RA5921 10918 Comparison
RA5921 10918 Comparison
RA5921 10918 Comparison
10918
An act regulating the practice of pharmacy and settings standards of An Act Regulating and Modernizing the Practice of Pharmacy in the
pharmaceutical education in the Philippines and of other purposes. Philippines, repealing for the Purpose Republic Act Numbered Five
Thousand Nine Hundred Twenty-One (R.A. No. 5921), Otherwise Known
as the Pharmacy Law
Section 2. Statement of Policy. — The State recognizes the vital role of
pharmacists in the delivery of quality health care services through the
provision of safe, effective, and quality pharmaceutical products,
pharmaceutical care, drug information, patient medication counseling,
and health promotion. The pharmacists’ professional services shall,
therefore, be promoted as an indispensable component of the total
health care system to ensure the physical well-being of the Filipinos.
B. render pharmaceutical service in any office or drug and cosmetic (b) Render services, such as clinical pharmacy services, drug information
establishment where scientific, technological or professional services, regulatory services, pharmaceutical marketing, medication
knowledge of pharmacy is applied; or engage management, or whenever the expertise and technical knowledge of the
in teaching scientific, technological or professional pharmacy subject in pharmacist is required; or
a college of pharmacy;
(c) Engage in teaching scientific, technical, or professional pharmacy
C. conduct or undertake scientific pharmaceutical research for biological courses in a school or college of pharmacy; or (d) Dispense
and bacteriological testings and examinations. pharmaceutical products in situations where supervision of dispensing of
pharmaceutical products is required; or
(c) “Wholesaler” means and includes every person who acts as a jobber, (c) Adulterated/Deteriorated pharmaceutical products refer to
merchant, broker or agent, who sells or distributes for resale pharmaceutical products unfit for human consumption, following the
pharmaceuticals, proprietary medicines or pharmaceutical specialties. standards of quality or purity of which, are as those stated in the United
States Pharmacopeia/National Formulary and Philippine Pharmacopeia
(d) “Person” means and includes an individual, partnership, corporation in its latest edition or any standard reference for drugs and medicines
or association. which are given official recognition as well as those provided for in
Republic Act No. 3720, otherwise known as the “Food, Drug, and
(e) “Drug” means (1) articles recognized in the official United States Cosmetic Act”, as amended, and Republic Act No. 9711, known as the
Pharmacopoeia, official Hemeopathic Pharmacopoeia of the United “Food and Drug Administration Act of 2009”;
States or official National Formulary, or any of their supplements; (2)
articles intended for use in the diagnosis, cure, mitigation, treatment, or (d) Biopharmaceuticals refer to pharmaceutical products that are used
prevention of disease in man or animals; (3) articles (other than food) for therapeutic or for in vivo diagnostic purposes, such as vaccines, sera,
intended to effect the structure or any function of the body of man or and drugs derived from life forms using biotechnology. These include
animals; and (4) articles intended for use as a component of any articles proteins, nucleic acids, or living microorganisms where the virulence is
specified in clauses (1), (2), or (3), but not include devices or their reduced and are used for therapeutic or for in vivo diagnostic purposes;
components, parts or accessories.
(e) Brand name refers to the proprietary name given by the
(f) “Pharmaceuticals”, “Proprietary Medicines” or “Pharmaceutical manufacturer to distinguish its product from those of competitors;
Specialties” means any drug, preparation or mixture of drugs marked
under a trade name and intended for the cure, mitigation or prevention (f) Cipher, Code, or Secret Key refers to a method of secret writing or use
of disease in man or animals. of characteristic style or symbol by substituting other letter/s or
(g) “Device” means instruments, apparatus or contrivances including character/s for the letter/s intended, for the purpose of misleading the
their components, parts and accessories, intended (1) for use in the consumer;
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 (g) Compounding refers to the sum of processes performed by a
or animals. pharmacist in drug preparation including the calculations, mixing,
assembling, packaging, or labeling of a drug: (i) as the result of a
(h) “Biologic Products” are viruses, sera, toxins and analogous products prescription or drug order by a physician, dentist, or veterinarian; or (ii)
used for the prevention or cure of human diseases. for the purpose of, or in relation to, research, teaching, or chemical
analysis;
(i) “Poison” is any drug, active principle, or preparation of the same,
capable of destroying life or seriously endangering health when applied (h) Continuing professional development (CPD) refers to the inculcation
externally to the body or introduced internally in moderate doses. of advanced knowledge, skills, and ethical values in a post-licensure
specialized or in an inter- or multidisciplinary field of study for
(j) “Cipher” means a method of secret writing that substitutes other assimilation into professional practice, self-directed research, and/or
letters or characters for the letter intended or transposes the letter after lifelong learning;
arranging them in blocks or squares.
