELOPMENT ACT OF 2016
• An act mandating and strengthening the continuing
professional development program for all regulated
professions, creating the continuing professional development
council, and appropriating funds thereof
• Pharmacists are required to accomplish 45 CPD units before
renewal of license
RA 7796

TESDA ACT OF 1994


• TESDA Pharmacy Services NC III Program aims to train and
develop Competent Pharmacy Assistants that play a significant
role in the delivery of pharmacy services in the country. - the
process of how the program was developed and how the
Certification process will happen
THANK YOU