BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER
Inventory of Administrative Issuances

DEPARTMENT OF HEALTH
FOOD AND DRUGS ADMINISTRATION
Date Filed
Ref. No.
Subject No.
26-Jul-10
10-290
Memo Cir. No. 2010-012
26-Jul-10
10-290
Circular No. 2010-011
26-Jul-10
10-290
26-Jul-10
10-290
26-Jul-10
10-290
26-Jul-10
10-290
26-Jul-10
10-290
26-Feb-10
10-085
26-Feb-10
10-085
26-Feb-10
10-085
21-Jan-10
10-038
Subject Title
Republic Act No. 9442 and Its Implementing
Rules and Regulations
Declaring the Products Identified Below to be
Imminently Injurious, Unsafe or Dangerous and
Authorizing the FDA Inspectors to Seize Said
Products from Public Sale or Distribution
Cut-Off Time for Receiving of Applications and
Payments of Fees in FDA
Amendment to Memorandum Circular No. 5, s.
1994 Dated April 20, 1994 Regarding Reports on
Adverse Drug Reaction
Adoption of the CODEX Standards on Food
Contaminants in Processed Food
Automatic Renewal of License to Operate (LTO)
Automatic Revalidation of License to Operate
(LTO)
Submission of Process Flow in Handling Adverse
Events from Drugs, Medical Devices, Food
Supplements, Milk Products, Herbals, etc.
Revised Fees for Seminar on Licensing of Drug
Establishments
93
Date
Adopted
8-Jul-10
16-Jun-10
24-May-10
16-Apr-10
29-Mar-10
15-Mar-10
9-Mar-10
17-Feb-10
18-Feb-10
20-Jan-10
8-Jan-10

Date Filed
Ref. No.
Subject No.
21-Jan-10
10-038
24-Nov-09
09-440
6-Nov-09
09-413
6-Nov-09
09-413
6-Nov-09
09-413
6-Nov-09
09-413
6-Nov-09
09-413
Subject Title
End Dates in the Importation and Distribution of
Metered Dose Inhalers Containing
Chlorofluorocarbon (CFC)
Grace Period for the 4th Updates and
Amendments of the Asean Cosmetic Directive
(ACD)
Specific Operational Instructions Implementing
Administrative Order No. 2008-0033 Dated
December 2, 2008, Subject: Rules and
Conditions in Exempting Antibiotic Drug Products
from the Batch Certification Requirement
Amending for this Purpose Item III (C) and (D)
of Administrative Order No. 103 s. 2002 "Batch
Certification of Antibiotics", and for Other
Purposes
Rules on the Pilot Implementation of the Bureau
of Food and Drugs Integrated Information
System (BIIS)
Department of Health's Reiteration of the Policy
on Donation of Milk Products
Grace Period for the 3rd Updates and
Amendments of the Asean Cosmetic Directive
(ACD)
94
Date
Adopted
8-Jan-10
5-Nov-09
2-Jul-09
19-Jan-09
21-Jan-09
2-Oct-09
9-Dec-08

Date Filed
Ref. No.
Subject No.
6-Nov-08
08-403
Joint DOH-DTI-IPO-BFAD
Adm. Ord. No. 2008
14-Oct-08
08-377
14-Oct-08
08-377
14-Oct-08
08-377
14-Oct-08
08-377
14-Oct-08
08-377
Circular No. 2007-013-A
14-Oct-08
08-377
14-Oct-08
08-377
Subject Title
The Implementing Rules and Regulations of
Republic Act No. 9502 Otherwise Known as the
"Universally Accessible Cheaper and Quality
Medicines Act of 2008"
Testing of Infant Formula and Other Milk Product
for the Presence of Melamine
Grace Period for the 2nd Updates and
Amendments of the ASEAN Cosmetic Directive
(ACD)
Seminar Fees for the Participants of Seminars on
Licensing of Establishments and Product
Registration
Grace Period for the New Updates and
Amendments of the ASEAN Cosmetic Directive
(ACD)
Amendment to Bureau Circular No. 2007-013
"Updated Guidelines for the Implementation of
the Association of South East Asian Nation
(ASEAN) Cosmetic Directive and the Association
of South East Asian Nation (ASEAN) Common
Technical Documents"
Updated Guidelines for the Implementation of
the Association of South East Asian (ASEAN)
Cosmetic Directive and Association of South East
Asian Nation (ASEAN) Common Technical
Documents
Updates on Site Information File
95
Date
Adopted
4-Nov-08
29-Sep-08
7-Aug-08
10-Jun-08
2-May-08
21-Jan-08
21-Dec-07
28-Nov-07

Date Filed
Ref. No.
Subject No.
14-Oct-08
08-377
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
Circular No. 2007-008-B
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
Subject Title
Amendment to Bureau Circular No. 2007-006
Providing for the "Additional Requirement for
Importation of Processed Food Products for
Distribution in the Philippines."
Adoption of the Association of Southeast Asian
Nations Common Technical Documents (ACTD)
and Common Technical Requirements (ACTR) on
the Pharmaceutical Product Registration for
Human Use
Guidelines in the Initial Issuance and Renewal of
License to Operate for Iron Rice Premix
Manufacturer/Repacker/Importer and Setting
Forth the Standards for Iron Rice Premix
Updated Standards for Iodine Level of Salts
Amendment of Bureau Circular No. 2007-008
Dated 1 August 2007
Amendment of Bureau Circular No. 2007-008
Dated 1 August 2007
Creation of Sub-Committee Task Force for
Pharmaceuticals
Products Imported from China
Additional Requirement for Importation of
Processed Food Products for Distribution in the
Philippines
Supplemental Guidelines for the Processing of
Principal Certificate of Product Registration
(CPR)
96
Date
Adopted
24-Mar-08
1-Oct-07
10-Oct-07
10-Oct-07
27-Sep-07
9-Aug-07
1-Aug-07
27-Jul-07
12-Jul-07
2-Apr-07

Date Filed
Ref. No.
Subject No.
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
7-Dec-07
07-415
Subject Title
Guidelines for the Implementation of
Administrative Order No. 2007-006 (Amendment
of Administrative Order No. 46 s. 1988 Re:
Organizational Arrangements to Implement the
National Drug Policy)
Cold Chain Management Requirements
Guidelines in the Use of Nutrition and Health
Claims in Food
Mandatory Submission of List of Products Being
Handled
Additional Requirements in the Registration of
Virgin Coconut Oil Food Supplement with Flavor
Amendment to Bureau Circular 2006-001
"Updated Guidelines for the Submission of
Application for Notification, Registration and
Export of Cosmetic Products"
Updated List of Food Additives
Amendment to Bureau Circular No. 008 s. 2006,
The Subject of Which is the "Lifting of
Moratorium on the Conduct of
Bioavailability/Bioequivalence Studies for
Selected Pharmaceutical Products and Bureau
Circular No. 2007-005 or the "Supplemental
Guidelines for the Processing of Principal
Certificate of Product Registration", and
Providing for the Procedures and/or Guidelines
Thereof
List of Recognized Laboratories
97
Date
Adopted
23-Feb-07
1-Feb-07
23-Jan-07
29-Jan-07
28-Dec-06
18-Dec-06
18-Oct-06
8-Oct-07
10-Feb-05

Date Filed
Ref. No.
Subject No.
9-Nov-06
06-437
9-Nov-06
06-437
9-Nov-06
06-437
9-Nov-06
06-437
9-Nov-06
06-437
Circular No. 011, s. 2006
9-Nov-06
06-437
9-Nov-06
06-437
9-Nov-06
06-437
Subject Title
Guidelines for the Issuance of a Conditional
Certificate of Product Registration for Veterinary
Products with Initial Registration with the Bureau
of Food and Drugs
Licensing of Veterinary Establishments
Amendment to Bureau Circular No. 17 S. 2005
Further Updating the Accepted Whitening Agents
for Cosmetics
Maximum Allowable Limits of Heavy Metals for
Cosmetic Products
Specific Operational Instructions Implementing
Administrative Order No. 2005-0031 Dated
December 7, 2005, Subject: Guidelines and
Procedure for the Issuance of the Principal
Certificate of Product Registration and the Listing
of Identical Drug Products Based on the Identity
of Manufacturer and Pharmaceutical Formulation
Good Manufacturing Practices Seminar for Food
Establishments Based on A.O. 153, s. 2004 and
Other Related Regulations
Amendment to Bureau Circular No. 06 s. 2005 List of Recognized Laboratories
Lifting of Moratorium on the Conduct of
Selected Pharmaceutical Products
98
Date
Adopted
18-Oct-06
4-Oct-06
5-Sep-06
4-Sep-06
26-Jun-06
19-Jun-06
22-May-06
27-Apr-06

