Title
Reclassification of Ephedrine and Pseudoephedrine
Law
Ddb Board Regulation No. 4
Decision Date
Jul 19, 2005
The Dangerous Drugs Board in the Philippines reclassifies Ephedrine and Pseudoephedrine as dangerous drugs, with exemptions for certain preparations that meet specific criteria, and imposes restrictions on their sale, distribution, and advertising.
A

Q&A (DDB BOARD REGULATION NO. 4)

The Dangerous Drugs Board reclassified Ephedrine and Pseudoephedrine, including any of their salts and preparations containing them, as dangerous drugs.

The reclassification was promulgated pursuant to Section 93, Article XI of Republic Act No. 9165, otherwise known as "The Comprehensive Dangerous Drugs Act of 2002".

Yes, exemptions apply to preparations containing Ephedrine and Pseudoephedrine if they are compounded to present negligible risk of abuse, cannot have the substances readily extracted in an abusable form, contain other non-narcotic medical ingredients to prevent abuse enhancement, are devoid of narcotic or psychotropic substances under Schedule I, and are not injectable forms.

Such a preparation shall be deemed a dangerous drug.

No, preparations containing Ephedrine or Pseudoephedrine cannot be sold over-the-counter without a prescription from a licensed practitioner.

No, they shall not be advertised to the general public except in scientific journals.

Violations are grounds for administrative sanctions and may also lead to criminal prosecution if warranted.

The regulation took effect 15 days after its publication in two newspapers of general circulation and upon registration with the Office of the National Administrative Register (ONAR).

Signatories included representatives from the Integrated Bar of the Philippines, Departments of National Defense, Labor and Employment, Interior and Local Government, Social Welfare and Development, Health, Justice, and officials from the Philippine Drug Enforcement Agency and the Dangerous Drugs Board chairman.

No, such preparations cannot be distributed as physician’s samples.


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