QuestionsQuestions (MEMORANDUM CIRCULAR NO. 2 s. 1993)
BFAD limits the registration and allowance of cough syrup preparations containing dextromethorphan to specific commercial pack sizes: 30 mL, 60 mL, and 120 mL, as a measure to prevent abuse.
Only 30 mL, 60 mL, and 120 mL packing/presentation are allowed for registration and permitting.
Such products are not registered and/or not allowed; therefore, they should not be found in any drug outlet.
They are given 45 days to retrieve the products from the market; otherwise, the products will be subject to confiscation.
It is counted from the date of the circular (February 09, 1993). Manufacturers and traders must retrieve dextromethorphan cough syrup products packaged larger than 120 mL from the market.
The National Drug Policy (NDP) Office conducted surveys, and the Bureau of Food and Drugs (BFAD) received reports.
Surveys and reports showed that certain cough syrup products containing dextromethorphan have been abused.
No. It states that the abuse potential is under study, but it still imposes pack size limits as a preventive measure.
They must closely monitor the dispensing of the subject products in their jurisdictions and report indications or evidence of abuse.
Since products in more than 120 mL presentations are not registered and/or allowed, their presence in drug outlets indicates noncompliance and potential enforcement action.
Manufacturers and traders are addressed. They must retrieve from the market the dextromethorphan-containing cough syrup packaged larger than 120 mL within 45 days.
By restricting permissible commercial presentations to only 30 mL, 60 mL, and 120 mL, and prohibiting larger pack sizes from being registered/allowed and from being present in drug outlets.
Confiscation of the said products.
BFAD registers and allows cough syrup preparations containing dextromethorphan only in the specified pack sizes; presentations outside those sizes are not registered and/or allowed.