Definitions of Dangerous Preparations
- A “Dangerous Drug Preparation” is any solution or mixture, in whatever physical state, containing one or more dangerous drugs or one or more dangerous drugs in dosage form.
- A dangerous drug preparation is in dosage form when it consists of a measured, small quantity of dangerous drugs or a combination of dangerous drugs in any form (including tablet or pill, ampul or powder) ready for consumption by, or administration to, a patient or animal, whether orally or parenterally or through other routes.
- An “Exempt Dangerous Drug Preparation” is compounded so that it presents no, or a negligible, risk of abuse, and the dangerous drug it contains cannot be recovered by readily applicable means in a quantity liable to abuse, such that it does not give rise to public health and social problem.
- An exempt dangerous drug preparation must also have high therapeutic value, be for wide use for legitimate purposes, and be a much needed medicine required to be easily available to the public in medical need.
- “Compounded” means the process of combining a controlled drug with a non-controlled ingredient that counteracts the abuse liability of the controlled drug present.
Exempt Regulated Dangerous Preparations
- An “Exempt Regulated Drug Preparation” is any dangerous drug preparation that meets all of the following requirements:
- It contains only one regulated drug internationally controlled under Schedule III or IV of the 1971 Convention on Psychotropic Substances, and does not exceed the quantitative limits determined by the Board.
- It is not a combination of a regulated drug with a prohibited drug.
- It is not a combination of an internationally controlled psychotropic drug with an unc ontrolled drug having similar psychotropic properties.
- It does not contain any psychotropic substance listed in Schedule II annexed to the 1971 Convention on Psychotropic Substances.
- It includes one or more non-narcotic or non-psychotropic active medicinal ingredients in a proportion sufficient to confer valuable medicinal properties other than those possessed by the regulated drug alone, and to prevent enhancement, potentiation, or synergism of the abuse liability of the regulated drug (or any of its salts) it contains.
- If it consists of a single psychotropic substance in dosage form, it is compounded with a counteracting non-psychotropic or non-narcotic material.
- It is devoid of any prohibited drug under Schedule IV of the 1961 Convention on Narcotic Drugs or another psychotropic drug not under domestic or international control but with known abuse potential.
- It is not in injectable form.
- The “injectable form” restriction does not apply when the preparation has high therapeutic usefulness.
- A preparation in injectable form is deemed to have high therapeutic usefulness if it is:
- very effective for the indicated use,
- safely administered by skilled professionals, and
- widely used in medicine.
Jurisdiction and Regulatory Control Boundaries
- The Dangerous Drugs Board has jurisdiction and control over all exempt dangerous drug preparations.
- Registration and the determination of efficacy, purity, and safety of the product fall within the functions of the Bureau of Food and Drugs under Republic Act No. 3720, as amended.
Control Measures Not Required
- Exempt regulated preparations are not subject to the following control measures:
- Compulsory use of DDB Form 1-72 or Yellow Prescription.
- The preparation shall be prescribed through an Ordinary Prescription, and the practitioner’s S-2 license shall be indicated.
- Recording in the Dangerous Drugs Record Book.
- The preparation should be recorded in the Additional Dangerous Drugs Record Book.
- Compulsory use of DDB Form 1-72 or Yellow Prescription.
Legal Effect of Prohibited Drug Compounding
- When an exempt regulated preparation is compounded with a prohibited drug, the compounded preparation is deemed to be a prohibited drug.
Advertising Rules for Exempt Dangerous Preparations
- Exempt dangerous drug preparations may be advertised in scientific journals.
- Such preparations shall not be advertised to the general public.
Prohibition on Sample Distribution
- The regulation contains a prohibition against sample distribution of the covered preparations.
Sanctions and Enforcement
- Any individual or entity found, after notice and hearing, guilty of violating the regulation is penalized with the sanctions embodied in Section 36(1), Article VIII of Republic Act No. 6425, as amended.
- The imposition of these sanctions is without prejudice to the institution of criminal proceedings if the circumstances so warrant.
Repeal of Inconsistent Regulations
- All regulations inconsistent with DDB Board Reg. No. 9 are repealed or modified accordingly.