Title
DDB Reg. No.2: Regulating Toluene-Based Cement
Law
Ddb Board Regulation No. 2, Series Of 2009
Decision Date
Apr 21, 2009
The Philippine Jurisprudence case explores the comprehensive guidelines and regulations set forth by Dangerous Drugs Board Regulation No. 02-09, which classifies and regulates the handling, sale, and record-keeping of toluene-based contact cement products without at least 5% mustard oil content, aiming to ensure safety and proper handling of these dangerous drugs.
dangerous drugs
mustard oil content
regulations
A

Legal basis, governing framework, and intent

  • The regulation implements Board Regulation No. 6, Series of 2007, which classifies toluene-based contact cement products without at least five percent (5%) mustard oil content as dangerous drugs.
  • The regulation is expressly issued as implementing guidelines for Board Regulation No. 6, Series of 2007.
  • Section 32 of Republic Act No. 9165 supplies the penalty rule for violations of these implementing guidelines.
  • The definition of “dangerous drugs” is anchored on Republic Act No. 9165 and the schedules referenced therein under the 1961 UN Single Convention on Narcotic Drugs (as amended by the 1972 Protocol) and the 1971 UN Convention on Psychotropic Substances.
  • The regulation provides for suppletory application of Board Regulation No. 3, Series of 2003.

Coverage and who must comply

  • These implementing guidelines cover all importers, exporters, manufacturers, distributors, retailers, end-users and handlers of toluene-based contact cement products classified as dangerous drugs.
  • Licensing rules apply to persons engaged in activities involving the dangerous drug, including importation, exportation, manufacturing, distribution, retail, storage, industrial use, and laboratory analysis/technical or teaching programs.
  • The regulatory rules on records and reports apply to all persons granted a license under these implementing guidelines.
  • The industrial-use rules specifically apply to license holders with LTI or LTPI licenses.
  • The retail-sale rules apply to retailers and individuals or industrial users who purchase from retailers.

Core classification standards for “dangerous drugs”

  • If a toluene-based contact cement product has without at least five percent (5%) mustard oil content, it is classified as a dangerous drug under Board Regulation No. 6, Series of 2007, and the term “dangerous drug” is used in these guidelines as “dangerous drug(s)”.
  • Mustard oil may be natural or synthetic, and the required mustard oil content is computed based on the total weight/volume of the toluene content of the product as stated in the product label, carton or other container.
  • Products with at least five percent (5%) mustard oil must have labels (product labels, cartons, or other containers) that:
    • indicate the presence of the additive; and
    • state the percentage content relative to the total weight/volume of the toluene content.
  • The product must have an obnoxious odor from the time of manufacture or importation until utilization by the end-user, and/or its mustard oil volatility must be less than that of the toluene content of the product.
  • Failure to comply with the labeling and odor/volatility requirements under Sections 3 and 4 makes the product a dangerous drug despite the presence of at least five percent (5%) mustard oil.

Licensing, permits, and regulated transactions

  • No person shall manufacture, distribute, or retail the dangerous drug except pursuant to and in accordance with a license granted by the Philippine Drug Enforcement Agency (PDEA).
  • No person shall import, export, bring into the Philippines in transit, or redirect from the Philippines while in transit except pursuant to:
    • a PDEA license authorizing the person to carry out the activities; and
    • a separate permit for the specific transaction (import, export, transit, or redirection) authorizing that transaction as indicated in the permit application.
  • Transfer or delivery of the dangerous drug from one license holder to another license holder is allowed except retail sales, but such transfers/deliveries require prior PDEA approval.
  • Unless specified otherwise, the following activities are treated as independent and require separate registration and licensing:
    • importation (for wholesale distribution or as industrial end-user),
    • exportation,
    • manufacturing,
    • wholesale distribution,
    • retail,
    • storage at separate address(es),
    • industrial use from local source,
    • laboratory analysis or technical or teaching program.
  • Each person must secure from PDEA as many licenses as there are places of business and/or activities; if two or more types of business occur at the same location, the person must secure a separate license for each type, and PDEA issues a consolidated license detailing the activities and corresponding licenses.

