Enforcement Agencies
- Creation of Council of Pharmaceutical Education.
- Creation of the Board of Pharmacy.
Council of Pharmaceutical Education Composition
- Secretary of Education (Chairman).
- Undersecretary of Health Services.
- Food and Drug Administrator.
- Chairman of the Board of Pharmacy.
- Dean of the University of the Philippines College of Pharmacy.
- Dean representing accredited private colleges of pharmacy.
- Representative of bona fide national pharmaceutical organizations.
- Deans and pharmaceutical organizations select representatives by agreement.
- Members serve until successors qualify.
Council of Pharmaceutical Education Functions
- Promulgate rules and regulations on pharmaceutical education.
- Submit binding rules for implementation to appropriate agencies.
- Recognize and accredit colleges of pharmacy.
- Approve accreditation of pharmacies and pharmaceutical establishments for internship purposes.
Council Operations
- Meet at least monthly or as decided.
- Members receive no compensation except travel expenses.
Board of Pharmacy Composition
- Chairman and two members appointed by the President with Commission on Appointments consent.
- Nominees recommended by Civil Service Commissioner from professional pharmacist organizations.
Qualifications of Board Members
- Natural-born Filipino citizen.
- Registered pharmacist with 10 years practice.
- Good moral character and professional standing.
- Not faculty or financially interested in pharmacy schools at appointment.
- Member in good standing of a national pharmaceutical association.
Tenure and Compensation of Board Members
- Three-year term with staggered initial terms.
- Maximum continuous service of six years.
- Most senior member automatically Chairman.
- Receive ten pesos per applicant examined.
Removal of Board Members
- Possible by the President for neglect, incompetence, malpractice, unethical or immoral conduct after investigation.
- Suspension during investigation not exceeding 60 days with automatic reinstatement pending outcome.
Executive and Secretary of the Board
- Civil Service Commissioner acts as Executive Officer.
- Secretary of the Board as per Republic Act No. 546.
- Additional assistants appointed with specified compensation.
- Secretary keeps all Board records confidential.
Powers and Duties of the Board
- Examine pharmacist applicants.
- Issue registration certificates.
- Reprimand, suspend, or revoke licenses after investigation.
- Promulgate rules for enforcement.
- Study pharmacy practice conditions.
- Inspect establishments employing qualified personnel.
- Promote botanical gardens and Philippine medicinal plants.
Registration of Detailmen
- Detailmen must register annually with the Board.
- Must be preferably pharmacy graduates.
- Fees: 20 pesos initial, 15 pesos annual renewal.
- Detailmen promote pharmaceutical products to healthcare professionals.
Grounds for Sanctions Against Pharmacists
- Criminal convictions related to sections 40 and 41.
- Immoral or dishonorable conduct.
- Fraud in obtaining registration.
- Gross negligence causing harm.
- Malpractice including illegal abortion-related activities.
- Acting as dummy for unqualified persons.
- Addiction impairing professional capacity.
- Insanity.
- False or unethical advertisement.
- Violations of adopted Code of Ethics.
Administrative Investigations
- All Board members sit en banc.
- Apply rules of evidence as practicable.
- May reprimand, suspend (max 6 months), or revoke certificate.
- Re-issuance after 6 months possible upon good conduct.
Investigation Procedures
- Formal complaint under oath required.
- Respondent given copy and 10 days to answer.
- Formal hearing with subpoena power.
- Proceedings recorded and decided within 90 days.
Rights of Respondent Pharmacist
- Right to be heard personally or with counsel.
- Speedy, public hearing.
- Confront and cross-examine witnesses.
- Present witnesses.
- Other protections of civil rights.
Appeal from Board Decisions
- Decision final after 30 days unless appealed to the President.
Examination Candidate Qualifications
- Natural-born Filipino citizen.
- Good moral character.
- Completed 960-hour internship evenly split among accredited prescription pharmacy, manufacturing lab, hospital pharmacy.
- Graduated with Bachelor of Science in Pharmacy or equivalent from accredited institution.
Examination Scope
- Theoretical: Chemistry (30%), Biological Sciences (20%), Pharmacy (50%).
- Practical: Drug identification, compounding, dispensing, manufacturing.
- Board sets schedules and syllabi.
Examination Passing Criteria
- General average 75% or higher.
- No grade below 50% in more than two theoretical subjects.
- Re-examination allowed for failed section.
- Mandatory pre-board review after three failures.
Examination Administration
- Held twice yearly in Manila and environs.
Examination and Registration Fees
- 50 pesos examination fee.
- 20 pesos registration fee.
- 10 pesos for duplicate certificates.
Definition of Pharmacy Practice
- Preparation, manufacturing, analysis, dispensing, sale of medicines, drugs, chemicals, cosmetics.
