DDB Board Regulation No. 4 (2005)

(NAR) VOL. 16 NO. 3 / JULY - SEPTEMBER 2005

[ DDB BOARD REGULATION NO. 4, July 19, 2005 ]

RECLASSIFYING EPHEDRINE AND PSEUDOEPHEDRIN AS DANGEROUS DRUGS

WHEREAS, Ephedrine and Pseudoephedrine or any of their salts, as well as preparations containing any of the said drugs are included in the list of controlled precursors and essential chemicals;

WHEREAS, the Philippine Drug Enforcement Agency (PDEA) recommended that said precursor and essential chemicals be re-classified as dangerous drugs;

WHEREAS, said recommendation was adopted in a public hearing conducted by this Board on June 14, 2005;

NOW, THEREFORE, pursuant to Section 93, Article XI of Republic Act No. 9165, otherwise known as "The Comprehensive Dangerous Drugs Act of 2002", the Board hereby promulgate as follows:

SECTION 1. CLASSIFICATION OF EPHEDRINE AND PSEUDOEPHEDRINE AS DANGEROUS DRUGS - All raw materials of Ephedrine and Pseudoephedrine of any of their salts, as well as preparations containing any of the said drugs are hereby reclassified as DANGEROUS DRUGS.

SECTION 2. EXEMPTION. Section 1 hereof shall not apply to a preparation containing Ephedrine and Pseudoephedrine or any of their salts under such preparation:

a. is so compounded as to present negligible risk of abuse;

b. can not be readily extracted or removed from the preparation by any means and the Ephedrine and Pseudoephedrine or any of its salts thus extracted or removed is of a quality susceptible to abuse;

c. contains one or more non-narcotic or non-psychotic active medical ingredient in proportion sufficient to prevent enhancement or potentiation or synergism of the abuse liability of Ephedrine or Pseudoephedrine, or any of its salts;

d. is devoid of any narcotic drug or another psychotropic substance under Schedule I of the 1972 Convention on Psychotropic Substances or another psycho-active drugs not under domestic or international control but with known abuse potential, and e. is not injectable forms.SECTION 3. EFFECT OF PRESENCE OF DANGEROUS DRUGS OR CONTROLLED SUBSTANCES - When the contents of the subject preparation containing Ephedrine and Pseudoephedrine or any of their salts is in association / combination with dangerous drugs, said preparation shall be deemed to be a dangerous drug.

SECTION 4. PROHIBITIONS AGAINST OVER-THE-COUNTER SALE AND DISTRIBUTION AS PHYSICIAN'S SAMPLE - In no case shall a preparation in any form and in whatever physical state containing EPHEDRINE, PSEUDOEPHEDRINE or any of their salts be sold as over-the-counter items without a prescription of a licensed practitioner or distributed as physician's samples.

SECTION 5. PROHIBITION AGAINST ADVERTISING - Ephedrine and Pseudoephedrine shall not be advertised to the general public except in scientific journals.

SECTION 6. VIOLATIONS - any violation of this Regulation shall be ground for administrative sanction without prejudice to criminal prosecution if warranted.

SECTION 7. EFFECTIVITY - This Regulation shall take effect fifteen (15) days after its publication in two (2) newspapers of general circulation and after registration with the Office of the National Administrative Register (ONAR), UP Law Center, Diliman, Quezon City. Adopted: 19 July 2005

(SGD.) LUCITO A. TAN Representing the President, Integrated Bar of the Philippines Regular Member

(SGD.) RAFAEL M. SANTOS (SGD.) MANUEL G. IMSON Undersecretary, Representing the Undersecretary, Representing the Secretary Secretary of National Defense of Labor and Employment Ex-Officio Member Ex-Officio Member

(SGD.) WENCELITO T. ANDANAR (SGD.) LOURDES G. BALANON Undersecretary, Representing the Undersecretary, Representing the Secretary Secretary of Department of Interior and Local Social Welfare and Development Government Ex-Officio Member Ex-Officio Member

(SGD.) JADE F. DEL MUNDO (SGD.) RAMON J. LIWAG Undersecretary, Representing the Undersecretary, Representing the Secretary of Health Secretary of Justice Ex-Officio Member Ex-Officio Member(SGD.) ANSELMO S. AVENIDO, JR. (SGD.) EDGAR C. GALVANTE Director General, Philippine Drug Undersecretary, Permanent Member Enforcement Agency Dangerous Ex-Officio Member Drugs Board

(SGD.) ANGELO T. REYES Secretary, Department of the Interior and Local Government OIC, Chairman, Dangerous Drugs Board Attested:

(SGD.) DIONISIO R. SANTIAGO Senior Undersecretary Executive Director, DDB