(i) Cosmetics refer to a substance or preparation intended to be placed
(k) “Code” means a system of words or other symbols arbitrarily used to in contact with the various external parts of the human body or with the
represent words. teeth and the mucous membranes of the oral cavity, with a view
exclusively or mainly to cleaning them, perfuming them, changing their
(l) “Secret Keys” means a characteristics style or symbols kept from the appearance and/or correcting body odor, and/or protecting the body or
knowledge of others or disclosed confidentially to but one of few. keeping them in good condition, as defined under Republic Act No. 9711;
(k) Dangerous drugs refer to those listed in the: (1) Schedules annexed to
the 1961 Single Convention on Narcotic Drugs, as amended by the 1972
Protocol; (2) Schedules annexed to the 1971 Single Convention on
Psychotropic Substances; and (3) Annex of Republic Act No. 9165,
otherwise known as the “Comprehensive Dangerous Drugs Act of 2002”,
and its amendments;
(2) Any article intended for use in diagnosis, cure, mitigation, treatment,
or prevention of disease of man or animals;
(3) Any article, other than food, intended to affect the structure or any
function of the human body or animals;
(o) Expiration date refers to the end date when the manufacturer can
guarantee that a product possesses its claimed potency, efficacy, quality,
and safety; after which its sale or distribution is prohibited;
(x) Labeling materials refer to all labels and other written, printed, or
graphic matter: (1) upon any item or any of its containers or wrappers;
or (2) accompanying any such item;
(mm) Pharmacy aides refer to persons who assist the pharmacists in the
different aspects of pharmacy operation based on established standard
operating procedures and processes, with very minimal degree of
independence or decision making and without direct interaction with
patients:
(a) To examine applicants for the practice of pharmacy; (a) Administer and implement the provisions of this Act;
(b) To issue certificates of registration or pharmacists. (b) Promulgate rules and regulations, administrative orders, and
issuances necessary to carry out the provisions of this Act;
(c) To reprimand any pharmacist or to suspend or revoke his certificate
of registration on the grounds as provided for in Section thirteen hereof, (c) Prepare licensure examination questions, score, and rate the
after a formal administrative investigation has been conducted by it. examinations and submit the results thereof to the PRC. The Board shall
prepare, adopt, issue, or amend the syllabi or tables of specifications of
(d) To promulgate from time to time the necessary rules and regulations the subjects in the licensure examination, in consultation with the
for the effective enforcement of this Act, subject to the approval of the academe and the Commission on Higher Education (CHED);
President upon advice of the Commissioner of Civil Service;
(d) Recommend the issuance, suspension, revocation, or reinstatement
(e) To study the conditions affecting the practice of pharmacy in the of the COR, PIC or Special/Temporary Permits (STP) for the practice of
Philippines; pharmacy;
(f) To check the employment of qualified personnel in drug stores, (e) Administer oaths in accordance with the provisions of this Act;
hospital pharmacies, drug or pharmaceutical laboratories, cosmetic
laboratories and similar establishments for which the Board may (f) Regulate and monitor the practice of pharmacy in the Philippines,
designate inspectors from the Board of Pharmacy; and including the practice of subprofessional services such as pharmacy
technicians, pharmacy assistants, aides, and other medicine handlers, as
(g) To encourage the development of botanical gardens and their described in this Act; adopt measures that may be deemed proper for
inspection particularly the propagation of Philippine medicinal plants the enhancement of the profession and the maintenance of high
with the cooperation of the Department of Agriculture and Natural professional, academic, ethical, and technical standards; and conduct
Resources. ocular inspection of pharmaceutical establishments and higher
education institutions (HEIs), in coordination with concerned
government agencies;
(h) Represent the pharmacy profession in all fora involving concerns and
issues related to pharmaceutical products and the practice of pharmacy;
(i) Investigate cases arising from violations of this Act, the rules and
regulations promulgated pursuant thereto, the Pharmacists’ Code of
Ethics, Code of Technical Standards and Guidelines for the Professional