Date Filed
Ref. No.
Subject No.
9-Nov-06
06-437
9-Nov-06
06-437
9-Nov-06
06-437
9-Nov-06
06-437
9-Nov-06
06-437
9-Nov-06
06-437
9-Nov-06
06-437
9-Nov-06
06-437
10-Nov-05
05-433
10-Nov-05
05-433
Circular No. 19,s. 2005
Subject Title
Amendment to Bureau Circular No. 2006-005 re:
Guidelines for the Submission of Application for
Automatic Renewal Registration of
Pharmaceutical Products, Medical Devices,
Prepackaged Food and Food Products, and
Household Hazardous Substances
Creation of BFAD Food Fortification Data
Management System Team
Guidelines for the Submission of Application for
Automatic Renewal Registration of
Pharmaceutical Products, Medical Devices,
Prepackaged Food and Food Products, and
Mandatory Fortification of Flour
Mandatory Attendance to the Cosmetic Seminar
Covering the 13 ASEAN Training Modules on
Good Manufacturing Practice
Implementation of Bureau of Food and Drugs
Quality Seal Program in Line with the FOURmula
ONE for Health Initiative
Updated Guidelines for the Submission of
Application for Notification, Registration and
Export of Cosmetic Products
Cut-Off Time for the Receiving of Payments of
Fees in BFAD
Revised Assessment Slips
Extension of Submission of Site Information File"
(SIF)
99
Date
Adopted
21-Mar-06
28-Feb-06
22-Feb-06
28-Feb-06
10-Feb-06
9-Feb-06
3-Jan-06
11-Nov-05
24-Oct-05
21-Oct-05

Date Filed
Ref. No.
Subject No.
10-Nov-05
05-433
10-Nov-05
05-433
26-Aug-05
05-353
26-Aug-05
26-Aug-05
05-353
05-353

26-Aug-05
05-353
Circular No. 13-A, s. 2005
26-Aug-05
29-Jun-05
05-353
05-266
Circulr No. 13, s. 2005

29-Jun-05
05-266
29-Jun-05
4-May-05
4-May-05
05-266
05-189
05-189

16-Mar-05
05-121
16-Mar-05
16-Mar-05
05-121
05-121

16-Mar-05
05-121
16-Mar-05
05-121
19-Jan-05
05-032
19-Jan-05
05-032
Subject Title
New Advisory on Labeling Selective
Cycloxygenase-2 (COX-2) Inhibitors and NonSteroidal Anti-Inflammatory Drugs (NSAIDS)
Update of Accepted Whitening Agents for
Cosmetics
Adopting the 2002 Recommended Energy and
Nutrient Intakes as the New Dietary Standard
PARECOXIB (DYNASTAT)
Re: GENE THERAPY
Reconstitution of the BFAD-Cosmetics Industry
Joint Committee
Submission of Site Information File (SIF)
BFAD Quality Seal
Revised Labeling of Selective COX-2 Inhibitor
Drugs and NSAIDS
Creation of the Joint BFAD Inspectorate Team
Submission of Site Information File
Selective COX-2 Inhibitors
Full Implementation of the Lot or Batch Release
Certification Requirement
List of Recognized Laboratories
Black Box Warning for All Antidepressant Drugs
Establishments
Submission of Site Information File
Establishments
Classification of All Injectable Hyaluronic Acid as
Device
100
Date
Adopted
12-Oct-05
22-Sep-05
9-Aug-05
14-Jul-05
6-Jul-05
29-Jun-05
22-Jun-05
20-Jun-05
7-Jun-05
5-May-05
7-Apr-05
4-Apr-05
2-Mar-05
10-Feb-05
3-Jan-05
1-Feb-05
19-Jan-05
10-Jan-05
4-Jan-05

Date Filed
Ref. No.
Subject No.
19-Jan-05
05-032
19-Jan-05
05-032
19-Jan-05
05-032
19-Jan-05
19-Jan-05
05-032
05-032

27-Oct-04
04-355
27-Oct-04
04-355
Circular No. 14, a. 2004
27-Oct-04
04-355
27-Oct-04
04-355
27-Oct-04
04-355
27-Oct-04
04-355
Subject Title
Submission of Application for Registration in
Accordance with the ASEAN Common Technical
Document (ACTD) Format
Delisting of ROFECOXIB from Bureau of Food
and Drugs Registry of Drug Products
Mandating the Use of Vitamin A and Iron
Fortified Flour
TAHEEBO / Pau d' arco / Lapacho
Guideline on Probiotics
Guidelines in Advertising, Promotion and Other
Marketing Materials of Breastmilk Substitutes,
Breastmilk Supplement and Other Related
Products
Submission of Adverse Drug Reaction Reports on
COX-2 Inhibitors as Part of Safety Monitoring
Clarification of Par. A, Bureau Circular No. 6, s.
1999 (Revised B.C. No. 4 s. 1999 "New Protocol
for Registration of Drugs, Foods, Cosmetics and
Medical Devices)
Entry of Meat-Based Food Products into the EU
Food and Drugs (Composition and Labeling
Amendment) Regulation 2004 Issued by
Hongkong Food and Environmental Hygiene
Department
Information on the Exportation of Fresh/Frozen
Marine Products and Fresh, Frozen and Chilled
Chicken Meat from the Philippines
101
Date
Adopted
13-Dec-04
26-Nov-04
17-Nov-04
28-Oct-04
26-Oct-04
20-Oct-04
12-Oct-04
27-Sep-04
14-Sep-04
2-Aug-04
27-Jul-04

Date Filed
Ref. No.
Subject No.
3-Sep-04
04-293
3-Sep-04
04-293
3-Sep-04
04-293
3-Sep-04
04-293
3-Sep-04
04-293
3-Sep-04
04-293
Circular No. 4-B, s. 2004
3-Sep-04
04-293
3-Sep-04
04-293
3-Sep-04
04-293
3-Sep-04
04-293
3-Sep-04
04-293
26-Jan-04
04-027
26-Jan-04
04-027
Subject Title
Articles Regarding the Bioterrorism Act
Published/Released by the US Food and Drug
Administration
Regulation and Monitoring of the Mandatory
Fortification of Staples (Rice, Sugar, Flour and
Cooking Oil) and Their Utilization by Food
Processors as Ingredients
Registration of Veterinary Products
Office of the President Memorandum Order No.
136: Approving the 2004 Investment Priorities
Plan
Consolidation and Update of Permissible
Cosmetic Claims
Whitening Agents in Cosmetics Preparations
Different Brand Names for Narcotic/Opioid
Analgesic Drugs for Cancer Pain
Reiterating Memorandum Circular No. 008, s.
1988 (RE: Drug and Medical Devices
Registration)
Guidelines for the Registration and Performance
Validation of Methamphetamine
(MET)/Tetrahydrocannabinol (THC) Drug
Screening Test Kits
Re: GINKGO BILOBA
Guidelines for the Assessment of Microbiological
Quality of Processed Foods
Sale of BFAD:ICR Mice and BFAD:SD Rat
Addendum to Bureau Circular No. 7, s. 2000
Dated 29 August 2000
102
Date
Adopted
1-Jul-04
10-Jun-04
3-Jun-04
18-May-04
6-Apr-04
3-Apr-04
31-Mar-04
30-Mar-04
26-Mar-04
10-Feb-04
4-Feb-04
8-Jan-04
3-Dec-03

Date
Adopted
20-Nov-03
Date Filed
Ref. No.
Subject No.
Subject Title
26-Jan-04
04-027
26-Jan-04
04-027
26-Jan-04
04-027
12-Jun-03
03-284
Circular No.06, s. 2003
12-Jun-03
03-284
12-Jun-03
03-284
Re: GINGKO BILOBA

Clarification of Guidelines on the Use of BFAD
Registered Brand Names
DOH Administrative Order No. 51 Dated 30 May
2003, Subject: Amendment to Administrative
Order No. 154 Dated 16 November 2003 re:
Revised Guidelines for Designation of Authority
for Certain Administrative Transactions in the
Central Office, Department of Health (DOH)
Accreditation of Liaison Officers to BFAD
Attendance in Licensing Seminar as a
Requirement in the Application for A License to
Operate of a Drug Establishment/Drug Outlet
(AO 56 s. 1989)
Lifting of Moratorium on the Acceptance of
Application for Initial Registration of
Pharmaceutical Products
12-Jun-03
03-284
Classification of Hemodialysis Products as Drugs
10-Apr-03
12-Jun-03
03-284
27-Mar-03
12-Jun-03
03-284
12-Jun-03
03-284
12-Jun-03
03-284
Establishment of the BFAD Medical Clinic

