Exemptions from Reclassification
- Preparations containing Ephedrine and Pseudoephedrine are exempt from the dangerous drug classification if all of the following conditions apply:
- The preparation poses negligible risk of abuse.
- Ephedrine or Pseudoephedrine cannot be readily extracted or removed, or if extracted, are of a quality susceptible to abuse.
- Contains non-narcotic or non-psychotic active medical ingredients in sufficient proportions to prevent abuse potentiation.
- Does not contain narcotic drugs or psychotropic substances listed under Schedule I of the 1972 Convention or substances with known abuse potential.
- The preparation is not in injectable form.
Effect of Presence with Other Dangerous Drugs or Controlled Substances
- Any preparation containing Ephedrine or Pseudoephedrine combined or associated with other dangerous drugs is itself considered a dangerous drug.
Prohibition on Over-the-Counter Sale and Distribution as Physician's Samples
- Preparations containing Ephedrine or Pseudoephedrine in any form or physical state cannot be sold over-the-counter without a prescription from a licensed practitioner.
- Distribution of these preparations as physician’s samples is also prohibited.
Advertising Restrictions
- Ephedrine and Pseudoephedrine shall not be advertised to the general public.
- Advertising may only be conducted in scientific journals.
Violations and Sanctions
- Violations of this regulation will result in administrative sanctions.
- Criminal prosecution may also be pursued if warranted by the offense.
Effectivity of the Regulation
- The regulation takes effect fifteen (15) days after publication in two newspapers of general circulation.
- It also requires registration with the Office of the National Administrative Register (ONAR) at UP Law Center, Diliman, Quezon City before effectivity.