Practice of the Pharmacy Profession, and other Board issuances; issue
summons, subpoena ad testificandum and subpoena duces tecum to
secure the attendance of witnesses or production of documents, or both,
and other evidence necessary for such investigation or hearing; and
render decision thereon which shall, unless appealed to the PRC, become
final and executory after fifteen (15) days from receipt of notice of
judgment or decision;
(k) Conduct, through the Legal Officers of the PRC, summary proceedings
on minor violations of this Act, the General Instruction to the Examinees,
including the implementing rules and regulations issued by the Board,
and to render summary judgment thereon which shall, unless appealed
to the PRC, become final and executory after fifteen (15) days from
receipt of notice of judgment or decision;
(l) Issue and promulgate guidelines on CPD, in coordination with the APO;
(c) He shall have completed an Internship Program which shall consist of (b) Of good moral character and reputation;
at least nine hundred sixty hours, one-half of which shall be spent equally
distributed in a prescription pharmacy, a pharmaceutical manufacturing (c) A degree holder of Bachelor of Science in Pharmacy or its equivalent
laboratory and a hospital pharmacy duly accredited by the Council of degree conferred by an HEI in the Philippines or an institution of learning
Pharmacy and the rest of the hours of internship shall be spent in any or in a foreign country duly recognized by the CHED; and
all of the said establishments at the choice of the candidate.
(d) Has completed an internship program approved by the Board,
pursuant to such guidelines as may hereinafter be promulgated, in
For this purpose, the above-mentioned prescription pharmacy, consultation with the duly recognized associations of pharmacy schools
pharmaceutical manufacturing laboratory and hospital pharmacy shall and the CHED.
keep a separate record of Pharmacy students who have undergone said
internship program directly under their control and as a result thereof
shall issue the proper certificate of said hours of internship. It shall also
be the duty of said establishments to submit annually a complete report
of the names of those who have undergone training under their
supervision and the corresponding number of hours of internship credit
of each of the pharmacy students to their respective colleges or school
and to the Board of Pharmacy for proper accreditation; and
A PIC bearing the registration number and dates of its issuance and
expiry, duly signed by the Chairperson of the PRC, shall likewise be issued
to every registrant, upon payment of the prescribed fees. The PIC shall
be renewed every three (3) years, upon presentation of the Certificate of
Good Standing (COGS) from the APO and proof of completion of the CPD
requirements.
Oath of Profession. — All successful candidates in the licensure
examination shall take their oath of profession before any member of
the Board, officer of the PRC, or any person authorized by law to
administer oaths, prior to entering the practice of the pharmacy
profession.
Foreign Reciprocity. — Unless the country or state of which the foreign
pharmacist is a subject or citizen, specifically permits Filipino pharmacists
to practice within its territorial limits on the same basis as the subjects
or citizens of the said foreign country or state under reciprocity and
under international agreements, no foreigner shall be admitted to
licensure examinations, given a COR to practice as pharmacist nor be
entitled to any of the privileges under this Act.
Practice Through Special/Temporary Permit (STP).— The practice of
pharmacy in the Philippines shall be limited to natural persons only and
shall be governed by the provisions of Republic Act No. 8981 and other
issuances pertinent thereto: Provided, That any foreign citizen who has
gained entry in the Philippines to perform professional services within
the scope of the practice of pharmacy, including the following: (a) being
a consultant in foreign-funded or assisted projects of the government;
(b) being engaged or employed by a Filipino employer or establishment;
(c) providing free services in humanitarian missions: and (d) being a
visiting faculty member in any field or specialty in pharmacy shall, before
assuming such duties, functions and responsibilities, secure an STP from
the Board and the PRC, under the following conditions:
The CORs, PICs or STPs held by such persons in good standing shall have
the same force and effect, as though they were issued on or after the
effectivity of this Act.
