Practice and Education of Pharmacy Regulation

Council of Pharmaceutical Education

Section 3 establishes the Council of Pharmaceutical Education and sets its composition: the Secretary of Education (Chairman), the Undersecretary of Health Services, the Food and Drug Administrator, the Chairman of the Board of Pharmacy, the dean of the College of Pharmacy, University of the Philippines, the dean of a college of pharmacy representing duly accredited private schools of pharmacy, and a representative of bona fide national pharmaceutical organizations in the Philippines.
Section 3 requires deans of duly accredited private colleges of pharmacy to promulgate rules on selection of their representative in the Council through agreement among themselves.
Section 3 requires presidents of bona fide national pharmaceutical organizations to promulgate rules on selection of their representative in the Council through agreement among themselves.
Section 3 provides that Council members hold office until their successors have been appointed/elected/designated and duly qualified.
Section 4 mandates the Council to: (a) promulgate rules and regulations on pharmaceutical education, (b) submit rules and regulations with binding effect to proper agencies (including the Department of Education and the Board of Pharmacy) for implementation, (c) recognize and accredit colleges of pharmacy in private colleges and universities, and (d) approve accreditation of community or prescription pharmacies, pharmaceutical manufacturing laboratories, and hospital pharmacies for purposes of pharmacy internship.
Section 5 requires the Council to meet at least once a month, and to meet as often as it decides; Council members receive no compensation except traveling expenses in connection with official duties.

Board of Pharmacy and appointment structure

Section 6 establishes the Board of Pharmacy with a Chairman and two members, appointed by the President of the Philippines with consent of the Commission on Appointments.
Section 6 requires that nominees come from lists recommended by the Commissioner of Civil Service, with those lists obtained from bona fide professional national organizations of pharmacists certified under Republic Act Numbered Five hundred forty-six.
Section 7 requires Board members to be: (a) natural-born citizens, (b) duly registered pharmacists with at least ten years in practice, (c) of good moral character and recognized standing in the pharmaceutical profession, (d) not members of faculty of any pharmacy school/college/university at appointment time and without direct or indirect pecuniary interests in such schools/colleges, and (e) members in good standing of any bona fide national pharmaceutical association of the Philippines.
Section 8 provides that Board members serve three years after appointment or until successors are appointed and qualified.
Section 8 sets initial staggering for the first Board post-approval: Chairman for three years, one member for two years, and one member for one year.
Section 8 allows reappointment for another three-year term but caps continuous service at no more than six years total; the most senior member automatically becomes Chairman.
Section 8 grants Board members ten pesos for each applicant examined, regardless of whether the member is already in government service at appointment.
Section 9 authorizes removal by the President upon a finding of neglect of duty, incompetence, malpractice, or unprofessional/ unethical/ immoral/ dishonorable conduct, after an opportunity to defend in a proper administrative investigation.
Section 9 permits discretionary suspension during investigation, but the suspension cannot exceed sixty days, after which the member is automatically reinstated pending investigation outcome.

Board functions and administrative structure

Section 10 designates the Commissioner of Civil Service as the Executive Officer of the Board and as the official to conduct examinations under rules/regulations approved by the President.
Section 10 designates the Secretary of the Board of Examiners (in accordance with Republic Act Numbered Five hundred forty-six) as the Board’s Secretary.
Section 10 requires appointment of assistant and legal and records support officers from ranking employees: Assistant Secretary, Legal Officer, and Records Officer, with compensation of eight thousand eight hundred thirty-two pesos, seven thousand two hundred thirty-six pesos, and five thousand nine hundred twenty-eight pesos, respectively.
Section 10 requires the Board to keep all records—including examination papers, minutes of deliberation, and records of administrative proceedings—by the Board’s Secretary.
Section 11 vests the Board of Pharmacy with authority to: (a) examine applicants for pharmacy practice, (b) issue certificates of registration to pharmacists, (c) reprimand or suspend/revoke certificates on grounds under Section thirteen, after formal administrative investigation, (d) promulgate enforcement rules subject to Presidential approval on advice of the Commissioner of Civil Service, (e) study conditions affecting pharmacy practice, (f) check employment of qualified personnel in covered establishments through inspectors designated by the Board, and (g) encourage development and inspection of botanical gardens and propagation of Philippine medicinal plants with cooperation of the Department of Agriculture and Natural Resources.
Section 12 requires detailmen employed by pharmaceutical/drug laboratories and related manufacturers/distributors/wholesalers doing business in the Philippines to register with the Board at the beginning of each year.

