1. BOARD REGULATION 1, SERIES OF 2014 REGULATORY CONTROL ON LICIT USE OF
UPDATES ON BOARD REGULATION 1, SERIES OF 2014
BOARD REGULATION 1, SERIES OF 2014
REGULATORY CONTROL ON LICIT USE OF
CONTROLLED PRECURSORS
AND ESSENTIAL CHEMICALS
Rowena A. Kalalo, RPh
Jannice P. Manalili. RPh

2. LEGAL MANDATE RA 9165 and B.R. NO. 1, s. 2014
(Comprehensive Amendments to Board Regulation No. 3 Series 2003, "Comprehensive Guidelines on Importation, Distribution, Manufacture, Prescription, Dispensing and Sale of, and Other Lawful Acts in Connection with Any Dangerous Drugs, Controlled Precursors and Essential Chemicals and Other Similar or Analogous Substances", as Amended, and Other Related Board Issuances)
Aside from the RA 9165, you should also familiarize yourselves with the following regulations, particularly Board Regulation 1 s which is the Comprehensive guidelines on importation, distribution, manufacture, prescription, dispensing and sale of, and other lawful acts in connection with any DD, CPECS and other similar or analogous substances. The other regulations ( DDB Res. 8 s. 2004, DDB Reg 3 & 4, s. 2005) we shall be touching as we go on. 2

5. Philippine Drug Enforcement System
Reorganization of the
Philippine Drug Enforcement System
Creation of …
The new Dangerous Drugs Board
(DDB) as the policy and strategy
formulating body.
Among other things, RA 9165, reorganized the Philippine drug enforcement system and paved for the creation of a new Dangerous Drugs Board that serves as the policy-making and strategy formulating body of the Phil. Gov’t on matters pertaining to drug abuse prevention and control
and the establishment of the Philippine Drug Enforcement Agency as its primary implementing arm.
The Philippine Drug Enforcement Agency (PDEA) as its implementing arm. 5

6. PDEA Key Officials Atty. Roselyn A Borja
The PDEA was officially activated on July 30, 2002 when Her Excellency appointed its 1st Director General with a rank equivalent to an Undersecretary. On April 26, 2006, the President appointed PDEA’s 2nd Director General, Sr. Undersecretary Dionisio R. Santiago. He is assisted by 2 Deputy Director Generals, one for Administration and one for Operation, in the person of Assistant Secretary Baltazar S. Balangauan and Assistant Secretary Rodolfo N. Caisip, respectively
Atty. Roselyn A Borja
Deputy Director General for Administration
ASEC Ricardo C Quinto
Deputy Director General for Operations

7. A D M I N S T A F F O P E R A T I O N A L S T A F F
DIRECTOR GENERAL
HEAD EXECUTIVE ASSISTANT
PIO
DEP DIR GEN FOR ADMIN
DEP DIR GEN FOR OPNS
A D M I N S T A F F
O P E R A T I O N A L S T A F F
ADMIN & HUMAN RESOURCE SERVICE
FINANCIAL MGNT SERVICE
LOGISTICS MGNT SERVICE
INTERNAL AFFAIRS
SERVICE
INTEL
& INVES SERVICE
PLANS & OPNS SERVICE
LEGAL & PROSECUTION SERVICE
COMP-LIANCE SERVICE
INT’L COOP & FOREIGN AFFAIRS SERVICE
PREV EDUC
& COMTY INVOLVEMENT SERVICE
Shown is the Organizational Structure of PDEA. The Compliance Service is one of the Operational Staff Services of PDEA
Regions 1 to 13, ARMM, CAR, RONCR = 16
ADMIN SUPPORT UNIT
OPERATIONAL SUPPORT UNITS
PDEA
ACADEMY
REGIONAL OFFICES
SPECIAL ENFORCEMENT SERVICE
PDEA
LABORATORY SERVICE 7