Affixing RPh After a Registered Pharmacist’s Name. — Only duly
registered and licensed pharmacists shall have the right to affix to one’s
name, the title “Registered Pharmacist” or “RPh”.
Indication of Information. — A pharmacist shall be required to indicate
the serial numbers, the date of expiry of the pharmacist’s PIC and APO
Certificate of Membership on all pertinent documents signed by him/her.
Display of certificate required. — It shall be the duty of every pharmacist Display of Certificate of Registration. — It shall be the duty of every
engaged in the practice of pharmacy either on his own account or under pharmacist engaged in the practice, whether in private or under the
the employ of another, to display his certificate of registration in a employ of another, to display the original copy of one’s COR in a
prominent and conspicuous place in pharmacy, drugstore, hospital prominent and conspicuous place in the drug establishment in which one
pharmacy or drug establishment which he operates or in which he is is employed in a professional capacity as pharmacist. When employed in
employed. No pharmacist shall with his knowledge allow his certificate establishments under Category B, as defined in Section 31 of this Act, the
of registration to be displayed in such establishments when he is not duplicate copy of the pharmacist’s COR shall also be displayed therein.
actually employed or operating therein in his professional capacity.
No pharmacist shall knowingly allow the COR to be displayed in an
establishment where one is not actually employed as a professional
pharmacist.
Sale of medicine, pharmaceuticals, drugs and devices. — No medicine, Dispensing/Sale of Pharmaceutical Products.— No pharmaceutical
pharmaceutical, or drug of whatever nature and kind or device shall be product, of whatever nature and kind, shall be compounded, dispensed,
compounded, dispensed, sold or resold, or otherwise be made available sold or resold, or otherwise be made available to the consuming public,
to the consuming public except through a prescription drugstore or except through a retail drug outlet duly licensed by the FDA.
hospital pharmacy, duly established in accordance with the provisions of
this Act. Prescription drugs and pharmacist-only OTC medicines shall be
dispensed only by a duly registered and licensed pharmacist, except in
Pharmaceutical, drug or biological manufacturing establishments, emergency cases, where the services of a registered and licensed
importers and wholesalers of drugs, medicines, or biologic products are pharmacist are not available: Provided, That a report shall be made to
authorized to sell their products only at wholesale to duly established the supervising pharmacist within twenty-four (24) hours after the
retail drugstore or hospital pharmacies. occurrence of the emergency so that product recording in the
prescription books can be done.
(4) Government units, including local government, city, first to third class
municipal health units, nongovernment organizations and/or
associations involved in the procurement, distribution, dispensing and
storage of pharmaceutical products;
(3) Fourth, fifth and sixth class municipal health units involved in the
procurement, distribution, dispensing, and storage of pharmaceutical
products;
The FDA, in coordination with the Board, and the approval of the PRC,
may add to, delete, reclassify, or modify the above list of establishments,
as the need arises, in order to keep pace with the developments in the
pharmacy practice.
The statement “Sample, not for sale” shall appear conspicuously on the The statement “Sample, Not for Sale”, or its equivalent, shall appear
container, package or carton of the drug or device to be given. conspicuously on the primary and secondary packaging of the drug or
combination products (medical device and drug) classified as drug
according to the primary intended mode of action to be given. It shall be
unlawful to remove, erase, deface or mark the original labels of samples.
No pharmacist dispensing or compounding prescriptions shall substitute The pharmacist dispensing or compounding prescriptions shall not
the drug or drugs called for in the prescription with any other drug or substitute the medicine called for in the prescription with any other drug,
substance or ingredient without prior consultation with, and a written substance or ingredient, without prior consultation with, and written
consent of, the person prescribing. consent of the person prescribing, except in accordance with Republic
Act No. 6675, as amended, otherwise known as the “Generics Act of
1988”, and other pertinent laws and regulations.