Pharmacy internship accreditation; exam qualifications

Section 18 requires pharmacy-board examination candidates to be: (a) natural-born citizens, (b) of good moral character, (c) completed an internship program of at least nine hundred sixty hours, with one-half equally distributed among a prescription pharmacy, a pharmaceutical manufacturing laboratory, and a hospital pharmacy duly accredited by the Council, and the remaining hours in any or all of those establishments by candidate choice.
Section 18 requires accredited establishments to keep separate records of pharmacy students who underwent the internship under their control and to issue certificates of internship hours.
Section 18 requires establishments to submit annually to the respective colleges/schools and to the Board of Pharmacy a complete report of trainees and each trainee’s credited internship hours for accreditation.
Section 18 requires candidates to have graduated with a Bachelor of Science in Pharmacy or an equivalent degree from a Council-accredited school, college, or university after completing a standard pharmacy course of not less than five academic years.
Section 19 requires the pharmacist examination to include both theoretical and practical examinations.
Section 19 defines theoretical subjects: Chemistry (30% total weighting), Biological Sciences (20%), and Pharmacy (50%), with named subject areas including: General/Inorganic/Pharmaceutical/Physical Chemistry; Organic and Medicinal/Pharmaceutical Chemistry; Qualitative/Quantitative/Drug Assaying; Physiology and Biochemistry; Microbiology and Public Health; Pharmacology and Toxicology; Botany and Pharmacognosy; General Pharmacy; Compounding and Dispensing; Physical and Manufacturing Pharmacy; Pharmacy Administration; and Pharmaceutical Jurisprudence and Ethics.
Section 19 defines practical subjects and weighting: Identification and Analysis of Drugs (30%), and Compounding of Official Pharmaceutical Preparations, Dispensing and Fixing of Price of Prescription, and Manufacturing Pharmacy and Quality Control (70%).
Section 19 requires the Board to prepare schedules of theoretical/practical examinations and each subject syllabus two months before exam dates.
Section 21 provides that the examination for registration to practice pharmacy in the Philippines is given twice a year in the City of Manila and environs as the Board fixes.
Section 20 requires passing with a general average of at least seventy-five per cent based on one hundred per cent for both theoretical and practical examinations, with no ratings below fifty per cent in more than two subjects in the theoretical examinations.

Exam pass rules and re-examination limits

Section 20 allows a candidate who passed the theoretical examination but failed the practical examination to repeat only the practical examination upon re-examination, and vice-versa.
Section 20 bars admission in the fourth examination for any candidate who fails to pass the theoretical or practical examination in three successive attempts unless the candidate presents to the Board certification of enrollment and completion within the year preceding a pre-board review course from a duly accredited college of Pharmacy.
Section 22 requires fees for examination and registration: fifty pesos per applicant for examination; twenty pesos for each certificate of registration after passing; and ten pesos for each duplicate registration certificate.
Section 22 requires all fees to be paid to the cashier of the Board of Examiners and all expenses, including fees of Board members, to be disbursed by that cashier.

Detailmen registration and credentials

Section 12 requires detailmen to register with the Board at the beginning of each year that they are employed as detailmen.
Section 12(a) prefers that registration applicants be graduates of a college of pharmacy.
Section 12(a) sets fees for detailmen registration at an initial twenty pesos, and fifteen pesos annually thereafter for renewal; upon payment the Board issues proper credentials.
Section 12(b) requires drug establishments to require employed or to-be-employed detailmen to possess credentials issued by the Board as provided in the Act.
Section 12 defines a detailman as a representative of a duly authorized manufacturer/dealer/distributor/representative/wholesaler of drugs, pharmaceuticals, biologic products and devices whose primary duty is to introduce or reacquaint products to physicians, dentists, pharmacists, veterinarians, or other qualified persons through promotion describing use, composition, action, dosage, administration, contra-indication, advantages, and other salient information.

