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

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. 2014 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

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

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

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

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)

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.

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. 2005 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.

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.

APPLICATION SHEET - red folder P-LICENSE APPLICATION SHEET - red folder

JOINT AFFIDAVIT - red folder P-LICENSE JOINT AFFIDAVIT - red folder

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

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

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.

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

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.

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

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

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

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

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

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

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.

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 (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

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

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

IMPORTED CONTROLLED CHEMICALS

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

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%

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%

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 – www.nsw.gov.ph 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  

IMPORTED BATTERIES

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

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

LOCALLY ACQUIRED BATTERIES

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

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

IMPORTED BATTERIES

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

LOCALLY ACQUIRED BATTERIES

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

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.

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 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

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

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.

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 62

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 Submission Date January 1 to June 30 July 01 to 15 July 1 to December 31 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 67

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: 0999-888 7332 (0999-888PDEA) (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

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 0949-1308482 pdeacs_4a@yahoo.com