Policy basis and regulatory purpose
- BFAD bases the regulation on surveys by the National Drug Policy (NDP) Office and reports received by BFAD.
- BFAD finds that certain dextromethorphan cough syrup products have been abused.
- BFAD states that the abuse potential of dextromethorphan cough syrup preparations is under study.
- BFAD limits registration and allowance of dextromethorphan cough syrup to specified pack sizes to prevent abuse.
Covered products and packing-size limits
- BFAD registers and allows cough syrup preparations containing Dextromethorphan only in the packing/presentation sizes of 30 mL, 60 mL, and 120 mL.
- Cough syrup preparations containing dextromethorphan in commercial presentations larger than 120 mL are not registered and/or allowed.
- Cough syrup preparations in sizes more than 120 mL should not be found in any drug outlet.
- The packing-size restriction applies to manufacturers and traders producing dextromethorphan-containing cough syrup.
Prohibited market presence and retrieval period
- Manufacturers and traders producing dextromethorphan-containing cough syrup in packing larger than 120 mL must retrieve the same from the market.
- The retrieval must be completed within 45 days from the date of the circular.
- If retrieval is not completed within 45 days, the affected products become subject to confiscation.
- The circular treats products in presentations more than 120 mL as unauthorized for distribution through drug outlets.
Monitoring, enforcement, and reporting
- All Food and Drug Regulation Officers must closely monitor the dispensing of dextromethorphan subject products within their respective jurisdictions.
- Food and Drug Regulation Officers must report any indication or evidence of abuse.
- Monitoring and reporting are directed to support enforcement of the packing-size limitations.
Confiscation consequence for non-compliance
- Products of dextromethorphan-containing cough syrup in packing larger than 120 mL that are not retrieved within 45 days are subject to confiscation.
- The circular ties confiscation directly to failure to comply with the 45-day retrieval requirement.
- Confiscation functions as the consequence for continued market presence of unauthorized larger-pack presentations.