Professional regulation: pharmacists, investigations, appeals

Section 13 provides grounds to reprimand or suspend/revoke a pharmacist’s certificate, including: (a) court conviction for violations penalized in Sections forty and forty-one, (b) immoral or dishonorable conduct including court conviction involving moral turpitude, (c) fraud or deceit to obtain the certificate, (d) gross negligence, ignorance, or incompetence causing injury/damage/death, (e) malpractice including aiding/abetting criminal abortion or sex crimes through illegal compounding/dispensing/sale of abortive or sex drugs, (f) acting as a dummy of an alien or an unqualified person to establish and operate a retail drugstore, (g) addiction to alcoholic beverage or habit-forming drug rendering the pharmacist incompetent, (h) insanity, (i) false/extravagant/unethical advertisements stating more than the name, profession, limitation of practice, office/home address and similar matters, and (j) violations of any Code of Ethics adopted as part of Board Rules and Regulations.
Section 14 mandates that administrative investigations be conducted by all Board members sitting en bane, applying existing rules of evidence as practicable.
Section 14 authorizes the Board, by majority vote after sustaining evidence, to reprimand or suspend/revoke the certificate; suspensions are for not more than six months.
Section 14 permits, after revocation and after six months, upon application, the issuance of a new certificate without examination if the respondent has conducted himself in an exemplary manner in the interim.
Section 15 establishes complaint procedure: on receipt of a formal complaint under oath, the Board furnishes the pharmacist a copy; the pharmacist must answer within ten days from receipt.
Section 15 requires formal investigation with hearing dates when valid grounds are found; the Board’s Chairman may issue a subpoena or subpoena duces tecum.
Section 15 requires that proceedings are always recorded and that investigation is terminated and resolved within ninety days from the time the first hearing date is set and heard.
Section 16 grants the respondent pharmacist the rights to be heard personally or by counsel; to a speedy and public hearing; to confront and cross-examine witnesses; to summon and present witnesses; and to other processes protecting individual and civil rights.
Section 17 provides automatic finality of Board decisions after thirty days from notice to the respondent unless the respondent appeals to the President of the Philippines within the same period after receiving the decision.

Grounds, limits, and penalties for practice violations

Section 18 provides qualifications for candidates for board examination (handled above) that qualify individuals for registration to practice.
Section 24 requires that no person may engage in pharmacy practice in the Philippines unless he is at least twenty-one years of age, has passed the Board examination, and holds a valid certificate of registration issued by the Board.
Section 40 imposes penalties on persons (not only pharmacists) who violate specified sections (Sections twelve, twenty-four, twenty-five, twenty-six, twenty-seven and twenty-nine) or who make false representations to procure registration certificates for self/another, or who allow non-registered personnel to practice, or who falsely display a certificate when not actually employed/operating, or act as dummy for aliens/unqualified persons to open and operate a retail drugstore; upon conviction, the penalty is a fine of not less than one thousand pesos but not exceeding four thousand pesos, or imprisonment of not less than six months and one day but not more than four years, in the discretion of the court.
Section 41 imposes penalties for pharmacist violations of Sections twenty-eight, thirty, thirty-one, thirty-two, thirty-three, thirty-four, thirty-five, thirty-seven and thirty-eight, and for pharmacists who continue practicing after lawful suspension/revocation; upon conviction, the penalty is a fine of not less than one hundred pesos but not exceeding five hundred pesos, or imprisonment of not less than thirty days but not more than four months, in the discretion of the court.
Section 41 subjects any person other than citizens of the Philippines found guilty under this and the preceding section to deportation after payment of fine, serving sentence, or both when so required.
Section 41 authorizes both fine and imprisonment within the stated ranges, in the court’s discretion.