Mandatory Dissemination of Information
Regarding the Precaution/Warning of Drug
Products Containing Phenylpropanolamine (PPA)
Mandatory Printing of Boxed Warning on All
Phenylpropanolamine (PPA) Containing Products
(OTC and Rx).
Classification of Paracetamol Syrup/Suspension
120mg/5ml and 125mg/5ml
103
18-Nov-03
27-Jun-03
20-May-03
10-Apr-03
10-Apr-03
17-Mar-03
17-Mar-03
13-Feb-03

Date Filed
Ref. No.
Subject No.
12-Jun-03
03-284
19-Sep-02
02-422
19-Sep-02
02-422
19-Sep-02
02-422
19-Sep-02
02-422
19-Sep-02
02-422
19-Sep-02
02-422
19-Sep-02
02-422
Memo Cir. No. 4, s. 2002
19-Sep-02
02-422
19-Sep-02
02-422
Subject Title
Pattern in Writing of Date in All
Communications/Documents Addressed to BFAD
and Emanating from BFAD
Revised List of Permissible Cosmetics Claims
that Require Justification
Customs Memorandum Circular No. 218-2000
Dated 18 July-2002
Guidelines for Monitoring Iodized Salt
Upgrading of Manufacturing Facilities in
Harmony with A.O. No. 90 s. 2002, Current
Good Manufacturing Practice (cGMP) Guidelines
for Cosmetic Products
Amending Bureau Circular No. 02, s. 2002
Setting the Deadline for Compliance on the
Labeling and Advertisement of Cigarettes
Mandated Under DOH-Administrative Order No.
10, s. 1993 and Bureau Circular No. 16-A s,
2001
Extension of the Validity Period of Initial and
Renewal Registration of In-Vitro Diagnostic
Reagents/Kits
Certificate of Analysis on 3-MCPD in Soy Sauce
and Related Food Products Containing Acid
Hydrolyzed Vegetable Protein
Reclassification of Sambong 250mg Tablet From
Over-The-Counter (OTC) to Household Remedy
Setting the Deadline for Compliance with Bureau
Circular No. 16-A s. 2001 on the Labeling and
Advertisement of Cigarettes
104
Date
Adopted
12-Feb-03
11-Sep-02
15-Aug-02
19-Sep-02
29-Apr-02
4-Apr-02
4-Apr-02
19-Feb-02
31-Jan-02
22-Jan-02

Date Filed
Ref. No.
Subject No.
19-Sep-02
02-422
19-Sep-02
02-422
Adm. Ord. No. 134, s. 2002
19-Sep-02
02-422
Adm. Ord. No. 90, s. 2002
19-Sep-02
02-422
Adm. Ord. No. 70, s. 2002
19-Sep-02
02-422
Adm. Ord. No. 56, s. 2001
19-Sep-02
02-422
Adm. Ord. No. 50, s. 2001
19-Sep-02
02-422
19-Sep-02
02-422
5-Dec-01
01-474
5-Dec-01
01-474
5-Dec-01
01-474
Subject Title
Notarized Application Forms for Product
Registration
Amendment to the Revised 2001 Schedule of
Fees and Charges of BFAD for Food
Manufacturers
Current Good Manufacturing Practice Guidelines
for Cosmetic Products
Licensing of Botika ng Barangays (BnB) in
Various Local Government Units
Guideline on Labeling and Advertisement of
Cigarettes and Designating the Bureau of Food
and Drugs as Its Regulating Agency
Revised 2001 Schedule of Fees and Charges for
the Corresponding Services Rendered by the
Bureau of Food and Drugs
Delisting of LEVENORGESTREL 750 mcg
(POSTINOR) from Bureau of Food and Drugs
Registry of Drug Products
Classification of Oral Rehydration Salts, Lagundi
300mg Tablet, Multivitamins Oral Formulations
and Pyrantel Embonate
Labeling and Advertisement of Cigarettes
Guidelines for the Immediate Processing of
Applications for Initial Registration of
Amendment to BFAD Circular No. 23 Dated 16
September 1994
105
Date
Adopted
18-Jan-02
16-Jul-02
18-Mar-02
3-Jan-02
24-Oct-01
17-Sep-01
7-Dec-01
29-Nov-01
20-Nov-01
20-Nov-01
13-Nov-01

Date Filed
Ref. No.
Subject No.
5-Dec-01
01-474
5-Dec-01
01-474
5-Dec-01
01-474
5-Dec-01
01-474
5-Dec-01
01-474
5-Dec-01
01-474
5-Dec-01
01-474
5-Dec-01
01-474
5-Dec-01
01-474
26-Jul-01
01-294
26-Jul-01
01-294
26-Jul-01
26-Jul-01
01-294
01-294

17-May-01
01-205
Subject Title
Guidelines for the Immediate Processing of
Pending Applications for Renewal Registration of
Amendment to Bureau Circular No. 13-A s. 2001
"Over-The-Counter (OTC) Drugs Reclassified as
Household Remedies"
Amendment to Bureau Circular No. 11 s., 2001
"Over-the-Counter (OTC) Drugs Reclassified as
Houshold Remedies"
Erratum to Bureau Circular No. 9, s. 2001
Addendum to Bureau Circular No. 6-A s. 2001
Dated June 11, 2001
Re: Over-the-Counter (OTC) Drugs Reclassified
as Household Remedies
Submission of Site Information File and Updating
1. Glass Ionomers of Automatic Restorative
Treatment (ART) 2. Fit and Fissure Sealant 3.
Hand Instruments with Kits for ART
Revised Minimum Required Samples for
Laboratory Analysis
Guidelines to be Observed on the
Implementation of Product Recall System
Proposed Guidelines for the Assessment of
Microbiological Quality of Processed Foods
Aflatoxin M1 in Milk
Acute Toxicity of Tin
Extension of the Validity of Monitored Release
Study
106
Date
Adopted
26-Oct-01
26-Oct-01
17-Oct-01
17-Oct-01
5-Oct-01
20-Aug-01
10-Aug-01
7-Aug-01
11-Jun-01
6-Jul-01
22-Jun-01
30-May-01
30-May-01
20-Apr-01

Date Filed
Ref. No.
17-May-01
01-205
17-May-01
01-205
17-May-01
01-205
2-Feb-01
01-062
2-Feb-01
01-062
2-Feb-01
01-062
2-Feb-01
01-062
2-Feb-01
01-062
Subject No.
Subject Title
Cancellation of the Certificates of Product

Registration, Seizure and Confiscation of BFAD
Registered Products, which do not Conform to
their Registered Specifications
Advisory on Voluntary Recall of Processed Meat
Products Imported from European Countries
Guidelines on the Temporary Ban on the
Importation of Processed Meat Products from
Cattle, Sheep and Goat, and Other Food
Ingredients Containing Substances Derived from
these Animals
Bureau of Licensing and Regulation, Bureau of
Adm. Ord. No. 104-A, s.
Research and Laboratories, Bureau of Food and
2000
Drugs and National Quarantine Office
(Amendment to Administrative Order No. 40 s.
2000)
The Need and Role of A Medical Director in the
Adm. Ord. No. 86, s. 2000
Phamaceutical Industry
Adm. Ord. No. 40, s. 2000
Bureau of Licensing and Regulation, Bureau of
Research and Laboratories, Bureau of Food and
Drugs and National Quarantine Office
Records Filing, Retrieval/Borrowing and Disposal
Confiscation of Unregistered CLARIDEM
Astringent No.3
107
Date
Adopted
5-Apr-01
8-Mar-01
8-Mar-01
21-Aug-00
18-Jul-00
17-Apr-00
12-Dec-00
21-Nov-00

Date Filed
Ref. No.
Subject No.
2-Feb-01
01-062
7-Sep-00
00-346
Adm. Ord. No. 99, s. 2000
7-Sep-00
00-346
Adm. Ord. No. 98, s. 2000
7-Sep-00
00-346
Adm. Ord. No. 97, s. 2000
7-Sep-00
00-346
Adm. Ord. No. 85, s. 2000
7-Sep-00
00-346
7-Sep-00
00-346
Adm. Ord. No. 23-C, s.

2000
7-Sep-00
00-346
25-Jul-00
00-264
25-Jul-00
00-264
25-Jul-00
00-264
29-Jun-00
00-239
DOH Adm. Ord. No. 4-A, s.

