This document outlines the requirements for obtaining and renewing a license to operate (LTO) for a drug establishment. It lists 11 documents required for an initial inspection, including documents proving ownership or lease of the establishment, permits, pharmacist qualifications, and standard operating procedures. An additional 13 documents are required for importers, wholesalers, or exporters. Reference materials and standard operating procedures must be presented at inspection. Reissuance of an LTO requires surrender of the original LTO, a picture of the establishment, and proof of renewal fees.

1. Myla R. Postadan, RPh, MDA
FDRO II

2. 1. Letter Request for Inspection
2. Photocopy of Official Receipt for Renewal/Initial fee
3. Notarized Petition Form/Joint Affidavit of
Undertaking duly accomplished (Affidavit of
Undertaking for Pharmacist/owner)
4. For Single proprietorship, photocopy of Certificate of
Business Name of Registration with the Bureau of
Trade Regulation and Consumer Protection (BTRCP)
formerly Bureau of Domestic Trade.
5. For Corporation and Partnership, registration
Certificate with SEC and Articles of Incorporation on
Partnership

3. 6. Mayor’s Permit/ Barangay Business Clearance of the
Establishment
7. Contract of lease, for the space to be occupied if the
owner does not own it, or any proof of ownership
8. Pharmacist Registration Certificate, PRC-ID, 2pcs 2 x
2 ID picture, valid PTR, Certificate of Attendance of
owner/pharmacist to a FDA sponsored accredited
seminar on licensing of drug establishment and
outlets, Pharmacist Clearance, duly noted resignation
letter from previous employer.
9. Tentative list of products using generic names and
brand names, if any
10. Generic Red and white labels
11. Drugstore seal or rubber stamp of outlets

4. Reference Books: (during inspection)
 Philippine National Drug Formulary (c/o FDA)
 R.A. 3720, otherwise known as the Foods, Drugs
& Devices & Cosmetic Act
 R.A. 6675, Generics Act of 1983 and relevant
implementing rules and regulations
 R.A. 9711, FDA Act of 2009
◦ Remington’s Pharmaceutical Sciences (latest edition)
◦ Goodman and Gilman Pharmacological Basis of
Therapeutics (latest edition)
 United States Pharmacopeia/National Formulary
(USP-NF) Latest Edition

5. Additional:
 Floor area, not less than 15 square meters
with washing facilities
 Location Plan/ Vicinity map
 Picture of Drugstore with signboard and
without stocks

6. Record Books duly registered with BFAD: (during
inspection)
 Prescription Book
 Record Book for Senior Citizen
 Record Book for Disabled Persons
 Dangerous Drug Book
 Exempt Preparation Book
 Poison Book
 Record Book for selected Non-Prescription
 Drugs, Subject to abuse as determine by BFAD
and/or Dangerous Drug Board (DDB)

7. Standard Operating Procedures for the following:
(during inspection)
 Procurement of Stocks
 Handling of Product Complaint
 Handling of Product Recall
 Good Dispensing Practice
 Good Storage Practice (GSP)
 Distribution of stocks to different stations/ areas
(e.g. Nurse Stations, Satellite Pharmacy, etc.)
 Good Housekeeping (Pest Control/ Garbage
Disposal)

8. Standard Operating Procedures for the following:
(during inspection)
 Cold Chain Management Requirements
 Reporting of Adverse Drug Reactions/ Events
 Extemporaneous Compounding
 Handling of Expired/ Damaged/ Rejected/
Returned Stocks
 Disposal of Used Empty Vials
 Special Projects/ Programs (e.g. Donated
products, PITC products (BNB), Anti-TB Project,
Therapeutics Committee, etc.)

