Study Set Content:
Licensed manufacturers, importers, distributors, and wholesalers of pharmaceutical products are authorized to sell their products only to duly
licensed pharmaceutical outlets
Implementation
o Appropriate ()() at the time of dispensing of medicines should be provided to patients or caregivers, the content of which should include indication, proper use, precautions, and other relevant information
medication review and patient medication counselling
Establishments/outlets which are required to employ and/or retain and maintain the professional services of duly registered and licensed pharmacists shall be classified as follows:
Category A and B
Pharmaceutical establishments/outlets where the direct and immediate control and supervision of a duly registered and licensed pharmacist is required, per establishment, whether in- store or online
Category A
Pharmaceutical establishments/outlets selling or otherwise making available to the consuming public prescription/ethical medicines, combination products (medical device and drugs) classified as drugs according to the primary intended mode of action, pharmacist-only OTC medicine, whether owned by the government or by a private person or firm, whether sold at wholesale or retail;
Category A
Pharmaceutical establishments/outlets where the supervision and oversight of a duly registered and licensed pharmacist is required under pertinent provisions of law, including: ¨ Retail outlets selling household remedies and OTC drugs as differentiated from the pharmacist- only OTC medicines
Category B
Establishments involved in the manufacture, importation, exportation, distribution, and sale of combination products (medical device and drugs) classified as drugs according to the primary intended mode of action
Category A
Satellite institutional pharmacies providing medicines solely to employees of their respective companies or the employees’ qualified dependents, or both; or members of a duly registered organization or institution
Category B
¨ Fourth, fifth and sixth class municipal health units involved in the procurement, distribution, dispensing, and storage of pharmaceutical product ¨ institutions providing telepharmacy services
Category B
Departments/Divisions/Units of pharmaceutical laboratories, pharmaceutical manufacturing laboratories, or other establishments with processes involving the preparation, manufacture, assay, regulation, product research and development, quality control, repacking, importation, exportation, distribution, sale or transfer of pharmaceutical products in quantities greatly in excess of single therapeutic doses
Category A
Nontraditional outlets of pharmaceutical products: Provided, That no prescription medicines and pharmacist-only OTC medicines are sold
Category B
All of the following oversight requirements and considerations must be satisfied: Implementation ¨ The supervising pharmacist must be physically present in the establishment/outlet for a minimum of
2 hours a week
The location of each establishment/outlet which the pharmacist supervises must be within the same provincial () within each region. The () is considered as a single area due to tis comparatively smaller landmass
LGU, NCR
The distance between 2 farthest establishments/outlets supervised by a single pharmacist must not exceed () in distance
25 km
All other establishment/outlets supervised by a single pharmacist must be within a() area when plotted between the 2 farthest establishments/outlets
circumferential
A maximum of () establishments/outlets is allowed to be supervised by a single pharmacist ¨ Other relevant requirements as may be prescribed and/or modified by the FDA
15
The FDA, in coordination with the Board, and the approval of the PRC, may ()()()() the above LIST OF ESTABLISHMENTS, as need arises, in order to keep pace with the developments in the pharmacy practice.
add to, delete, reclassify, or modify
A PHARMACIST working in() establishment may be allowed to simultaneously work or render pharmacy services in CATEGORY B establishments, the maximum number of hours of which shall be determine, in accordance with such guidelines as may be established therefor by the(), in coordination with the(), and other agencies, establishments, institutions, and regulatory bodies.
CATEGORY A, Board, FDA
Under this provision, a simultaneous work means that a pharmacist can be employed in()ESTABLISHMENTS provided that there is NO OVERLAP of () time ¨ A pharmacist may be ALLOWED to supervise a maximum of () establishments classified under CATEGORY B
4, MULTIPLE , working
Procurement, storage, distribution, or dispensing of any PP in the national government and local government shall be made only under the supervision of a duly registered and
licensed pharmacist
