Republic of the Philippines 1

Professional Regulation Commission 2

Manila 3

4

Professional Regulatory Board of Pharmacy 5

Resolution No. ___ 6

Series of 2016 7

8

9

IMPLEMENTING RULES AND REGULATIONS (IRR) OF PHILIPPINE PHARMACY 10

ACT 11

(REPUBLIC ACT NO. 10918) 12 13

14

Pursuant to Sections 8 (b) and Section 50 of the Republic Act No. 10918, known as the 15

“PHILIPPINE PHARMACY ACT”, the Professional Regulatory Board of Pharmacy, with the 16

approval of the Professional Regulation Commission, hereby issues and promulgates this 17

Implementing Rules and Regulations to carry out the provisions of Republic Act No. 10918. 18

19

20

RULE I 21

GENERAL PROVISIONS 22

23 Section 1. Title. – This resolution shall be known as the “IMPLEMENTING RULES AND 24

REGULATIONS (IRR) OF REPUBLIC ACT (R.A.) NO. 10918, OTHERWISE 25 KNOWN AS THE PHILIPPINE PHARMACY ACT”, hereinafter referred to as 26

the IRR of R.A. No. 10918. 27

28

Section 2. Statement of Policy. – The IRR of R.A. No. 10918 is promulgated to recognize the 29

vital role of pharmacists in the delivery of quality healthcare services through the 30

provision of safe, effective, and quality pharmaceutical products, pharmaceutical 31

care, drug information, patient medication counseling, and health promotion. The 32

pharmacists’ professional services shall, therefore, be promoted as an indispensable 33

component of the total healthcare system to ensure the physical well-being of the 34

Filipinos. 35

36

Hence, the State shall develop and nurture competent, productive, morally upright, 37

and well-rounded pharmacists whose standards of professional practice and service 38

shall be excellent and globally competitive through regulatory measures, programs, 39

and activities that promote and sustain their continuing professional development. 40

41

Section 3. Objectives. – The IRR of R.A. No. 10918 is likewise promulgated to provide for and 42

govern the: 43

a. Standardization and regulation of pharmacy education; 44

b. Administration of licensure examination, registration, and licensing of 45

pharmacists; 46

c. Supervision, control, and regulation of the practice of pharmacy in the 47

Philippines; 48

d. Development and enhancement of professional competence of pharmacists, 49

through continuing professional development, research and other related 50

activities; and 51

e. Integration of the pharmacy profession. 52

53

Section 4. Interpretation of the IRR of RA No. 10918. – Any doubt in the interpretation of the 54

IRR of R.A. No. 10918 shall be resolved in a manner that would be consistent to the 55

declared aforementioned policy and objectives. 56

57

Section 5. Scope of the Practice of Pharmacy. – A person is deemed to be practicing 58

pharmacy, within the meaning of the Act, when with or without a fee, salary, 59

percentage or other rewards, paid or given directly or indirectly, shall perform the 60

following activities: 61

62

A. Activities Exclusive to Pharmacists 63 1. Prepare, compound or manufacture, preserve, store, distribute, procure, sell, or 64

dispense, or both, any pharmaceutical product or its raw materials; or 65

2. Render services, such as clinical pharmacy services, drug information services, 66

regulatory services, pharmaceutical marketing, medication management, or 67

whenever the expertise and technical knowledge of the pharmacist is required; or 68

3. Engage in teaching scientific, technical, or professional pharmacy courses in a 69

school or college of pharmacy; or 70

4. Supervise the practice of sub-professionals in the dispensing of pharmaceutical 71

products; or 72

5. Provide other services where pharmaceutical knowledge is required. 73

74

B. Activities which are Non-exclusive to Pharmacists 75 1. Conduct chemical, biological or microbiological analyses and assay of 76

pharmaceutical products, food/dietary supplements, health supplements, 77

cosmetics; or 78

2. Perform physicochemical analyses of medical devices used in aid of 79

administration of pharmaceutical products; or 80

3. Administer adult vaccines that are approved by the Food and Drug Administration 81

(FDA) subject to the training, certification and other requirements as provided in 82

this IRR of R.A. No. 10918; or 83

4. Conduct or undertake scientific research in all aspects, involving pharmaceutical 84

products and health care. 85

86

All pharmacists are expected to abide by current standards such as but not limited to 87

the Philippine Practice Standards for Pharmacists, Good Pharmacy Practice, Good 88

Regulatory Practice, Good Laboratory Practice, Good Distribution Practice, Good 89

Storage Practice, Good Warehousing Practice, Good Manufacturing Practice and 90

Good Clinical Practice, which are deemed vital in the performance of their roles and 91

functions in different practice areas. 92

93

The Professional Regulatory Board of Pharmacy, hereinafter created, subject to the 94

approval of the Professional Regulation Commission (PRC), as provided for by 95

Republic Act 8981, otherwise known as “PRC Modernization Act of 2000”, and in 96

consultation with the Accredited Professional Organization (APO), may modify the 97

above enumerated acts, services, or activities, as the need arises, in order to conform 98

to the latest trends and developments in the practice of the pharmacy profession: 99

Provided, that such modifications are consistent with the enumeration above. 100

101

Section 6. Definition of Terms. – As used in this IRR of R.A. No. 10918: 102

103

A. Accredited Professional Organization (APO) refers to the duly accredited 104

professional organization of pharmacists, of which there shall be only one (1), as 105

prescribed under Section 41 Article V of the Act. 106

107

B. Act refers to Republic Act 10918 known as The Philippine Pharmacy Act 108

109

C. Adult Vaccines refer to cervical cancer, flu (influenza), pneumococcal, other pre-110

exposure prophylactic vaccines to be administered to patients aged eighteen (18) 111

years and above, and such other vaccines as may be defined by the Department of 112

Health (DOH) in an administrative issuance. 113

114

D. Adulterated/Deteriorated Pharmaceutical Products refer to pharmaceutical 115

products, unfit for human consumption, following the standards of quality or purity of 116

which are, as those stated in the United States Pharmacopeia/National Formulary and 117

Philippine Pharmacopeia in its latest edition or any standard reference for drugs and 118

medicines which are given official recognition as well as those provided for in R.A. 119

No. 3720, otherwise known as “the Food, Drug and Cosmetic Act”, as amended, and 120

R.A. No. 9711, known as “the Food and Drug Administration Act of 2009”. 121

122

E. Adverse Drug Reaction refers to a noxious and unintended reaction to a drug which 123

occurs at doses normally used in human for the prophylaxis, diagnosis or treatment of 124

disease or for the modification of physiologic function. 125

126

F. Biopharmaceuticals refer to pharmaceutical products that are used for therapeutic or 127

for in vivo diagnostic purposes, such as vaccines, sera, and drugs derived from life 128

forms using biotechnology. These include proteins, nucleic acids, or living 129

microorganisms where the virulence is reduced and are used for therapeutic or for in 130

vivo diagnostic purposes. 131

132

G. Brand Name refers to the proprietary name given by the manufacturer to distinguish 133

its product from those of competitors. 134

135

H. Cipher, Code, or Secret Keys refer to a method of secret writing or use of 136

characteristic style or symbol by substituting other letter/s or character/s for the 137

letter/s intended, for the purpose of misleading the consumer. 138

139

I. Clinical Pharmacy Services refer to any patient care provided by a pharmacist, 140

through pharmacologic and non-pharmacologic strategies, that promote the 141

appropriate selection and utilization of medication to optimize individualized 142

therapeutic outcomes, achieve wellness or prevent diseases. 143

144

J. Compounding refers to the sum of processes performed by a pharmacist in drug 145

preparation including the calculations, mixing, assembling, packaging, or labeling of 146

a drug (i) as the result of a prescription or drug order by a physician, dentist or 147

veterinarian, or (ii) for the purpose of, or in relation to, research, teaching, or 148

chemical analysis. 149

150

K. Continuing Professional Development (CPD) refers to the inculcation of advanced 151

knowledge, skills, and ethical values in a post-licensure specialized or in an inter- or 152

multi-disciplinary field of study for assimilation into professional practice, self-153

directed research, and/or lifelong learning. 154

155

L. Cosmetics refer to a substance or preparation intended to be placed in contact with 156

the various external parts of the human body or with the teeth and the mucous 157

membranes of the oral cavity, with a view exclusively or mainly to cleaning them, 158

perfuming them, changing their appearance and/or correcting body odor, and/or 159

protecting the body or keeping them in good condition, as defined under R.A. No. 160

9711. 161

162

M. Counterfeit Pharmaceutical Products refer to pharmaceutical products which do 163

not contain the amounts as claimed; with wrong ingredients; without active 164

ingredients; or, with insufficient quantity of active ingredients, which result in the 165

reduction of the products’ safety, efficacy, quality, strength or purity. These also refer 166

to products that are deliberately and fraudulently mislabeled with respect to identity 167

and/or source or with fake packaging, and can apply to both branded and generic 168

products, including the following: 169

1. the pharmaceutical product itself or the container or labeling thereof or any part of 170

such product, container, or labeling, bearing without authorization; the trademark, 171

trade name or other identification marks or imprints or any likeness to that which 172

is owned or registered in the Intellectual Property Office (IPO) in the name of 173

another natural or juridical person; 174

2. a pharmaceutical product refilled in containers bearing legitimate labels or marks, 175

without authority; and 176

3. a pharmaceutical product which contains no amount of or a different active 177

ingredient; or less than eighty percent (80%) of the active ingredient it purports to 178

possess, as distinguished from an adulterated drug including reduction or loss of 179

efficacy due to expiration. 180

181

N. Dangerous Drugs refer to those listed in the (1) Schedules annexed to the 1961 182

Single Convention on Narcotic Drugs, as amended by the 1972 Protocol; (2) 183

Schedules annexed to the 1971 Single Convention on Psychotropic Substances; (3) 184

Annex of R.A. No. 9165, otherwise known as the Comprehensive Dangerous Drugs 185

Act of 2002, and its amendments. 186

187

O. Dispensing refers to the sum of processes performed by a pharmacist from reading, 188

validating, and interpreting prescriptions; preparing, packaging, labeling, record 189

keeping, dose calculations, counseling or giving information, in relation to the sale or 190

transfer of pharmaceutical products, with or without a prescription or medication 191

order. 192

193

P. Drugs refer to pharmaceutical products that pertain to chemical compounds or 194

biological substances, other than food, intended for use in the treatment, prevention, 195

or diagnosis of disease in humans or animals, including the following: 196

1. any article recognized in the official United States Pharmacopoeia - National 197

Formulary, Homeopathic Pharmacopoeia of the United States of America, 198

Philippine Pharmacopoeia, Philippine National Formulary, British 199

Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, and any 200

official compendium or any supplement to them; 201

2. any article intended for use in diagnosis, cure, mitigation, treatment, or prevention 202

of disease of man or animals; 203

3. any article, other than food, intended to affect the structure or any function of the 204

human body or animals; 205

4. any article intended for use, as a component of articles, specified in clauses (1), 206

(2), and (3), not including devices or their components, parts, accessories; and, 207

5. herbal or traditional drugs as defined in R. A. No. 9502 known as “Universally 208

Accessible, Cheaper and Quality Medicines Act”. 209

210

Q. Drug Distributor/Importer/Exporter/Wholesaler refers to any drug or 211

pharmaceutical establishment that imports or exports raw materials, active ingredients 212

and /or finished drug products for its own use or for wholesale distribution to other 213

drug or pharmaceutical establishments or outlets. If the 214

distributor/importer/exporter/wholesaler sells to the general public, it shall be 215

considered a retailer. 216

217

R. Drug Information Services refer to any activity in response to a drug information 218

request or query from healthcare professionals, organizations, committees, patients 219

and other individuals with the goal of providing carefully evaluated, evidence-based 220

drug information and recommendation to support medication use practice, enhance 221

quality of patient care, improve patient outcomes and ensure prudent use of resources. 222

