legal requirements for hospital pharmacy philippines

The board reviews each incident on a case-by-case basis. Section 37. 7323, Otherwise Known as the Special Program for Employment of Students, University of Science and Technology of Southern Philippines (USTSP) Act. No person, except pharmacy graduates, shall be allowed to render such services without undergoing a comprehensive standardized training program: Provided, That the job description is defined in the implementing rules and regulations of this Act. Section 8. Grounds for Suspension or Removal from Office of the Chairperson or Member of the Board.— The President of the Philippines may, upon recommendation of the PRC and after due process, suspend or remove the Chairperson or any member of the Board on any of the following grounds: (a) Gross neglect, incompetence, or dishonesty in the discharge of duty; (b) Involvement in the manipulation, tampering, or rigging of the licensure examination, its questions or results, or both, and in the disclosure of classified and confidential information pertaining to the licensure examination; (c) Conviction of an offense involving moral turpitude by a court of competent jurisdiction; and. Instruct, train and supervise all employees of the Pharmacy Service; 3. Review and approve schedule of duties of the pharmacy staff 4. Revocation or Suspension of the Certificate of Registration and Cancellation of Special/Temporary Permit.— The Board shall have the power, upon notice and hearing, to revoke or suspend the COR of a registered pharmacist or to cancel an STP of a foreign pharmacist on any of the following grounds: (a) Violation of any provision of this Act, its rules and regulations, the Pharmacists’ Code of Ethics, Code of Technical Standards for the Professional Practice of the Pharmacy Profession, Code of Good Governance and all other guidelines, policies and regulatory measures of the Board and/or the PRC relating to the practice of the pharmacy profession; (b) Conviction of an offense involving moral turpitude by a court of competent jurisdiction; (c) Unprofessionalism, immorality, malpractice, incompetence, gross negligence, or imprudence in the practice of the profession; (d) Fraud or deceit in the acquisition of the COR, PIC or STP, or renewal thereof; (e) Allowing the COR to be used or displayed in establishments where the pharmacist is not actually employed and practicing; (f) Addiction to alcoholic beverages or to any habit-forming drug rendering a pharmacist incompetent to practice the profession as provided for in Section 23 hereof; (g) Aiding or abetting the illegal practice of a non-registered and licensed person; (h) Insanity or any mental disorder that would render the person incompetent to practice pharmacy; (i) False, extravagant, or unethical advertisements and endorsements of pharmaceutical products, pharmaceutical outlets and establishments where the pharmacist’s name or the pharmacist’s professional organization and similar information, or both, are used; (j) Manufacture, sale, offering for sale of counterfeit, spurious, substandard and falsified pharmaceutical products and committing other acts in violation of Republic Act No. These also refer to products that are deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products, including the following: (1) The pharmaceutical product itself or the container or labeling thereof or any part of such product, container, or labeling, bearing without authorization; the trademark, trade name, or other identification marks or imprints or any likeness to that which is owned or registered in the Intellectual Property Office (IPO) in the name of another natural or juridical person; (2) A pharmaceutical product refilled in containers bearing legitimate labels or marks, without authority; and. (3) A pharmaceutical product which contains no amount of or a different active ingredient; or less than eighty percent (80%) of the active ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration; (k) Dangerous drugs refer to those listed in the: (1) Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol; (2) Schedules annexed to the 1971 Single Convention on Psychotropic Substances; and (3) Annex of Republic Act No. Section 2. A guide to understanding and implementing Web Content Accessibility Guidelines 2.0 It usually is in the form of capsules, tablets, liquids, gels, powders, or pills and not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs and medicines, as defined under Republic Act No. injectibles, eyedrops); (t) Household remedies refer to any preparation containing pharmaceutical substances of common or ordinary use to relieve common physical ailments and which may be dispensed without a medical prescription in original packages, bottles or containers, of which the nomenclature has been duly approved by the FDA; (u) Institutional pharmacies refer to pharmacies of institutions, organizations, and/or corporations that provide a range of pharmaceutical services, given exclusively to the employees and/or their qualified dependents; (v) Internship program refers to a supervised practical experience that is required to be completed for licensure as a registered pharmacist; (w) Label refers to a display of