8. Compliance Service Implements regulatory enforcement on
dangerous drugs and controlled precursors
essential chemicals to ensure its availability and
prevent its diversion into the illicit market.
LICENSING AND RECORDS
DIVISION
COMPLIANCE AND
INVESTIGATION DIVISION
The Compliance Service assists the Director General in monitoring the legitimate acquisition and use of DD and CPECS. We have 2 divisions under the CS, namely the Licensing and Records Division, tasked with the issuance of licenses and permits to legitimate handlers and the Compliance and Investigation Division, tasked with monitoring transaction through checking of reports/records, conduct of inspection, investigation and backtracking.
Compliance Inspection/Investigation/
PSI/ Audit Records in Registers
vs stocks/ Evaluates SARs/
Backtracking/Chemical Diversion
ISSUES LICENSES AND PERMITS
Local Transfer (DD) / Import/ Export)

9. Controlled Precursors and Essential Chemicals
SUBSTANCES CONTROLLED UNDER 1988 UN CONVENTION AGAINST ILLICIT TRAFFIC ON NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES
Dangerous Drugs
Controlled Precursors and Essential Chemicals
Substances controlled under RA 9165 include the DD and CPECS. DD are so controlled because of its addicting properties while CPECS are controlled because they are frequently used in the illegal manufacture of DD.
Shabu, a slang term for the drug methamphetamine used in Japan, Hong Kong, Philippines, Malaysia and Indonesia.
MDMA (contracted from 3,4-methylenedioxy-methamphetamine). MDMA has become widely known as "ecstasy" (shortened to "E", "X", or "XTC"). The UK term "Mandy" and the US term "Molly" colloquially refer to MDMA in a crystalline powder form that is relatively free of adulterants.

10. CONTROLLED PRECURSORS & ESSENTIAL CHEMICALS
TABLE 1
TABLE II
Acetic anhydride
N-acetylanthranilic acid
Ergometrine
Ergotamine
Isosafrole
Lysergic acid
3-4-Methylenedioxyphenyl-
2-propanone
Norephedrine/PPA
1-Phenyl-2propanone
Piperonal
Potassium Permanganate
Pseudoephedrine
Safrole
Acetone
Anthranilic acid
Ethyl Ether
Hydrochloric acid
Methyl ethyl ketone
Phenylacetic acid
Piperidine
Sulphuric acid
Toluene
Thionyl Chloride – DDB Reg 5 s. 2005
CPECS as defined under RA 9165 include those listed in Tables 1 and 2 of the 1988 UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. As of date, we have 22 substances classified as CPECS (including Thionyl Chloride which ws included in the list pursuant to DDB Reg. 5 s and excluding Ephedrine and Pseudoephedrine which are reclassified as DD, as previously mentioned).
Locally classified CPECs – i.e. Thionyl Chloride-Board Regulation No. 6,Series 2005
Most of the CPECS are used industrially. Ergotamine, ergometrine and PPA however are used pharmaceutically.
With the exception of HCl & H2SO4,
the salts of substances listed in the
Tables, whenever the existence of such
salt is possible, are also controlled.

11. NOT CONTROLLED MEKPO MIBK Acetic Acid Toluene Diisocyanate
Ethyl Acetate
Methyl Ethyl Ketone Peroxide
Methyl Iso Butyl Ketone
Vinegar
Used to form polyurathanes
used in glues, nail polish removers, decaffeinating tea and coffee and cigarettes.
Polyurethane is a resilient, flexible and durable manufactured material that can take the place of paint, cotton, rubber, metal or wood in thousands of applications across virtually all fields. It can be hard like fiberglass, squishy like upholstery foam, protective like varnish, bouncy like rubber or sticky like glue. Since its invention during the 1940s, polyurethane has been used in a wide range of items, from baby toys to airplane wings, and it continues to be adapted for contemporary technology.
Ethyl Acetate - this colorless liquid has a characteristic sweet smell and is used in glues, nail polish removers, decaffeinating tea and coffee, and cigarettes.

