Regulation of Pharmacy Practice

Automatic Registration

Pharmacists registered before Act's effectivity are automatically registered.

Affixing RPh

Only registered pharmacists can use 'Registered Pharmacist' or 'RPh' in their name.

Indication Requirement

Pharmacists must indicate serial numbers, expiry dates on signed documents.

Registry Maintenance

Board and PRC maintain a registry of registered pharmacists' information.

Display of Registration

Pharmacists must display COR in prominent place at the drug establishment.

Dispensing Restrictions

Only licensed pharmacists can dispense prescription drugs and pharmacist-only OTC medicines.

Compounding Standards

Pharmacists must follow Good Manufacturing Practice and dispensing guidelines.

Product Sale Authorization

Manufacturers can sell pharmaceutical products to licensed outlets only.

Pharmacist Requirement Classification

Establishments are classified into Category A (direct pharmacist control) and Category B (pharmacist oversight).

Category A Examples

Includes pharmaceutical outlets selling prescription medicines and government units involved in pharmaceuticals.

Category B Examples

Includes retail outlets selling OTC drugs and institutions providing telepharmacy services.

Regulatory Updates

FDA can modify establishment classifications to align with pharmacy practice developments.

Simultaneous Work Allowance

Pharmacists in Category A can work in Category B establishments with set guidelines.

Quality Responsibility

Pharmacists are responsible for the quality of pharmaceutical products.

Pharmaceutical Establishment

Facility where pharmaceutical products are handled and dispensed

Adulterate

To make impure by adding inferior or harmful substances

Partial Filling of Prescription

Dispensing less than the total quantity prescribed

Physician's Sample

Pharmaceutical products given free to health professionals for promotion

Cipher in Prescriptions

Use of secret codes or unusual terms in prescriptions

Dispensed Medicines Label

Information affixed on medicine packaging including patient name and drug details

Patient Medication Profile

Record of patient prescriptions with details kept for inspection

Retail Pharmaceutical Outlet

Establishment selling pharmaceutical products to the public

Pharmacy Support Personnel

Individuals assisting pharmacists in handling pharmaceutical products

Comprehensive Training Program

Standardized training required for handling pharmaceutical products

Generics Act of 1988

Law allowing substitution of generic drugs for branded ones

Republic Act No. 9502

Law ensuring accessible and affordable quality medicines

Republic Act No. 9165

Law regulating dangerous drugs and their dispensing

Certification Requirement

Non-pharmacists handling pharmaceutical products must be certified by government agencies after accredited training.

Adult Vaccines Administration

Licensed pharmacist administering adult vaccines must have a doctor's prescription not older than seven days.

Vaccination Reporting

Pharmacists administering vaccines submit monthly vaccination and AEFI reports to DOH regional offices.

Integrated APO

National organization for pharmacists recognized by the Board and PRC.

Membership Requirement

Registered pharmacists must be members of the APO throughout their practice.

Specialty Boards

Boards in different pharmacy practice areas accredited by the Board and PRC.

Revocation Grounds

Reasons for revoking/suspending pharmacist registration or canceling permits.

Unprofessional Conduct

Actions like malpractice, incompetence, or fraud leading to registration suspension.

Mental Health Criteria

Insanity or mental disorders rendering a pharmacist unfit for practice.

Illegal Practices

Engaging in unauthorized pharmaceutical activities or illegal drug-related offenses.

Penal Provisions

Stipulations for penalties related to violations of pharmacy regulations.

Fine Range

P250,000.00 to P500,000.00 or 1-6 years imprisonment

COR Display Violation

Displaying COR where pharmacist is not employed

Dispensing Violation

Offering prescription drugs in unlicensed place

Noncompliance Penalty

Fine of P100,000.00 to P200,000.00 or 30 days to 1 year imprisonment

RPh Title Misuse

Using 'RPh' title without being a licensed pharmacist

Pharmacy Practice Violation

Practicing pharmacy without valid COR, PIC, or STP

Labeling Requirement

Failure to comply with dispensed medicine labeling

Training Noncompliance

Failure to train and certify pharmacy personnel

Dispensing Service Violation

Dispensing drugs without pharmacist supervision

Enforcement Responsibility

Primary duty of the Board and PRC to enforce the Act

Appropriations

Funding implementation charged against current appropriations

Transitory Provision

Incumbent Board members continue until new Board appointment

Implementing Rules Deadline

Rules and regulations within 120 days of Act approval

Separability Clause

Unconstitutional part doesn't affect other valid provisions

Repealing Clause

Repeals conflicting laws and administrative issuances

Effectivity Date

Takes effect 15 days after publication in Official Gazette