implementing rules and regulations (irr) of … irr of ra10918 (090916)_e.pdf · interpretation of...
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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