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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.

Adopted: 23 May 1990

(SGD.) CECILE P. GONZALEZ

Director

 

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.

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