UPDATES ON BOARD REGULATION 1 SERIES OF 2014

UPDATES ON 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

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)

Reorganization of the Philippine Drug Enforcement System Creation of … The new Dangerous Drugs Board (DDB) as the policy and strategy formulating body. The Philippine Drug Enforcement Agency (PDEA) as its implementing arm.

PDEA Key Officials Atty. Roselyn A Borja Deputy Director General for Administration ASEC Ricardo C Quinto Deputy Director General for Operations

DIRECTOR GENERAL HEAD EXECUTIVE ASSISTANT DEP DIR GEN FOR ADMIN DEP DIR GEN FOR OPNS A D M I N S T A F F ADMIN & HUMAN RESOURC E SERVICE FINANCIA L MGNT SERVICE LOGISTIC S MGNT SERVICE O P E R A T I O N A L S T A F F INTERNAL AFFAIRS SERVICE INTEL & INVES SERVICE ADMIN SUPPORT UNIT PDEA ACADEMY PIO REGIONAL OFFICES PLANS & OPNS SERVICE LEGAL & PROSEC UTION SERVICE COMPLIANCE SERVICE OPERATIONAL SUPPORT UNITS SPECIAL ENFORCEMEN T SERVICE PDEA LABORATO RY SERVICE INT’L COOP & FOREIGN AFFAIRS SERVICE PREV EDUC & COMTY INVOLVE MENT SERVICE

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 ISSUES LICENSES AND PERMITS Local Transfer (DD) / Import/ Export) COMPLIANCE AND INVESTIGATION DIVISION Compliance Inspection/Investigation/ PSI/ Audit Records in Registers vs stocks/ Evaluates SARs/ Backtracking/Chemical Diversion

SUBSTANCES CONTROLLED UNDER 1988 UN CONVENTION AGAINST ILLICIT TRAFFIC ON NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES Dangerous Drugs Controlled Precursors and Essential Chemicals

CONTROLLED PRECURSORS & ESSENTIAL CHEMICALS TABLE 1 Acetic anhydride N-acetylanthranilic acid Ergometrine Ergotamine Isosafrole Lysergic acid 3 -4 Methylenedioxypheny l 2 -propanone Norephedrine/PPA 1 -Phenyl-2 propanone Piperonal Potassium Permanganate TABLE II Acetone Anthranilic acid Ethyl Ether Hydrochloric acid Methyl ketone Phenylacetic acid Piperidine Sulphuric acid Toluene Thionyl Chloride – DDB Reg 5 s. 2005 With the exception of HCl & H 2 SO 4, the salts of substances listed in the Tables, whenever the existence of such salt is possible, are also controlled.

NOT CONTROLLED MEKPO Ø MIBK Methyl Ethyl Ketone Peroxide Methyl Iso Butyl Ketone Acetic Acid Vinegar Toluene Diisocyanate Used to form polyurathanes Ethyl Acetate used in glues, nail polish removers, decaffeinating tea and coffee and cigarettes.

P-LICENSE APPLICATION SHEET - red folder

P-LICENSE JOINT AFFIDAVIT - red folder

P-LICENSE LETTER OF AUTHORIZATION - red folder

REGISTRATION Activity Retail Fee per annum P 1 (Php 500) End-use P 3 (Php 2500) Wholesale / Trade P 4 (Php 3000) Manufacture /Repack /Recycle P 5 -C (Php 5, 000) Depot / Storage P 5 -D (Php 5000) Export P 5 -E (Php 5, 000) Import / Import for End-use P 5 -I /P 5 -IM (Php 5, 000) Research / Laboratory Use P 6 (Php 500)

TYPE OF LICENSE DESCRIPTION P 1 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. P 3 End-User End-user of specified controlled chemicals. NOT authorized to resell the controlled chemicals. Authorized to purchase from local sources only. P 4 Wholesale distributor License to sell, procure, acquire, dealing in or with specified controlled chemicals except drugs containing controlled chemicals for wholesale distribution to license holders.

TYPE OF LICENSE DESCRIPTION P 5 C 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. P 5 D 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 P 3, PIM & P 5 C

TYPE OF LICENSE DESCRIPTION P 5 E Exporter License to export specified controlled chemicals excluding drug preparations containing controlled chemicals P 5 IM 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. P 5 I 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.

Example 1 Company A with P 3 License has an office in Cabuyao, Laguna and its warehouse for controlled substances is in Rosario, Cavite. No P 5 D because its P 3 license in the office covers the warehouse already. P 5 D 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 P 3, PIM & P 5 C

Example 2 Company A with P 3 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 P 3 license and its warehouse in Quezon will be issued a P 5 D license P 5 D 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 P 3, P 5 IM & P 5 C

Example 3 Company C with P 5 IM License has an office in Cabuyao, Laguna and its warehouse for controlled substances is in Rosario, Cavite. No P 5 D because its P 5 IM license in the office covers the warehouse already. P 5 D 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 P 3, P 5 IM & P 5 C

Example 4 Company D with P 5 IM 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 P 5 IM license and its warehouse in Quezon will be issued a P 5 D license. P 5 D 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 P 1, P 3, P 4 & P 5 C

Example 5 Company with P 4 or P 5 I License with an office in Cabuyao, Laguna and warehouse for controlled substances is in Rosario, Cavite With P 5 D for Cavite warehouse. P 5 D 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 P 3, PIM & P 5 C

Example 6 Company with P 4 or P 5 I License has an office with warehouse 1 for controlled substances is in Rosario, Cavite and warehouse 2 in Sariaya, Quezon. With P 5 DW 1 for Cavite warehouse and P 5 DW 2 for Quezon warehouse. P 5 D 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 P 3, PIM & P 5 C

TYPE OF LICENSE DESCRIPTION P 6 Research/ Analysis /Instruction al 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.

