Regulation of dextromethorphan cough syrup size

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MEMORANDUM CIRCULAR NO. 2 s. 1993: Regulation of dextromethorphan cough syrup size

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Title Supreme Court: Regulation of dextromethorphan cough syrup size

Law: Memorandum Circular No. 2 S. 1993

Decision Date: Feb 9, 1993

To combat the abuse of dextromethorphan-containing cough syrups, the Bureau of Food and Drugs mandates that only 30 mL, 60 mL, and 120 mL packaging is permitted, requiring manufacturers to withdraw larger sizes within 45 days or face confiscation.

dextromethorphan

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Regulation of Packaging Sizes

BFAD permits registration and sale only of cough syrup preparations containing Dextromethorphan in packaging sizes of 30 mL, 60 mL, and 120 mL.
Cough syrup preparations with packaging larger than 120 mL are not registered nor allowed.
Such larger pack sizes should not be available in any drug outlet.

Compliance and Enforcement Measures

Manufacturers and traders producing or distributing dextromethorphan cough syrup in pack sizes larger than 120 mL are given a 45-day period from the issuance date to withdraw these products from the market.
Failure to comply will lead to confiscation of the said products.

Role of Food and Drug Regulation Officers

Officers are directed to closely monitor the dispensing of dextromethorphan-containing cough syrups within their jurisdiction.
They must report any evidence or indications of abuse associated with these products.

Purpose and Authority

The regulation aims to prevent abuse of dextromethorphan-containing cough syrups while allowing controlled legitimate use.
Issued by the Director of BFAD with the authority to enforce the regulations effectively.

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