Page:Urbiztondo Ordinance No. 5- 2022.pdf/3

 g. Compounding is generally a practice in which licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.

h. Business establishment shall refer to any entity whether a single proprietorship, partnership or corporation engaged in business in the municipality.

i. Owner shall refer to a person or group of persons who is the registered owner of a license to operate a business or businesses undertaking in the municipality.

j. Household remedies refer to any preparation containing pharmaceutical substances of common or ordinary use to relieve common physical ailments and which may be dispensed without a medical prescription in original packages, bottles or containers, of which the nomenclature has been duly approved by the FDA.

k. Sari-Sari tores refer to retailing stores selling a general line of merchandise, classified as micro-enterprises.

l. LTO - License to Operate

m. Over- the- Counter Medicine refer to medicine used to symptomatic relief of minor ailments and which may be dispensed without a prescription.

Sec. 4. Prohibited Acts.

a. The sale, dispensing, reselling, brokering or possession of counterfeit drugs or any drugs as defined in Sec. 3 hereof otherwise covered by RA No. 3720, as amended. The presence or availability of such counterfeit drugs or over the counter drugs within the premises of any entity engaged in the sale, dispensing, reselling in any sari-sari store or retail outlets shall constitute a prima facie evidence of violation of this ordinance.

b. Sari-sari stores and other similar retail outlets and micro-enterprises are prohibited from dispensing, selling, or reselling prescription and pharmacist-only OTC medicines, as defined and classified by the FDA, as these medicines may only be dispensed by or obtained from a licensed pharmacist and with said licensed pharmacist’s advice, pursuant to RA 10918.

c. No pharmaceutical product of whatever nature and kind shall be compounded, dispensed, sold or resold or otherwise be made available to the consuming public except through a retail drug outlet duly licensed by the FDA.

d. Any owner of the sari-sari store or owner of retail outlets is not authorized to sell, resell or dispense over the counter medicines without permit from the FDA – Food and Drug Administration as enumerated in Sec. 5 and shall be penalized under Sec. 11.

e. Other stores such as convenience stores, cooperative-run stores, and other small and medium enterprises which intend to sell household remedies and OTC drugs (other than pharmaceutical stores) are first required to apply as a retail outlet for non-prescription drugs (RONPD) pursuant to FDA Circular No. 2014 - 028) and secure the following:

i. A license to operate (LTO) from the FDA;

ii. The employment supervision and oversight of a duly registered and licensed pharmacist pursuant to Section 31 (b) of RA 10918; and

iii. Other requirements imposed by the FDA on its LTO applicants.