Question & AnswerQ&A (DDB BOARD REGULATION NO. 1)
Preparation means (i) any solution or mixture, in whatever physical state, containing benzodiazepine substances; and (ii) any benzodiazepine substances in dosage form.
Pharmaceutical preparations containing any quantity of specified benzodiazepine substances such as Alprazolam, Diazepam, Lorazepam, Clonazepam, and several others listed in Section 2 are classified as exempt preparations, provided they are not in association with another benzodiazepine substance, regulated drug, prohibited drug, or psychoactive drug with known abuse potential.
Applications for registration and issuance of licenses to deal in dangerous drugs and exempt preparations must be filed with the Dangerous Drugs Board or with its authorized representatives outside Metro Manila, and the pharmaceutical preparations must also be registered with the Bureau of Food and Drugs.
Establishments such as importers, manufacturers, producers, compounders, distributors, and retailers must maintain true and accurate records of receipt and disposal of benzodiazepine drug preparations for at least two years. The records must include detailed information such as dates, quantities, names, addresses, import permits, and prescription details where applicable.
They must render semi-annual and annual reports of transactions on or before the tenth day of the month following the reporting period to the Dangerous Drugs Board, showing data such as name of the preparation, package size, dosage form, stocks on hand, amounts imported, locally purchased, sold, used, disposed, and balance on hand.
Only one drug per prescription is allowed. The quantity prescribed should not exceed a week's supply or 3 ampules x 2 ml or 1 ampule x 10 ml per prescription for ampules, except for hospital use. The prescription must be an ordinary prescription containing specific information including date, prescriber details with privilege tax receipt and narcotic license numbers, patient details, drug quantity in words, directions for use, and the word "non-repetition".
The Executive Director, Chief of CRID, and DROs deputized by the Chairman of the Board may enter and inspect premises, require production of registers, records, and prescriptions, and inspect stocks of benzodiazepine substances/preparations at any reasonable time.
Yes, all bulk importations or exportations of any benzodiazepine drug preparations require a Special Permit pursuant to the Dangerous Drugs Board regulation, specifically under Board Regulation No. 3-A, s. 1983.
No, advertising of benzodiazepine drug preparations in any form is not allowed.
Packaging must include directions for use, a clear statement of principal hazards such as "Warning: may be habit forming," precautionary measures, instructions for first-aid treatment when necessary, handling or storage instructions, and the statement "Keep out of reach of children" or its equivalent.
Violations are subject to provisions under RA 3720, as amended, and RA 6425, as amended, which include penalties related to improper handling and dealing in dangerous drugs.
Benzodiazepine substances other than in preparation form are classified as dangerous drugs and further categorized as regulated drugs under this regulation.