2000
Memorandum No. 8, s.
2000
Subject Title
Creation of a BFAD-Cosmetics Industry Joint
Committee
Banning and Withdrawal of the Fixed-DoseCombination Drug Product loratadine +
Pseudoephedrine (Clarinase) from the Market
Voluntary Withdrawal of Astemizole (Hismanal)
from the Market
Banning and Withdrawal of Cisapride (Prepulsid)
from the Market
Registration Requirements for A Government
Agency Importing A Pharmaceutical Product with
a Registered Counterpart Brand in the
Philippines
Policies and Guidelines on Over the Counter
(OTC) Drug Products
Authentication of Documents
Standard Policy on Labeled Potency of
Phamaceutical Products
Banning and Withdrawal of Olaquindox and
Carbadox from the Market
Revised Permissible Claims for Cosmetic
Preparations
Amendment to FDA Circular No. 2 s. of 1982 on
the Importation of Semi-Synthetic Antibiotics
Provision of Speakers for the Joint Bureau of
Food and Drugs - Philippine Pharmaceutical
Association Sponsored Continuing Professional
Education Programs
108
Date
Adopted
29-Aug-00
9-Aug-00
9-Aug-00
9-Aug-00
14-Jul-00
9-Mar-00
16-Aug-00
3-Aug-00
11-Jan-00
7-Jul-00
8-Jun-00
23-Jun-00

Date Filed
Ref. No.
29-Jun-00
00-239
29-Jun-00
00-239
29-Jun-00
00-239
29-Jun-00
00-239
6-Mar-00
00-085
6-Mar-00
00-085
6-Mar-00
00-085
6-Mar-00
00-085
6-Mar-00
00-085
Subject No.
Subject Title
Attendance to the Joint Bureau of Food and

Drugs - Philippine Pharmaceutical Association
Sponsored Continuing Professional Education
Program
Implementation of Administrative Order No. 13,
Circular No. 4, a. 2000
s. 1999, "Use of Hydroquinone and/or Tretinoin
(Retinoic Acid)
Amendment to the Rules and Regulations
Implementing Republic Act No. 8203 Otherwise
Known as the "Special Law on Counterfeit
Drugs"
Use of Hydroquinone and/or Tretinoin (Retinoic
Adm. Ord. No. 13, s. 1999
Acid)
Submission of Test Procedures and Test
Specifications for Products to be Included in the
Philippine Pharmacopeia
Submission of List of All Pending Applications for
Registration/Listing of Cosmetic Products and
Banning and Withdrawal of Trovafloxacin
Adm. Ord. No. 1, s. 2000
(Trovan) from the Market
Change of Manufacturers of Drug Products in
Adm. Ord. No. 54, s. 1999
Compliance with the CGMP Requirements
Submission of Suggested Retail Price of
Adm. Ord. No. 48-C, s.
Pharmaceutical Product as Additional
1999
Requirement for Product Registration
109
Date
Adopted
23-Jun-00
14-Jun-00
31-Jan-00
6-Apr-99
28-Feb-00
24-Jan-00
3-Jan-00
22-Dec-99
21-Nov-99

Date Filed
Ref. No.
6-Mar-00
00-085
6-Mar-00
00-085
17-Jan-00
00-023
17-Jan-00
00-023
17-Jan-00
00-023
17-Jan-00
00-023
17-Jan-00
00-023
17-Jan-00
00-023
17-Jan-00
00-023
17-Jan-00
00-023
Subject No.
Subject Title
Fee for Re-Submission of Application for Initial

or Renewal Registration of Pharmaceutical
Products Previously Disapproved Pursuant to
1999
Bureau of Food and Drugs (BFAD) Bureau
Rules and Regulations Implementing Republic
Act No. 8203 Otherwise Known as the Special
Law on Counterfeit Drug
Moratorium on the Acceptance of Application for
Initial Registration of Pharmaceutical Products
Expoliant and Expoliate as Permissible Claims for
Cosmetic Preparations
Deletion of the Requirement for a Certificate of
Brand Name Clearance in Filing an Application
for Registration of Branded Products
Guidelines for the Evaluation of Brand Names for
Products to be Registered with the Bureau of
Food and Drugs
Amended Criteria for Selection of Employees for
Filling of Vacant Position
Re-Iterating Section 20 (b)(1))B) of R.A. 3720
as Amended by Section 12 of E.O. 175 and
Section 29-A of E.O. 175
Importation and Registration of Imported PreCircular No. 18, s. 1999
packed Food Products
Resumption of Acceptance of Application for
Registration of Branded Ethical/Prescription
110
Date
Adopted
29-Sep-99
19-Nov-96
13-Jan-00
24-Nov-99
27-Oct-99
27-Oct-99
14-Oct-99
no date
16-Aug-99
23-Jul-99

Date Filed
Ref. No.
Subject No.
17-Jan-00
00-023
22-Jun-99
99-211
22-Jun-99
99-211
22-Jun-99
99-211
22-Jun-99
99-211
22-Jun-99
99-211
22-Jun-99
99-211
22-Jun-99
99-211
22-Jun-99
99-211
Circular No. 10,. S.1999
Subject Title
Transfer of Processing of Brand Name Clearance
for Pharmaceutical Products to the Intellectual
Property Office (IPO)_
Moratorium on the Conduct of
Pharmaceutical Products Included in the List B'
(Products with Reported Problems on
Bioavailability/Bioequivalence)
Dioxin Contaminated Food Products Monitored
by BFAD
Phasing-Out the Registration of Branded Version
of Registered Unbranded Drug Product and
Unbranded Version of Registered Branded Drug
Product (Memorandum Circular No. 10-A s.
1992)
Withdrawal from the Market of Products
Suspected to be Tainted with Meat and Other
Materials Containing Dioxin
Inventory and Temporary Cessation of
Distribution of Certain Food Products Produced
in Belgium and Other Suspected Countries
Submission of List of Products Validly Registered
and in the Market
Certification of Registrations' Annotation of
Suspension/Cancellation of Drug or Drug Product
Combination found to be
Adulterated/Misbranded
Criteria for Selection of Employees for Filling of
Vacant Position
111
Date
Adopted
23-Jul-99
14-Jun-99
14-Jun-99
11-Jun-99
11-Jun-99
11-Jun-99
9-Jun-99
1-Jun-99
31-May-99

Date Filed
Ref. No.
Subject No.
22-Jun-99
99-211
22-Jun-99
99-211
22-Jun-99
99-211
Adm. Ord. No. 16, s. 1999
22-Jun-99
99-211
Adm. Ord. No. 14, s. 1999
22-Jun-99
99-211
Adm. Ord. No. 13, s. 1999
16-Apr-99
99-129
Adm. Ord. No. 13, s. 1999
16-Apr-99
99-129
16-Apr-99
99-129
16-Apr-99
99-129
16-Apr-99
99-129
16-Apr-99
99-129
Subject Title
Labeling of Prepackaged Processed Meat
Products
Guidelines in the Collection and Submission of
Samples of Food, Drugs, Cosmetics, and Medical
Devices for Physico-Chemical Analysis
Delisting Oral Proteolytic Enzyme-Containing
Drug Products in the Registry of Drugs with the
Bureau of Food and Drugs (BFAD)
Regulations for the Licensing of Salt
Manufacturers
Acid)
Acid)
Amendment to Bureau Circular No. 8, s. 1998
"Registration of Imported Food Products Covered
by An Exlusive Distributorship Agreement and
Sale or Offer for Sale of the Same Products
Whose Registration Papers are Still In-Process"
Re-Iterating Article IV, Section 30 of Republic
Act 5921
Revised Bureau Circular No. 4, s. 1999 "New
Protocol for Registration of Drugs, Foods,
Cosmetics and Medical Devices
Revised Process of Submission of Application for
Product Registration
New Protocol for Registration of Drugs, Foods,
Cosmetics and Medical Devices
112
Date
Adopted
22-Apr-99
19-Apr-99
13-May-99
3-May-99
6-Apr-99
6-Apr-99
13-Apr-99
18-Feb-99
15-Feb-99
10-Feb-99
3-Feb-99

Date Filed
Ref. No.
Subject No.
Subject Title
16-Apr-99
99-129
16-Apr-99
99-129
16-Apr-99
99-129
25-Nov-98
98-349
25-Nov-98
98-349
25-Nov-98
98-349
Circular No.6-A, s. 1998
25-Nov-98
98-349
25-Nov-98
98-349
25-Nov-98
98-349
29-Jul-98
98-215
29-Jul-98
29-Jul-98
30-Oct-97
30-Oct-97
98-215
98-215
97-300
97-300

