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Dos and don’ts under new drugs board rules


Philippine Daily Inquirer
First Posted 01:41:00 11/22/2009

Filed Under: Economy and Business and Finance, Medicines, Laws

Regulation No. 6 Series of 2007
(Classifying toluene-based contact cement products without at least five-percent mustard oil as dangerous drugs)

* All toluene-based contact cement products imported, manufactured, distributed, sold and/or handled shall include at least five-percent mustard oil.

* The presence of the additive shall be legibly printed on all product labels, cartons and containers.

* The obnoxious odor of the mustard oil additive shall be maintained from the time of manufacture or importation of said products until the same are utilized and/or the mustard oil?s volatility shall be less than that of the toluene content of the products.

* Any violation of this regulation shall be penalized under Section 32 of RA No. 9165: Imprisonment of six months and one day to four years, and a fine of P10,000 to P50,000.

Regulation No. 2 Series of 2009
(Implementing Guidelines for Board Regulation No. 6 Series of 2007)

* No person shall manufacture, distribute or retail the dangerous drug, except pursuant to and in accordance with the terms and conditions of a license granted by the Philippine Drug Enforcement Agency (PDEA).

* No person shall import, export, bring the dangerous drug into the Philippines except pursuant to and in accordance with any of the terms or conditions of the PDEA license and separate import permit, export permit, transit permit or redirection permit, as the case may be.

* An applicant shall apply in writing to the PDEA for the grant of a license and specify the applicant?s full name, business address, premises where the drug will be stored, security arrangements, business permits and NBI clearance.

* A license shall remain in force for one year, unless earlier surrendered, suspended or revoked. A permit shall only remain in force for such period as may be specified in it, which in the case of an import permit shall not exceed six months, and in the case of an export or transit permit shall not exceed three months.

License fees

* To import contact cement without mustard oil: P5,000
* To export: P 5,000
* To manufacture: P 5,000
* To distribute: P 5,000
* To retail: P 3,000
* To store: P 3,000
* To procure from a local source: P3,000
* To conduct laboratory analysis: P500

Sale to individuals

* An individual who purchases the dangerous drug from a retailer shall be required to present a valid identification card and submit a barangay clearance for the particular purchase, duly issued by the chair of the barangay where the individual is residing, to the retailer.

* The barangay clearance shall indicate, among others, the quantity of the dangerous drug to be purchased, the purpose thereof and the tax identification number of the individual. It shall be valid only for three days from date of issuance.

Sale to industrial users

* A holder of an LTPI license may procure the dangerous drug from a retailer by presenting a copy of the license duly certified to by its chief executive officer, managing partner, manager or proprietor, as the case may be, to the retailer.

Prohibited sale to minors

* No retailer shall sell or deliver, with or without consideration, to a minor any quantity of the dangerous drug.



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