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(NAR) VOL. 2 NO. 1/JANUARY-MARCH 1991
[ BFAD MEMORANDUM CIRCULAR NO. 7, May 23, 1990 ]
CLASSIFICATION OF COUGH SYRUPS
Attached herewith is the general classification of cough formulation indicating their respective active ingredients category, prescription requirements and the agency exercising jurisdiction in relation with their regulatory requirement. All concerned are enjoined to observe and monitor compliance of the regulatory requirements with these pieces of information in view.
[*] DDB in charge of compliance regulatory requirements covering registration, record-keeping, production, distribution, retail, import and export of dangerous drugs.
Adopted: 23 May 1990
(SGD.) CECILE P. GONZALEZDirector
GENERAL CLASSIFICATION OF COUGH FORMULATION Active Ingredient Category Prescription Agency with Requirements Jurisdiction HYDROCODONE OR DIHYDRO-CODEINONE Prohibited Drugs Yellow Prescription (DDB Form 1-72) DDB* EPHEDRINE & PSEUDO-EPHEDRINE Regulated Drugs Yellow Prescription (DDB Form 1-72) DDB CODEINE Exempt (BR No. 1, s. 1973) Preparation Ordinary Prescription with S-2 license DDB EPHEDRINE & PSEUDO-EPHEDRINE IN COMBINATION WITH OTHER INGREDIENTS Exempt Preparation Ordinary Prescription with S-2 license DDB DEXTROME-TORPHAN (Single Component) Prescription Drug Ordinary Prescription BFAD** PHENYLPRO-PANOLAMINE OTC NONE BFAD MUCOLYTIC AND EXPECTORANT OTC NONE BFAD ANTIHISTAMINIC OTC NONE BFAD
[*] DDB in charge of compliance regulatory requirements covering registration, record-keeping, production, distribution, retail, import and export of dangerous drugs.
[**] BFAD in charge of registration, licensing, etc. as to efficacy, purity and quality of both dangerous drugs and non-dangerous drugs.