EXAMPLES OF CONTROLLED CHEMICALS FOR LAB USE

FOR LABORATORY USE • Toluene 99. 5% - for fuel oil analysis • Hydrochloric Acid 36% - for water analysis • Acetone 99. 5% - for water analysis

LOCALLY ACQUIRED CONTROLLED CHEMICALS

CONTROLLED CHEMICAL - PURE LOCAL ACQUISITION & END-USE (P 3) LABORATORY USE (P 6) above threshold limits – not exempted from license below threshold limits – exempted from license q 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 25 Liters Ethyl Ether 5 Liters Toluene 5 Liters Methyl Ethyl Ketone 5 Liters Potassium Permanganate(for medical purpose) 100 grams

CONTROLLED CHEMICAL - PURE LOCAL ACQUISITION & LOCAL DISTRIBUTION (P 4) not exempted from license

CONTROLLED CHEMICAL - MIXTURES LOCAL ACQUISITION & END-USE (P 3) LOCAL ACQUISITION & LOCAL DISTRIBUTION (P 4) LABORATORY USE (P 6) exempted from license

IMPORTED CONTROLLED CHEMICALS

CONTROLLED CHEMICAL - PURE IMPORTED FINISHED PRODUCTS FOR END-USE (P 5 IM) IMPORTED FINISHED PRODUCTS FOR LOCAL DISTRIBUTION (P 5 I) LABORATORY USE (P 6) not exempted from license with Special Permit may apply Board Resolution for Exemption / Deliberation of Technical Working Group

CONTROLLED CHEMICAL - MIXTURE IMPORTED FINISHED PRODUCTS FOR END-USE (P 5 IM) LABORATORY USE (P 6) 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 SINGLE COMPONENT CHEMICAL CONCENTRATION LIMITS Acetone < or = 35% Hydrochloric Acid < or = 30% Sulfuric Acid < or = 30% Ethyl Ether CONCENTRATION LIMITS < or = 35% Toluene < or = 35% Methyl Ethyl Ketone < or = 35% Potassium Permanganate < or = 15%

CONTROLLED CHEMICAL - MIXTURE IMPORTED FINISHED PRODUCTS FOR LOCAL DISTRIBUTION (P 4) 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 P 4 & P 3 are automatically exempted CONCENTRATION LIMITS SINGLE COMPONENT CHEMICAL CONCENTRATION LIMITS Acetone < or = 35% Hydrochloric Acid < or = 30% Sulfuric Acid < or = 30% Ethyl Ether < or = 35% Toluene < or = 35% Methyl Ethyl Ketone < or = 35% Potassium Permanganate < or = 15%

SPECIAL PERMIT ØValidity: 6 months from date of issuance Ø 1 set contains 6 copies for PURE ØAnother set contains 4 copies for MIXTURES Ø BOC/File Copy/Client ØPhysical feature of permit: Pink-colored security paper with PDEA watermark. ØWorkflow status posted at the Philippine National Single Window Website – www. nsw. gov. ph ØSubmit at least 15 working days, 2 mos at most prior to arrival ØApplication requires TIN and CCN ØTo include MSDS, Proforma Invoice/PO/Air Waybill Amendment Requirements: ØCover Letter with/EDA and Air Waybill ØCertificate of Shipment from Shipping Line/Air Line ØFor qty – at most is 30% of total qty ØShould be submitted immediately

IMPORTED BATTERIES

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

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

LOCALLY ACQUIRED BATTERIES

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

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

IMPORTED BATTERIES

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

LOCALLY ACQUIRED BATTERIES

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

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

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 500. 00) 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

LTH CERTIFICATE

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 § date of transaction § 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

üA 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. üAny change in the category of activity or change in ownership shall require a new license application. üA 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. üTo 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

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 P 5 C LICENSE IF ITEM WILL BE RE-PACKAGED AND/OR RELABELED.

STORAGE REQUIREMENT ANNEX L

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

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

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

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

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

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

CONTACT US… 24/7 TEXT HOTLINES 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: 0999 -888 7332 (0999 -888 PDEA) (Smart Subscribers) 0925 -573 7332 (Sun Subscribers) 0927 -915 0616 (Globe Subscribers) To know the status of your concern, text: STAT (space) reference number to any of the above numbers

Republic of the Philippines Office of the President PHILIPPINE DRUG ENFORCEMENT AGENCY NIA Northsite Road, National Government Center Quezon City COMPLIANCE SECTION 4 A Camp Vicente Lim, Calamba, Laguna 0949 -1308482 pdeacs_4 a@yahoo. com