223

S. Drugstore/Pharmacy/Botica and Hospital Pharmacy refer to pharmaceutical 224

outlets where registered drugs are dispensed directly to the end users or patients. 225

226

T. Emergency Cases refer to life-threatening situations where a patient needs 227

immediate medical attention and treatment, including the occurrence of epidemic or 228

natural calamities. 229

230

U. Expiration Date refers to the end date when the manufacturer can guarantee that a 231

product possesses its claimed potency, efficacy, quality, and safety; after which its 232

sale or distribution is prohibited. 233

234

V. Filling refers to the act of dispensing or providing medicines in accordance with a 235

prescription or medication order. 236

237

W. Food/Dietary Supplements refer to processed food products intended to supplement 238

the diet that bear or contain one or more of the following dietary ingredients: 239

vitamins, minerals, herbs, or other botanicals, amino acids, and dietary substances to 240

increase the total daily intake in amounts conforming to the latest Philippine-241

recommended energy and nutrient intakes or internationally agreed minimum daily 242

requirements. It usually is in the form of capsules, tablets, liquids, gels, powders, or 243

pills and not represented for use as a conventional food or as the sole item of a meal 244

or diet or replacement of drugs and medicines, as defined under R. A. No. 9711. 245

246

X. Generic Name refers to the scientifically and internationally recognized name of the 247

active ingredients, as approved by the FDA pursuant to R. A. No. 6675, otherwise 248

known as the “Generics Act of 1988”. 249

250

Y. Good Clinical Pharmacy Practice (GCPP) refers to an international ethical and 251

scientific quality standard for designing, conducting, recording, and reporting trials 252

that involve the participation of human subjects. 253

254

Z. Good Distribution Practice (GDP) refers to that part of quality assurance which 255

ensures that the quality of a pharmaceutical product is maintained through adequate 256

control throughout the numerous activities which occur during the distribution 257

process. 258

259

AA. Good Laboratory Practice (GLP) refers to the quality system concerned with the 260

organizational process and the conditions under which non-clinical health and 261

environmental safety studies are planned, performed, monitored, recorded, archived 262

and reported. 263

264

BB. Good Manufacturing Practice (GMP) refers to a system of quality assurance aimed 265

at ensuring that products are consistently manufactured to a quality appropriate for 266

their intended use. It is thus concerned with both manufacturing and quality control 267

processes and procedures. 268

269

CC. Good Pharmacy Practice (GPP) refers to the practice of pharmacy that responds to 270

the needs of the people who use the pharmacists’ services to provide optimal, 271

evidence-based care. 272

273

DD. Good Regulatory Practice (GRP) refers to the practice of regulation that should be 274

clear, simple and practical for users through identified policy objectives, consistent 275

with international standards in a sound legal and empirical basis which produces 276

benefits that justify and minimize costs and market distortions, in consideration of its 277

effects across society and taking into account the economic, environmental and social 278

factors. 279

280

EE. Good Storage Practice (GSP) refers to that part of quality assurance which ensures 281

that the quality of a pharmaceutical product is maintained through adequate control 282

throughout its storage. 283

284

FF. Good Warehousing Practice (GWP) refers to that part of quality assurance which 285

ensures that the quality of a pharmaceutical product is maintained through adequate 286

control throughout the warehousing. 287

288

GG. Handling of Pharmaceutical Products refers to the activities or range of pharmacy 289

operations from selecting, ordering, delivery, transport, receipt, inventory of stocks, 290

to arranging and display, compounding, storage, dispensing, provision of medication 291

and health information to patients and healthcare providers, selling of pharmaceutical 292

products including waste disposal. 293

294

HH. Health Promotion refers to the process of enabling communities, patients and clients 295

to increase control over their health and its determinants by engaging in healthy 296

behaviors to reduce the risk of developing diseases and other comorbidities. 297

298

II. Health Supplements refer to any product that is used to maintain, enhance and 299

improve the healthy function of the human body and contains one (1) or more or a 300

combination of the following: (1) herbal fatty acids, enzymes, probiotics and other 301

bioactive substances; (2) substances derived from natural sources, including animal, 302

plant, mineral and botanical materials in the form of extracts, isolates, concentrates, 303

metabolites and synthetic sources of substances mentioned in (1) and (2). These are 304

presented in dosage forms or in small unit doses such as capsules, tablets, powder, 305

liquids and shall not include any sterile preparations (i.e. injectibles, eye drops). 306

307

JJ. High-alert Medications refers to the drugs that bear a heightened risk of causing 308

significant patient harm when used in error. 309

310

KK. Household Remedies refer to any preparation containing pharmaceutical substances 311

of common or ordinary use to relieve common physical ailments and which may be 312

dispensed without a prescription in original packages, bottles or containers, of which 313

the nomenclature has been duly approved by the FDA. 314

315

LL. Immunizing Pharmacist refers to a certified pharmacist who administers selected 316

vaccines for adult immunization as prescribed under Section 40 Article 4 of the Act. 317

318

MM. Institutional Pharmacies refer to pharmacies of institutions, organizations, and/or 319

corporations that provide a range of pharmaceutical services, given exclusively to the 320

employees and/or their qualified dependents. 321

322

NN. Internship Program refers to a supervised practical experience or supervised 323

pharmacy practice experience that is required to be completed for licensure as a 324

Pharmacist. 325

326

OO. Label refers to a display of written, printed, or graphic matter on the immediate 327

container of any article. 328

329

PP. Labeling Materials refer to all labels and other written, printed, or graphic matter (1) 330

upon any item or any of its containers or wrappers or (2) accompanying any such 331

item. 332

333

QQ. Marketing Authorization (MA) refers to an official document issued by the FDA 334

for the purpose of marketing or free distribution of a product after evaluation 335

of its safety, efficacy, and quality. 336

337

RR. Marketing Authorization Holder (MAH) refers to the company or corporate or 338

legal entity in the field of pharmaceuticals in whose name the MA for a drug product 339

has been granted. This party is responsible for all aspects of the product, including 340

quality and compliance with the conditions of the MA. The MAH may either be a 341

manufacturer or distributor /exporter/ importer/ wholesaler. 342

343

SS. Medical Device refers to any instrument, apparatus, implement, machine, appliance, 344

implant, in vitro reagent or calibrator, software, material or other similar or related 345

article intended by the manufacturer to be used alone , or in combination, for human 346

beings, for one (1) or more of the specific purpose of: diagnosis, prevention, 347

monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment or 348

alleviation of or compensation for an injury; investigation, replacement, modification 349

or support of the anatomy of a physiological process; supporting or sustaining life; 350

preventing infection; control of conception; disinfection of medical devices; and 351

providing information for medical or diagnostic purposes by means of in vitro 352

examination of specimens derived from the human body. This device does not 353

achieve its primary intended action in or on the human body by pharmacological, 354

immunological, or metabolic means, but which may be assisted in its intended 355

function by such means, as defined under R. A. No. 9711. 356

357

TT. Medical Mission refers to an activity conducted in normal circumstances by an 358

individual or group of health care practitioners to provide health services outside the 359

hospital, clinic, and health care facility premises as differentiated from humanitarian 360

missions and relief operations which are conducted during emergency situations such 361

as calamity, war, or natural and man-made disasters. 362

363

UU. Medication Error is any preventable event that may cause or lead to inappropriate 364

medication use or patient harm while the medication is in the control of the health 365

care professional, patient, or consumer. 366

367

VV. Medication Management involves the patient-centered care provided by the 368

pharmacist to optimize safe, effective and appropriate drug therapy by ensuring the 369

proper selection, procurement, storage, order, transcription, preparation, dispensation, 370

administration of the drug and monitoring of the drug utilization and effect. 371

372

WW. Medicines refer to drugs in their appropriate dosage forms, with assured quality, 373

safety and efficacy for humans or animals, or both. 374

375

XX. Medical Representative or Professional Service Representative refers to one who 376

represents any duly authorized manufacturer, distributor, trader, and wholesaler of 377

pharmaceutical products and whose primary duty is to promote their products to duly-378

licensed health professionals. 379

380

YY. Non-traditional Outlets refer to entities licensed by appropriate government 381

agencies to dispense over-the-counter medicines based on an approved list. 382

383

ZZ. Online Pharmacy Services refer to pharmaceutical services of a duly licensed 384

pharmaceutical outlet done over the internet. 385

386

AAA. Over-the-counter (OTC) Medicines refer to medicines used for symptomatic relief 387

of minor ailments and which may be dispensed without a prescription. 388

389

BBB. Patient Medication Counseling refers to a one-on-one interaction between a 390

pharmacist and a patient, client or a caregiver to provide appropriate, understandable 391

and relevant information about the medications prescribed and/or dispensed 392

393

CCC. Patient Medication Profile is a comprehensive summary of all medications taken by 394

a patient, including prescription, over-the-counter, health supplements and dietary 395

supplements. 396

397

DDD. Pharmaceutical Care refers to any patient-centered, outcomes-oriented activity or 398

intervention that requires the pharmacist to cooperate with other healthcare 399

professionals, patients and their caregivers, and other clients in preventing, 400

identifying and resolving any drug-related problem. 401

402

EEE. Pharmaceutical Establishments refer to entities licensed by appropriate government 403

agencies, which are involved in the manufacture, importation, exportation, repacking, 404

and distribution of pharmaceutical products to pharmaceutical outlets. 405

406

FFF. Pharmaceutical Manufacturers or Drug Manufacturers refer to establishments 407

engaged in any or all operations involved in the production of pharmaceutical 408

products including the preparation, processing, compounding, formulating, filling, 409

packaging, repackaging, altering, ornamenting, finishing and labeling, preparatory to 410

their storage, sale, or distribution, except the compounding and filling of prescriptions 411

in pharmaceutical outlets. 412

413

GGG. Pharmaceutical Marketing refers to any activity undertaken, organized, or 414

sponsored by a pharmaceutical establishment or outlet which is directed at promoting 415

its product. 416

417

HHH. Pharmaceutical Outlets refer to entities licensed by appropriate government 418

agencies, which are involved in compounding and/or dispensing and selling of 419

pharmaceutical products directly to patients or end-users. 420

421

III. Pharmaceutical Products refer to drugs, medicines, biologicals, pharmaceutical and 422

biopharmaceutical products/specialties, veterinary products, veterinary biologics and 423

veterinary medicinal products. 424

425

JJJ. Pharmacist refers to a health professional who has been registered and issued a valid 426

Certificate of Registration (COR) and Professional Identification Card (PIC) by the 427

PRC and Professional Regulatory Board of Pharmacy (BOP). 428

429

KKK. Pharmacist-only OTC Medicines refer to over-the-counter medicines classified by 430

appropriate government agencies that can be obtained only from a pharmacist, with 431

mandatory pharmacist’s advice on their selection and proper use. 432

433

LLL. Pharmacy Aide refers to a persons who assists the pharmacist in the different aspects 434

of pharmacy operation based on established standard operating procedures and 435

processes, with very minimal degree of independence or decision making and without 436

direct interaction with patients. 437

438

MMM. Pharmacy Assistant refers to a person who assists the pharmacist in different aspects 439

of pharmacy operation based on established standard operating procedures and 440

processes, with a minimum degree of independence or decision making and may have 441

supervised interaction with patients. 442

443

NNN. Pharmacy Technician refers to a person who assists in compounding and dispensing 444

of medicines in community, hospital, institutional and industrial settings or engaged 445

in other activities under the supervision of the pharmacist as described in Section 39 446