9. *SUBMIT COMPLETE DOCUMENTARY
REQUIREMENTS IN TWO SETS
 Note:
 Inspection shall be scheduled only after
compliance with all documentary requirements
 Only owner and pharmacist/or authorized
technical staff will be entertained
 Submit (2) copies of documents in a green folder;
w/ table of contents & ear tags
 Scanned electronic/scanned copy of
requirements PDF Searchable format at least
300dpi on a DVD-R (2) copies


10.  RE-ISSUANCE OF LTO
1. Surrender original copy of LTO or Affidavit
of Loss in case of loss, Leave a photocopy at
the LTO displayed in your drugstore.
2. Photocopy of latest Official Receipt for
Renewal Fee.
3. Picture of Drugstore with Signboard.

11. 1. Letter request for inspection
2. Photocopy of latest Official Receipt for
Renewal/Initial Fee
3. Accomplished Notarized Petition Form/Joint
Affidavit of Undertaking
4. Notarized Contract of lease, for the space to
be occupied if the owner does not own it, or
any proof of ownership

12. 5. If corporation, Registration Certificate with SEC and
Articles of incorporation or Partnership
6. If single proprietorship, Certificate of Business name
Registration with Bureau of Trade Regulation and
Consumer Production (BTRCP)
7. Barangay Clearance of the establishment/ Mayor’s
permit
8. Copies of Pharmacist Board Registration Certificate,
PRC-ID, valid PTR, ID picture (2pcs) 2x2, Duties and
9. Responsibilities, Certificates of Attendance of
Owner/Pharmacist to a BFAD seminar on
10. Licensing of Drug Establishments and Outlets,
Pharmacist clearance, Resignation letter noted by
the previous employer

13. 11. List of Products identified by generic names
and brand names to be distributed
12. Location Plan and Floor Plan (Office and
Storage Room) with dimensions in meters
If Importer:
 Foreign Agency Agreement from each
supplier duly authenticated by the Territorial
 Philippine Consulate
 Certificate of Registration of manufacturer
and its conformity with GMP from Health
Authority

14.  If Wholesaler:
 A Valid contract with BFAD licensed
supplier/manufacturer
 Indicate the Area of Distribution & Validity of the
contract
 The phrase “ Both the supplier and distributor are
jointly responsible for the quality of products to
be distributed” must be stipulated in the contract
 Certification that the product it sells are
registered with FDA (CPRs)
 Photocopy of LTO of supplier or manufacturer

15.  If Exporter:
 A Valid contract with BFAD licensed
supplier/manufacturer
 Certification that the product it sells are
registered with BFAD (CPRs)
 LTO of supplier or manufacturer

16. THE FOLLOWING MUST BE PRESENTED UPON INSPECTION:
1. Reference Materials:
 Philippine National Drug Formulary
 R.A. 3720, Foods, Drugs, Devices and Cosmetic Act
 R.A. 6675, Generics Act of 1988 and relevant
Implementing of rules and regulations
 R.A. 5921, Pharmacy Law as amended and relevant
implementing rules and regulations
2. Any one of the following reference books:
 United State Pharmacopeia/National Formulary (USP/NF)
latest edition
 Remington’s Pharmaceutical Sciences (latest edition)
 Goodman and Gilman Pharmacological Basis of
Therapeutics (latest edition)
3. Batch Distribution Record Book

17. Additional:
1. Picture of Office with signboard and storage area
2. Standard Operating Procedures for the
following:
3. Product complaint
4. Procurement of stocks
5. Good Storage Practice (Include Pest
Control/Garbage Disposal)
6. Cold Chain Management
7. Photocopy of the Sales Invoice of the
establishment

18. FOR THE RE-ISSUANCE OF LTO:
 Surrender original copy of LTO or Affidavit of
Loss in case of loss. Leave a photocopy at the
LTO displayed in your drug establishment
 Picture of Office with Signboard

19. Note:
 Inspection shall be scheduled only after
compliance with all documentary requirements
 Only owner and pharmacist/or authorized
technical staff will be entertained
 Submit electronic/scanned copy of requirements
in PDF Searchable format at least 300 dpi on a
DVD-R (2) copies
 Submit (2) copies of (original) documents in a
green folder
 Properly labelled with table of contents indicating
the no. of pages, divider with ear tags