30 Questions
What is the primary responsibility of a pharmacist in a pharmaceutical establishment/outlet?
Ensuring all pharmaceutical products conform to safety, quality, and efficacy standards
Which of the following is the responsibility of the Marketing Authorization Holder (MAH)?
All of the above
In cases where pharmaceutical products are sold in their original, unopened package, who is responsible for their quality and purity?
The manufacturer, importer, distributor, representative, or dealer
What is the responsibility of licensed pharmaceutical establishments and outlets regarding good practices?
They must comply with applicable standards of good practices prescribed by the FDA
Which of the following is not a responsibility of the Marketing Authorization Holder (MAH)?
Ensuring proper disposition and destruction of pharmaceutical products
What is the responsibility of the Marketing Authorization Holder (MAH) regarding the safety, efficacy, and quality of drug products?
The MAH is responsible for ensuring drug products continuously comply with safety, efficacy, and quality standards prescribed by the FDA
How many hours a week must the supervising pharmacist be physically present in the establishment/outlet?
2 hours
What is the maximum distance allowed between the two farthest establishments/outlets supervised by a single pharmacist?
20 kilometers
How many establishments/outlets can a pharmacist supervise at a maximum?
15 establishments/outlets
In which region is the National Capital Region (NCR) considered as a single unit for pharmacy supervision purposes?
Americas Region
What is the requirement concerning a virtual pharmacy without a licensed physical outlet?
Not allowed
What unit should the location of each establishment/outlet which the pharmacist supervises be within?
Provincial local government unit (LGU)
What is the minimum fine for a person who affixes the title 'RPh' when they are not a pharmacist?
$100,000
What does compounding refer to in the context of drug preparation?
Mixing various drugs together
What is a dangerous drug?
Drugs listed in specific schedules by international conventions or laws
What is the maximum prison sentence for practicing pharmacy without a valid Certificate of Registration (COR), Pharmacist-in-Charge (PIC) or Special Temporary Permit (STP)?
1 year
What is encompassed in the process of dispensing by a pharmacist?
Preparing, packaging, and labeling medications
Which of the following is not required to be displayed by a pharmacist in their place of employment?
Special Temporary Permit (STP)
What is the minimum fine for a pharmacist who does not comply with the requirements on filling prescriptions?
$100,000
How are drugs defined in the context of the provided text?
Chemical compounds or biological substances intended for disease treatment or prevention
Who is allowed to dispense prescription and pharmacist-only OTC drugs without the supervision of a pharmacist?
Private institutions and establishments
What makes a drug fall under the category of a dangerous drug?
Listed in specific schedules by international conventions or laws
What is the maximum prison sentence for a person who commits an act analogous to the violations listed in the text?
1 year
Which among the following is NOT a part of the compounding process by a pharmacist?
Interpreting prescriptions
Which of the following actions violates the Act, IRR, and other relevant laws regarding pharmaceutical products?
Compounding pharmaceutical products greatly exceeding single therapeutic doses without pharmacist supervision
What is a prohibited action related to the manufacturing, selling, or importing of pharmaceutical products?
Manufacturing counterfeit pharmaceutical products
Which activity would be considered operating an unlicensed pharmaceutical outlet?
Operating a Category A establishment without a pharmacist
What is a violation related to practicing pharmacy without a valid license?
Practicing pharmacy with an expired license
What is a common infraction related to the compounding of pharmaceutical products?
Compounding adulterated pharmaceutical products
What action would not be classified as operating a Category B establishment/outlet without required supervision?
Operating an outlet with pharmacist oversight
Test your knowledge on pharmacy terms including Code, Compounding, and Dangerous Drug definitions. Learn about drug preparation, calculations, mixing, packaging, and more.
Make Your Own Quizzes and Flashcards
Convert your notes into interactive study material.
Get started for free
