EXERCISE 1 General Requirements for Issuance of LTO KEY TERMS: Pharmacy/Drugstore - A place or establishment wherein o Drugs o Active Ingredients

s o Chemicals o Poisons o Cosmetics o Healthcare Products o General Merchandise o Nutraceuticals - Are sold in retail Drugs - Agent that cures (heal, preserve), treats (manipulate, manage), prevents (e.g. vaccine), mitigates (reduce, soothe pain) and diagnose (recognize, identify) - Agents official in USP/NF, HPUS, BP and JP - Agents used to affect some functions - Articles used as component for other articles Medicines - Processed material of a drug Dosage Forms - Device/administration in prescribed and measured amount Pharmaceutics - Concern about the physical, chemical and biological factors that influence the manufacturing effectivity and stability of pharmaceutical products. Dosage - Frequency of giving Dose - Amount of drug Poison - Preparation capable of destroying life and seriously endanger the patient Code/ Secret Keys - System of words to represent other words Cipher - A method of secret writing that substitutes other letters or characters for the letter intended, or transposes the letter after arranging them in blocks or squares Biological Products - Refers to sera, toxins, and analogous products used for the prevention or cure of human diseases Wholesale - The business of buying goods in large quantity and selling them especially to retailers for resale.

Pharmaceuticals/ Proprietary Medicines

RA 5921 of 1969: Article IV Practice of Pharmacy Section 25 Sales of Medicines, Pharmaceuticals, Drugs and Devices No medicine, pharmaceutical or drug of whatever nature and kind or device shall be compounded, dispensed, sold, resold, or otherwise be made available to the consuming public except through a prescription drugstore or hospital pharmacy duly established in accordance with the provision of this act. Pharmaceutical, drug, or biological manufacturing establishments, importers and wholesalers of drugs , shall not sell their products for resale except only to retail drugstores, hospital pharmacies or to other drug wholesalers under the supervision of registered pharmacists duly established and licensed under the Retail Drug Law (as amended by P.D. 1363 on May 1, 1978) Section 27 Pharmacist Required and Compensation Every pharmacy, drugstore or hospital pharmacy, whether owned by the government or private person or firms shall, at all times when open for business, be under the personal and immediate supervision of a registered pharmacist: PROVIDED, that no pharmacist shall have personal supervision of more than one establishment. In cases where a drug establishment operates in more than one shift, each shift must be under the supervision and control of registered pharmacist. Section 28 Display of Certificate Required It shall be the duty of every pharmacist engaged in the practice of pharmacy, either on his own account or under the employment of another, to display his certificate of registration in a prominent and conspicuous place in the pharmacy, drugstore, hospital pharmacy or drug establishment which he operates or in which he is employed. No pharmacist shall, with his knowledge, allow his certificate of registration to be displayed in such establishments when he is not actually employed or operating therein in his professional capacity. Section 33 Inhibitation Against Use of Cipher or Unusual Terms in Prescription and Prescription Switching No pharmacist shall compound nor dispense prescription, recipes or formulas which are written in ciphers, codes or secret keys or in which there are

employed unusual names of drugs which differ from the names ordinarily used for such drugs in USP/NF. No pharmacist dispensing or compounding prescription shall substitute the drug or drugs called for in the prescription with any other drug or substance or ingredient without prior consultation with, and with a written consent of the person prescribing. Section 39 Requirements for the Opening and Operations of Drugstores and Pharmacies The minimum requirements necessary for the opening and operation of drugstores and pharmacies shall be in accordance with the rules and regulations prescribed by the FDA. No application for the opening of a retail drugstore shall be approved unless it is signed by a Filipino registered pharmacist, either as owner or as supervising pharmacist (as amended by P.D. 1363 on May 1, 1978)

REQUIREMENTS DRUGSTORES NON-RX DRUGS 1. 2. 3. 4. 5. 6. Notarized petition/ Joint affidavit Tentative list of products Floor Area (nlt 15 sq. m.) Generic white and red labels Rubber stamp of outlets Pharmacist a. Registration Cert. b. PRC-ID c. Valid PTR d. ID picture e. Cert. of attendance to BFAD Seminar 7. Single proprietorship 8. Corporation 9. Contract of lease 10. Picture of drugstore with signboard 11. Location plan an floor plan with dimension 12. Opening fee MUST BE PRESENTED UPON INSPECTION: I. REFERENCE BOOK A. Remingtons Pharmaceutical Sciences B. Philippine National Drug Formulary C. United States Pharmacopeia/ National Formulary D. Copy of Republic Acts concerning Pharmacy E. Goodman-Gilmans Pharmaceutical Basis on Therapeutics Record Books duly Registered with BFAD A. Prescription Book B. Dangerous Drug Book C. Exempt Preparation Book D. Poisons Book E. Record Book for Non-Rx Drugs that are subject to abuse

REQUIREMENTS FOR OPENING A DRUGSTORE UNDER PREMISES 1. 2. 3. 4. 5. 6. Signboard Well-ventilated area, not less than 15 sq. meters Compounding Area, sterilization area Storage area for drugs Cabinet (Poisons, Dangerous Drugs) Water Supply

II.

REQUIREMENT FOR OPENING A DRUGSTORE UNDER UTENSILS, APPARATUS AND EQUIPMENT 1. Biological Refrigerator REQUIREMENTS FOR RENEWAL OF LTO 1. 2. Standard Petition Form (Name, Citizenship, Picture, Proposed Area) Proof of Registration a. Single Proprietorship Business Name Registration b. Partnership or Corporation Certificate of Registration issued by SEC c. Valid certificate of Registration of Establishments Filipino Pharmacist d. Certificate of Attendance to a FDA sponsored, accredited seminar on licensing of drug outlets e. Tentative list of products intended to be sold using generic names with brand names when applicable f. Authenticated photocopy of Contract Lease for the space to be occupied if the applicant does not own it