written, printed, or graphic matter on the immediate container of any article; (x) Labeling materials refer to all labels and other written, printed, or graphic matter: (1) upon any item or any of its containers or wrappers; or (2) accompanying any such item; (y) Medical device refers to any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used alone, or in combination, for human beings, for one (1) or more of the specific purposes of: diagnosis, prevention, monitoring, treatment, or alleviation of disease; diagnosis, monitoring, treatment, or alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy of a physiological process; supporting or sustaining life; preventing infection; control of conception; disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body. 9502; (n) Emergency cases refer to life-threatening situations where a patient needs immediate medical attention and treatment, including the occurrence of epidemic or natural calamities; (o) Expiration date refers to the end date when the manufacturer can guarantee that a product possesses its claimed potency, efficacy, quality, and safety; after which its sale or distribution is prohibited; (p) Filling refers to the act of dispensing or providing medicines in accordance with a prescription or medication order; (q) Food/Dietary supplements refer to processed food products intended to supplement the diet that bears or contains one (1) or more of the following dietary ingredients: vitamins, minerals, herbs, or other botanicals, amino acids, and dietary substances to increase the total daily intake in amounts conforming to the latest Philippine-recommended energy and nutrient intakes or internationally agreed minimum daily requirements. Learn more about the Philippine government, its structure, This device does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means, as defined under Republic Act No. Section 26. Section 16. These include proteins, nucleic acids, or living microorganisms where the virulence is reduced and are used for therapeutic or for in vivo diagnostic purposes; (e) Brand name refers to the proprietary name given by the manufacturer to distinguish its product from those of competitors; (f) Cipher, Code, or Secret Key refers to a method of secret writing or use of characteristic style or symbol by substituting other letter/s or character/s for the letter/s intended, for the purpose of misleading the consumer; (g) Compounding refers to the sum of processes performed by a pharmacist in drug preparation including the calculations, mixing, assembling, packaging, or labeling of a drug: (i) as the result of a prescription or drug order by a physician, dentist, or veterinarian; or (ii) for the purpose of, or in relation to, research, teaching, or chemical analysis; (h) Continuing professional development (CPD) refers to the inculcation of advanced knowledge, skills, and ethical values in a post-licensure specialized or in an inter- or multidisciplinary field of study for assimilation into professional practice, self-directed research, and/or lifelong learning; (i) Cosmetics refer to a substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odor, and/or protecting the body or keeping them in good condition, as defined under Republic Act No. Section 51. Section 38. each guideline. Title.—This Act shall be known as the “Philippine Pharmacy Act”. 6675; (j) Forcing, coercing, or intimidating a duly registered and licensed pharmacist to compound or dispense medical and pharmaceutical products in violation of the provisions of this Act; (k) Preparing and compounding of pharmaceutical products in quantities greatly in excess of single therapeutic doses, without the presence and supervision of a duly registered and licensed pharmacist; (l) Noncompliance with the labeling requirements for dispensed medicines by a pharmaceutical outlet; (m) Manufacturing and selling of pharmaceutical products under fraudulent name or address, or both; (n) Adulterating and misbranding of pharmaceutical products; (o) Manufacturing and selling of unsafe, substandard and counterfeit pharmaceutical products; (p) Operating an unlicensed pharmaceutical outlet such as online pharmacy service or direct selling not authorized by the FDA; (q) Operating a Category A establishment which opens for business without a duly registered and licensed pharmacist; (r) Operating a Category B establishment without the supervision and oversight of a duly registered and licensed pharmacist; (s) Practicing pharmacy with an expired, suspended or revoked license; (t) Filling and refilling of prescription and pharmacist-only OTC pharmaceutical products by a person other than a duly registered and licensed pharmacist without the direct and immediate supervision; (u) Dispensing prescription drugs and pharmacist-only OTC drugs by rural health units without the supervision of a duly registered and licensed pharmacist; and. Statement of Policy.— The State recognizes the vital role of pharmacists in the delivery of quality health care services through the provision of safe, effective, and quality pharmaceutical products, pharmaceutical care, drug information, patient medication counseling, and health promotion. Completion of a pharmacy residency program, Masters in Clinical Pharmacy, and/or 3-5 years previous clinical hospital pharmacy experience preferred. This Act was passed by the House of Representatives as House Bill No. Section 53. 