License application requirements

  • An application for a license must be filed in writing with PDEA and must state:
    • the applicant’s full name and private/business address;
    • each activity covered by the application;
    • if the applicant is a company: full name and residential address of each director and the company secretary;
    • if the applicant operates under a business name: the business name;
    • the brand name of the dangerous drug and the address of each place where the activity will be carried out;
    • premises where the dangerous drug will be stored;
    • security arrangements at each address (storage, access, building construction, alarm systems, adequacy of supervision, handling of guest and maintenance personnel, adequacy of monitoring system for receipt), and distribution/disposition plan;
    • the name, residential address, and qualification of each person who will supervise the activity;
    • whether the applicant and, if a company, any director or company secretary has been convicted in the Philippines or elsewhere for a serious offense or any offense relating to trafficking in dangerous drugs or their preparations;
    • volume estimate for the forthcoming year and volume statistics for the past year; and for manufacturing, the extraction/manufacturing/denaturing procedure, the names and quantities of substances and raw materials, and production estimates.
  • A license application must be accompanied by:
    • a plan of each relevant premises showing where the dangerous drug will be stored and the location/nature of security device(s);
    • registration with the Philippine Export Zone Authority or Board of Investments, as applicable;
    • business permit or certificate of registration from the local government unit, Department of Trade and Industry, or Securities and Exchange Commission;
    • NBI clearance;
    • the prescribed fee; and
    • other requirements PDEA may prescribe.

Import, export, transit permit applications

  • A licensee must apply in writing for an import, export, or transit permit at least fifteen (15) working days before the transaction date and must provide:
    • full names/addresses of importer/exporter/carrier/consignee and, if known, ultimate consignee;
    • trade name/brand name (for proposed import/export/transit);
    • quantity, mass, and volume;
    • the date or period for the planned transaction;
    • planned transport route and planned point of entry/exit; and
    • for bonded warehouse imports: warehouse identity and address.
  • For proposed export, the application must attach the import permit issued by the government of the foreign State of intended import.

Contents, duration, and conditions of licenses and permits

  • A PDEA license must specify:
    • the licensee’s full name and address;
    • each activity covered;
    • the brand name of the dangerous drug;
    • each address and premises where the licensed activity will be carried out and where the dangerous drug will be stored;
    • terms and conditions necessary and reasonable for proper supervision, record maintenance/preservation, and reporting to PDEA;
    • for licenses involving import/export/transit: the condition that a separate permit must first be obtained before the transaction takes place; and
    • the official receipt number for the prescribed fee.
  • A license remains in force for one (1) year, unless earlier surrendered, suspended, or revoked.
  • A permit remains in force only for the period specified in it:
    • an import permit may not exceed six (6) months; and
    • an export permit or transit permit may not exceed three (3) months.

Annual license fees by type

  • Fees are required per year unless specifically exempted by a Board issuance, special law, or charter. The annual fees are:
    • License to Import (LTI): PHP 5,000.00
    • License to Export (LTE): PHP 5,000.00
    • License to Manufacture (LTM): PHP 5,000.00
    • License to Distribute (LTD): PHP 5,000.00
    • License to Retail (LTR): PHP 3,000.00
    • License to Store (LTS) (when facility address is separate and distinct from office address): PHP 3,000.00
    • License to Procure from Local Source for Industrial Purposes (LTPI):
      • Corporation: PHP 3,000.00
      • Partnership: PHP 2,000.00
      • Cooperative: PHP 1,000.00
      • Individual: PHP 500.00
    • License to Conduct Laboratory Analysis or Technical Research or Instructional Program (LTC): PHP 500.00

Rule on dealing only with licensees

  • Except in retail sales, a license holder must transact the dangerous drug only to another license holder.

Industrial use: control book and reporting

  • Holders of LTI or LTPI licenses must maintain a Dangerous Drug Control Book (computerized or manual) registered with PDEA to record daily issuances of the dangerous drug to workers who directly handle it.
  • The control book must be kept in a secure place by the authorized custodian and is subject to PDEA inspection at any reasonable time and day.
  • The control book must include, among others:
    • date and time of issuance or receipt;
    • full name of the worker receiving or returning the dangerous drug;
    • quantity issued or received;
    • signature of the worker receiving or returning; and
    • for each day’s last entry, a day’s summary of actual usage computed as issued minus returned per worker.
  • LTI and LTPI holders must submit to PDEA a monthly summary of actual usage per worker for the month reported.
  • The monthly summary must be submitted within ten (10) days of the succeeding month.

Retail sales: buyer requirements and prohibitions

  • When an individual purchases from a retailer, the individual must:
    • present a valid identification card; and
    • submit a barangay clearance issued by the Barangay Chairman of the barangay where the individual presently resides.
  • The barangay clearance must indicate:
    • the quantity of the dangerous drug;
    • the purpose; and
    • the Tax Identification Number (TIN).
  • The barangay clearance is valid only for three (3) day
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