Alcohol with Disinfectant and Antiseptic Actions

Amendment to BFAD M.C. No. 25, s. 1992
Otherwise Known as "Additional Labeling
Requirement for Food Supplements"
Revised BFAD's Receipt of Renewal Application
Stamp
Registration of Imported Food Products Covered
by An Exclusive Distributorship Agreement;
and Sale or Offer for Sale of the Same Products
Whose Registration Papers are Still In-Process
Adoption of the Guiding Principles for Good
Manufaturing Practice (GMP) Guidelines in the
Manufacture of Cosmetic Products
Permissible Net Content Variation in PrePackaged Food
Fictitious, or Impostors Food and Drug
Regulation Officers (FDROs)
Extension of the Validity Period of Renewal
Registration of Medical and Dental Devices
Deadline for the Final Phase-Out of Potassium
Bromate as a Flour Treatment Agent set in A.O.
25, s. 1996
Upgrading of Manufacturing Facilities in
Consonance with CGMP Requirements Beginning
1996 up to Year-End 1999
Amended Criteria for Promotion
Criteria for Promotion
Submission of the List of Winners
1997 Updated Listing of Cosmetic Ingredients
113
Date
Adopted
2-Feb-99
15-Jan-99
14-Jan-99
27-Oct-98
23-Oct-98
20-Oct-98
13-Oct-98
3-Aug-98
30-Jul-98
14-May-98
7-May-98
3-Mar-98
5-Sep-97
4-Sep-97

Date Filed
Ref. No.
Subject No.
30-Oct-97
97-300
30-Oct-97
97-300
30-Oct-97
97-300
30-Oct-97
97-300
30-Oct-97
97-300
30-Oct-97
97-300
30-Oct-97
97-300
30-Oct-97
97-300
11-Mar-97
97-081
Subject Title
Extension of the Period to Declare Unregistered
Imported Food Products Under Bureau Circular
No. 4, s. 1997
Calendars/Posters and Other Form of
Advertisement Using Picture of Women that are
Perceived as Vulgar and Obscene
Specific Guidelines for Preparation of Order of
Payment and Collection of Fees for Certificate of
Authentication for Copies of BFAD Official
Document(s)
Implementation Details of BFAD Circular No. 1,
s. 1997
Batch Recall of Dexamethasone Sodium
Phosphate Injection (Dextrapin Injection)
8mg/2ml vial, Batch No. 1296, 2/99
Extension of the Period to Declare Unregistered
Imported Food Products Under Bureau Circular
No. 4, s. 1997
Amendment of Office Circular No. 1, s. 1994
Subject: Employee Suggestion and Incentive
Awards System
Revised Checklist of Requirements and the 1997
Guidelines for the Registration of Pharmaceutical
Products
Declaration of Unregistered Imported Food
Products in the Market and Allowing These
Declared Products on Certain Conditions Upon
Payment of Administrative Fine
114
Date
Adopted
2-Sep-97
21-Aug-97
10-Jul-97
30-Apr-97
14-Apr-97
31-Mar-97
20-Mar-97
19-Mar-97
14-Feb-97

Date Filed
Ref. No.
Subject No.
11-Mar-97
97-081
11-Mar-97
97-081
11-Mar-97
97-081
11-Mar-97
97-081
11-Mar-97
97-081
3-Sep-96
96-221
3-Sep-96
96-221
25-Jul-96
96-183
Bureau Order No.67-B, s.

1996
25-Jul-96
96-183
Adm. Order No. 20-A, s.

1996
Subject Title
Guidelines for the Processing of Requests for
Authentication for Copies of BFAD Official
Documents by Parties Other Than the
Department of Health or any of Its Agencies
Accreditation of Drug Liaison Officers to BFAD
Enforcement of the Requirement for
Bioavailability Studies for Registration of
Products Included in the List B' (Prime) Under
DOH-Administrative Order 67 Series of 1989
Exclusion of Quinolone Derivatives and
Veterinary Antibiotic Products from the BFAD
Batch Certification Requirement
Iterating Article IV, Section 25 of Republic Act
5921
Iterating Article IV, Section 25 of Republic Act
5921, as Amended
Pertinent Provisions of Republic Act (R.A.) 7581
Otherwise Known as the Price Act
Requiring the Inclusion of Warning Statement
for Products Containing Sodium Metabisulfite
and Other Derivatives of this Sodium Salt
Authority of the Bureau of Food and Drugs and
DOH-Integrated Regional Field Offices to Levy,
Assess, Collect and Retain Fees to Cover the
Certification of Supervision Issued in the Sales
Promotion Activities Involving Raffles, Seedings,
and Contests, Pursuant to the Provisions of
Consumer Act of the Philippines (RA 7394)
115
Date
Adopted
3-Feb-97
4-Feb-97
21-Jan-97
1-Oct-96
7-Aug-96
7-Aug-96
30-Jul-96
5-Jun-96
24-May-96

Date Filed
Ref. No.
14-Jun-96
96-141
14-Jun-96
96-141
14-Jun-96
96-141
11-Apr-96
96-083
11-Apr-96
96-083
11-Apr-96
96-083
11-Apr-96
96-083
11-Apr-96
96-083
11-Apr-96
96-083
20-Jun-95
95-139
20-Jun-95
95-139
20-Jun-95
95-139
20-Jun-95
95-139
Subject No.
Subject Title
Provisional Permit to Market Food Products

Pending Approval of the Application for Product
Registration
Selling of Drugs or Medicines to the Public
Ban Against Importation of UK Beef and Beef
Products Effective Immediately
Establishments
Period Within Which An Initial Conditional
Registration Shall be Processed and Issued
Revised and/or Updated Lists of Ingredients or
Substances in Cosmetics Recommended After A
Series of Review and Studies by the BFADIndustry Joint Study Group
BFAD Posters for Consumers of Drug Products
Amending Sections Three (III) Four (IV), Five
Bureau Order No. 101-H, s.
(V) and Six (VI) of Memorandum Circular No. 191995
A, s. 1992
Bureau Memo. No. 21, s.
Lists of Permissible Claims for Cosmetic
1995
Preparations, etc.
Cancellation of 1988-1989-1990 Inactive
Applications for Product Registrations
Phase-Out of Potassium Bromate as Flour
Treatment Agent in Bread-Making
Amendment of MC No. 4, s. 1994
Bureau Order No. 59-B, s.
1996
Memorandum Circular No. 18, Series 1994

Dated August 11, 1994 and September 20, 1994
116
Date
Adopted
21-May-96
22-Apr-96
11-Apr-96
1-Mar-96
17-Oct-95
9-Oct-95
12-Sep-95
9-Oct-95
25-Sep-95
15-May-95
16-Feb-95
18-Nov-94
24-Oct-94

Date Filed
Ref. No.
Subject No.
20-Jun-95
95-139
Adm. Order No. 33, s. 1994
20-Jun-95
95-139
Adm. Order No. 32, s. 1994
25-May-95
95-120
25-May-95
95-120
25-May-95
95-120
25-May-95
95-120
26-Aug-94
94-260
26-Aug-94
94-260
26-Aug-94
94-260
Subject Title
Supplementary Instructions to DOH
Adminstrative Order No. 32 s. 1994 to Cover
Administrative Issuances to be Issued by Other
Major Offices and Organizational Units of the
Department of Health to Take Effect July 15,
1994
Instructions Governing the Preparation,
Classification, Review, Approval, Dissemination,
Use and Monitoring of Administrative Issuances
and Amending DOH Administrative Order No.
111, s. 1963, to Take Effect July 15, 1994
Amending Memo Circular No. 4, s. 1994
Compliance with the IRR of the Senior Citizens
Act
Inventory, Proper Disposal and/or Destruction of
Used Vials or Bottles
Creation of BFAD/Industry Joint Committee on
Management Systems and Procedures
Minimum Required Samples for Laboratory
Analysis
Reclassification of Hydroquinone 1-2% from
Cosmetics to Drugs
Additional Labelling Requirement for PrePackaged Food Products
System and Procedure for Application of
Certificate of Product Listing as Per
Administrative Order No. 29-A, s. 1994
117
Date
Adopted
8-Jul-94
4-Jul-94
16-Sep-94
8-Sep-94
6-Sep-94
7-Sep-94
15-Aug-94
11-Aug-94
21-Jul-94

Date Filed
Ref. No.
Subject No.
Subject Title
26-Aug-94
94-260
Memo Cir. No. 16-A, s.