Label of dispensed medicine. — Upon every box, bottle, or other package Label of Dispensed Medicines.— Upon every box, bottle, or package of
containing medicine sold or dispensed by a pharmacist based on medicines compounded or dispensed by a registered and licensed
prescription, there shall be pasted, affixed or imprinted a seal of label pharmacist based on prescription, there shall be pasted, affixed, or
bearing, among others, the name and address of pharmacy; the names imprinted a seal or label bearing, among others, the name of patient and
and quantities of the ingredients; required doses thereof, its expiration generic name of drug; brand name, if any, strength, expiry date,
date if any; the name of the prescriber, date and the number of directions for use; and name and address of pharmacy, name of the
prescription; and the direction for its use. doctor, the dispensing pharmacist and other requirements prescribed in
the Philippine Practice Standards for Pharmacists and Dispensing
Every prescription, which in its preparation, contains any quantity of a Guidelines, Republic Act No. 9502, otherwise known as the “Universally
drug which is habit-forming, or a derivative of such drug, shall have in the Accessible Cheaper and Quality Medicines Act of 2008”, its implementing
label attached to the container the added statement “Warning may be rules and regulations and such other guidelines that may be promulgated
habit forming. by the Board.
Every prescription for external use filled in the drugstore shall bear a red Auxiliary labels containing special pharmacists” instructions for the
label showing in black ink the components of such prescription and the patient shall be required as prescribed for dangerous drugs, external-
words “For external use only” at the bottom of the label. use-only drugs, drugs with special storage and administration
instructions and such other drugs as may be required by law.
Recording of Patient Medication Profile.— All prescriptions dispensed in
the pharmacy shall be recorded in an appropriate recording system
indicating therein, among other things, the name and address of the
patient, name of prescribes generic name and brand, dosage strength,
quantity of drug and initials of pharmacist. It shall be open for inspection
by the representatives of the Board or the FDA, or both, at any time of
the day, when the pharmacy is open, and must be kept for a period of
not less than two (2) years after the last entry.
(d) Gross negligence, ignorance or incompetence in the practice of his (b) Conviction of an offense involving moral turpitude by a court of
profession resulting in the injury damage or death of another; competent jurisdiction;
(e) Malpractice, including aiding or abetting the commission of criminal (c) Unprofessionalism, immorality, malpractice, incompetence, gross
abortion or sex crimes through illegal compounding, dispensing or sale negligence, or imprudence in the practice of the profession;
of abortive or sex drugs as the case may be;
(d) Fraud or deceit in the acquisition of the COR, PIC or STP, or renewal
(f) Acting as a dummy of an alien or of a person who is not qualified to thereof;
establish and operate a retail drugstore;
(e) Allowing the COR to be used or displayed in establishments where the
(g) Addiction to alcoholic beverage or to any habit-forming drug pharmacist is not actually employed and practicing;
rendering him incompetent to practice his profession;
(f) Addiction to alcoholic beverages or to any habit-forming drug
(h) Insanity; rendering a pharmacist incompetent to practice the profession as
provided for in Section 23 hereof;
(i) False or extravagant or unethical advertisements wherein other things (g) Aiding or abetting the illegal practice of a non-registered and licensed
than his name, profession, limitation of practice, office and home person;
address and the like are mentioned; and
(h) Insanity or any mental disorder that would render the person
(j) Violations of any provision of the Code of Ethics which may be adopted incompetent to practice pharmacy;
as part of the Rules and Regulations of the Board.
(i) False, extravagant, or unethical advertisements and endorsements of
pharmaceutical products, pharmaceutical outlets and establishments
where the pharmacist’s name or the pharmacist’s professional
organization and similar information, or both, are used;
Any person other than citizens of the Philippines having been found (b) Practicing the pharmacy profession in the Philippines without a valid
guilty of any violation as provided for in this and the preceding section COR, PIC or STP;
shall, after having paid the fine or having served his sentence or both
when so required be also subject to deportation. (c) Non-indication of a pharmacist of his/her COR and professional tax
receipt numbers in official documents requiring such information;
(t) Violation of any provision of this Act and its rules and regulations not
aforementioned above. Any person, other than the citizens of the
Philippines, having been found guilty of any violation as provided for in
this section and the preceding section shall, after having paid the fine or
having served the sentence, or both, when so adjudged, shall also be
subject to immediate deportation.