15. APPLICATION SHEET - red folder
P-LICENSE
APPLICATION SHEET - red folder

16. JOINT AFFIDAVIT - red folder
P-LICENSE
JOINT AFFIDAVIT - red folder

17. LETTER OF AUTHORIZATION - red folder
P-LICENSE
LETTER OF AUTHORIZATION - red folder

18. REGISTRATION Activity Fee per annum Retail P1 End-use P3
(Php 500)
End-use P3
(Php 2500)
Wholesale / Trade P4
(Php 3000)
Manufacture /Repack /Recycle
P5-C
(Php 5,000)
Depot / Storage
P5-D
(Php 5000)
Export
P5-E
Import / Import for End-use
P5-I /P5-IM
Research / Laboratory Use P6

19. TYPE OF LICENSE DESCRIPTION
Retail distributor
License to sell, procure, acquire, dealing in or
with specified controlled chemicals or their
mixtures or preparations, except drugs
containing controlled chemicals, for retail sale. P3
End-User
End-user of specified controlled chemicals. NOT
authorized to resell the controlled chemicals.
Authorized to purchase from local sources only. P4
Wholesale
distributor
with specified controlled chemicals except drugs
containing controlled chemicals for wholesale
distribution to license holders.

20. TYPE OF LICENSE DESCRIPTION
P5C
Manufacturer
License to manufacture or recycle specified
controlled chemicals or chemical mixtures
excluding drugs containing controlled chemicals.
May distribute that substance or class for which
license was issued; may not distribute any
substance or class which are not licensed. May
conduct chemical analysis and quality control
analysis with those substances for which license
as a manufacturer was issued. May procure and
acquire scientific apparatus or laboratory
equipment for the manufacture or recycling of
chemicals.
P5D
Bulk
depot/storage
License for bulk depot/storage the address of
which is separate and distinct from the office
address of the license holder.
*EXCEPT FOR P3, PIM & P5C

21. TYPE OF LICENSE DESCRIPTION
Exporter
License to export specified controlled chemicals
excluding drug preparations containing
controlled chemicals
P5IM
Importer/ Enduser
License to import specified controlled chemicals,
as End-user. Acquisition of controlled chemicals
shall be made through importation. The license
holder is authorized also to acquire controlled
chemicals from local sources but is not
authorized to resell the chemicals acquired.
P5I
Importer
License to import specified controlled chemicals.
May distribute that substance for which license
was issued; may not distribute any substance for
which license was not issued.

22. Example 1 Company A with P3 License has an office in Cabuyao, Laguna and its warehouse for controlled substances is in Rosario, Cavite.
No P5D because its P3 license in the office covers the warehouse already.
P5D
Bulk
depot/storage
License for bulk depot/storage the address of
which is separate and distinct from the office
address of the license holder.
*EXCEPT FOR P3, PIM & P5C

23. Example 2 Company A with P3 License has an office in Cabuyao, Laguna with warehouse 1 for controlled substances is in Rosario, Cavite and warehouse 2 in Sariaya, Quezon.
The warehouse in Cavite is covered by the P3 license and its warehouse in Quezon will be issued a P5D license
P5D
Bulk
depot/storage
License for bulk depot/storage the address of
which is separate and distinct from the office
address of the license holder.
*EXCEPT FOR P3, P5IM & P5C

24. Example 3 Company C with P5IM License has an office in Cabuyao, Laguna and its warehouse for controlled substances is in Rosario, Cavite.
No P5D because its P5IM license in the office covers the warehouse already.
P5D
Bulk
depot/storage
License for bulk depot/storage the address of
which is separate and distinct from the office
address of the license holder.
*EXCEPT FOR P3, P5IM & P5C

25. Example 4 Company D with P5IM License has an office with warehouse 1 for controlled substances is in Rosario, Cavite and warehouse 2 in Sariaya, Quezon.
The warehouse in Cavite is covered by the P5IM license and its warehouse in Quezon will be issued a P5D license.
P5D
Bulk
depot/storage
License for bulk depot/storage the address of
which is separate and distinct from the office
address of the license holder.
*EXCEPT FOR P1, P3, P4 & P5C

26. With P5D for Cavite warehouse.
Example 5 Company with P4 or P5I License with an office in Cabuyao, Laguna and warehouse for controlled substances is in Rosario, Cavite
With P5D for Cavite warehouse.
P5D
Bulk
depot/storage
License for bulk depot/storage the address of
which is separate and distinct from the office
address of the license holder.
*EXCEPT FOR P3, PIM & P5C