Definition of practice and who is authorized

Section 23 defines who is practicing pharmacy: preparing/manufacturing/analyzing/assaying/preserving/storing/distributing/selling medicine/drugs/chemicals/cosmetics/pharmaceuticals/devices/contrivances for reward; rendering pharmaceutical service where pharmacy knowledge is applied; teaching pharmacy subjects in a college of pharmacy; and conducting/undertaking scientific pharmaceutical research for biological and bacteriological testing and examinations.
Section 23 excludes from the definition for purposes of “practice of pharmacy” persons performing executive managerial or administrative functions and their subordinate personnel employed in pharmaceutical laboratories referred to in Section twenty-seven.
Section 25 prohibits retail availability of medicines/drugs/devices to the consuming public except through a prescription drugstore or hospital pharmacy duly established under the Act.
Section 25 allows pharmaceutical/drug/biological manufacturing establishments, importers, and wholesalers to sell only at wholesale to duly established retail drugstore or hospital pharmacies.

Structure and supervision requirements

Section 27 requires every pharmacy/drugstore/hospital pharmacy, whether government or private, to be under the personal and immediate supervision of a registered pharmacist whenever open for business.
Section 27 prohibits a pharmacist from personally supervising more than one such establishment.
Section 27 requires that if a drug establishment operates in more than one shift, each shift must be under supervision and control of a registered pharmacist.
Section 27 requires that drug or pharmaceutical laboratories and similar establishments engaged in repackaging, manufacture, or sale in quantities greatly in excess of therapeutic doses keep processes (including preparation, quality control, and repackaging) under direct and immediate supervision of a registered pharmacist.
Section 27 requires wholesale sales in those establishments to be conducted under the immediate supervision of a registered pharmacist practicing only in that establishment.
Section 27 grants pharmacists employed as such in establishments with capitalization not less than ten thousand pesos a minimum compensation “similar to that of government pharmacists,” notwithstanding any law to the contrary.
Section 28 requires pharmacists to display their certificate of registration prominently and conspicuously in the pharmacy/drugstore/hospital pharmacy/drug establishment where they operate or are employed.
Section 28 prohibits a pharmacist, with knowledge, from allowing the certificate to be displayed when the pharmacist is not actually and regularly employed/operating in the professional capacity.
Section 39 requires minimum requirements for opening and operation of drugstores and pharmacies to follow Food and Drug Administration rules and regulations under this Act.
Section 39 restricts applicants for opening a retail drugstore to only natural-born Filipino citizens who are registered pharmacists.

Requirements for prescriptions, labels, records

Section 30 prohibits filling or compounding any prescription except by a registered pharmacist in the employ of the drugstore or pharmacy.
Section 30 requires the compounding/filling pharmacist to ensure every component meets standards of purity and quality in standard references.
Section 30 permits pharmaceutical internship students to assist the pharmacist in compounding and dispensing the prescription.
Section 30 requires refilling only upon express order of the prescribing person.
Section 31 requires that boxes/bottles/packages of prescription-based dispensed medicine bear a seal/label stating among others: name and address of pharmacy, names and quantities of ingredients, required doses, expiration date if any, name of prescriber, date and number of prescription, and directions for use.
Section 31 requires a warning label “Warning—may be habit-forming” for prescriptions containing any quantity of habit-forming drugs or derivatives.
Section 31 requires that prescriptions for external use bear a red label with black ink listing components and the words “For external use only” at the bottom.
Section 32 requires recording all prescriptions dispersed in a prescription book indicating, among others: name of manufacturer, original stock, lot and control numbers of the main ingredients.
Section 32 requires the prescription book to be open to inspection by proper authorities any time during pharmacy hours.
Section 32 requires preservation of the prescription book for not less than two years after the last entry.
Section 32 requires prescriptions to be attached to the book, numbered consecutively, and preserved for the same length of time as the prescription book.
Section 33 prohibits pharmacists from compounding/dispensing prescriptions written in ciphers, codes, or secret keys or using unusual drug names differing from those in standard pharmacopeias or formularies.
Section 33 prohibits substituting drugs/substances/ingredients in a dispensed prescription without prior consultation with and written consent of the prescribing person.

Drug safety, fraudulent practices, and standards

Section 29 assigns quality/purity liability for sealed original packings: liability rests on the manufacturer, and if absent, on the importer, distributor, representative, or dealer responsible for distribution/sale.
Section 29 makes it unlawful for any person to manufacture/prepare/sell/administer a prescription or drug under a fraudulent name/direction/pretence or to adulterate any drug/pharmaceutical/medicine/poison sold or offered for sale.
Section 29 deems a drug/pharmaceutical/medicine/poison adulterated or deteriorated if it differs from the quality/purity standards in the United States Pharmacopoeia or National Formulary (latest edition), or, in lieu thereof, any officially recognized standard reference for drugs/medicines, or if it falls within the meaning provided for in the Food, Drug and Cosmetic Act (Republic Act Numbered Thirty-seven hundred twenty).