(2) A pharmaceutical product refilled in containers bearing legitimate (2) Any article intended for use in diagnosis, cure, mitigation, treatment,
labels or marks, without authority; and or prevention of disease of man or animals;
(3) A pharmaceutical product which contains no amount of or a different (3) Any article, other than food, intended to affect the structure or any
active ingredient; or less than eighty percent (80%) of the active function of the human body or animals;
ingredient it purports to possess, as distinguished from an adulterated
drug including reduction or loss of efficacy due to expiration; (4) Any article intended for use, as a component of articles, specified in
clauses (1), (2) and (3), not including devices or their components, parts
(k) Dangerous drugs refer to those listed in the: (1) Schedules annexed to and accessories; and
the 1961 Single Convention on Narcotic Drugs, as amended by the 1972
Protocol; (2) Schedules annexed to the 1971 Single Convention on (5) Herbal or traditional drugs as defined in Republic Act No. 9502;
Psychotropic Substances; and (3) Annex of Republic Act No. 9165,
otherwise known as the “Comprehensive Dangerous Drugs Act of 2002”, (n) Emergency cases refer to life-threatening situations where a patient
and its amendments; needs immediate medical attention and treatment, including the
occurrence of epidemic or natural calamities;
(l) Dispensing refers to the sum of processes performed by a pharmacist
from reading, validating, and interpreting prescriptions; preparing; (o) Expiration date refers to the end date when the manufacturer can
packaging; labeling; record keeping; dose calculations; and counseling or guarantee that a product possesses its claimed potency, efficacy, quality,
giving information, in relation to the sale or transfer of pharmaceutical and safety; after which its sale or distribution is prohibited;
products, with or without a prescription or medication order;
(p) Filling refers to the act of dispensing or providing medicines in
(m) Drugs refer to pharmaceutical products that pertain to chemical accordance with a prescription or medication order;
compounds or biological substances, other than food, intended for use
in the treatment, prevention, or diagnosis of disease in humans or (q) Food/Dietary supplements refer to processed food products intended
animals, including the following: to supplement the diet that bears or contains one (1) or more of the
following dietary ingredients: vitamins, minerals, herbs, or other
botanicals, amino acids, and dietary substances to increase the total daily
intake in amounts conforming to the latest Philippine-recommended
energy and nutrient intakes or
internationally agreed minimum daily requirements. It usually is in the registered pharmacist;
form of capsules, tablets, liquids, gels, powders, or pills and not
represented for use as a conventional food or as the sole item of a meal (w) Label refers to a display of written, printed, or graphic matter on the
or diet or replacement of drugs and medicines, as defined under Republic immediate container of any article;
Act No. 9711;
(x) Labeling materials refer to all labels and other written, printed, or
(r) Generic name refers to the scientifically and internationally graphic matter: (1) upon any item or any of its containers or wrappers;
recognized name of the active ingredients, as approved by the FDA or (2) accompanying any such item;
pursuant to Republic Act No. 6675, otherwise known as the “Generics
Act of 1988”; (y) Medical device refers to any instrument, apparatus, implement,
machine, appliance, implant, in vitro reagent or calibrator, software,
(s) Health supplement refers to any product that is used to maintain, material or other similar or related article intended by the manufacturer
enhance and improve the healthy function of the human body and to be used alone, or in combination, for human beings, for one (1) or
contains one (1) or more or a combination of the following: (1) herbal more of the specific purposes of: diagnosis, prevention, monitoring,
fatty adds, enzymes, probiotics, and other bioactive substances; and (2) treatment, or alleviation of disease; diagnosis, monitoring, treatment, or
substances derived from natural sources, including animal, plant, alleviation of or compensation for an injury; investigation, replacement,
mineral, and botanical materials in the form of extracts, isolates, modification or support of the anatomy of a physiological process;
concentrates, metabolites, synthetic sources of substances mentioned in supporting or sustaining life; preventing infection; control of conception;
(1) and (2). It is presented in dosage forms or in small unit doses such as disinfection of medical devices; and providing information for medical or
capsules, tablets, powder, liquids and it shall not include any sterile diagnostic purposes by means of in vitro examination of specimens
preparations (i.e. injectables, eyedrops); derived from the human body. This device does not achieve its primary
intended action in or on the human body by pharmacological,
(t) Household remedies refer to any preparation containing immunological, or metabolic means, but which may be assisted in its
pharmaceutical substances of common or ordinary use to relieve intended function by such means, as defined under Republic Act No.
