Myla R. Postadan, RPh, MDA

FDRO II

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

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

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

Additional:

Floor area, not less than 15 square meterswith washing facilities

Location Plan/ Vicinity map

Picture of Drugstore with signboard and without stocks

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)

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)

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.)

*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

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.

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

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

11. List of Products identified by generic names and brand names to be distributed12. 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

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

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

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 regulations2. 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

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

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

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