Study Set Content:
All units or sub-units of establishments, institutions, and regulatory bodies whether government or private with functions and activities that are EXCLUSIVE FOR PHARMACISTS, shall be headed ang managed by a qualified duly registered and licensed (); provided, that an appointment in government service shall comply with the provisions of other pertinent laws.
pharmacist
Section 32. RESPONSIBITY FOR QUALITY OF PHARMACEUTICAL PRODUCTS
¨ It shall be the duty of a duly licensed and registered pharmacist of a pharmaceutical establishment and outlet to ENSURE that ALL PHARMACEUTICAL PRODUCTS () to standards of safety, quality and efficacy, as provided for in this Act and other pertinent rules and regulations and issuance
conform
()()() in charge of the operation of pharmaceutical establishments and outlets shall be held jointly responsible for non conformance with these standards
¨ It shall be unlawful for any person to manufacture, prepare, sell, or dispense any pharmaceutical product under a (), or pretense or to () any pharmaceutical product offered for sale.
Owners, managers, or pharmacist, fraudulent name, adulterate
All prescription and pharmacist-only OTC medicines shall be filles, compound, and dispended ONLY by a registered and licensed pharmacist, in accordance with the (), Dispensing Guidelines and other standards pertaining to purity, safety and quality.
PhilPSP
Section 33. FILLING AND PARTIAL FILLING OF PRESCRIPTION ¨ Completely filled prescriptions should be () to the pharmacist for recording
¨ Partial filling of prescription less than the total quantity indicated in the prescription shall be (), subject to dispensing guidelines as provided in the immediately preceding paragraph
¨ It is the responsibility of the pharmacist dispensing the () completing the prescription to KEEP the Rx according to proper prescription recording guidelines
surrendered, allowed, LAST QUANTITY
¨ Prescription medicines may be dispensed only by a duly registered and licensed () and only with a valid prescription of a ()()()
¨ PRESCRIPTION TO BE FILLED should be ()()Clarifications on the content of the prescription must be referred to the prescriber by the pharmacist on duty to ENSURE patient medication safety
pharmacist, physician, dentist, or veterinarian., CLEAR and COMPLETE ¨
Pharmaceutical products given or intended to be given free to any health professional by a manufacturer or distribututor or its PSR as a part of its program or promotions SHALL NOT BE SOLD to any () or the consuming ()
pharmaceutical outlet, public
The statement (), or its equivalent, shall appear conspicuously on the primary and secondary packaging of the drug or combination products (medical device and drug) classified as drug according to the primary intended mode of action to be given
"Sample , Not for Sale"
It shall be UNLAWFUL to()()()() the original labels of samples
remove, erase, deface or mark
Pharmaceutical products classified as(), including anti-TB medicines and other classifications of medicines, as may be prescribed by the FDA, shall not be given or distributed as physician’s samples.
antimicrobials
IMPLEMENTATION ¨ Upon effectivity of this IRR, all MAHs shall cease distribution of approved samples of () including () medicines
¨ FDA shall () longer approve applications for physician’s samples of these drugs
¨ Disposal and expired physician’s samples hall be the responsibility of the () who provided the sample.
antimicrobials, anti-TB, no, supplier/distributor
Pharmacists shall not compound or dispense prescriptions, recipes, or formulas which are written in () or prescriptions of pharmaceutical products with unusual names which differ from those in standard pharmacopeias or formularies
ciphers, codes or secret keys
The pharmacist dispensing or compounding prescriptions shall not () the medicine called for in the prescription with any other drug, substance or ingredient, without prior consultation with, and written consent of the person prescribing, except in accordance with RA (), as amended, otherwise known as the Generic Act of 1988, and other pertinent laws and regulations
substitute, 6675
Upon every box, bottle, or package of medicines compounded or dispensed by a registered and licensed pharmacist based on prescription, there shall be pasted, affixed, or imprinted a seal or label bearing, among others
the name of patient and generic name of drug; b ¨ rand name, if any, ¨ strength, ¨ expiry date, ¨ directions for use; and ¨ name and address of pharmacy, ¨ name of the doctor, ¨ the dispensing pharmacist
other requirements prescribed in the Philippine Practice Standards for Pharmacists and Dispensing Guidelines, Republic Act No. (), otherwise known as the "Universally Accessible Cheaper and Quality Medicines Act of 2008", its implementing rules and regulations and such other guidelines that may be promulgated by the Board.
9502
Auxiliary labels containing special pharmacists’ instructions for the patient shall be required as prescribed for ()()() and such other drugs as may be required by law.
dangerous drugs, external-use- only drugs, drugs with special storage and administration instructions
SHOULD NOT COVER the primary display panel of the drug product
Auxilliary labels
Exceptions to labelling prior to dispensing requirement are during cardiopulmonary resuscitation emergencies and other () situations when the medicine dispensed is to be administered immediately by a licensed professional
emergency
All prescriptions dispensed in the pharmacy shall be recorded in an appropriate recording system indicating:
o the name and address of the patient
o name of prescribes generic name and brand
o dosage strength
o quantity of drug
o initials of pharmacist
It shall be open for inspection by the representatives of the Board or the FDA, or both , at any time of the day, when the pharmacy is open , and must be kept for a period of not less than() years after the last entry
two (2)