common physical ailments and which may be dispensed without a 9711;
medical prescription in original packages, bottles or containers, of which
the nomenclature has been duly approved by the FDA; (z) Medical mission refers to an activity conducted on normal
circumstances of an individual or a group of health care practitioners to
(u) Institutional pharmacies refer to pharmacies of institutions, provide health services outside the hospital, clinic, and health care
organizations, and/or corporations that provide a range of facility premises as differentiated from humanitarian missions and relief
pharmaceutical services, given exclusively to the employees and/or their operations which is conducted during emergency situations such as
qualified dependents; calamity, war, or natural and man-made disasters;
(v) Internship program refers to a supervised practical experience that is (aa) Medicines refer to drugs in their appropriate dosage forms, with
required to be completed for licensure as a assured quality, safety and efficacy for humans or animals
(bb) Medical representative or professional service representative refers (ii) Pharmaceutical outlets refer to entities licensed by appropriate
to one who represents any duly authorized manufacturer, distributor, government agencies, and which are involved in compounding and/or
trader, and wholesaler of pharmaceutical products and whose primary dispensing and selling of pharmaceutical products directly to patients or
duty is to promote their products to duly licensed health professionals; end-users;
(cc) Nontraditional outlets refer to entities licensed by appropriate (jj) Pharmaceutical products refer to drugs, medicines, biologicals,
government agencies to dispense over-the-counter medicines based on pharmaceutical and biopharmaceutical products/specialties, veterinary
an approved list; products, veterinary biologies and veterinary medicinal products;
(dd) Online pharmacy services refer to pharmaceutical services of a duly (kk) Pharmacist refers to a health professional who has been registered
licensed pharmaceutical outlet done over the internet; and issued a valid Certificate of Registration (COR) and Professional
Identification Card (PIC) by the PRC and the Professional Regulatory
(ee) Over-the-counter (OTC) medicines refer to medicines used for Board of Pharmacy;
symptomatic relief of minor ailments and which may be dispensed
without a prescription; (ll) Pharmacist-only OTC medicines refer to over-the-counter medicines
classified by appropriate government agencies to be obtained only from
(ff) Pharmaceutical establishments refer to entities licensed by a licensed pharmacist, with mandatory pharmacist’s advice on their
appropriate government agencies, and which are involved in the selection and proper use;
manufacture, importation, exportation, repacking, and distribution of
pharmaceutical products to pharmaceutical outlets; (mm) Pharmacy aides refer to persons who assist the pharmacists in the
different aspects of pharmacy operation based on established standard
(gg) Pharmaceutical manufacturers refer to establishments engaged in operating procedures and processes, with very minimal degree of
any or all operations involved in the production of pharmaceutical independence or decision making and without direct interaction with
products including the preparation, processing, compounding, patients:
formulating, filling, packaging, repackaging, altering, ornamenting,
finishing and labeling, preparatory to their storage, sale, or distribution, (nn) Pharmacy assistants refer to persons who assist the pharmacists in
except the compounding and filling of prescriptions in pharmaceutical different aspects of pharmacy operation based on established standard
outlets; operating procedures and processes, with a minimum degree of
independence or decision making and may have supervised interaction
(hh) Pharmaceutical marketing refers to any activity undertaken, with patients;
organized, or sponsored by a pharmaceutical establishment or outlet
which is directed at promoting its product; (oo) Pharmacy technicians refer to persons who assist in compounding
and dispensing of medicines in community, hospital, institutional and
industrial settings or engaged in other activities under the supervision of
the pharmacist as described in Section 39, Article IV of this Act;
(pp) Philippine Practice Standards for Pharmacists refer to the
established national framework for quality standards and guidelines of
the practice of pharmacy that respond to the needs of the people who
require the pharmacists’ services to provide optimal, evidence-based
care as formulated by the integrated APO and approved by the
Professional Regulatory Board of Pharmacy;
(k) Conduct, through the Legal Officers of the PRC, summary proceedings
on minor violations of this Act, the General Instruction to the Examinees,
including the implementing rules and regulations issued by the Board,
and to render summary judgment thereon which shall, unless appealed
to the PRC, become final and executory after fifteen (15) days from
receipt of notice of judgment or decision;
(1) Retail outlets selling household remedies and OTC drugs as differentiated from the pharmacist-only OTC
medicines;
(2) Satellite institutional pharmacies providing medicines solely to employees of their respective companies
or the employees’ qualified dependents, or both; or members of a duly registered organization or
institution;
(3) Fourth, fifth and sixth class municipal health units involved in the procurement, distribution, dispensing,
and storage of pharmaceutical products;
(5) Nontraditional outlets of pharmaceutical products: Provided, That no prescription medicines and
pharmacist-only OTC medicines are sold.