27. With P5DW1 for Cavite warehouse and P5DW2 for Quezon warehouse.
Example 6 Company with P4 or P5I License has an office with warehouse 1 for controlled substances is in Rosario, Cavite and warehouse 2 in Sariaya, Quezon.
With P5DW1 for Cavite warehouse and P5DW2 for Quezon warehouse.
P5D
Bulk
depot/storage
License for bulk depot/storage the address of
which is separate and distinct from the office
address of the license holder.
*EXCEPT FOR P3, PIM & P5C

28. TYPE OF LICENSE DESCRIPTION
Research/Analysis /Instructional Program
License to conduct laboratory analysis or
technical research or instructional / training
programs, using controlled substances or drugs
containing controlled chemicals or plant sources
of controlled substances. May procure, acquire
syringe, scientific apparatus or laboratory
equipment.

29. EXAMPLES OF CONTROLLED CHEMICALS
FOR LAB USE

30. FOR LABORATORY USE Toluene 99.5% - for fuel oil analysis
Hydrochloric Acid 36% - for water analysis
Acetone 99.5% - for water analysis

31. LOCALLY ACQUIRED CONTROLLED CHEMICALS

32. CONTROLLED CHEMICAL - PURE
LOCAL ACQUISITION & END-USE (P3)
LABORATORY USE (P6)
above threshold limits – not exempted from license
below threshold limits – exempted from license
Note: Supplier to provide end user declaration
THRESHOLD LIMITS PER MONTH
SINGLE COMPONENT CHEMICAL
TOTAL WEIGHT/VOLUME
Acetone
5 Liters
Hydrochloric Acid
25 Liters
Sulfuric Acid
Ethyl Ether
Toluene
Methyl Ethyl Ketone
Potassium Permanganate(for medical purpose)
100 grams

34. CONTROLLED CHEMICAL - PURE
LOCAL ACQUISITION & LOCAL DISTRIBUTION (P4)
not exempted from license
CONTROLLED CHEMICAL - PURE

35. CONTROLLED CHEMICAL - MIXTURES
LOCAL ACQUISITION & END-USE (P3)
LOCAL ACQUISITION & LOCAL DISTRIBUTION (P4)
LABORATORY USE (P6)
exempted from license
CONTROLLED CHEMICAL - MIXTURES

36. IMPORTED CONTROLLED CHEMICALS

37. CONTROLLED CHEMICAL - PURE
IMPORTED FINISHED PRODUCTS FOR END-USE (P5IM)
IMPORTED FINISHED PRODUCTS FOR LOCAL DISTRIBUTION (P5I)
LABORATORY USE (P6)
not exempted from license
with Special Permit
may apply Board Resolution for Exemption / Deliberation of Technical Working Group

38. CONTROLLED CHEMICAL - MIXTURE
IMPORTED FINISHED PRODUCTS FOR END-USE (P5IM)
LABORATORY USE (P6)
not exempted from license regardless of the percentage concentration limits
If above concentration limits – with Special Permit
If below concentration – no Special Permit
Client to Report Notice of Arrival within 5 days from date of arrival at the Port
may apply Board Resolution for Exemption / Deliberation of Technical Working Group
CONCENTRATION LIMITS
SINGLE COMPONENT CHEMICAL
CONCENTRATION LIMITS
Acetone
< or = 35%
Hydrochloric Acid
< or = 30%
Sulfuric Acid
Ethyl Ether
Toluene
Methyl Ethyl Ketone
Potassium Permanganate
< or = 15%

39. CONTROLLED CHEMICAL - MIXTURE
IMPORTED FINISHED PRODUCTS FOR LOCAL DISTRIBUTION (P4)
Products below concentration limits are automatically exempted from both License and Special Permit
Products above concentration limits are not exempted from both License and Special Permit
may apply Board Resolution for Exemption / Deliberation of Technical Working Group
Certificate of Exemption is issued once unless Finished Product is Reformulated
Both P4 & P3 are automatically exempted
CONCENTRATION LIMITS
SINGLE COMPONENT CHEMICAL
CONCENTRATION LIMITS
Acetone
< or = 35%
Hydrochloric Acid
< or = 30%
Sulfuric Acid
Ethyl Ether
Toluene
Methyl Ethyl Ketone
Potassium Permanganate
< or = 15%