Controlled dispensing: poisons, abortion-prevention, potent drugs

Section 34 requires that a pharmacist dispensing/selling/delivering listed violent poisons (including specified named substances such as arsenical preparations, phosphorus, corrosive sublimate, atrophine, strychnine, and others; and other substances later classified by the Food and Drug Administration) must do so only upon prescription of a duly licensed physician, dentist, or veterinarian.
Section 34 requires separate poison-book entries for violent poisons stating: date of each sale; name and address of purchaser; name and quantity of poison; and purpose claimed before delivery.
Section 34 prohibits filling a prescription dose of dangerous quantity of poison without first consulting the prescribing authority and verifying the prescription; it requires the pharmacist to acquaint the purchaser of the poison’s poisonous character before delivery.
Section 34 requires a red paper label with large letters “Poison” and a skull-and-crossbones vignette on every package containing a dangerous/poisonous drug before delivery.
Section 34 prohibits sale/delivery of violent poisons to persons less than eighteen years of age, mentally deranged persons, persons under the influence of liquor, or persons apparently addicted to opiates and other habit-forming drugs.
Section 34 requires that violent-poison books be open at all times to inspection by proper authorities and preserved for at least five years after the last entry.
Section 34 allows sale without prescription when the poisons are intended for purposes other than medicinal, while still requiring compliance with the other requirements of Section thirty-four.
Section 35 permits dispensing/selling/delivery of less violent poisons even without a physician’s prescription, with poison-book recording, while requiring compliance with the other requirements of Section thirty-four.
Section 36 requires keeping violent and less violent poisons specified under Sections thirty-four and thirty-five in a cabinet provided in every pharmacy carrying such drugs, kept securely locked when not in use.
Section 37 prohibits delivery/sale of any drug or chemical product or device capable of provoking abortion or preventing conception (classified by the Food and Drug Administration) without a proper prescription by a duly licensed physician.
Section 37 requires pharmacists to maintain a separate register book for abortives and anti-conceptionals, recording: (a) number and date of prescription; (b) physician name and address; (c) drug name, quantity, and manufacturer; (d) purchaser name and address; (e) date of filling; and (f) pharmacist signature filling the prescription.
Section 38 requires that pharmacists dispensing/selling/delivering potent drugs classified by the Food and Drug Administration do so only upon prescription of a duly licensed physician, dentist, or veterinarian.

Promotional samples restrictions

Section 26 prohibits selling any drug/biologic product/device/proprietary medicine sample intended to be given for free to physicians and other qualified persons as part of promotional programs.
Section 26 requires the statement “Sample, not for sale” to appear conspicuously on the container/package/carton of the sample.

Drugstores and minimum opening requirements

Section 39 requires minimum requirements for opening and operation of drugstores and pharmacies to follow Food and Drug Administration rules and regulations prescribed under the Act.
Section 39 requires applicants for opening a retail drugstore to be only natural-born Filipino citizens who are registered pharmacists.

Funding, repeal, and separability

Section 43 authorizes appropriation of thirty thousand pesos from any National Treasury funds not otherwise appropriated within the fiscal year of approval, and requires that thereafter necessary funds for maintenance and operation of the Board of Pharmacy and Council of Pharmaceutical Education be included in the annual General Appropriations Act.
Section 44 repeals: Sections seven hundred seventeen to seven hundred fifty-seven inclusive and Sections two thousand six hundred seventy-five to two thousand six hundred seventy-seven inclusive of the Revised Administrative Code as amended, and all other inconsistent/incompatible laws or parts of laws, executive orders, administrative orders, circulars, regulations, and memoranda.
Section 45 provides separability: if any part/section/provision is held invalid or unconstitutional, the remainder remains unaffected.
Section 46 provides effectivity upon approval: June 21, 1969.