- Professional pharmaceutical services in drug establishments.
- Teaching pharmacy subjects.
- Conducting pharmaceutical research.
- Excludes executive or administrative personnel in pharmaceutical labs.
Prerequisites for Practice
- Minimum age 21.
- Passed Board examination.
- Holding valid registration certificate.
Sale and Distribution of Drugs
- Drugs sold only through duly established retail or hospital pharmacies.
- Manufacturing, importers and wholesalers sell only to retail or hospital pharmacies.
Sale of Drug Samples
- Samples given free to qualified persons cannot be sold.
- Containers must be marked "Sample, not for sale".
Pharmacist Supervision Requirements
- Retail, hospital pharmacies under immediate supervision when open.
- One pharmacist per establishment.
- Shift operations require pharmacist supervision per shift.
- Pharmaceutical labs require pharmacist supervision for repackaging, manufacturing.
- Wholesale drug business must be supervised by registered pharmacist.
- Minimum compensation for pharmacists in establishments with capitalization ≥ 10,000 pesos aligned with government pharmacists.
Display of Certificates
- Pharmacists must display registration conspicuously in establishments.
- Certificates not to be displayed where pharmacist is not actively employed.
Responsibility for Drug Quality
- Manufacturer or responsible distributor liable for original, unopened drugs.
- Unlawful to sell adulterated or mislabeled drugs.
- Adulteration standards based on recognized pharmacopoeias and Philippine Food, Drug and Cosmetic Act.
Filling and Refilling Prescriptions
- Only registered pharmacists may fill or compound prescriptions.
- Pharmacist must ensure purity and quality standards.
- Interns may assist pharmacists.
- Refills only with express order of prescriber.
Labeling of Dispensed Medicines
- Labels must include pharmacy name and address, drug ingredients, dosage, expiration date, prescriber, prescription number, directions.
- Habit-forming drugs must carry a warning label.
- External use prescriptions to carry a red label stating "For external use only".
Prescription Record-Keeping
- All dispensed prescriptions recorded with lot and control numbers.
- Records open for inspection and retained for at least two years.
Prohibition on Cipher or Code Prescriptions
- Pharmacists prohibited from filling prescriptions written in ciphers, codes, or secret keys.
- Drug substitutions require prescriber's prior written consent.
Dispensing Violent Poisons
- Violent poisons dispensed only on prescription from authorized health professionals.
- Sales must be recorded with purchaser information and purpose.
- Prescriptions verified before filling.
- Pharmacist to warn purchaser of poison's nature.
- Packages must carry red "Poison" label with skull and crossbones.
- Sales to minors, mentally deranged, intoxicated persons prohibited.
- Poison sale books open to authorities and retained for five years.
- Non-medicinal poison sales allowed without prescription but records required.
Dispensing Less Violent Poisons
- Less violent poisons may be sold without prescription but recorded.
- Other regulatory requirements apply.
Secure Storage of Poisons
- Poisonous drugs to be kept in securely locked cabinets when not in use.
Dispensing Abortifacients and Contraceptives
- Sales only with proper prescription.
- Separate register must record prescriptions including detailed data.
Dispensing Potent Drugs
- Potent drugs dispensed only upon prescription.
Drugstore Opening and Operation Requirements
- Governed by rules of the Food and Drug Administration.
- Only natural-born Filipino registered pharmacists may apply to open retail drugstores.
Penal Provisions
- Violations of key sections lead to fines (1,000-4,000 pesos) or imprisonment (6 months to 4 years).
- Includes false certification, unauthorized practice, dummy operators.
Other Penalties
- Violations of duties by pharmacists lead to fines (100-500 pesos) or imprisonment (30 days to 4 months).
- Practicing after suspension or revocation penalized.
- Foreign violators subject to deportation after penalties.
Legal Definitions
- Pharmacy/Drugstore: retail establishment selling drugs and compounding prescriptions.
- Pharmaceutical Laboratory: establishment preparing and distributing drug products.
- Wholesaler: person selling drugs for resale.
- Person: individual, partnership, corporation or association.
- Drug: articles recognized by official pharmacopoeias or used for diagnosis, cure or treatment.
- Pharmaceuticals/Proprietary Medicines: drugs under trade name for disease treatment.
- Device: instruments for diagnosis or treatment of disease.
- Biologic Products: viruses, sera, toxins used for prevention or cure.
- Poison: substances capable of destroying life or seriously endangering health.
- Cipher, Code, Secret Key: methods of secret writing or symbols.
Appropriations
- Initial funding of 30,000 pesos authorized.
- Subsequent funds included in General Appropriations Act.
Repealing Clause
- Repeals inconsistent secti