Reclassification of Ephedrine and Pseudoephedrine

This Regulation is promulgated pursuant to Section 93, Article XI of Republic Act No. 9165 (“The Comprehensive Dangerous Drugs Act of 2002”).
The Board acts after the Philippine Drug Enforcement Agency (PDEA) recommends reclassification of Ephedrine and Pseudoephedrine from controlled precursor/essential chemical status to dangerous drugs.
The Board adopts the recommendation after a public hearing conducted on June 14, 2005.
The Regulation implements the Board’s authority to reclassify controlled precursors and essential chemicals as dangerous drugs under Republic Act No. 9165.

The Regulation applies to preparations containing Ephedrine and Pseudoephedrine or any of their salts.
Section 3 provides that if the subject preparation is in association/combination with dangerous drugs, the entire preparation is deemed a dangerous drug.
Section 3 covers association/combination situations involving dangerous drugs, even if the preparation also contains other substances.
Section 1 covers both raw materials and finished preparations containing Ephedrine/Pseudoephedrine or their salts.

Section 2 exempts a preparation containing Ephedrine and Pseudoephedrine (or their salts) only when all conditions are satisfied under Section 2(a)–(e).
Section 2(a) requires the preparation be so compounded as to present negligible risk of abuse.
Section 2(b) requires the preparation cannot be readily extracted or removed, and any extracted/removed Ephedrine/Pseudoephedrine or salts be of a quality susceptible to abuse.
Section 2(c) requires the preparation contains one or more non-narcotic or non-psychotic active medical ingredients in a proportion sufficient to prevent enhancement, potentiation, or synergism of abuse liability.
Section 2(d) requires the preparation be devoid of any narcotic drug or another psychotropic substance under Schedule I of the 1972 Convention on Psychotropic Substances, or other psycho-active drugs not under domestic or international control but with known abuse potential.
Section 2(e) requires the preparation be not in injectable forms.

Section 4 prohibits selling any preparation in any form and in whatever physical state containing Ephedrine and Pseudoephedrine (or any of their salts) as over-the-counter items without a prescription of a licensed practitioner.
Section 4 prohibits distributing the same preparations as physician’s samples.
Section 4 applies to all forms and all physical states of the covered preparations.
Section 4 establishes prescription control and sample prohibition for Ephedrine/Pseudoephedrine-containing preparations.

Section 5 prohibits advertising Ephedrine and Pseudoephedrine to the general public.
Section 5 allows advertising only in scientific journals.
Section 5 treats this advertising restriction as a rule governing public promotion of Ephedrine and Pseudoephedrine.

Section 6 states that any violation of this Regulation is a ground for administrative sanction.
Section 6 provides that administrative sanctions do not prejudice criminal prosecution if warranted.
Section 6 links non-compliance to both administrative accountability and potential criminal liability.

Section 7 provides that the Regulation takes effect fifteen (15) days after its publication in two (2) newspapers of general circulation.
Section 7 further requires completion of registration with the Office of the National Administrative Register (ONAR), UP Law Center, Diliman, Quezon City.
The effectivity rule in Section 7 makes both publication and ONAR registration conditions for the 15-day commencement.
The Regulation was adopted on July 19, 2005.