1994
26-Aug-94
94-260
26-Aug-94
94-260
26-Aug-94
94-260
26-Aug-94
94-260
26-Aug-94
94-260
26-Aug-94
94-260
26-Aug-94
94-260
26-Aug-94
94-260
26-Aug-94
94-260
12-May-94
94-155
12-May-94
94-155
12-May-94
94-155
12-May-94
94-155
Memo Cir. No. 12, s. 1994 Addendum to BFAD Memo Circular No. 4 s. 1994
Joint BFAD-RITM Operational Procedure for
Registration of HIV Test Systems
Revocation of Office Memo No. 5, s. 1990, Use
of Universal Product Code (UPC) on Locally
Manufactured Products
Restriction of Sale and Distribution of
Misoprostol (Cytotec)
Regulation Part D-5 Cosmetic: Listing of
1994
Cosmetics Specialists
Allowing the Use of Butylated Hydroxytoluene
(BHT) on Both Rinse-Off and Leave-On Products
Implementing Guidelines for Certain Cosmetic
Registration Requirements
Limiting the Sale of OTC Cough Preparations to
One (1) Bottle of 120 ml. per Customer
Reports on Adverse Drug Reaction
Limiting the Number of Proposed Brandname for

Brandname Clearance for a Single Drug Product
or Pharmaceutical Specialty
Clarification on Administrative Order No. 29-A s.
1994
Change of Capsule Color of A Registered Drug
Product or Pharmaceutical Preparations
Sales Promotion of Foods, Drugs, Cosmetics and
Household Hazardous Substances Products
Revised Seminar Fees for the Participants to the
Series of Seminar on Licensing of Establishments
118
Date
Adopted
15-Jul-94
15-Jul-94
1-Jul-94
14-Jun-94
17-Jun-94
7-Jun-94
23-May-94
10-May-94
6-May-94
18-May-94
28-Apr-94
12-Apr-94
19-Apr-94
20-Apr-94

Date Filed
Ref. No.
12-May-94
94-155
12-May-94
94-155
12-May-94
94-155
12-May-94
94-155
12-May-94
94-155
7-Oct-93
93-229
7-Oct-93
93-229
7-Oct-93
93-229
7-Oct-93
93-229
7-Oct-93
93-229
7-Oct-93
93-229
Subject No.
Subject Title
Amendment of MC No. 1, s. 1994: Compliance

with the IRR of the Senior Citizens Act.
Drug Store Personnel Development Program
Amendment of Memorandum Circular No. 5 and
9 s. 1993 and Updating the List of Drug Outlets
Authorized to Dispense Nalbuphine
Hydrochloride 10mg/5ml. (Nubain Injection)
Compliance with the IRR of the Senior Citizens
Act.
Confirmation of the Expansion of the Joint Study
Memo Cir. No. 12, s. 1993 Group of the Cosmetic Industry and BFAD (JSGCIB)
Supplementary Labelling Guidelines for Cosmetic
Products
Amendment of Certain Cosmetic Registration
Guidelines and Requirements
Amendment of MC No 20 s. 1992, MC No. 5 s.
1993 and Updating the List of Drug Outlets
Authorized to Dispense Nalbuphine
Hydrochloride 10mg/5ml. (Nubain Injection)
Validity Period of Provisional Registration of
Fixed-Dosed Combinations (FDCs)
Applications for Initial Registration Filed on July
16, 1993 re: Products Undergoing Renewal
Registration are Allowed in the Market Until the
Application for Renewal Registration is Finally
Acted by BFAD.
Monitoring of Food Products Requiring an Open
Date Marking
119
Date
Adopted
11-Apr-94
4-Apr-94
11-Mar-94
14-Feb-94
22-Oct-93
20-Sep-93
7-Sep-93
16-Aug-93
12-Aug-93
28-Jul-93
9-Jun-93

Date Filed
Ref. No.
Subject No.
7-Oct-93
93-229
11-May-93
93-110
11-May-93
93-110
24-Feb-93
24-Feb-93
93-055
93-055
24-Feb-93
93-055

Office Order No. 8-A, s.
1993
24-Feb-93
93-055
24-Feb-93
93-055
6-Nov-92
IPD-605
6-Nov-92
IPD-605
6-Nov-92
IPD-605
6-Nov-92
6-Nov-92
6-Nov-92
IPD-605
IPD-605
IPD-605

6-Nov-92
IPD-605
Subject Title
Amendment of MC No. 20 s. 1992 and Updating
the List of Drug Outlets Authorized to Dispense
Nalbuphine Hydrochloride 10mg/ml (Nubain
Injection)
Phasing Out of the Process of Extending the
Effectivity of CPR or Memorandum of Extension
(MOE)
Maximum Allowable Concentration of BORIC
ACID in Cosmetics
Cough Syrup Containing Dextromethorphan
Unregistered Methergin Ampoule
Prescribing Procedures for the Speedy
Disposition of Administrative Cases in BFAD
Sale of ASEAN Reference Substance Produced by
the Bureau of Food and Drugs (ASEAN Reference
Substance Project).
Confiscation of Lily's Peanut Butter
Extension of the Deadline for the Listing of
Unregistered Cosmetic Products
Additional Labelling Requirement for Food
Supplements
Sale of Official Publication of BFAD Operational
Manual on Drug Evaluation and Control
Confiscation of RX Supercandy
Aqua Babe Infant Formula Water
Peanut Butter with High Aflatoxin Content
Authorized Outlets of Nalbuphine Hydrochloride
10mg/ml (Nubain Injection)
120
Date
Adopted
4-May-93
15-Apr-93
12-Apr-93
9-Feb-93
2-Feb-93
10-Feb-93
12-Nov-92
3-Nov-92
30-Oct-92
15-Oct-92
19-Oct-92
14-Oct-92
8-Oct-92
14-Sep-92
11-Sep-92

Date Filed
Ref. No.
Subject No.
Subject Title
Date
Adopted
6-Nov-92
IPD-605

1992
Specific Standards and Requirements
30-Jul-92
6-Nov-92
IPD-605
6-Nov-92
IPD-605
6-Nov-92
IPD-605
28-Jul-92
IPD-549
28-Jul-92
IPD-549
28-Jul-92
IPD-549
28-Jul-92
IPD-549
28-Jul-92
IPD-549
10-Jun-92
IPD-516
10-Jun-92
IPD-516

1992
10-Jun-92
IPD-516
10-Jun-92
IPD-516
Memo Cir. No. 9-A, s. 1992
Clarificatory Guidelines on Administrative Order

150 s. 1971
Confirmation of the Policy Not to Require Patent
Clearance for the Registration of the Drug
Products
Registration of Household Remedies
Declaration of Amnesty for Unregistered
Cosmetics in the Market
Measures of Establishment's Compliance with
Good Manufacturing Practices
Substandard Golden Sun Vinegar Processed by
Golden Sun Food Products
Dimehydrinate B.P. Ampoule mfd. By:
Maripharm Pharmaceuticals
Unregistered Musamycetin/Chloramphenicol 125
mg/5ml
Samples Requirement for the Purpose of
Registration of Drugs and Devices
Registration of Branded Version of Registered
Unbranded Generic Drug Product, and Generic
Version of Registered Branded Drug Products
Clarifying FDA (BFAD) Memorandum Circular No.
001 s. 1983, Sec. 4.2.2 of Chapter 1 and Section
4.2.1, Chapter 11 of A.O. 56 s. 1989
Information on Counterfeit Pharmaceutical
Products
121
30-Jul-92
28-Jul-92
27-Jul-92
17-Jul-92
7-Jul-92
19-Jun-92
18-Jun-92
17-Jun-92
30-May-92
27-May-92
27-May-92
18-May-92

