Amendment on Phentermine Drug Regulations

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DDB BOARD REGULATION NO. 5-A: Amendment on Phentermine Drug Regulations

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Title Source: Supreme Court: Amendment on Phentermine Drug Regulations

Law: Ddb Board Regulation No. 5-a

Decision Date: Oct 19, 1983

The Dangerous Drugs Board regulation amends previous drug classifications by exempting certain preparations of Phentermine Resin and HCL from regulation, allowing them to be prescribed under specific conditions without the need for a special license.

Law Summary

Conditions for Phentermine Resin Preparations (Up to 30 mg)

Such preparations can be prescribed via ordinary prescription.
No requirement to indicate the S-2 license of the prescribing physician on the prescription.
Prescription must include the name and address of both the physician and the patient.

Conditions for Phentermine HCL Combination Preparations (Up to 15 mg)

These can also be prescribed by ordinary prescription.
Prescription must indicate the prescribing physician's S-2 license.
Prescription must include the name and address of the physician and the patient.

Registration Requirements

All exempt preparations must be registered with the Bureau of Food and Drugs.
Retailers selling exempt preparations that require the S-2 license on prescriptions must secure an S-1 license from the Dangerous Drugs Board if they do not already have an S-3 license.

Records-Keeping Requirements

For exempt preparations prescribed without the need to indicate the S-2 license:
- Sales must be recorded in the ordinary prescription book by retail drug establishments.
For exempt preparations prescribed with S-2 license indicated:
- Sales must be recorded in the additional opium book.

Inspection Provisions

Products classified as exempt preparations are subject to inspection by authorized officers:
- Bureau of Food and Drugs officers inspect for purposes within their jurisdiction.
- Dangerous Drugs Board officers inspect for their specific functions.

Limitations on Import and Export

The regulation imposes unspecified limitations on the import and export of the exempt preparations.
Importers and manufacturers must furnish reports as required.

Effectivity

The regulation becomes effective fifteen (15) days after its publication in a newspaper of general circulation.
The publication requirement mandates once-a-week publication for two consecutive weeks.

Authority and Adoption

The regulation was adopted on October 19, 1983.
Approved and signed by J.C. Azurin, Minister of Health and Chairman of the Dangerous Drugs Board.

END