40. SPECIAL PERMIT Validity: 6 months from date of issuance
1 set contains 6 copies for PURE
Another set contains 4 copies for MIXTURES
BOC/File Copy/Client
Physical feature of permit: Pink-colored security paper with PDEA watermark.
Workflow status posted at the Philippine National Single Window Website –
Submit at least 15 working days, 2 mos at most prior to arrival
Application requires TIN and CCN
To include MSDS, Proforma Invoice/PO/Air Waybill
Amendment Requirements:
Cover Letter with/EDA and Air Waybill
Certificate of Shipment from Shipping Line/Air Line
For qty – at most is 30% of total qty
Should be submitted immediately

41. IMPORTED BATTERIES

42. WITH <51% SULFURIC ACID FOR END USE
with PDEA License
without Special Permit
without PDEA License
WITH <51% SULFURIC ACID FOR END USE
WITH <51% SULFURIC ACID
FOR END USE
WITH <51% SULFURIC ACID
FOR LOCAL DISTRIBUTION

43. WITH <51% SULFURIC ACID FOR END USE
with PDEA License
with Special Permit
without PDEA License
without Special Permit
WITH <51% SULFURIC ACID FOR END USE
WITH >51% SULFURIC ACID
FOR END USE
WITH >51% SULFURIC ACID
FOR LOCAL DISTRIBUTION

44. LOCALLY ACQUIRED BATTERIES

45. WITH <51% SULFURIC ACID FOR END USE
without PDEA License
without Special Permit
WITH <51% SULFURIC ACID FOR END USE
WITH <51% SULFURIC ACID
FOR END USE
WITH <51% SULFURIC ACID
FOR LOCAL DISTRIBUTION

46. WITH <51% SULFURIC ACID FOR END USE
without PDEA License
without Special Permit
WITH <51% SULFURIC ACID FOR END USE
WITH >51% SULFURIC ACID
FOR END USE
WITH >51% SULFURIC ACID
FOR LOCAL DISTRIBUTION

47. IMPORTED BATTERIES

48. WITH <51% SULFURIC ACID FOR END USE
with PDEA License
with Special Permit
without PDEA License
without Special permit
WITH <51% SULFURIC ACID FOR END USE
WITH THIONYL CHLORIDE (PURE) FOR LOCAL DISTRIBUTION
WITH THIONYL CHLORIDE (MIXTURE) FOR LOCAL DISTRIBUTION

49. LOCALLY ACQUIRED BATTERIES

50. WITH <51% SULFURIC ACID FOR END USE
without PDEA License
without Special Permit
without Special permit
WITH <51% SULFURIC ACID FOR END USE
WITH THIONYL CHLORIDE (PURE) FOR LOCAL DISTRIBUTION
WITH THIONYL CHLORIDE (MIXTURE) FOR LOCAL DISTRIBUTION

53. NOTICE OF ARRIVAL
Importation made shall be reported to PDEA within five (5) working days upon arrival of the shipment.
1st Notice Only
Attach Bill of Lading/PO/Proforma Invoice and Special Permit
Only H or AO are allowed to Sign.
Even if Controlled Chemical is exempted and without SP – Notice of Arrival is still a must.

55. TRANSPORTER/HAULER/CARRIER OF BULK CONTROLLED SUBSTANCE WHICH IS NOT AN INTEGRAL UNIT OF
shall be required to obtain accreditation from PDEA to be authorized for such activity and pay an annual accreditation fee of five hundred pesos (Php )
Requirements:
Certificate of authorization to operate a trucking company and Mayor’s Permit/Business Permit;
Name and address of trucking company, owner and contact number;
NBI clearance of owner or manager;
Inventory of trucks indicating the make/form and plate numbers that will be used to transport controlled substances;
Agreement Contract of contracting parties which shall include among others the provision of the security measures that will be undertaken to prevent diversion, loss, theft, pilferage and other analogous circumstances during transport of controlled substance;
Industrial Technology Development Institute (ITDI)/Department of Science and Technology (DOST) Calibration Certificate/Test Report;
Sworn Statement of Undertaking that transporter/hauler will strictly abide with the provisions of RA 9165 and other pertinent rules and regulations for transporting
controlled substances, and that ITDI/DOST Calibration Certificate/Test Report shall be made available upon inspection by PDEA at all times