Date Filed
Ref. No.
Subject No.
10-Jun-92
IPD-516
10-Jun-92
IPD-516
10-Jun-92
IPD-516
10-Jun-92
IPD-516
14-Apr-92
IPD-492
Memo Cir. No. 5-D, s. 1992
14-Apr-92
IPD-492
Memo Cir. No. 5-C, s. 1992
14-Apr-92
IPD-492
Memo Cir. No. 5-B, s. 1992
14-Apr-92
IPD-492
14-Apr-92
IPD-492
14-Apr-92
IPD-492
28-Feb-92
IPD-467
Subject Title
Chemesco Dicycloverine Hydrochloride
10mg/5ml Syrup Mfd. By: Drugmaker's Labs.,
Inc. For: Chemesco, Ic.
Multivitamins and Minerals (Leginsol Vita) Drops
Manufactured by; Phil-Genetics Laboratories
For: Dyna Drug Corp. DR-XY12413
Inclusion of Hepatitis C Testing Kits in List 1-B of
Diagnostic Reagents Required to be Registered
Amendment of Categories of Drug Products to
Qualify Under Special Lane
Medifortan Capsule - DR-XY2203 Mfd. By:
Biodrug Medical Labs., Inc. For: Medi Rx. Inc.
Paracetamol 500 mg Tablet Manufactured by:
Sydenham Labs., Inc.
Aminogesic Forte 500 mg. Tablet Mfg. By:
Sydenham Labs., Inc.
Quinine Sulfate Film Coated 325 mg. Tablet Mfd.
By: Labatec Pharma S.A. - DR-XY1201 Impt.
By: Medecor Phils., Inc.
Aspirin (Pedia) 100 mg. Tablet - DR - 901 Mfd.
By: United Labs., Inc. For: Myra
Pharmaceuticals
Hemo K Tablet - DR-X4030 Manufactured by:
Am-Europharma Corp.
Clarification of Section 3.4 of A.O. 96 s. 90 on
the Exemption from the Criteria Prescribed for
Fixed-Dose-Combination
122
Date
Adopted
18-May-92
28-Apr-92
24-Apr-92
22-Apr-92
31-Mar-92
31-Mar-92
31-Mar-92
31-Mar-92
31-Mar-92
19-Mar-92
28-Jan-92

Date Filed
Ref. No.
Subject No.
28-Feb-92
IPD-467
28-Feb-92
IPD-467
Regulation No. 2, s. 1986
28-Feb-92
IPD-467
19-Nov-91
IPD-240
16-Oct-91
IPD-240-A
Memo Cir. No. 001, s. 1983
16-Oct-91
IPD-240-A
21-Aug-91
IPD-359
21-Aug-91
IPD-359
21-Aug-91
IPD-359
21-Aug-91
IPD-359
21-Aug-91
IPD-359
21-Aug-91
IPD-359
Subject Title
Creation of A Joint Study Group of the Cosmetic
Industry and BFAD to Compile, Publish, Review
and Study Rules and Regulations Governing
Cosmetic Preparations
Assignment of Brand Name and/or Generic
Names for a Formulation of a Drug or
Pharmaceutical Specialty
New Labeling Requirements of Preparations
Containing Salicylates
Guidelines on Advertisement and Promotions of
Prescription Pharmaceutical Products
Procurement or Buying of Stocks Only from
Legitimate or Authorized Manufacturers or
Distributors
Re-Issuance of BFAD Circulars, Rules and
Regulations
Fake/Imitation Consumer Products in Plastic
Bottles or Containers
Clarification of New Registration When There is a
Change of Manufacturer
Modification of Memorandum Circular No. 6 s.
1991: Implementation Details of A.O. 99 s.
1990
Unregistered Epogen
Inclusion of Abdominal Pads in List 1 A Medical
Devices Required to be Registered and
Correction of No. 30 of the Same List
Special Cases of Drug Products Eligible for
Memorandum of Extension (MOE)
123
Date
Adopted
21-Jan-92
17-Nov-86
1-Aug-86
8-Dec-87
10-Mar-83
7-Oct-91
24-Jul-91
28-Jun-91
18-Jun-91
13-Jun-91
11-Jun-91
15-May-91

Date Filed
Ref. No.
21-Aug-91
IPD-359
21-Aug-91
IPD-359
21-Aug-91
IPD-359
21-Aug-91
IPD-359
21-Aug-91
IPD-359
21-Aug-91
IPD-359
21-Aug-91
IPD-359
21-Aug-91
IPD-359
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Subject No.
Subject Title
Clarification of Prescribed Periods for Renewal of

Registration and Compliance to Letter of
Abeyance
Implementation Details of A.O. 99 s. 1990
The Designation and Registration of An Official
Liaison Officer
Amending List 1-A and List II of Memorandum
Circular No. 1 s. 1991 Dated 03 January 1991
Subject: Registration of Medical Devices and
Diagnostic Reagents
Requirements for Application for Drug
Registration Extension Pursuant to Memo
Procedure in the Processing of Certificate of
Good Manufacturing Practice (GMP), Certificate
of Free Sale and Certificate of GMP and the Free
Sale
Clarification of "Packing" and 'Repacking" in the
Definition of Drug Manufacturer
Registration of Medical Devices and Diagnostic
Reagents
Exemption of Certified Countryside and
Barangay Business Enterprises (CCBE) from
BFAD License to Operate (LTO) and Compliance
to Technical Requirement (CRT) Fees
Exemption from the Requirement Providing One
Pharmacist for Each Licensed Activity
124
Date
Adopted
27-Mar-91
26-Mar-91
4-Feb-91
23-Jan-91
23-Jan-91
10-Jan-91
7-Jan-91
3-Jan-91
28-Dec-90
6-Dec-90

Date Filed
Ref. No.
Subject No.
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Memo Cir. No. 5, s. 1990.
8-Feb-91
IPD-240
Subject Title
Submission of the First and Last Batch Number
of Products Complying with Generic Labelling
Requirements and Using the Old Labels
Respectively
Provisional Requirement for Licensing of
Establishments to Engage in the Manufacture,
Distribution and Sale of Diagnostic Reagents for
Laboratory Use
Signatures Required in Reports of Laboratory
Analysis
Information From World Health Organization
Headquarters Regarding A Batch of Mislabelled
Diethylene Glycol Used in Paracetamol Syrup
Bureau of Patents, Trademarks and Technology
Transfer (BPTTT) Clearance in the Processing of
BFAD Brand Name Clearance
Revised Implementing Guidelines for the
Effective Implementation of A.O. No. 151 s.
1971 Re: Certification of Antibiotics
Clarification on the Rules and Regulations
Governing Dispensing and Drug Outlets
Licensing Requirements
Classification of Cough Syrups
Confirmation of the Resolution During the
Conference with Food Importers at the BFAD on
April 2, 1990
Facilitating Action on Registration of Certain
Batch Certification of Antibiotics
125
Date
Adopted
2-Nov-90
31-Oct-90
26-Oct-90
15-Oct.90
5-Sep-90
17-Aug-90
6-Jun-90
23-May-90
16-May-90
15-May-90
7-May-90

Date Filed
Ref. No.
Subject No.
Subject Title
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Fake Products of Colgate-Palmolive Phils., Inc.

Compliance with Administrative Order No. 56 s.
1989
Public Information About the Generics Act of
1988
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Memo Cir. No. 24-B, s.

1989
1989
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
8-Feb-91
8-Feb-91
IPD-240
IPD-240
IPD-240

8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Confiscation of SHENYUNG (Growth) Balls

Adulterated and Unregistered Imported Food
Products
Guidelines to Implement A.O. 79, s. 1989
US-FDA Ban on Methylene Chloride in Hair
Sprays
USFDA Revised Policy on Country of Origin
Labelling for Imported Food
Solicitation of Advertisement by Quest
Publications
Registration of Imported Food Products
Requirement for Tablet Hardness
Drug Registration Extension
Monitoring of Drugstore Pharmacist's Office
Hours
Monitoring of Voluntary Compliance with the
Generics Act of 1988
Final Deadline for Generic Labelling and Generic
Advertising of Drug Products Containing Single
Active Ingredients
Batch Certification of Antibiotic and Antibiotic
Containing Products
126
Date
Adopted
19-Apr-90
20-Mar-90
5-Dec-89
29-Nov-89
27-Nov-89
27-Oct-89
16-Oct-89
12-Oct-89
15-Sep-89
4-Sep-89
21-Aug-89
16-Aug-89
15-Aug-89
7-Aug-89
19-Jul-89
18-Jul-89

Date Filed
Ref. No.
Subject No.
8-Feb-91
IPD-240
8-Feb-91
8-Feb-91
IPD-240
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Memo Cir. No. 007. S. 1989
8-Feb-91
IPD-240
Memo Cir. No. 006, s. 1989
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Subject Title
Methanol Content in Alcohol Beverages as

Defined by Memo Circular No. 88-003
Fake Efficascent Oil
Fake Drug Products
Administrative Order No. 70, s. 1989 ReClassifying Pseudoephedrine and Drug Products
Containing Pseudoephedrine as Prescription
Drugs
Specification of Quality Control
Equipment/Facilities for Repacking of
1989
Clarification on the Period of Time
Memo Cir. No. 009, s. 1989 Pharmaceutical Products with Old Label shall be
Allowed to Remain in the Market
Implementation of Schedule of Cost of
Laboratory Analysis for Registration of Drug
Memo Cir. No. 008, s. 1989
Products in Relation to Section 6 of
Administrative Order No. 67 s. 1989
DEPO-PROVERA
Garamycin Injection 80mg. Lot No. PH5AMKZ-1

