EXERCISE 1

General Requirements for Issuance

of LTO by the FDA
QUESTIONS
1. Enumerate specific requirements
opening a drugstore under Premises.
-

of

Signboard
Well ventilated area nlt 15 sq.m.
Compounding area
Sterilization area
Storage area for drugs
Cabinet (poisons, DD)
Water supplies

2. Enumerate specific requirements of

opening a drugstore under Utensils,
Apparatus and Other Equipment.
-

Refrigerator

3. Enumerate specific requirements

Renewal of License to Operate (LTO).

of

Standard Petition Form name, citizenship,

picture, proposed area
Proof of registration
Single proprietorship cert. of business
nameregistration (BDT of DTI)
Partnerships, corporations cert. of
registration
(SEC)
and
articles
of
Incorporationor partnership
4. Enumerate the checklist of requirements
for
drugstore/hospital
pharmacy/retail
outlet for non-prescription drugs.

Rey Sebastian S. Moron 2B-Pharmacy 2015-2016

Notarized petition/Joint affidavit

Tentative list of products (Paracetamol,
Biogesic,
Tempra,
Tylenol,
Winadol
Acetadol, Rexidol)
Floor area (nlt 15 sq.m)
Generic white and red labels
Rubber stamp of outlets
Pharmacist
Registration cert.
PRC-ID
valid PTR
ID picture
cert. of attendance to BFAD seminar
Single proprietorship Corporation
Contract of lease
Picture of drugstore with signboard
Location plan and floor plan with dimension
Opening fee ( A.O. 50 s. 2001)

5.The following must be presented upon

inspection:
A. Reference Books
- PNDF
- RA 3720
- RA 6675
- RA 5921
- RA 8203
- USP/NF
- RPS
- Goodman and Gilman Pharmacological
Basisof Therapeutics
- Remington Pharmaceutical Sciences
- Philippine National Drug Formulaty
- United States Pharmacopeia
B. Record Books duly registered with FDA
- Prescription Book
- Dangerous Drug Book
- Poison Book
- Exempt Preparation Book