BFAD Memorandum Circular No. 7 (1990)

(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. Adopted: 23 May 1990

(SGD.) CECILE P. GONZALEZ Director GENERAL CLASSIFICATION OF COUGH FORMULATION Agency with Requirements Active Ingredient Category Prescription Jurisdiction HYDROCODONE Yellow OR DIHYDRO- Prescription CODEINONE Prohibited (DDB Drugs Form 1-72) DDB* EPHEDRINE & Yellow PSEUDO- Prescription EPHEDRINE Regulated (DDB Drugs Form 1-72) DDB CODEINE Exempt Ordinary (BR No. 1, s. 1973) Prescription with S-2 Preparation license DDB EPHEDRINE & PSEUDO- EPHEDRINE IN Ordinary COMBINATION Prescription WITH OTHER Exempt with S-2 INGREDIENTS Preparation license DDB DEXTROME- TORPHAN (Single Prescription Ordinary Component) Drug Prescription BFAD** PHENYLPRO- PANOLAMINE OTC NONE BFADMUCOLYTIC 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.