Classification of Exempted Benzodiazepine Preparations
- Pharmaceutical preparations containing specific benzodiazepine substances are classified as exempt preparations unless they are otherwise regulated.
- The substances include Alprazolam, Bromazepam, Camazepam, Chlordiazepoxide, Clobazam, Clonazepam, Clorazepate, and others listed with detailed chemical names.
- Exempted status is contingent on the benzodiazepine substance not being combined with another benzodiazepine, regulated drugs, prohibited drugs, or psychoactive drugs with known abuse potential.
Requirements for Exempted Benzodiazepine Preparations
Registration:
- Applications for registration and licensing must be filed with the Dangerous Drugs Board (DDB) or authorized representatives.
- All benzodiazepine preparations must also be registered with the Bureau of Food and Drugs (BFD).
Record-Keeping:
- Importers, manufacturers, producers, compounders, distributors, and retailers must maintain accurate records for all benzodiazepine preparations received and disposed.
- Records must be preserved for at least two years and be available for inspection by authorized DDB officers.
- Specific data must be recorded depending on the role (manufacturer, importer, retailer) including dates, quantities, recipient details, and prescription information.
- Hospitals and similar institutions must maintain additional detailed records for in-patient dispensing.
Reporting:
- Semi-annual and annual reports of transactions involving benzodiazepine preparations must be submitted to the DDB.
- Reports must detail stock levels, importations, local purchases, sales, usages, and disposal quantities.
Prescription and Dispensing:
- Prescriptions should contain only one benzodiazepine drug and should not exceed a week's supply (or specified limits for ampules except in hospitals).
- Prescriptions must be ordinary prescriptions with detailed information including date, physician’s credentials, patient details, drug description, and usage instructions.
Inspection:
- Authorized DDB officers may inspect premises, require production of records, and inspect stocks of benzodiazepine substances/preparations at any reasonable time.
Import/Export and Permits:
- Bulk importation or exportation requires a special permit issued by the DDB, following procedures under Board Regulation No. 3-A, s. 1983.
Samples and Advertising:
- Distribution of physician samples of benzodiazepine preparations is prohibited.
- Advertising of these preparations in any form is not allowed.
Warnings and Labeling:
- Packaging must include directions for use, hazard warnings (e.g., habit-forming potential), precautionary statements, first-aid instructions if necessary, and storage instructions including "Keep out of reach of children."
Classification of Other Benzodiazepine Substances
- Benzodiazepine substances not in pharmaceutical preparation form are classified as dangerous drugs and regulated as such.
Supersession and Effectivity
- This regulation supersedes Board Regulation No. 2-A, Series of 1985.
- The regulation took effect upon publication for two consecutive weeks in a newspaper of general circulation.
Penalties for Violations
- Non-compliance or violations are subject to penalties under Republic Act No. 3720, as amended, and Republic Act No. 6425, as amended.
This provides a clear and comprehensive legal framework for the regulation, handling, and control of benzodiazepine pharmaceutical preparations in the Philippines, balancing control measures with exemptions for certain preparations under specified conditions.