Article IV of the Act. 447

448

OOO. Philippine Practice Standards for Pharmacists refers to the established national 449

framework for quality standards and guidelines of the practice of pharmacy that 450

respond to the needs of the people who require the pharmacists’ services to provide 451

optimal, evidence-based care as formulated by the APO and adopted and promulgated 452

by the Professional Regulatory Board of Pharmacy. 453

454

PPP. Physician’s Samples refer to medicines given to health professionals for promotional 455

purposes only. 456

457

QQQ. Prescription Book refers to the patient medication profile which can be either 458

electronic or hard copy wherein the dispensed prescription drugs, among others, are 459

recorded. 460

461

RRR. Prescription / Ethical Medicines refer to medicines which can only be dispensed by 462

a pharmacist to a patient, upon the presentation of a valid prescription from a 463

physician, dentist, or veterinarian and for which a pharmacist’s advice is necessary. 464

465

SSS. Refilling of a Prescription refers to the act of dispensing the remaining balance of 466

medicines ordered in the prescription. 467

468

TTT. Referral refers to the process wherein the pharmacist provides consultative services 469

and conducts preliminary assessment of symptoms and refers the patient to a 470

physician or other healthcare professional. 471

472

UUU. Referral Registry refers to the record book maintained by pharmacists listing the 473

patients referred to different health facilities for further diagnosis. 474

475

VVV. Refresher Program refers to a prescribed study program of an accredited school of 476

pharmacy or organization of colleges of pharmacy. 477

478

WWW. Regulatory Services refer to services provided by pharmacists to ensure the 479

compliance of pharmaceutical products to specifications, policies, standards or laws. 480

481

XXX. Retail Outlet for Non-prescription Drugs (RONPD) otherwise known as non-482

traditional outlets, refers to pharmaceutical outlets such as a supermarket, 483

convenience store and other similar retail establishment authorized to sell only 484

identified Over-the-Counter (OTC) and household remedy products directly to the 485

general public on a retail basis. 486

487

YYY. Sub-professional Services refer to services provided by persons handling 488

pharmaceutical products other than the pharmacists, such as but not limited to 489

pharmacy owners, medical representatives, pharmacy technicians, pharmacy 490

assistants and pharmacy aides. 491

ZZZ. Telepharmacy Services refer to pharmaceutical services of a duly licensed 492

pharmaceutical outlet done through the use of telephone, teleconferencing or 493

facsimile. 494

495

496

RULE II 497

THE PROFESSIONAL REGULATORY BOARD OF PHARMACY 498

499 Section 1. Creation of the Professional Regulatory Board of Pharmacy. – There is hereby 500

created a Professional Regulatory Board of Pharmacy, hereinafter called the Board, 501

under the administrative control and supervision of the PRC, to be composed of a 502

Chairperson and two (2) members, who shall be appointed by the President of the 503

Philippines from a list of three (3) recommendees for each position ranked in the 504

order of preference and submitted by the PRC from a list of five (5) nominees 505

submitted for each position by the APO of pharmacists. 506

507

Section 2. Qualifications of the Chairperson and Members of the Board. – The Chairperson 508

and members of the Board, at the time of nomination, must: 509

510

a. Be a citizen of the Philippines and a resident thereof for at least five (5) years; 511

512

b. Be a pharmacist in the Philippines, preferably a holder of a Master’s degree in 513

Pharmacy or PhD, or their equivalent; 514

515

c. Have been in the active practice of pharmacy for the past ten (10) years; 516

517

d. Have not been convicted of a crime involving moral turpitude; 518

519

e. Be a member in good standing of the APO for at least five (5) years, but not 520

an officer or trustee thereof; and 521

522

f. At the time of appointment, he/she must neither be a member of the faculty or 523

an administrative officer of any school, college or university offering degree 524

programs in pharmacy nor has any direct or indirect pecuniary interest or 525

connection in any review center or similar institution; 526

527

Assessment and evaluation of the nominees for Board of Pharmacy shall be based on 528

the rubric provided by the BOP in consultation with APO. 529

530

Section 3. Powers, Functions and Responsibilities of the Board. – The Board shall exercise 531

the following powers, functions, and responsibilities: 532

533

a. Administer and implement the provisions of the Act; 534

535

b. Promulgate rules and regulations, administrative orders and issuances 536

necessary to carry out the provisions of the Act; 537

538

c. Prepare licensure examination questions, score and rate the examinations and 539

submit the results thereof to the PRC; 540

541

d. The Board shall prepare, adopt, issue or amend the syllabi or tables of 542

specifications of the subjects in the licensure examination, in consultation 543

with the academe and the Commission on Higher Education (CHED); 544

545

e. Recommend the issuance, suspension, revocation or reinstatement of the 546

COR, PIC or Special/Temporary Permits (STP) for the practice of pharmacy; 547

548

f. Administer oaths in accordance with the provisions of the Act; 549

550

g. Regulate and monitor the practice of pharmacy in the Philippines, including 551

the practice of sub-professional services such as pharmacy technicians, 552

pharmacy assistants, aides and other medicine handlers, as described in the 553

Act; 554

555

h. Adopt measures that may be deemed proper for the enhancement of the 556

profession and/or the maintenance of high professional, academic, ethical and 557

technical standards; 558

559

i. Conduct ocular inspection of pharmaceutical establishments and higher 560

educational institutions (HEIs), in coordination with concerned government 561

agencies; 562

563

j. Promulgate and prescribe the Pharmacists’ Code of Ethics, code of technical 564

standards and guidelines for the professional practice of the pharmacy 565

profession, in coordination with the APO; 566

567

k. Represent the pharmacy profession in all fora involving concerns and issues 568

related to pharmaceutical products and the practice of pharmacy; 569

570

l. Investigate cases arising from violations of the Act, the rules and regulations 571

promulgated pursuant thereto, the Pharmacist’s Code of Ethics, Code of 572

technical standards and guidelines for the professional practice of the 573

pharmacy profession, and other Board issuances; issue summons, subpoena ad 574

testificandum and subpoena duces tecum to secure the attendance of witnesses 575

or production of documents, or both, and other evidence necessary for such 576

investigation or hearing: and render decision thereon which shall, unless 577

appealed to the PRC, become final and executory after fifteen (15) days from 578

receipt of notice of judgment or decision; 579

580

m. Delegate the hearing or investigation of administrative cases filed before the 581

Board, except where the issue or question involves the practice of the 582

profession, in which case, the hearing shall be presided over by at least one (1) 583

member of the Board, to be assisted by a Legal or Hearing Officer of the PRC; 584

585

n. Conduct, through the Legal Officers of the PRC, summary proceedings on 586

minor violations of the Act, the General Instructions to Examinees, including 587

the implementing rules and regulations issued by the Board, and to render 588

summary judgment thereon which shall, unless appealed to the Commission, 589

become final and executory after fifteen (15) days from receipt of notice of 590

judgment or decision; 591

592

o. Issue and promulgate guidelines on CPD, in coordination with the APO and 593

duly recognized association of schools and colleges of pharmacy; 594

595

p. Recommend the accreditation of the standardized training programs for the 596

certification of the registration of medical representatives or professional 597

service representatives, pharmacy technicians, pharmacy assistants, pharmacy 598

aides and other medicine handlers covered in Section 39 Article IV of the Act. 599

The Board shall promulgate the criteria and guidelines in the accreditation of 600

training programs and issue certificates of registration as described above, in 601

coordination with the APO and other concerned government agencies; 602

603

q. Accredit Specialty Boards of Pharmacy based on the criteria that it shall 604

establish and prescribe; and 605

606

r. Perform and discharge such other functions and responsibilities, as may be 607

deemed implied, incidental and necessary, to preserve the integrity of the 608

pharmacy licensure examination and to enhance and upgrade the practice of 609

the pharmacy profession in the country. 610

611

Section 4. Term of Office of the Members of the Board. – The Chairperson and members of 612

the Board shall hold office for a term of three (3) years from date of appointment or 613

until their successors shall have been appointed. They may be reappointed in the same 614

office for another term of three (3) years immediately after the expiry of their term; 615

Provided, that no member of the board shall hold office for more than six (6) years. 616

Provided further, that the first Board appointed under the Act shall hold these terms 617

of office: the Chairperson for three (3) years, the first member for two (2) years, and 618

the second member for one (1) year: Provided, finally, that an appointee to a vacancy 619

shall serve only the unexpired portion of the term of office. The Chairperson and 620

members of the Board shall take their oaths of office before a duly authorized officer. 621

622

Section 5. Compensation and Allowances of the Board. – The Chairperson and members of 623

the Board shall receive compensation and allowances comparable to the 624

compensation and allowances received by the members of the other existing 625

professional regulatory boards under the PRC, as provided for in the General 626

Appropriations Act. 627

628

Section 6. Grounds for Suspension or Removal from Office of the Chairperson or Member 629 of the Board. – The President of the Philippines may, upon recommendation of the 630

PRC and after due process, suspend or remove the Chairperson or any member of the 631

Board, on any of the following grounds: 632

633

a. Gross neglect, incompetence or dishonesty in the discharge of duty; 634

635

b. Involvement in the manipulation, tampering or rigging of the licensure 636

examination, its questions or its results, or both, and in the disclosure of 637

classified and confidential information pertaining to the licensure 638

examination; 639

640

c. Conviction of an offense involving moral turpitude by a court of competent 641

jurisdiction; and 642

643

d. Unprofessional, unethical, immoral or dishonorable conduct. 644

645

The PRC, in the conduct of investigation, shall be guided by Sections 7 and 15 of 646

Republic Act No. 8981, the existing rules on administrative investigation, and the 647

Rules of Court. 648

649

Section 7. Custodian of its Records, Secretariat and Support Services. – All records of the 650

Board pertaining to the applications for examinations, administrative and other 651

investigative hearings conducted by the Board, shall be under the custody of the PRC. 652

The PRC shall designate a Secretary who shall provide the Board with a secretariat 653

and other support services to implement the provisions of the Act. 654

655

656

RULE III 657

EXAMINATION, REGISTRATION, AND LICENSURE 658

659 Section 1. Licensure Examination Requirement. – Unless exempted therefrom, all applicants 660

for registration for the practice of pharmacy shall be required to pass a licensure 661

examination, as provided for in the Act and Section 7 (d) of Republic Act No. 8981. 662

663

Section 2. Qualifications for the Licensure Examination. – An applicant for the Pharmacists 664

Licensure Examination shall establish to the satisfaction of the Board that the 665

following qualifications are met: 666

667

a. A citizen of the Philippines or of a foreign country which has a law or policy 668

on reciprocity for the practice of the pharmacy profession; 669

670

b. Of good moral character and reputation; 671

672

c. A graduate of Bachelor of Science in Pharmacy or its equivalent degree 673

conferred by an HEI in the Philippines or an institution of learning in a foreign 674

country duly recognized by the CHED; 675

676

d. Has completed an internship program approved by the Board, pursuant to such 677

guidelines as may hereinafter be promulgated, in consultation with the duly 678

recognized association of pharmacy schools and colleges and the CHED; 679

680

Documentary requirements include: 681

682

a. Original and photocopy of the Philippine Statistics Authority-issued 683

Certificate of Birth; 684

685

b. Original and photocopy of the Philippine Statistics Authority-issued Marriage 686