ED 01/89
BFAD Program on Inspection of Drug
Memo Cir. No. 005, s. 1989
Establishment
Memo Cir. No. 004, s. 1989
Quality Control Facilities and Equipment as A

Requirement in the Repacking of Finished
Pharmaceutical Products Including Raw Materials
127
Date
Adopted
15-Jun-89
6-Jun-89
30-May-89
29-May-89
18-May-89
18-May-89
9-May-89
20-Apr-89
27-Mar-89
3-Apr-89
3-Mar-89

Date Filed
Ref. No.
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Subject No.
Subject Title

1989
Memo Cir. No. 003, s. 1989
1989
Drugs Validly Registered and Active in the

Market
Bronchopen Vial and Bronchopen Ampoule
8-Feb-91
IPD-240
Memo Cir. No. 002, s. 1989
8-Feb-91
IPD-240
Memo Cir. No. 001, s. 1989
8-Feb-91
IPD-240
Memo Cir. No. 019, s. 1988
8-Feb-91
8-Feb-91
IPD-240
IPD-240
Memo Cir. No. 018, s. 1988

Memo Cir. No. 017, s. 1988
8-Feb-91
IPD-240
Memo Cir. No. 016, s. 1988
8-Feb-91
IPD-240
Memo Cir. No. 015, s. 1988
8-Feb-91
IPD-240
Memo Cir. No. 014, s. 1988
8-Feb-91
IPD-240
Memo Cir. No. 013, s. 1988
8-Feb-91
IPD-240
Memo Cir. No. 012, s. 1988
8-Feb-91
IPD-240
Memo Cir. No. 011, s. 1988
8-Feb-91
IPD-240
Memo Cir. No. 010, s. 1988
Submission of Prototype Labels, etc.

Applications for License to Operate Filed Directly
at the Bureau of Food and Drugs or Offering to
Pay the Fees Therefor Directly with the Same
Office
Netromycin 150 mg/ampoule LN-PH7UWHAZ ED - 3/92 Manufactured by Interphil Lab. Inc.
for Schering Corporation (Phil.) Inc.
Sensitive Eye Effervescent Cleansing Tablet
Manufactured by Bausch and Lomb
Dairy Meadow Full Cream Powdered Milk
Medicycline 250 mg.
Birch Tree Milk Powder with Expiry Date of May
1989 and June 1989
Banned Alaska Products
Fake Pentrexyl 500mg. Capsule; PL 734;
11/90 Purportedly Manufactured by Bristol Lab.
Inc.
"Muscle Pain"/Methyl Salicyclate Manufactured
by Breagh Food Products
Fenix Capsules of Ethegal Laboratories
Amplipen 250mg. Lot No. 041021 Expiration
Date October 1989 Manufactured by Sigjohn
Pharmaceuticals, Quezon City
Submission of Samples for Analysis
128
Date
Adopted
14-Feb-89
14-Feb-89
13-Feb-89
25-Jan-89
16-Jan-89
19-Dec-88
14-Dec-88
19-Oct-88
6-Sep-88
30-Aug-88
23-Aug-88
23-Aug-88
19-Aug-88
19-Aug-88
19-Aug-88

Date Filed
Ref. No.
Subject No.
Subject Title
Date
Adopted
8-Feb-91
IPD-240
Memo Cir. No. 009, s. 1988
Confirmation of the Phase Out Action on Mercury

Containing Preparations for Antiseptic Use
18-Jul-88
8-Feb-91
IPD-240
Drug & Medical Device Registration
14-Jul-88
8-Feb-91
IPD-240
"Mommy's Like" Baby Oil
5-Jul-88
8-Feb-91
IPD-240
Memo Cir. No. 008, s. 1988

Memo Cir. No. 007-88, s.
1988
Memo Cir. No. 005-88, s.
1988
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Registration of Diagnostic Reagents and Test

Kits for AIDS
BFAD General Guidelines on Donation of
Methanol Content in Alcoholic Beverages
Provisions of Section 4 of Board Regulation No. 2
s. 1988 Dated March 17, 1988 of the Dangerous
Drugs Board
Implementation of the Provisions of
Administrative Order No.134 s. 1970
Amended General Regulations for the Licensing
of Drug Establishments
Deferment of Implementation of BFAD
Regulation No. 2 s. 1987 Regarding Guidelines
on Evaluation and Registration of Fixed-Dose
Combination Drugs and BFAD Regulation No. 3
s. 1987 Regarding Dipyrone and Related
Compounds
Further Amendments to BFAD Memorandum
Memo Cir. No. 1-D, s. 1987 Circulars Relative to Guidelines for Monitoring of
Imported Foodstuffs
Dipyrone and Related Compounds
129
2-Jun-88
2-May-88
19-May-88
4-Apr-88
9-Mar-88
4-Jan-88
9-Nov-87
2-Feb-87
19-Oct-87

Date Filed
Ref. No.
Subject No.
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Regulation No. 1-A, s. 1987
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Memo Cir. No.1-C, s. 1986
8-Feb-91
IPD-240
Memo Cir. No.1-B, s. 1986
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Memo Ord. No. 1, s. 1985
8-Feb-91
IPD-240
8-Feb-91
IPD-240
Regulation No. 001-E, s.

1982
Regulation No. 001-D, s.
1982
Subject Title
Amending A.O. No. 7, s. 1986 Re: Guidelines on
the Evaluation and Registration of Fixed-Dose
Combination Drugs
Addendum to BFAD Regulation No. 1 Dated April
1, 1987
Withdrawing Approval of Drug Registration for
Oral Anti-Inflammatory Proteolytic Enzymes
Birch Tree Milk Powder
Amendments to BFAD Memorandum Circulars
Relative to Guidelines for Monitoring of Imported
Foodstuffs
Modified Guidelines for Monitoring of Foodstuffs
Amendments to BFAD Memorandum Circular
Dated 01 July 1986 Concerning the Guidelines
for Monitoring of Foodstuffs Imported from
Europe and China for Contamination with
Radioactive Substances
Assignment of Brand Name and/or Generic
Names for a Formulation of a Drug or
Pharmaceutical Specialty
New Labeling Requirements of Preparations
Containing Salicylates
Sale and Distribution of Glacial Acetic Acid as
Vinegar or for Vinegar Manufacture
Guidelines for the Open-Date Marking of Dried
Dairy Milk Powder
Guidelines for the Open-Date Marking of Vitamin
C - Enriched Liquid Fruit Drinks
130
Date
Adopted
7-Oct-87
10-Apr-87
1-Apr-87
20-Oct-86
27-Nov-86
27-Oct-86
19-Sep-86
17-Nov-86
1-Aug-86
27-Sep-85
8-Nov-82
8-Nov-82

Date Filed
Ref. No.
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
8-Feb-91
IPD-240
2-Feb-91
IPD-240
Subject No.
Subject Title
Regulation No. 001-C, s.

1982
Regulation No. 001-B, s.
1982
Guidelines for the Open-Date Marking of Infant

Food
Guidelines for the Open-Date Marking of Bakery
Products
Guidelines for the Open-Date Marking of Liquid
Regulation No. 001-A, s.
Milk Products, Pursuant to Administrative Order
1982
No. 16, s. 1979
Guidelines for Open-Date Marking of
Prepackaged Foods
Compliance with the DOH - Administrative Order
No. 55, s. 1989 or the Generic Labelling
131
Date
Adopted
1-Oct-82
7-Sep-82
30-Aug-82
23-Aug-82
12-Feb-90

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Inventory of Administrative Issuances

Memo Cir. No. 2010-012

Circular No. 2010-011

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OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Circular No. 2010-001

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Memo Cir. No. 2009-001

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OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Circular No. 2008-004

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OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Circular No. 2007-006-A

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Circular No. 2007-007

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OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Circular No. 2007-004

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Circular No. 2006-018

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Circular No. 06-2005

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Circular No. 2006-015

Circular No. 2006-014

Circular No. 2006-013

Circular No. 2006-012

Circular No. 011, s. 2006

Circular No. 10, s. 2006

Circular No. 09, s. 2006

Circular No. 008, s. 2006

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Circular No. 2006-007

Circular No. 006, s. 2006

Circular No. 2006-005

Circular No. 004, s. 2006