The FDA, in coordination with the Board, and the approval of the PRC, may add to, delete, reclassify, or
modify the above list of establishments, as the need arises, in order to keep pace with the developments in
the pharmacy practice.
All units or sub-units of establishments, institutions, and regulatory bodies whether government or private
with functions and activities that are exclusive for pharmacists, as defined in Section 4, paragraphs (a), (b),
(c), (d) and (i), shall be headed and managed by a qualified duly registered and licensed pharmacist:
Provided, that an appointment in government service shall comply with the provisions of other pertinent
laws.
(k) Filling of prescriptions where cipher, codes, or secret keys or unusual (i) False, extravagant, or unethical advertisements and endorsements of
names or terms are used; pharmaceutical products, pharmaceutical outlets and establishments
where the pharmacist’s name or the pharmacist’s professional
(l) Noncompliance with labeling requirements for dispensed medicines; organization and similar information, or both, are used;
(m) Noncompliance with the requirements on the keeping of record (j) Manufacture, sale, offering for sale of counterfeit, spurious,
books by a pharmaceutical outlet; substandard and falsified pharmaceutical products and committing other
acts in violation of Republic Act No. 9165 and Republic Act No. 8203,
(n) Employment of personnel in a pharmacy or pharmaceutical operation otherwise known as the “Special Law on Counterfeit Drugs”;
without the required training and certification;
(k) Illegal manufacture, sale, possession, dispensing of dangerous drugs
(o) Refusal of a non-pharmacist owner/operator of a pharmaceutical and other acts in violation of Republic Act No. 9165, and other applicable
outlet to undergo training and certification; laws and issuances;
(p) Refusal by the owner/operator to allow and require duly registered (l) Committing acts in violation of Section 6 of Presidential Decree No.
and licensed pharmacists and pharmacy support personnel to undergo 881, entitled “Empowering the Secretary of Health to Regulate the
CPD, training and certification; Labeling, Sale and Distribution of Hazardous Substances” and Section 11
of Republic Act No. 3720, as amended;
(q) Rendering dispensing-related services by non-pharmacists in a
pharmaceutical outlet without undergoing the required training and (m) Practicing pharmacy with a suspended COR or expired PIC;
certification;
(n) Unauthorized dispensing of pharmaceutical products through
(r) Dispensing pharmaceutical products in medical missions without the unregistered online services or direct selling businesses; and
supervision of a duly registered and licensed pharmacist;
(o) Being found guilty of immoral, unprofessional, or dishonorable
(s) Noncompliance with the required training and certification of conduct by the Board.
professional service or medical representatives or professional service
representatives, pharmacy technicians, pharmacy assistants, pharmacy
aides, pharmacy clerks, and other medicine handlers of pharmaceutical
products. Both the medical representatives or professional service
representatives, pharmacy technicians, pharmacy assistants, pharmacy
aides, pharmacy clerks, or medicine handlers and the pharmaceutical
establishment and outlet emploving any such individual shall be held
jointly liable;
(t) Violation of any provision of this Act and its rules and regulations not
aforementioned above. Any person, other than the citizens of the
Philippines, having been found guilty of any violation as provided for in
this section and the preceding section shall, after having paid the fine or
having served the sentence, or both, when so adjudged, shall also be
subject to immediate deportation.