RA 10918 (1) Flashcards
A PIC shall be renewed every ___ years, upon presentation of the Certificate of Good Standing (COGS) from the IAPO and proof of completion of the CPD requirements following existing guidelines
3 years
Replacement of Lost or Damaged Certificate of Registration, Professional Identification Card or Special/Temporary Permit.
The Board may, upon petition, reinstate or reissue a revoked COR after the expiration of ______ years from date of its revocation.
The Board may, in its discretion, require the applicant to take another licensure examination.
The petitioner shall prove to the Board that there is a valid reason for such reinstatement. For the grant of the petition, the Board shall issue a Board Resolution, to be approved by the PRC.
2 years
pharmacist whose name appears in the License To Operate (LTO) issued by the FDA for the establishment/outlet.
pharmacist-in-charge
The Board and the PRC shall prepare and maintain a registry of the names, residences or office addresses, or both, status of registration and area of practice of all pharmacists.
This registry shall be updated __________, in coordination with the IAPO.
It is the responsibility of the pharmacist to update his/her profile, notify and submit necessary documents to IAPO within such period of time specified in the guidelines to be prescribed by the Board and the PRC.
annually
Pharmaceutical establishments/outlets where the direct and immediate control and supervision of a pharmacist is required due to the nature of the pharmaceutical product that will be dispensed or the kind of service that will be provided.
One (1) pharmacist shall have direct and immediate control and supervision over the establishment/outlet in order to dispense prescriptions and pharmacist-only OTC medicines, whether in- store or online.
Virtual pharmacy without a licensed physical outlet is not allowed. Included under this Category are the following:
category a
Pharmaceutical establishments/outlets where the supervision and oversight of a pharmacist is required under pertinent provisions of the law. Included under this Category are the following:
category b
distance between 2 farthest establishements/outlets supervised by a single pharma must not exceed
25 km in distance
a pharmacist is allowed to supervise a maximum of ____ establishments
15
how many establishments can a pharmacist supervise under category b
4 establishments
- statement ___________________, or its equivalent shall appear conspicuously in red background or red font in the primary and secondary packaging on each labelling material of the drug or combination of products (medical device and drug) classified as drug according to the primary intended mode of action.
Sample, Not For Sale
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
- containing special pharmacists’ instructions for the patient shall be required for dangerous drugs, external-use only drugs, drugs with special storage and administration instructions, and such other drugs as may be defined by law.
- should not cover the primary display panel of the drug product.
Auxiliary labels
responsible for selecting, ordering, delivery, receipt, arranging, display and storage of pharmaceutical products. Owners are required to attend FDA licensing seminars
Pharmacy owners who are non-pharmacists
responsible for the promotion of pharmaceutical products to professional healthcare providers through provision of relevant health product information;
Medical representatives/professional service representatives
- responsible for the following tasks: monitoring of the supply/inventory of pharmaceutical products; handling and control of pharmaceutical products; arrangements of the display of pharmaceutical products;
observance of Good Laboratory Practices; preparation of the product label; compounding of formulations and dispensing of both OTC medicines and prescription pharmaceutical products; demonstration of product knowledge on medicines;
conduct of health promotion education; vigilance, observance and adherence to Good Manufacturing Practices; and exercise of supervision over pharmacy assistants and pharmacy aides;
Pharmacy Technicians who work under pharmacist supervision
responsible for the following tasks: performing general housekeeping; monitoring of the supply/inventory of pharmaceutical products; handling and control of pharmaceutical products; arrangements of the display of pharmaceutical products; observance of Good Laboratory Practices; assisting in the preparation of the product label;
counting of OTC tablets and capsules, reconstitution of powders for suspension; dispensing of OTC pharmaceutical products, subject to the provisions of Section 6 (b), Rule IV of this IRR; demonstration of product knowledge on medicines; conduct of health promotion education; and vigilance, observance and adherence to Good Manufacturing Practices;
Pharmacy Assistant who works under the supervision of the pharmacist
responsible for the following tasks: cleaning of work areas; answering phone calls and forwarding the calls or messages to the pharmacist; assisting in placing of prices on products; assisting in the stocking of products in the shelves and warehouse; filing of documents on orders, deliveries, sales; and other tasks as may be assigned by the pharmacist
Pharmacy Aide who works under the supervision of the pharmacist
a pharmacist is allowed to administer vaccines if
- may valid COR & PIC
Manufacture, sale, offering for sale of counterfeit, spurious, substandard, falsified pharmaceutical products and committing other acts in violation of R. A. No. ______, otherwise known as the ___________________-
RA 8203
special law on counterfeit drugs
Any person who shall commit any of the following acts shall, upon conviction, be sentenced to pay a fine of not less than ____________, but not exceeding ________________ or imprisonment of not less than ___ year and ___ day but not more than ___ years, or both, at the discretion of the court:
250, 000
500, 000
1 year
1 day
6 days