57. LTH CERTIFICATE

58. LATE RENEWAL Joint Affidavit/Explanation/Commitment
cite reason/s or explanation
with or w/o transactions after expiry
name of supplier
date of transaction
name of controlled chemicals
quantity purchased/distributed/ SOLD
Photocopies of proof of purchases/distributions
(Delivery Receipt, Sales Invoice, Official Receipts)
Execution Plan For Corrective Measure & Preventive Measure
Assurance of Non-Recurrence

59. A PDEA license may be renewed within three months prior to expiration of license provided that the applicant is able to submit a copy of documents as prescribed by PDEA.
Any change in the category of activity or change in ownership shall require a new license application.
A surcharge equivalent to fifty percent (50%) of the required annual fee, cumulatively by year not paid, shall be imposed for failure to renew the license within the period .
To avoid surcharges, licensee must notify PDEA in writing regarding its intention not to renew their license after expiration.
TRANSITORY PERIOD: MARCH 13, 2015 TO SEPTEMBER 15, 2015

60. SHALL SECURE P5C LICENSE IF ITEM WILL BE RE-PACKAGED AND/OR RELABELED.
LABELING REQUIREMENT
The containers should have labels indicating among others:
Chemical name, trade name;
Identity and concentration;
Name of manufacturer or
importer and address.
SHALL SECURE P5C LICENSE IF ITEM
WILL BE RE-PACKAGED AND/OR RELABELED.

61. STORAGE REQUIREMENT
ANNEX L

62. License Retirement Requirements
Letter re: retirement of license signed by the head and authorized officer, citing reason and intent on remaining CPECS if any
Original Copy of LTH / Certificate to be retired
CPECs register or record book
Subject to Validation/Inspection by RCO 62

63. Disposition of expired /surrendered DD/CPECS
Submit the following:
Letter re. surrender addressed to:
The Director General, PDEA
Attn: Director, Laboratory Service
cc: Director, Compliance Service
For DD to submit additional Local Permit Application
(indicate surrender due to expiry)
Surrender item/s to PDEA Lab Service or request presence of PDEA Chemist to witness destruction in DENR registered facility.
Notation of surrendered DD/CPECS to be entered in the register

64. REPORTING (PDEA Form 1-04)
To report transactions semi-annually
Covered Period
Submission Date
January 1 to June 30
July 01 to 15
July 1 to December 31
January 1 to 15

65. Other Duties of a PDEA Licensed Operator
(Secure / Safekeep stocks) To notify loss, theft, destruction, discrepancies in CPECS and registers
To check and notify suspicious orders and tranx
Not to deal with unlicensed operators
To notify Material Changes
Compliance to labeling /relabeling reqts
To comply with all other provisions of RA 9165 / IRR

66. Compliance Inspections
- During official business hours - Inspect premises - Examine records, reports, storage, actual stocks, etc. - May take samples, extract records, to be duly receipted

67. Usual Violation / Discrepancies
Late renewal of license
Not updated recording
Non or late reporting
With transactions (acquire/sell) after expiration of license
Transaction not in conformity with PDEA license issued
Importation w/o permit and/or license
Dealing with unlicensed operators
Failure to notify material change e.g change address, location of storage, PDEA authorized signatory/head of entity
Failure to secure PDEA License per location and/or activity
Failure to notify loss, destruction, discrepancies in stock and register
Inconsistencies in inventory, record and /or report 67

68. 24/7 TEXT HOTLINES CONTACT US… 0999-888 7332 (0999-888PDEA)
Protect your family from drugs and drug related crimes
Report any drug related information with name of drug users/
Pushers and COMPLETE address of the incident and
send to:
( PDEA)
(Smart Subscribers)
(Sun Subscribers)
(Globe Subscribers)
To know the status of your concern, text:
STAT (space) reference number to any of the above numbers

69. PHILIPPINE DRUG ENFORCEMENT AGENCY
Republic of the Philippines
Office of the President
PHILIPPINE DRUG ENFORCEMENT AGENCY
NIA Northsite Road, National Government Center
Quezon City
COMPLIANCE SECTION 4A
Camp Vicente Lim, Calamba, Laguna