9165, and other applicable laws and issuances; (l) Committing acts in violation of Section 6 of Presidential Decree No. All iGovPhil Project services and content are currently moving towards WCAG Level A 9165 and Republic Act No. it as a stable and referenceable technical standard. BS in Pharmacy. 6675, as amended, otherwise known as the “Generics Act of 1988”, and other pertinent laws and regulations. Standalone Pharmacy. compliance. The above legal requirements are only the essential requirements for starting a business in the Philippines. Both the medical representatives or professional service representatives, pharmacy technicians, pharmacy assistants, pharmacy aides, pharmacy clerks, or medicine handlers and the pharmaceutical establishment and outlet emploving any such individual shall be held jointly liable; and. Section 17. or an administrative specialty residency10 is desirable. The pharmacists’ professional services shall, therefore, be promoted as an indispensable component of the total health care system to ensure t… Recording of Patient Medication Profile.— All prescriptions dispensed in the pharmacy shall be recorded in an appropriate recording system indicating therein, among other things, the name and address of the patient, name of prescribes generic name and brand, dosage strength, quantity of drug and initials of pharmacist. The FDA, in coordination with the Board, and the approval of the PRC, may add to, delete, reclassify, or modify the above list of establishments, as the need arises, in order to keep pace with the developments in the pharmacy practice. 2436 on May 30, 2016. Activities under paragraphs (a), (b), (c), (d) and (i) are exclusive to licensed pharmacists. Likewise, a determination regarding an applicant’s approval for licensure cannot … That is, nothing is automatic. Compliance to these criteria is measured in three levels: A, AA, or AAA. Repealing Clause.— Republic Act No. There was support for the outcomes-based approach to the regulation, leaving specifics to supplemental documents such as standards, policies and guidelines that can be amended easily as practice evolves. Section 4. Title.— This Act shall be known as the “Philippine Pharmacy Act”. When employed in establishments under Category B, as defined in Section 31 of this Act, the duplicate copy of the pharmacist’s COR shall also be displayed therein. 3. WCAG 2.0 is also an international standard, ISO 40500. (v) All other acts or omissions analogous to the foregoing. Section 30. An applicant who failed in the licensure examination for the third (3rd) time shall not be allowed to take the next succeeding examinations without having undertaken a refresher program in a duly accredited institution. (e) Declared of unsound mind by a court of competent jurisdiction. Section 44. Begun and held in Metro Manila, on Monday, the twenty-seventh day of July, two thousand fifteen. 5921, as amended, is hereby repealed. The Board shall issue guidelines in the accreditation of specialty boards in various areas of pharmacy practice, which shall include the standards of practice within different specialties, qualifications, and requirements for the certification of practitioners under each specialty, among others. Effectivity.— This Act shall take effect fifteen (15) days after its publication in the Official Gazette or in a newspaper of general circulation. Application for Registration w/o Examination, Renewal of Professional Identification Card, Issuance of Duplicate Professional Identification Card, ■ Application for Registration without Examination, ■ Guidelines for Renewal of Professional Identification Card, ■ Accreditation of Real Estate Salesperson, ■ Accreditation of Medical Representative, ■ Stateboard Verification / Validation of Registration/License, ■ Replacement Certificate of Registration (COR), ■ Lists of Accreditation/ Registration/Compliance/Authority, Operational Guidlines During the Transition Period, Certificate of Ineligibility for Non-Filipino Citizens, AQRF Referencing Report of the Philippines, Online Request for Certification / Authentication, Stateboard Verification / Validation of Registration / License, Application Form Special Permit for Former Filipino Professional, Chrome for Linux press (Alt+Shift+shortcut_key), Chrome for Windows press (Alt+shortcut_key), Chrome for MAC OS press (ctrl+opt+shortcut_key), Safari for MAC OS press (ctrl+opt+shortcut_key), For Firefox press (Alt+Shift+shortcut_key), For Internet Explorer press (Alt+Shift+shortcut_key) then press (enter). how government works and the people behind it. Kumuha ng mga update sa email para sa bagong Clinical Pharmacist mga trabaho sa Philippines. Section 20. 8203, otherwise known as the “Special Law on Counterfeit Drugs”; (k) Illegal manufacture, sale, possession, dispensing of dangerous drugs and other acts in violation of Republic Act No. Scope of Examination.