Certificate (for married female); 687

688

c. Certification of Good Moral Character issued by any of the following: 689

barangay, church, school or employer; 690

691

d. National Bureau of Investigation Clearance; 692

693

e. Certified true copy of the Transcript of Records in the BS Pharmacy or its 694

equivalent degree coferred by an HEI in the Philippines or an institution of 695

learning in a foreign country duly recognized by the CHED; 696

697

f. Certificate of Completion of the internship program duly signed by the dean / 698

program head, and 699

700

g. Such other documents as may be reasonably required by the Board in 701

accordance with the provision of the Act. 702

703

Section 3. Scope of Examination. – The Pharmacists’ Licensure Examination shall cover the 704

following subjects on Pharmacy Science and Practice: Inorganic Pharmaceutical 705

Chemistry, Organic Pharmaceutical Chemistry, Qualitative and Quantitative 706

Pharmaceutical Chemistry, Pharmacognosy and Plant Chemistry, Pharmaceutical 707

Biochemistry, Microbiology and Parasitology, Physical Pharmacy, Biopharmaceutics, 708

Pharmacology and Toxicology, Manufacturing, Quality Assurance and 709

Instrumentation, Pharmaceutical Calculations, Drug Delivery Systems, Hospital 710

Pharmacy, Clinical Pharmacy, Dispensing and Medication Counseling, 711

Pharmaceutical Administration and Management, Public Health, Legal Pharmacy and 712

Ethics. 713

714

The subjects listed above shall be categorized into two major areas namely: Science 715

and Practice. 716

717

The Board, subject to the approval of the PRC, may introduce relevant changes in the 718

subject areas, format and content of the examination, as well as in the relative weight 719

attributed to each examination subject, as the need arises, and in consultation with the 720

duly recognized association of pharmacy schools and the CHED. 721

722

Section 4. Holding of Examination. – The Pharmacists’ Licensure Examination shall be given 723

two (2) times a year in such places and dates, as the PRC may designate in the 724

Resolution providing for the master schedule of all licensure examinations, pursuant 725

to Section 7 (d) of R. A. No. 8981. 726

727

Section 5. Ratings in the Licensure Examination. – In order to be a pharmacist, a candidate 728

must obtain a general weighted average of seventy-five percent (75%), with no rating 729

lower than fifty percent (50%) in any of the subjects. 730

731

An applicant who fails the licensure examination for the third (3rd) time shall not be 732

allowed to take the succeeding examination, without having undertaken a refresher 733

program in a duly accredited institution or a duly recognized organization of schools 734

and colleges of pharmacy. 735

736

An applicant who fails three (3) consecutive licensure examinations and desires to take 737

the examination again must comply with the following requirements: 738

739

a. He/she must have satisfactorily completed a refresher program offered by his/ 740

her school or university, where he/she obtained a Bachelor of Science in 741

Pharmacy degree or its equivalent; 742

743

b. In the event that the school or university from where he/she obtained his/her 744

degree does not offer a refresher program, the applicant must be allowed to 745

enrol in an institution or organization duly accredited by the PRC BOP based 746

on guidelines provided; and 747

748

c. He/she must submit to PRC a certificate of completion in a refresher program 749

duly signed by the dean or program head of the school from where he/she 750

obtained his/her degree. 751

752

The refresher program shall be conducted for a period of not less than one (1) year, 753

focusing on the subjects prescribed in Sec. 15 of RA 10918. Completion of the 754

refresher program will allow the applicant three (3) opportunities to take the 755

examinations. 756

757

Section 6. Report of Rating. – The Board shall submit to the PRC the ratings obtained by each 758

candidate within three (3) working days after the last day of the examination, unless 759

extended for just cause. Upon the release of the results of the examination, the PRC 760

shall send by mail the rating obtained by each examinee at the given address using the 761

mailing envelope submitted during the examination. 762

763

Section 7. Oath of Profession. – All successful candidates in the licensure examination shall 764

take their oath of profession before any member of the Board, officer of the PRC or 765

any person authorized by law to administer oaths, prior to entering the practice of the 766

pharmacy profession. 767

768

Section 8. Issuance of Certificate of Registration (COR) and Professional Identification 769 Card (PIC). – A COR as a pharmacist shall be issued to those who passed the 770

licensure examination, subject to compliance with the registration requirements and 771

payment of the prescribed fees. The COR shall bear the signatures of the Chairperson 772

of the PRC and the members of the Board, stamped with the official seals of the PRC 773

and of the Board, certifying that the person named therein is entitled to the practice of 774

the profession, with all the privileges appurtenant thereto. This COR shall remain in 775

full force and effect until suspended or revoked in accordance with the Act. 776

777

A PIC bearing the registration number and dates of its issuance and expiry, duly 778

signed by the Chairperson of the PRC, shall likewise be issued to every registrant, 779

upon payment of the prescribed fees. The PIC shall be renewed every three (3) years, 780

upon presentation of the Certificate of Good Standing (COGS) from the APO and 781

proof of completion of the CPD requirements following existing guidelines. 782

783

Section 9. Foreign Reciprocity. – No foreigner shall be allowed to take the Pharmacists 784

Licensure Examination, register or receive a COR and PIC, or practice Pharmacy in 785

the Philippines unless the requirements for the licensure examination, registration and 786

practice of Pharmacy imposed under the laws and regulations in such foreign country 787

or state are substantially the same as those required and contemplated by the 788

Philippine laws and regulations, and unless said foreign laws and regulations allow 789

Philippine citizens to practice Pharmacy within its territorial limits on the same basis, 790

and grant the same privileges as those enjoyed by its own citizens, subjects or 791

nationals. 792

793

A foreign citizen, whether he/she studied in the Philippines or not, who desires to take 794

the Pharmacists Licensure Examination through reciprocity shall initiate the 795

establishment of reciprocity between his/her country or state and the Philippines by 796

submitting a letter or any document signed by and under official seal of the 797

appropriate official of his/her country or state requesting the Board Chairperson to 798

allow the foreign applicant to take the licensure examination; and that by express 799

provision of the law of his/her country or state or international treaty, agreement or 800

covenant to which his/her country or state is a signatory, Philippine citizens are 801

allowed to take the Pharmacists Licensure Examination and to register as Pharmacists 802

in said foreign country or state on terms of strict and absolute equality with its own 803

citizens or subjects, including the unconditional recognition of prerequisite degrees 804

issued by institutions of higher learning duly recognized or established by the 805

Government of the Republic of the Philippines, attaching/appending thereto an 806

authenticated copy of said law, treaty, agreement or covenant officially translated in 807

the English language, if applicable. 808

809

If the letter/document and the copy of the law or treaty, agreement or covenant 810

submitted by the applicant is satisfactory to the Board, the foreign applicant shall be 811

allowed to take the Pharmacists Licensure Examination by requiring him/her to file 812

an application to take the licensure examination and by submitting the following 813

documents that shall accompany the application: 814

815

a. Original or certified true copy of any official document issued by the Bureau 816

of Immigration (BI) allowing the applicant to enter and reside in the 817

Philippines; 818

819

b. Copy of passport for examination and for photocopying of pertinent 820

information about the applicant; 821

822

c. Original or certified true copy of the transcript of records or equivalent 823

document of the course for licensure examination issued by an institution of 824

higher learning where he/she studied, duly authorized or accredited by his/her 825

country or state: Provided, that the documents must also be certified by CHED 826

to be equivalent to the Pharmacy courses accredited/recognized in the 827

Philippines; and 828

829

d. Other documents which may be required to be submitted by the Board. 830

831

Section 10. Practice through Special / Temporary Permit (STP). – The practice of pharmacy 832

in the Philippines shall be limited to natural persons only and shall be governed by 833

the provisions of Republic Act No. 8981 and other issuances pertinent thereto; 834

Provided, That any foreign citizen who has gained entry in the Philippines to perform 835

professional services within the scope of the practice of pharmacy, including the 836

following: 837

838

a. Consultant in foreign-funded or assisted projects of the government; 839

840

b. Engaged or employed by a Filipino employer or establishment; 841

842

c. Provides free services in humanitarian missions; and 843

844

d. Visiting faculty member in any field or specialty in pharmacy. 845

846

before assuming such duties, functions and responsibilities, shall secure an STP from 847

the Board and the PRC, under the following conditions: 848

849

a. The person is an internationally renowned pharmacist or an expert in a field or 850

specialty of Pharmacy; 851

852

b. The person is engaged in the provision of a professional service which is 853

determined to be necessary due to lack of Filipino specialist or expert; and 854

855

c. The person is required to work with a Filipino counterpart, a natural person 856

who is a pharmacist. 857

858

Section 11. Grounds for Non-registration. – The Board shall not register any successful 859

examinee who has been: 860

861

a. Convicted of an offense involving moral turpitude by a court of competent 862

jurisdiction; 863

864

b. Summarily adjudged by the Board as guilty for misrepresentation or 865

falsification of documents in connection with the application for examination 866

or for violation of the General Instructions to Examinees; 867

868

c. Found guilty of immoral or dishonorable conduct by the Board; 869

870

d. Medically proven to be addicted to any drug or alcohol by a medical or drug 871

testing facility accredited by the government such that it could render him/her 872

incompetent to practice the profession; and 873

874

e. Declared of unsound mind by a court of competent jurisdiction. 875

876

In refusing such registration, the Board shall give a written statement setting forth the 877

reasons therefor and shall file a copy thereof in its records. Should the grounds (d) to 878

be proven to be no longer existent, the Board shall issue a Board Resolution allowing 879

the issuance of such COR. 880

881

Section 12. Reissuance of Revoked Certificate of Registration, Replacement of Lost or 882

Damaged Certificate of Registration, Professional Identification Card or 883 Special/Temporary Permit. – The Board may, upon petition, reinstate or reissue a 884

revoked COR after the expiration of two (2) years from date of its revocation. The 885

Board may, in its discretion, require the applicant to take another licensure 886

examination. The petitioner shall prove to the Board that there is a valid reason for 887

such reinstatement. For the grant of the petition, the Board shall issue a Board 888

Resolution, to be approved by the PRC. 889

890

A duplicate copy, which is a certified true copy obtained from the PRC, of the COR 891

for display in Category B establishments may be issued. Replacement of lost or 892

damaged COR, PIC or STP may be issued, in accordance with the pertinent rules that 893

shall be issued thereon. 894

895

896

RULE IV 897

REGULATION OF THE PRACTICE OF PHARMACY 898 899

Section 1. Vested Rights and Automatic Registration. – All pharmacists registered before the 900

effectivity of the Act shall automatically be registered hereunder, subject to 901

compliance as to future requirements. 902

903

The CORs, PICs or STPs held by such persons in good standing shall have the same 904

force and effect, as though they were issued on or after the effectivity of R.A. No. 905

10918. 906

907

Section 2. Affixing RPh after a Registered Pharmacist’s Name. – Only a pharmacist shall 908

have the right to affix to his/her name, the title, “Registered Pharmacist” or “RPh”. 909

Any other pharmacy specialty title shall be recognized if granted by an international 910

certifying body or by the BOP. 911

912

Section 3. Indication of Information. – A pharmacist shall be required to indicate the COR 913

number and validity of his/her PIC and APO Membership number on all pertinent 914

documents signed by him/her. 915

916

Pertinent documents refer to legal documents submitted to government agencies in 917

the application of permits and licenses relative to the practice of pharmacy. 918

919

For the purpose of traceability and accountability, all other documents relative to the 920

practice of pharmacy must be signed by the pharmacist-in-charge. 921

922

Section 4. Registry of Pharmacists. – The Board and the PRC shall prepare and maintain a 923

registry of the names, residences or office addresses, or both, status of registration 924

and area of practice of all registered pharmacists, which shall be updated annually, in 925

coordination with the APO. This registry shall be made available to the public upon 926

inquiry or request, subject to such guidelines that shall be established therefor. 927

