Section 31Sec./Art. 31

Pharmacist Requirement. - 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:

(a) Category A 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, including:

(1) 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;

(2) 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;

(3) 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; and

(4) Government units, including local government, city, first to third class municipal health units, nongovernment organizations and/or associations involved in the procurement, distribution, dispensing and storage of pharmaceutical products;

(b) Category B Pharmaceutical establishments/outlets where the supervision and oversight of a duly registered and licensed pharmacist is required under pertinent provisions of law, including:

(1) Retail outlets selling household remedies and OTC drugs as differentiated from the pharmacist-only OTC medicines;

(2) 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;

(3) Fourth, fifth and sixth class municipal health units involved in the procurement, distribution, dispensing, and storage of pharmaceutical products;

(4) Institutions providing telepharmacy services; and

(5) Nontraditional outlets of pharmaceutical products: Provided, That no prescription medicines and pharmacist-only OTC medicines are sold.

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.

A pharmacist working in a Category A establishment may be allowed to simultaneously work or render pharmacy services in Category B establishments, the maximum number of hours of which shall be determined, in accordance with such guidelines as may be established therefor by the Board, in coordination with the FDA, and other agencies, establishments, institutions, and regulatory bodies.

Procurement, storage, distribution, or dispensing of any pharmaceutical product in the national government and local government units shall be made only under the supervision of a duly registered and licensed pharmacist.

All units or sub-units of establishments, institutions, and regulatory bodies whether government or private with functions and activities that are exclusive for pharmacists, as defined in Section 4, paragraphs (a), (b), (c), (d) and (i), shall be headed and managed by a qualified duly registered and licensed pharmacist: Provided, That an appointment in government service shall comply with the provisions of other pertinent laws.