QuestionsQuestions (DDB BOARD REG. NO. 9)
It is any solution or mixture, in whatever physical state, containing one or more dangerous drugs, or one or more dangerous drugs in dosage form.
When it consists of a measured, small quantity of dangerous drugs (or combination) in whatever form (tablet/pill/ampul/powder) ready for consumption or administration to a patient or animal, whether orally, parenterally, or through other routes.
A dangerous drug preparation compounded so it presents no or negligible risk of abuse, cannot be readily recovered in an abuse-quantity, does not create a public health/social problem, has high therapeutic value, wide use for legitimate purposes, and is needed medicine that should be easily available when medically required.
The process of combining a controlled drug with a non-controlled ingredient counteracting the abuse liability of the controlled drug present.
Among others: it contains only one internationally controlled regulated drug under Schedule III or IV within board-set quantitative limits; it is not a combination of a regulated drug with a prohibited drug; not a psychotropic-controlled drug combined with an uncontrolled drug with similar properties; does not contain any psychotropic substance in Schedule II; includes non-narcotic/non-psychotropic active ingredients in sufficient proportion to confer valuable medicinal properties other than the regulated drug alone and prevent abuse liability enhancement/synergism (or includes a counteracting non-psychotropic/non-narcotic material if it is a single psychotropic substance); is devoid of prohibited drugs under Schedule IV or other known-abuse-potential psychotropics; and is not in injectable form (unless it has high therapeutic usefulness as defined).
As a general rule, it must not be in injectable form. The last criterion does not apply when the preparation has “high therapeutic usefulness,” meaning it is very effective for the indicated use, safely administered by skilled professionals, and widely used in medicine.
The preparation shall be deemed a prohibited drug.
The Dangerous Drugs Board has jurisdiction and control over all exempt dangerous drug preparations except that registration of the product and determination of efficacy, purity and safety are within the functions of the Bureau of Food and Drugs under R.A. 3720, as amended.
They are not subject to: (1) compulsory use of DDB Form 1-72 or Yellow Prescription; and (2) recording in the Dangerous Drugs Record Book.
It shall be prescribed through an Ordinary Prescription, wherein the practitioner’s S-2 license shall be indicated.
They should be recorded in the Additional Dangerous Drugs Record Book.
The text includes a Section 5 “Prohibition Against Sample Distribution,” but the provided excerpt does not state the specific details. Students should identify that sample distribution is prohibited and confirm the exact prohibition language from the complete regulation text.
They may be advertised in scientific journals. They may not be advertised to the general public.
After notice and hearing, violators are penalized with the sanctions embodied in Section 36(1), Article VIII of R.A. No. 6425, as amended, without prejudice to criminal proceedings if warranted.
Yes. All regulations inconsistent herewith are repealed or modified accordingly.
After completion of its publication in the Official Gazette and in a newspaper of general circulation once a week for two consecutive weeks, whichever is earlier; it is indicated as effective November 28, 1989.