928

It is the responsibility of the pharmacist to update his/her profile, notify and submit 929

necessary documents to APO within the specified period as determined by the 930

guidelines that shall be established. 931

932

Other than the names and registration status, all information will remain confidential 933

and shall be made available upon order of competent authorities or with the consent 934

of the professional. 935

936

Section 5. Display of Certificate of Registration. – It shall be the duty of every pharmacist 937

engaged in the practice, whether in private or under the employ of another, to display 938

the original copy of one’s COR in a prominent and conspicuous place in the drug/ 939

pharmaceutical establishment and/or outlet in which one is employed in a 940

professional capacity as pharmacist. When employed in establishments under 941

Category B, as defined in Section 31 of the Act, the duplicate copy, which is a 942

certified true copy obtained from the PRC of the pharmacist’s COR shall also be 943

displayed therein. 944

945

No pharmacist shall knowingly allow the COR to be displayed in a drug/ 946

pharmaceutical establishment and/or outlet where one is not actually employed as a 947

professional pharmacist. 948

949

The original COR of all pharmacists employed in all areas of practice shall be kept 950

securely by the employer for the duration of her/his employment as pharmacist. 951

952

In cases when there are multiple pharmacists employed, the COR of the supervising 953

pharmacist on duty must be displayed. 954

955

Prominent and conspicuous place means an area where the COR of the supervising 956

pharmacist on duty can be easily seen by clients and/or regulators upon entry to the 957

establishment. 958

959

Section 6. Dispensing/Sale of Pharmaceutical Products. – No pharmaceutical product, of 960

whatever nature and kind, shall be compounded, dispensed, sold or resold, or 961

otherwise be made available to the consuming public, except through a retail drug 962

outlet duly licensed by the FDA. 963

964

a. Prescription medicines shall be dispensed only with a valid prescription of a 965

physician, dentist, or veterinarian. Dispensing of pharmaceutical or drug 966

products for veterinary use should be in accordance with the prescribed 967

guidelines of the FDA. 968

969

b. Prescription drugs and pharmacist-only OTC medicines shall be dispensed 970

only by a pharmacist, except in emergency cases where the services of a 971

pharmacist are not available, and in situations in accordance with the 972

provisions in Section 31 (b) (2),(3). In which case, a duly certified pharmacy 973

assistant or pharmacy technician may dispense the medicine. Provided, That a 974

report shall be submitted to the supervising pharmacist within twenty-four 975

(24) hours after the occurrence of the emergency so that product recording in 976

the prescription books may be done. For the purposes of the Act, prescription 977

books refer to the patient medication profile record which can be electronic or 978

manual. 979

980

c. Compounding and dispensing shall be done only by a pharmacist, in 981

accordance with appropriate guidelines such as but not limited to the current 982

Good Manufacturing Practice, Philippine Practice Standards for Pharmacists, 983

laboratory practice and dispensing guidelines. A pharmacist may refuse to 984

compound, dispense or sell drugs and pharmaceutical products, if not in 985

accordance with the Act and the abovementioned standards. 986

987

d. Appropriate medication review and patient medication counselling at the time 988

of dispensing of medicines should be provided to patients or caregivers, the 989

content of which should include indication, proper use, precautions, and other 990

relevant information. 991

992

e. Licensed manufacturers, importers, distributors, and wholesalers of 993

pharmaceutical products are authorized to sell their products only to duly 994

licensed pharmaceutical establishments and/or outlets. 995

996

f. Retail drug outlet duly licensed by the FDA shall compound, dispense, sell or 997

resell or otherwise make available any pharmaceutical product, of whatever 998

nature and kind, to the patient and/or caregiver. Retailing by duly licensed 999

drug retailers to hospital pharmacies or institutional pharmacies may be 1000

allowed in cases of valid emergency purchases following guidelines issued by 1001

the regulatory agencies. 1002

1003

Section 7. Pharmacist Requirement. – Establishments/outlets which are required to employ 1004

and/or retain and maintain the professional services of a pharmacists shall be 1005

classified as follows: 1006

1007

Category A. Pharmaceutical establishments/Outlets where the direct and immediate 1008

control and supervision of a pharmacist is required due to the nature of the 1009

pharmaceutical product that will be dispensed or the kind of service that will be 1010

provided. One pharmacist shall supervise each establishment/outlet in order to 1011

dispense prescriptions and pharmacist-only medicines, whether in-store or online. 1012

Virtual pharmacy without a licensed physical outlet is not allowed. Included under 1013

this category are the following: 1014

1015

1. Pharmaceutical establishments/outlets selling or otherwise making available to the 1016

consuming public prescription/ethical medicines, combination products (medical 1017

device and drugs) classified as drugs according to the primary intended mode of 1018

action, pharmacist-only OTC medicines, whether owned by the government or by 1019

a private person or firm, whether sold at wholesale or retail wherein the direct and 1020

immediate supervision of a pharmacist is required whenever the establishment is 1021

dispensing prescription and pharmacist-only OTC drugs; 1022

1023

2. Establishments involved in the manufacture, importation, exportation, 1024

distribution, and sale of prescription/ethical medicines, pharmacist-only OTC 1025

medicines, OTC medicines and combination products (medical device and drugs) 1026

classified as drugs according to the primary intended mode of action; 1027

1028

3. Departments/Divisions/Units of pharmaceutical laboratories such as FDA-1029

Licensed CROs and Sponsors including bioequivalence and other in vivo testing 1030

centers, pharmaceutical manufacturing laboratories, or other establishments with 1031

processes involving the preparation, manufacture, assay, regulation, product 1032

research and development, quality control, repacking, importation, exportation, 1033

distribution, sale or transfer of pharmaceutical products in quantities greatly in 1034

excess of single therapeutic doses; and 1035

1036

4. Government units, including local government, city, first to third class municipal 1037

health units, nongovernment organizations and/or associations involved in the 1038

procurement, distribution, dispensing and storage of pharmaceutical products. 1039

1040

5. Health facilities that dispense prescription drugs and pharmacist-only OTC drugs; 1041

1042

6. Other establishments/outlets as may be identified by the FDA 1043

1044

Category B. Pharmaceutical establishments/ outlets where the supervision and 1045

oversight of a pharmacist is required. 1046

1047

All of the following oversight requirements and considerations must be satisfied: 1048

1049

1. The supervising pharmacist must be physically present in the establishment/outlet 1050

for a minimum of two (2) hours a week; 1051

1052

2. The location of each establishment/outlet which the pharmacist supervises must 1053

be within the same provincial local government unit (LGU) within each region. 1054

The National Capital Region is considered as a single area due to its 1055

comparatively smaller land mass; 1056

1057

3. The distance between the two farthest establishments/outlets supervised by a 1058

single pharmacist must not exceed 25 km in distance; All other 1059

establishments/outlets supervised by a single pharmacist must be within a 1060

circumferential area when plotted between the two farthest establishments/outlets; 1061

1062

4. A maximum of fifteen (15) establishments/outlets is allowed to be supervised by a 1063

single pharmacist. 1064

1065

5. Other relevant requirements as may be prescribed and/or modified by the FDA. 1066

1067

Due considerations shall be given for geographically isolated and disadvantaged areas 1068

(GIDA) as identified by the Department of Health (DOH). 1069

1070

Included under this category are the following: 1071

1. Retail outlets selling household remedies and OTC medicines as differentiated 1072

from the pharmacist-only OTC medicines; 1073

1074

2. Satellite institutional pharmacies providing medicines solely to employees of their 1075

respective companies or the employees’ qualified dependents or both; or members 1076

of a duly registered organization or institution; 1077

1078

3. Fourth, fifth and sixth class municipal health units involved in the procurement, 1079

distribution, dispensing, and storage of pharmaceutical products; 1080

1081

4. Institutions providing telepharmacy services; 1082

1083

5. Non-traditional outlets of pharmaceutical products: Provided, that no prescription 1084

medicines and pharmacist-only OTC medicines are sold; 1085

1086

6. DOH licensed health facilities involved in the handling of medications used in 1087

clinic procedures. Clinic procedures include but not limited to minor surgery, 1088

diagnostic procedures, dialysis, cauterization and vaccination. Provided, that it 1089

shall comply with guidelines issued by the FDA. 1090

1091

7. Other establishments/outlets as may be identified by the FDA. 1092

1093

A pharmacist working in a Category A establishment/outlet may be allowed to 1094

simultaneously work and successively render pharmacy services in Category B 1095

establishments/outlets. Under this provision, simultaneous work means that a 1096

pharmacist can be employed in multiple establishments provided that there is no 1097

overlap of working time. A pharmacist may be allowed to supervise a maximum of 4 1098

establishments classified under Category B. 1099

1100

The FDA, in coordination with the Board, and the approval of the PRC, may add to, 1101

delete, reclassify, or modify the above list of establishments as the need arises, in 1102

order to keep pace with developments in the pharmacy practice. 1103

1104

All units or sub-units of establishments, institutions, and regulatory bodies whether 1105

government or private with functions and activities that are exclusive for pharmacists, 1106

as defined in Section 4, paragraphs (a), (b), (c), (d) and (i), shall be headed and 1107

managed by a qualified pharmacist: 1108

1109

Procurement, storage, distribution, or dispensing of any pharmaceutical product in the 1110

national government and local government units shall be made only under the 1111

supervision of a pharmacist. Provided, That an appointment in the government 1112

service shall comply with the provisions of other pertinent laws. 1113

1114

The FDA licensing requirement for LGUs shall be implemented in transitions: 1115

1. By 2018, the FDA licensing shall commence with TESDA-certified Pharmacy 1116

Assistants; and 1117

2. By 2020, LGUs must comply with the Pharmacist requirement. 1118

1119

The concerned government entity/ies shall take the necessary steps or measures to 1120

ensure that the foregoing provisions are implemented and complied with. 1121

1122

Section 8. Responsibility for Quality of Pharmaceutical Products. – To ensure the quality of 1123

health products, a pharmacist has the following duties and responsibilities: 1124

1125

a. It shall be the duty of a pharmacist of a pharmaceutical establishment and 1126

outlet, especially the marketing authorization holder (MAH), to ensure that all 1127

pharmaceutical products conform to standards of safety, quality, and efficacy, 1128

as provided for in the Act and other pertinent rules and regulations and 1129

issuances. It shall also be the responsibility of the pharmacist to report any 1130

adverse events associated with medication use such as medication errors, 1131

adverse drug reactions, product defects, counterfeit medications based on 1132

guidelines set by the FDA. 1133

1134

b. MAHs shall ensure that all drug products comply, and continually comply 1135

with the standards of safety, efficacy, and quality of FDA from registration up 1136

to post-marketing; likewise, all licensed pharmaceutical establishments and 1137

outlets shall comply with the applicable standards of good practices as 1138

prescribed by FDA. The MAH also has the responsibility to ensure proper 1139

disposition and destruction of pharmaceutical products including physician’s 1140

samples. 1141

1142

c. Owners, managers, or pharmacists in charge of the operation of 1143

pharmaceutical establishments and outlets shall be held jointly responsible for 1144

non-conformance with the standards of safety, quality, and efficacy, as 1145

provided for in the Act and other pertinent rules and regulations and 1146

issuances. 1147

1148

d. In cases of pharmaceutical products sold in their original package, the seal of 1149

which has not been broken or tampered with, the liability that may arise 1150

because of their quality and purity, rests upon the manufacturer or importer, 1151

the distributor, representative, or dealer, who is responsible for their 1152

distribution or sale. Dealer refers to retailer as used in this provision. 1153

1154

It shall be unlawful for any person to manufacture, prepare, sell, or dispense any 1155

pharmaceutical product under a fraudulent name, or pretence or to adulterate any 1156

pharmaceutical product offered for sale. 1157

1158

Efforts should be made by all stakeholders (i.e. manufacturing, regulatory, 1159

distribution, retail) to ensure safety, efficacy and quality of pharmaceuticals. 1160

