QuestionsQuestions (DDB BOARD REGULATION NO. 4)
It was issued pursuant to Section 93, Article XI of Republic Act No. 9165 (Comprehensive Dangerous Drugs Act of 2002).
All raw materials of ephedrine and pseudoephedrine (including their salts) and any preparations containing them are reclassified as “dangerous drugs.”
It applies to both raw materials and preparations containing ephedrine/pseudoephedrine or their salts.
It provides exemptions for certain preparations containing ephedrine/pseudoephedrine (or salts) if they meet specified conditions showing negligible abuse risk and inability to be readily extracted/abused.
Examples include: (1) the preparation is compounded to present negligible risk of abuse; (2) it cannot be readily extracted or removed; (3) it contains non-narcotic/non-psychotic active medical ingredients in sufficient proportion to prevent enhancement/potentiation/synergism of abuse liability; (4) it is devoid of narcotic drugs/psychotropic substances under Schedule I of the 1972 Convention (or other psycho-active drugs with known abuse potential not under control); and (5) it is not in injectable form.
The preparation must not be readily extracted or removed by any means; if extracted/removed, the substance would be of a quality susceptible to abuse.
To prevent enhancement, potentiation, or synergism of the abuse liability of ephedrine or pseudoephedrine (or their salts).
The exempt preparation must be devoid of any narcotic drug or psychotropic substance under Schedule I of the 1972 Convention (or another psycho-active drug with known abuse potential not under domestic/international control).
No. One of the exemption conditions is that the preparation is not in injectable forms.
If the preparation containing ephedrine/pseudoephedrine is associated/combined with dangerous drugs, it shall be deemed a dangerous drug.
No. In no case may such preparations be sold as OTC items without a prescription of a licensed practitioner.
It prohibits distributing ephedrine/pseudoephedrine-containing preparations as physician’s samples.
They shall not be advertised to the general public except in scientific journals.
The violation is a ground for administrative sanction, without prejudice to criminal prosecution if warranted.
After fifteen (15) days from 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.
The recitals state that the PDEA recommendation was adopted after a public hearing conducted by the Board on June 14, 2005, indicating compliance with procedural requirements.