— The Pharmacists’ Licensure Examination shall cover the following subjects on Pharmacy Science and Practice, Inorganic Pharmaceutical Chemistry, Organic Pharmaceutical Chemistry, Qualitative and Quantitative Pharmaceutical Chemistry, Pharmacognosy and Plant Chemistry, Pharmaceutical Biochemistry, Microbiology and Parasitology, Physical Pharmacy, Biopharmaceutics, Pharmacology and Toxicology, Manufacturing, Quality Assurance and Instrumentation, Pharmaceutical Calculations, Drug Delivery Systems, Hospital Pharmacy, Clinical Pharmacy, Dispensing and Medication Counseling, Pharmaceutical Administration and Management, Public Health, Legal Pharmacy, and Ethics. b) The pharmacy department shall establish and maintain adequate records of drug purchases necessary for inventory control and legal requirements. The Professional Regulatory Board of Pharmacy, hereinafter created, subject to the approval of the PRC, as provided for by Republic Act No. The following sections refer to the key generic resources and legislation and do not aim to cover the more specific requirements for services such as manufacturing, mental health legislation etc. The Chairperson and members of the Board shall duly take their oath of office before a duly authorized officer. Partial filling of prescription less than the total quantity indicated in the prescription shall be allowed, subject to dispensing guidelines as provided in the immediately preceding paragraph. The Board shall prepare, adopt, issue, or amend the syllabi or tables of specifications of the subjects in the licensure examination, in consultation with the academe and the Commission on Higher Education (CHED); (d) Recommend the issuance, suspension, revocation, or reinstatement of the COR, PIC or Special/Temporary Permits (STP) for the practice of pharmacy; (e) Administer oaths in accordance with the provisions of this Act; (f) Regulate and monitor the practice of pharmacy in the Philippines, including the practice of subprofessional services such as pharmacy technicians, pharmacy assistants, aides, and other medicine handlers, as described in this Act; adopt measures that may be deemed proper for the enhancement of the profession and the maintenance of high professional, academic, ethical, and technical standards; and conduct ocular inspection of pharmaceutical establishments and higher education institutions (HEIs), in coordination with concerned government agencies; (g) Promulgate and prescribe the Pharmacists’ Code of Ethics, Code of Technical Standards and Guidelines for the Professional Practice of the Pharmacy Profession, in coordination with the APO; (h) Represent the pharmacy profession in all fora involving concerns and issues related to pharmaceutical products and the practice of pharmacy; (i) Investigate cases arising from violations of this Act, the rules and regulations promulgated pursuant thereto, the Pharmacists’ Code of Ethics, Code of Technical Standards and Guidelines for the Professional Practice of the Pharmacy Profession, and other Board issuances; issue summons, subpoena ad testificandum and subpoena duces tecum to secure the attendance of witnesses or production of documents, or both, and other evidence necessary for such investigation or hearing; and render decision thereon which shall, unless appealed to the PRC, become final and executory after fifteen (15) days from receipt of notice of judgment or decision; (j) Delegate the he aring or investigation of administrative cases filed before the Board, except where the issue or question involves the practice of the profession, in which case, the hearing shall be presided over by at least one (1) member of the Board, to be assisted by a Legal or Hearing Officer of the PRC; (k) Conduct, through the Legal Officers of the PRC, summary proceedings on minor violations of this Act, the General Instruction to the Examinees, including the implementing rules and regulations issued by the Board, and to render summary judgment thereon which shall, unless appealed to the PRC, become final and executory after fifteen (15) days from receipt of notice of judgment or decision; (l) Issue and promulgate guidelines on CPD, in coordination with the APO; (m) Recommend the accreditation of the standardized training programs for and certifications of medical representatives or professional service representatives, pharmacy technicians, pharmacy assistants, pharmacy aides and other medicine handlers covered in Section 39, Article IV of this Act. Statement of Policy.—The State recognizes the vital role of pharmacists in the delivery of quality health care services through the provision of safe, effective, and quality pharmaceutical products, pharmaceutical care, drug information, patient medication counseling, and health promotion. stringent regulatory requirements pertaining to drug traceability, inventory reporting and inventory management elevate the importance of maintaining effective control over drug inventories in today’s ever-expanding healthcare compliance environment. The PIC shall not be renewed if the requirements for membership with the APO are not met including credit units for attendance to duly accredited CPD. Section 52. Establish and implement policies and procedures of the pharmacy in accordance with the policies of the hospital and of the DOH; 2. Section 9. 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