Strategies aimed at medication safety shall be implemented. These include prevention 1161

of medication errors for high-alert medications and sound-alike, look-alike drugs. 1162

1163

Section 9. Filling and Partial Filling of Prescription. – All prescriptions and pharmacist-only 1164

OTC medicines shall be filled, compounded and dispensed only by a pharmacist, in 1165

accordance with the Philippine Practice Standards for Pharmacists, Dispensing 1166

Guidelines as adopted and promulgated by the Board, and other standards pertaining 1167

to purity, safety, and quality by the FDA. 1168

1169

Filling of prescription drugs done by the pharmacy assistant or pharmacy technician 1170

shall be under the direct supervision of a pharmacist. The pharmacist shall be 1171

accountable to the dispensing of the prescription and patient medication counseling. 1172

1173

Prescription to be filled should be clear and complete. Clarifications on the content of 1174

the prescription must be referred to the prescriber by the pharmacist on duty to ensure 1175

patient medication safety. 1176

1177

Completely filled prescriptions should be surrendered to the pharmacist for recording 1178

purposes. Retention period for completely filled prescriptions shall be kept for a 1179

period as prescribed by the concerned regulatory agencies. 1180

1181

Disposal of prescriptions and other pharmacy documents that include the patient’s 1182

name and other identifiers must be discarded under the supervision of a pharmacist 1183

with utmost security to protect the patient’s privacy and confidentiality. 1184

1185

Partial filling of prescriptions less than the total quantity indicated in the prescription 1186

shall be allowed, subject to dispensing guidelines as provided in the immediately 1187

preceding paragraph. It is the responsibility of the pharmacist dispensing the last 1188

quantity completing the prescription to keep the prescription according to the proper 1189

prescription recording guidelines. 1190

1191

Drugstores/Pharmacies/Boticas and Hospital Pharmacies engaged in compounding 1192

practices are required to comply with the standards of Good Compounding Practices 1193

and other requirements as prescribed by FDA. 1194

1195

Section 10. Physician’s Sample. – Pharmaceutical products intended to be given free to any 1196

health professional by a manufacturer or distributor or its professional service 1197

representative as part of its program or promotion shall not be sold to any 1198

pharmaceutical outlet or the consuming public. 1199

1200

The statement “Sample, Not For Sale”, or its equivalent shall appear in red 1201

background or red font on each labeling material of the drug or combination of 1202

products (medical device and drug) classified as drug according to the primary 1203

intended mode of action. In addition, the FDA requirements for labeling materials of 1204

physician’s sample shall apply to all drug products. It shall be unlawful to remove, 1205

erase, deface or mark the original labels of samples. 1206

1207

Pharmaceutical products classified as antimicrobials, including anti-TB medicines 1208

and other classifications of medicines, as may be prescribed by the FDA, shall not be 1209

given or distributed as physician’s samples. Upon effectivity of this IRR, all MAHs 1210

shall cease distribution of approved samples of antimicrobials including anti-TB 1211

medicines. FDA shall no longer approve applications for physician’s samples of these 1212

drugs. 1213

1214

Section 11. Prohibition Against the Use of Cipher, Codes, or Unusual Terms in 1215 Prescriptions and Prescription Substitution. – Pharmacists shall not compound or 1216

dispense prescriptions, recipes, or formulas which are written in ciphers, codes, or 1217

secret keys or prescriptions of pharmaceutical products with unusual names which 1218

differ from those in standard pharmacopeias or formularies. These may be reported to 1219

the Board for appropriate action. 1220

1221

The pharmacist dispensing or compounding prescriptions shall not substitute the 1222

medicine called for in the prescription with any other drug, substance, or ingredient as 1223

prescribed by FDA without prior consultation with, and written consent of the person 1224

prescribing. Generic substitution shall be done in accordance with R.A. No. 6675, 1225

R.A. No. 9502, and other pertinent laws and regulations. 1226

1227

Section 12. Label of Dispensed Medicines. – Upon every bottle, box, or package of medicines 1228

compounded or dispensed by a pharmacist, based on the prescription, there shall be 1229

pasted, affixed, or imprinted a seal or label bearing, among others, the name of patient 1230

and generic name of drug, brand name, if any, strength, expiry date, directions for 1231

use; and name and address of pharmacy, name of the doctor, the dispensing 1232

pharmacist, and other requirements prescribed in the Philippine Pharmacy Act for 1233

Pharmacists and Dispensing Guidelines, RA 9502, its IRR and such other regulations. 1234

1235

Auxiliary labels containing special pharmacists’ instructions for the patient shall be 1236

required as prescribed by the FDA. Auxiliary labels should not cover the primary 1237

display panel of the drug product. 1238

1239

Exceptions to labeling prior to dispensing requirement are during cardiopulmonary 1240

resuscitation emergencies and other emergency situations when the medicine 1241

dispensed is to be administered immediately by a licensed professional. 1242

1243

Section 13. Recording of Patient Medication Profile. – All prescriptions dispensed in the 1244

pharmacy shall be recorded in an appropriate recording system (i.e., electronic or 1245

manual) as may be required by the Department of Health, FDA, and/or the Board, 1246

indicating the following: 1247

a. Name of prescriber 1248

b. Name and address of patient 1249

c. Product name (generic and brand name, if any) 1250

d. Dosage strength and form 1251

e. Quantity of drug dispensed 1252

f. Initials of pharmacists 1253

g. Others as may be prescribed 1254

1255

The Patient Medication Profile shall be open for inspection by the representatives of 1256

the Board or the FDA, or both, at any time of the day, when the pharmacy is open, 1257

and must be kept for a period of not less than two (2) years after the last entry. 1258

1259

All required information on dangerous drugs dispensed by a pharmacy shall be 1260

recorded in the Dangerous Drugs Book or an equivalent recording system as required 1261

by RA 9165 and other applicable laws and issuances. 1262

1263

For any partially filled prescriptions, these shall be appropriately noted in the Patient 1264

Medication Profile or Dangerous Drugs Book or an equivalent recording system. 1265

1266

All referrals such as TB patients undertaken by the pharmaceutical outlets shall be 1267

recorded in the Referral Registry and shall be open for inspection by the 1268

representatives of the Board or the representative of the DOH, or the FDA, or both, at 1269

any time of the day, when the pharmacy is open, and must be kept for a period of not 1270

less than two (2) years after the last entry. 1271

1272

Section 14. Requirements for the Opening and Operation of a Retail Pharmaceutical 1273 Outlet or Establishment. – The opening of a retail pharmaceutical outlet or 1274

establishment shall be subject to requirements provided for in the Act and the rules 1275

and regulations prescribed by the FDA. 1276

1277

All outlets are required to display in a conspicuous space the following information: 1278

a. office hours; 1279

b. schedule of the supervising pharmacist; and 1280

c. whereabouts or contact information of the supervising pharmacist. 1281

1282

The applications for the opening and operation of a retail drug outlet or other similar 1283

business establishments shall not be approved, unless applied for by a pharmacist, 1284

either as owner or as pharmacist-in-charge, pursuant to the provisions of the Act. 1285

1286

Telepharmacy and online services of FDA-licensed Drugstores/Pharmacies/Boticas 1287

and Hospital Pharmacies, RONPDs, and Institutional Pharmacies are allowed subject 1288

to the rules and regulations of FDA. 1289

1290

Section 15. Handling of Pharmaceutical Products by Persons Other Than a Pharmacist. – 1291

For the purpose of this Section, persons handling pharmaceutical products other than 1292

the pharmacist, which shall include, pharmacy owners who are non-pharmacists, 1293

medical representatives or professional service representatives or pharmacy support 1294

personnel working as pharmacy technicians, pharmacy assistants or pharmacy aides, 1295

persons who assist pharmacists in any part of a pharmacy operation, or any other 1296

persons performing functions involved in the handling of pharmaceutical products, 1297

shall be duly certified by appropriate government agencies after undergoing an 1298

accredited training program. By 2020, the said provision shall be fully implemented. 1299

1300

For purposes of the Act, “handling of pharmaceutical products” pertains to activities 1301

or range of pharmacy operations from selecting, ordering, delivery, transport, receipt, 1302

inventory of stocks, to arranging and display, compounding, storage, dispensing, , 1303

provision of medication and health information to patients and healthcare providers, 1304

selling of pharmaceutical products including waste disposal. Training of other 1305

persons handling pharmaceutical products shall be under the responsibility of the 1306

employer. 1307

1308

No person, except pharmacy graduates, shall be allowed to render such services 1309

without undergoing a comprehensive standardized training program following PRC 1310

and FDA guidelines. 1311

1312

All persons handling pharmaceutical products, other than the pharmacist, shall 1313

undergo an accredited comprehensive training program to be duly certified by 1314

appropriate government agencies. These persons include the following with their 1315

corresponding job descriptions relevant to handling of pharmaceutical products: 1316

1317

a. Pharmacy owners who are non-pharmacists – selecting, ordering, delivery, 1318

receipt, arranging, display and storage of pharmaceutical products. Owners are 1319

required to attend FDA licensing seminars 1320

1321

b. Medical representatives or professional service representatives –promotion of 1322

pharmaceutical products to professional healthcare providers through 1323

provision of relevant health product information 1324

1325

c. Pharmacy Technician – under pharmacist supervision, conducts the following 1326

tasks: monitors the supply/inventory of pharmaceutical products, handles and 1327

controls pharmaceutical products, arranges the display of pharmaceutical 1328

products, observes good laboratory practices, prepares the product label, 1329

compounds formulations and dispenses both OTC medicines and prescription 1330

pharmaceutical products, demonstrates product knowledge on medicines, 1331

conducts health promotion education, vigilance and observes adherence to 1332

good manufacturing practices; supervises pharmacy assistants and pharmacy 1333

aides. 1334

1335

d. Pharmacy Assistant - under pharmacist supervision, conducts the following 1336

tasks: performs general housekeeping, monitors the supply/inventory of 1337

pharmaceutical products, handles and controls pharmaceutical products, 1338

arranges the display of pharmaceutical products, observes good laboratory 1339

practices, assists in preparing the product label, counts OTC tablets & 1340

capsules, reconstitutes powders for suspension; dispenses OTC 1341

pharmaceutical products, demonstrates product knowledge on medicines, 1342

conducts health promotion education, vigilance and observes adherence to 1343

good manufacturing practices. 1344

1345

e. Pharmacy Aide - under pharmacist supervision, conducts the following tasks: 1346

cleans work areas, answers phone calls and forwards calls or messages to the 1347

pharmacist, assists in placing of prices on products, assists in stocking of 1348

products in the shelves and warehouse, files documents on orders, deliveries, 1349

sales and others assigned by the pharmacist. 1350

1351

Section 16. Administration of Adult Vaccines. – In addition to the requirements provided in 1352

Section 4, paragraph (g) of the Act, trained pharmacist who shall administer adult 1353

vaccines shall ensure that the vaccine to be administered shall have a doctor’s 1354

prescription, which is not more than seven (7) days old and submit a monthly 1355

vaccination report and Adverse Events Following Immunization (AEFI) report to 1356

