Question & AnswerQ&A (DDB BOARD REGULATION NO. 5-A)
The main purpose is to amend Board Regulation No. 1-A, series of 1983 by removing certain preparations containing limited quantities of Phentermine Resin or Phentermine HCL from the list of regulated drugs and placing them under the category of exempt preparations subject to certain conditions.
Preparations containing not more than 30 mg of Phentermine Resin are removed from the list of regulated drugs.
These preparations may be prescribed through an ordinary prescription without indicating the S-2 license of the prescribing physician. However, the prescription must indicate the name and address of the physician and the patient.
Combination preparations containing not more than 15 mg of Phentermine HCL are removed from the list of regulated drugs and categorized as exempt preparations.
The ordinary prescription for exempt preparations containing Phentermine HCL must indicate the S-2 license of the prescribing physician, as well as the name and address of both the physician and the patient.
All products must be registered with the Bureau of Food and Drugs.
Retailers must secure an S-1 license from the Dangerous Drugs Board if they do not already possess an S-3 license.
Sales must be recorded in the ordinary prescription book of the retail drug establishment.
Sales must be recorded in the additional opium book of the retail drug establishment.
They are subject to inspection by authorized officers of both the Bureau of Food and Drugs and the Dangerous Drugs Board as regards their respective functions.
Yes, the regulation includes limitations on the import and export of these exempt preparations.
Importers and manufacturers must furnish reports as required by the regulation.
The regulation took effect fifteen (15) days after its publication in a newspaper of general circulation once a week for two consecutive weeks.