DOH regional offices using the prescribed form. 1357

1358

The following guidelines are the regulatory and technical requirements for pharmacy-1359

based immunization services in the Philippines: 1360

1361

A. Pharmaceutical Outlet 1362

1363

1. It should have a valid License to Operate (LTO) issued by the FDA. 1364

2. Vaccine products should have duly valid Certificates of Product Registration 1365

(CPR) issued by the FDA. 1366

3. It should maintain patient medication profile/record. 1367

4. It should have Standard Operating Procedures (SOPs) for vaccine storage, 1368

handling, preparation, dispensing, administration, and disposal. 1369

5. It should have a procedure for monitoring, handling and reporting of AEFI. 1370

6. It should comply with other requirements as may be prescribed. 1371

1372

B. Immunizing Pharmacist 1373

1374

Only PRC-BOP certified immunizing pharmacist shall provide vaccination services in 1375

pharmacies. Below are the requirements of an immunizing pharmacist: 1376

1. Certificate of Current Employment in the Pharmaceutical Outlet; 1377

2. Valid Certificate in Basic Life Support Training; and, 1378

3. Valid Certificate of Training in Vaccination Issued by PRC-BOP. 1379

1380

An Immunizing Service Agreement or a notarized declaration of joint undertaking 1381

between the pharmacy owner and the pharmacist, whether employed on a permanent 1382

or contractual basis, shall be made available. 1383

1384

A written and signed service agreement shall be accomplished by both the pharmacy 1385

owner and the health professionals who will be involved in the pharmacy 1386

immunization program. This document shall define and specify the responsibilities 1387

and accountabilities associated with the provision of immunization services in the 1388

pharmacy concerned. 1389

1390

Further, patient informed consent must be secured by the immunizing pharmacist 1391

prior to any vaccination to be administered. 1392

1393

Section 17. Disposal of Medications and other Pharmacy Documents with Patient 1394 Protected Health Information (PHI). – It shall be the responsibility of the 1395

pharmacist to oversee disposal of expired products The pharmacist shall be 1396

responsible in coordinating with the supplier or manufacturer the return as per 1397

company policy and the timely retrieval, and/or proper disposal of pharmaceutical 1398

wastes, unused and expired pharmaceutical products in accordance to the provisions 1399

set by the Department of Health and the Department of Environment and Natural 1400

Resources. 1401

1402

Pharmacy documents with patient protected health information (PHI) that includes 1403

the patient name and other identifiers must be discarded under the supervision of a 1404

pharmacist with utmost security to protect the patient’s privacy and confidentiality. 1405

1406

Disposal of expired physician’s samples shall be the responsibility of the 1407

supplier/distributor who provided the sample. 1408

1409

Section 18. Returns of Medications from Clients/Patients. – Medication returns shall be in 1410

accordance to the existing laws and regulations of the Department of Trade and 1411

Industry and other regulatory agencies, provided that, safety of the patient will not be 1412

compromised. 1413

1414

To ensure quality and integrity of medications for all patients, drugs with special 1415

storage requirements and compounded products shall not be accepted for return. 1416

1417

1418

RULE V 1419

ACCREDITED PROFESSIONAL ORGANIZATION 1420 1421

Section 1. The Accredited Professional Organization (APO) of the Pharmacists. – The 1422

Pharmacy profession shall be integrated into one national organization registered with 1423

the Securities and Exchange Commission (SEC) which shall be recognized by the 1424

Board of Pharmacy and the Professional Regulation Commission (PRC) as the one 1425

and only integrated and accredited professional organization of pharmacists. 1426

1427

A pharmacist duly registered by the Board shall automatically become a member of 1428

the accredited professional organization of pharmacists and shall receive the benefits 1429

appurtenant thereto upon payment of the required fees and dues. 1430

1431

Membership in the APO shall not prevent membership in other associations of 1432

pharmacists. 1433

1434

Section 2. Membership to the Accredited Professional Organization. – All registered 1435

pharmacists must be members of the APO, and must maintain active membership by 1436

paying their annual member fees, throughout the duration of the practice of the 1437

profession. The PIC shall not be renewed if the requirements for membership with the 1438

APO, are not met including the requirements pursuant to the guidelines set by PRC. 1439

1440

Pharmacy support personnel working as Pharmacy Technicians, Pharmacy Assistants, 1441

and Pharmacy Aides must be registered as affiliate members of APO. They must 1442

maintain membership throughout the duration of their employment. 1443

1444

Section 3. Specialty Boards in Various Areas of Pharmacy Practice. – Specialty Boards in 1445

various areas of pharmacy practice shall be created, subject to the accreditation by the 1446

Board of Pharmacy and the Professional Regulation Commission as recommended or 1447

concurred by the Accredited Professional Organization. The Board shall issue 1448

guidelines in the accreditation of specialty boards in various areas of pharmacy 1449

practice, which shall include the standards of practice within different specialties, 1450

qualifications, and requirements for the certification of practitioners under each 1451

specialty. The guidelines shall be developed by a Committee headed by the PRC and 1452

composed of the APO and other concerned affiliate organizations. The Committee 1453

may invite an expert to serve as an adviser or as a consultant in the development of 1454

the guidelines. 1455

1456

1457

RULE VI 1458

VIOLATIONS, ADMINISTRATIVE SANCTIONS, AND PROCEDURES 1459 1460

Section 1. General Provisions. – These rules shall apply to all cases concerning violations of 1461

the Act and other relevant laws. 1462

1463

Section 2. Commencement of Action/Procedure. – An action is commenced when (a) a 1464

complaint or petition has been filed or (b) an administrative investigation has been 1465

initiated by the BOP. 1466

1467

A. Based on a Complaint 1468

1. A written complaint under oath shall be filed by any person against a pharmacist 1469

with the BOP. The complaint shall be in four (4) copies complaint with 1470

supporting documentary evidences and/or affidavits of witnesses. The respondent 1471

shall be furnished with a copy of the complaint and its attachments. 1472

2. Respondent shall submit a reply with supporting documentary evidences and/or 1473

affidavits including its witness/es within ten (10) calendar days from receipt of the 1474

complaint. 1475

3. The BOP hears and investigates cases arising from the violation of the Pharmacy 1476

Act, its implementing rules and regulations, Code of Ethics, and other laws 1477

relevant to the practice of pharmacy. It may issue summons, subpoena and 1478

subpoena duces tecum to compel attendance of respondent(s) and/or witnesses. 1479

4. The BOP may delegate the hearing or investigation of administrative cases filed 1480

before it, except when the issue or question strictly involves or concerns the 1481

practice of pharmacy profession or occupation, in which case, the hearing shall be 1482

presided over by at least one (1) member of the BOP assisted by a legal or hearing 1483

officer of the PRC, subject to applicable provisions of the Pharmacy Act and/or 1484

its implementing rules and regulations. 1485

5. The BOP shall conduct or delegate the conduct of summary proceedings on minor 1486

violations of the Pharmacy Act and its implementing rules and regulations, as 1487

well as, violations of the general instructions to examinees committed by 1488

examinees. 1489

6. The BOP renders judgements or decisions in all administrative investigations, as a 1490

collegial body, by a majority vote of all its members, subject to applicable 1491

provisions of the Pharmacy Act. 1492

7. A motion for reconsideration may be filed from an adverse judgement or decision 1493

within 10 calendar days from the receipt thereof. 1494

8. All judgements or decisions become final and executory, fifteen (15) days from 1495

the receipt thereof ,or from the receipt of the resolution of the motion for 1496

reconsideration, unless appealed to the PRC. 1497

1498

B. Based on Information or as a Result of BOP’s Inspection 1499

1500

The BOP prepares the charge sheet, containing the particulars of the violation, committed 1501

and the affidavit(s) of witness(es) and documentary evidence(s) attached thereto. Then 1502

the procedure in a., above is followed. 1503

1504

Section 3.Violations and Administrative Sanctions. – The Board shall have the power, upon 1505

notice and hearing, to revoke or suspend the COR of a registered pharmacist or to 1506

cancel an STP of a foreign pharmacist on any of the following grounds: 1507

1508

a. Violation of any provision of this Act, its Rules and Regulations, the 1509

Pharmacists’ Code of Ethics, Code of Technical Standards for the 1510

Professional Practice of the Pharmacy Profession (PhilPSP), Code of Good 1511

Governance, and all other guidelines, policies and regulatory measures of the 1512

Board and/or the Commission relating to the practice of the pharmacy 1513

profession; 1514

1515

b. Conviction of an offense involving moral turpitude by a court of competent 1516

jurisdiction; 1517

1518

c. Unprofessionalism, immorality, malpractice, incompetence, gross negligence, 1519

or imprudence in the practice of the profession; 1520

1521

d. Fraud or deceit in the acquisition of the COR, PIC or STP or renewal thereof; 1522

1523

e. Allowing the certificate of registration to be used or displayed in 1524

establishments where the pharmacist is not actually employed and practicing, 1525

whether on part-time or full time basis; 1526

1527

f. Addiction to alcoholic beverages or to any habit-forming drug, as provided for 1528

in Section 23 d), rendering a pharmacist incompetent to practice the 1529

profession; 1530

1531

g. Aiding or abetting the illegal practice of pharmacy; 1532

1533

h. Insanity or any mental disorder, as provided for in Sec. 23 (e), that would 1534

render the person incompetent to practice pharmacy, as determined by a 1535

competent medical professional; 1536

1537

i. False, extravagant, or unethical advertisements, endorsement, and promotion 1538

of pharmaceutical products, pharmaceutical outlets and establishments where 1539

the pharmacist’s name or the pharmacist’s professional organization and 1540

similar information, or both, are used; 1541

1542

j. Manufacture, sale, offering for sale of counterfeit, spurious, substandard, 1543

falsified pharmaceutical products and committing other acts in violation of 1544

R.A. No. 8203, otherwise known as the “Special Law on Counterfeit Drugs” 1545

The administrative sanctions under Section 7. of R.A. No. 8203, and Rule VII, 1546

Sections 1. to Section 9., Rules and Regulations Implementing Republic Act 1547

No. 8203, shall apply. 1548

1549

k. Illegal manufacture, sale, possession, dispensing of dangerous drugs and other 1550

acts in violation of Republic Act No. 9165, and other applicable laws and 1551

issuances. The administrative sanctions in the pertinent provisions of R.A. No. 1552

9165, “The Comprehensive Dangerous drugs Act of 2002”and its 1553

implementing rules and regulations, shall apply; 1554

1555

l. Committing acts in violation of Section 6 of Presidential Decree No 881, 1556

entitled, “Empowering the Secretary of Health to Regulate the Labeling, Sale 1557

and Distribution of Hazardous Substances” and Section 11 and Section 29-A 1558

of Republic Act No. 3720, as amended R.A. No. 9711, “The Food and Drug 1559

Administration act of 2009”; 1560

1561

m. Practicing pharmacy with a suspended or revoked COR, or with expired 1562

PIC; 1563

1564

n. Unauthorized dispensing of pharmaceutical products through unregistered 1565

online services or direct selling businesses, in accordance with the guidelines 1566

issued by FDA and BOD-PRC; and, 1567

1568

o. Being found guilty of immoral, unprofessional or dishonorable conduct by the 1569

Board. 1570

1571

1572

Administrative Sanctions shall also be imposed for violations under Section 45. and 1573

Section 46. of the Act. 1574

1575

a. Under Section 45. – b); d); g); i); l); n); q); s); v); and z) 1576

1577

b. Under Section 46 – c); e); f); g); h); i); k); and l) 1578

1579

1580

RULE VII 1581

PENAL PROVISIONS 1582 1583

Section 1. Violations and Penalties. – Any person who shall commit any of the following acts 1584

shall, upon conviction, be sentenced to pay a fine of not less than two hundred fifty 1585

thousand pesos (Php250,000.00), but not exceeding five hundred thousand pesos 1586

(Php500,000.00) or imprisonment of not less than one (1) year and one (1) day but 1587

not more than six (6) years or both at the discretion of the court: 1588

1589

a. Commission of any act in violation of Sections 30 and 31 of this Act; 1590

1591

b. Allowing the display of one’s COR in a pharmaceutical establishment where 1592

the pharmacist is not employed and practicing; 1593

1594

c. Displaying of the pharmacist’s COR by pharmacy owners/operators in a 1595

pharmaceutical establishment where the pharmacist is not employed and 1596

practicing; 1597

1598

d. Dispensing or allowing the dispensing or offering for sale of prescription 1599

drugs or pharmaceutical products in a place not licensed by FDA as a 1600

pharmaceutical outlet; 1601

1602

e. Dispensing of prescription and pharmacist-only OTC pharmaceutical products 1603

by a person other than those under the direct and immediate supervision of a 1604

pharmacist; 1605

1606

f. Allowing the dispensing of prescription and pharmacist-only OTC 1607

pharmaceutical products, without the direct and immediate supervision of a 1608

pharmacist; 1609

1610

g. Compounding and dispensing not in accordance with current Good 1611

Manufacturing Practice, Good Laboratory Practice and Philippine Practice 1612

Standards for pharmacists (PhilPSP), and such other standards and guidelines 1613

issued by the Board; 1614

1615

h. Selling of prescription and pharmacist-only OTC drugs by manufacturers, 1616

importers, and wholesalers to unlicensed pharmaceutical outlets and other 1617

establishments; 1618

1619

i. Substituting prescription drugs which are not generically equivalent to what 1620

was on the prescription, without the consent of the prescriber or not in 1621

accordance with R. A. No. 6675, any amendment thereto, and relevant 1622

issuances; 1623

1624

j. Forcing, coercing or intimidating a pharmacist to compound or dispense 1625

medical and pharmaceutical products in violation of the provisions of the Act, 1626

its IRR, and other relevant laws, rules and regulations; 1627

1628

k. Preparing and compounding of pharmaceutical products in quantities greatly 1629

in excess of single therapeutic doses, without the presence and supervision of 1630

a pharmacist, or in a place not duly registered with the FDA; 1631

1632

l. Noncompliance with the labeling requirements for dispensed medicines by a 1633

pharmaceutical outlet as provided for by law and current guidelines; 1634

1635

m. Manufacturing, selling, importing, and exporting of pharmaceutical products 1636

under fraudulent name or address, or both; 1637

1638

n. Adulterating and misbranding of pharmaceutical products, and/or causing the 1639

commission of the said acts; 1640

1641

o. Manufacturing, selling, importing, exporting, or making available in 1642

commerce unsafe, substandard and counterfeit pharmaceutical products; 1643

1644

p. Operating an unlicensed pharmaceutical outlet such as online pharmacy 1645

service or direct selling not authorized by the FDA; 1646

1647

q. Operating a Category A establishment which opens for business without a 1648

pharmacist; 1649

1650

r. Operating a Category B establishment, without the required supervision and 1651

oversight of a pharmacist; 1652

1653

s. Practicing pharmacy without a valid license or with an expired, suspended or 1654

revoked license; 1655

1656

t. Filling and refilling of prescription and pharmacist-only OTC pharmaceutical 1657

products by person other than a pharmacist or without his/her the direct and 1658

immediate supervision; 1659

1660

u. Dispensing prescription drugs and pharmacists-only OTC drugs by rural 1661

health units, and other national and local government units, agencies, and 1662

facilities, as well as, by other private institutions and establishments, without 1663

the required supervision of a pharmacist; 1664

1665

v. Manufacture, sale, offering for sale of counterfeit, spurious, substandard, 1666

falsified pharmaceutical products and committing other acts in violation of 1667

R.A. No. 8203, otherwise known as the “Special Law on Counterfeit Drugs”; 1668

1669

w. Illegal manufacture, sale, possession, dispensing of dangerous drugs and other 1670

acts in violation of Republic Act No. 9165, and other applicable laws and 1671

issuances. The penalties in the pertinent provisions of R.A. No. 9165, “The 1672

Comprehensive Dangerous drugs Act of 2002”and its implementing rules and 1673

regulations, shall apply; 1674

1675

x. Committing acts in violation of Section 6 of Presidential Decree No 881, 1676

entitled, “Empowering the Secretary of Health to Regulate the Labeling, Sale 1677

and Distribution of Hazardous Substances” and Section 11 and Section 29-A 1678

of Republic Act No. 3720, as amended by R.A. No. 9711, “The Food and 1679

Drug Act of 2009”; 1680

1681

y. Use and abuse of authority as pharmacist, to gain access to prohibited drugs 1682

for illicit use or purpose; 1683

1684

z. Engaging in immunization as provided for in the Act without the required 1685

training and license/certification from the appropriate agency; 1686

1687

aa. Compounding, dispensing, selling, reselling or otherwise making available to 1688

the consuming public, pharmaceutical products, not through a retail outlet 1689

duly licensed by FDA; 1690

1691

bb. Manufacturing, compounding, distribution, selling, offering for sale of 1692

medicines and other pharmaceutical products without license from FDA, and 1693

without the supervision of a pharmacist, when so required; and, 1694

1695

cc. Other acts/omissions analogous to the foregoing. 1696

1697

1698

RULE VIII 1699

OTHER PENALTIES 1700 1701

Section 1. Other Violations and Penalties. – Any person who shall commit any of the following 1702

acts shall, upon conviction, be sentenced to pay a fine of not less than one hundred 1703

thousand pesos (Php100,000.00), but not exceeding two hundred thousand pesos 1704

(Php200,000.00) or imprisonment of not less than thirty (30) days but not more than 1705

one (1) year, or both at the discretion of the court: 1706

1707

a. Affixing of the title “RPh” by a person who is not a pharmacist; 1708

1709

b. Practicing the pharmacy profession in the Philippines without a valid COR, 1710

PIC or STP; 1711

1712

c. Non-indication of a pharmacist of his/her COR and professional tax receipt 1713

numbers in official documents requiring such information, as prescribed by 1714

the Board in particular, in an issuance; 1715

1716

d. Refusal to display the COR of the pharmacist in a prominent and conspicuous 1717

place in the establishment and outlet where the pharmacist is employed and 1718

practicing; 1719

1720

e. Non-compliance by a pharmacist with the requirements on the filling of 1721

prescription, as provided for in the appropriate guidelines issued by BOP-1722

PRC; 1723

1724

f. Non-compliance by a pharmacist on the requirements for partially-filled 1725

prescription as provided for in the appropriate guidelines issued by BOP-PRC 1726

; 1727

1728

g. Selling of physician’s samples; 1729

1730

h. Distribution of antimicrobials, including anti-TB drugs and other product 1731

classification, as may be prohibited by law and pertinent regulations as 1732

physician’s samples; 1733

1734

i. Removal, erasure, and alteration of mark or label of physician’s sample, and 1735

non-labeling or marking of physician’s sample as such; 1736

1737

j. Use of cipher, codes or secret keys or unusual names or terms in prescriptions; 1738

1739

k. Filling or partial filling of prescriptions where cipher, codes, secret keys or 1740

unusual names and terms are used; 1741

1742

l. Non-compliance with labeling requirements for dispensed medicines; 1743

1744

m. Non-compliance with the requirements on the keeping of records or record 1745

books by a pharmaceutical outlet 1746

1747

n. Employment of personnel in a pharmacy or pharmaceutical operation without 1748

the required relevant training and certification; 1749

1750

o. Refusal of a non-pharmacist owner/operator of a pharmaceutical outlet to 1751

undergo the required and relevant training and certification; 1752

1753

p. Refusal by the owner/operator, general manager, supervisor, and other heads 1754

of units of government and of private establishments, to allow and require 1755

pharmacists and pharmacy support personnel to undergo CPD, training and 1756

certification; 1757

1758

q. Rendering dispensing-related services by non-pharmacists in a pharmaceutical 1759

outlet without undergoing the required training and certification; 1760

1761

r. Dispensing pharmaceutical products in medical missions without the direct 1762

and immediate supervision of a pharmacist; 1763

1764

s. Non-compliance with the required training and certification of by professional 1765

service or medical representatives or professional service representatives, 1766

pharmacy technicians, pharmacy assistants, pharmacy aides, pharmacy clerks, 1767

and other medicine handlers of pharmaceutical products. Both the medical 1768

representatives or professional service representatives, pharmacy technicians, 1769

pharmacy assistants, pharmacy aides, pharmacy clerks, or medicine handlers 1770

and the owners/proprietors, and responsible officers and employees of 1771

pharmaceutical establishment/outlet employing any such individual shall be 1772

held jointly liable; and, 1773

1774

t. Violation of any provision of this Act and its Rules and Regulations not 1775

aforementioned above. 1776

1777

u. Non-compliance with the requirements of the Act in dispensing prescription 1778

and pharmacist-only OTC medicines during emergency cases, where the 1779

services of a pharmacist are not available. 1780

1781

Section 2. – Any person, other than the citizens of the Philippines, having been found guilty of 1782

any violation as provided for in this section and the preceding section shall, after 1783

having paid the imposed fine or having served the sentence, or both, when so 1784

adjudged, shall also be subject to immediate deportation. 1785

1786

Section 3. – The penalties and liabilities herein provided shall be without prejudice to other 1787

sanctions that may be imposed for violation of other applicable laws, policies, rules 1788

and regulations. 1789

1790

Section 4. – The owner/operator of the pharmaceutical establishments/outlets, as well, as the 1791

other officers responsible for the violation , and the pharmacists/ pharmacy support 1792

personnel are jointly liable for the willful violation of any provision of the Act, as 1793

determined by the court. 1794

1795

1796

RULE IX 1797

FINAL PROVISIONS 1798 1799

Section 1. Enforcement. – It shall be the primary duty of the Board, PRC, and FDA to 1800

effectively enforce the provisions of this Implementing Rules and regulations. All 1801

duly constituted law enforcement agencies and officers of the national, provincial, 1802

city or municipal government or of any political subdivision thereof shall ensure the 1803

effective enforcement of this Implementing Rules and regulations. 1804

1805

Section 2. Prospectivity. – The administrative sanctions and penalties imposed herein shall not 1806

apply to acts committed prior to the date the Act becomes effective. 1807

1808

Section 3. Appropriations. – The Chairperson of the PRC shall immediately include in its 1809

programs the implementation of the Act, the funding of which shall be charged 1810

against their current years’ appropriations and thereafeter, in the annual General 1811

Approprations Act. 1812

1813

Section 4. Transitory Provisions. – The PRC-BOP and FDA shall set the period for 1814

compliance to their respective guidelines that they have to establish for a more 1815

effective enforcement of the requirements set forth by the Act and this Implementing 1816

Rules and Regulations. 1817

1818

Section 5. Separability Clause. – If for any reason, any part or provision of these rules and 1819

regulations shall be held or declared to be unconstitutional or invalid, such 1820

declaration shall not affect, invalidate or impair the other parts or provisions hereof 1821

which are otherwise valid and effective, and shall continue to be in full force and 1822

effect. 1823

1824

Section 6. Repealing Clause. – All administrative issuances or parts thereof which are contrary 1825

to or inconsistent with the provisions of this IRR are hereby repealed. 1826

1827

Section 7. Amendments. – These IRR may be amended, modified or supplemented when the 1828

effective implementation and enforcement of the Act would require. 1829

1830

Section 8. Effectivity. – This Implementing Rules and Regulations shall take effect fifteen (15) 1831

days after its publication in the Official Gazette or in the newspaper of general 1832

circulation. 1833