QuestionsQuestions (BFAD MEMORANDUM CIRCULAR NO. 7)
It provides the general classification of cough formulations by active ingredient category, the corresponding prescription requirements, and the agency (DDB or BFAD) exercising regulatory jurisdiction, and directs concerned parties to monitor and comply with these regulatory requirements.
They are classified as Prohibited Drugs.
They require a Yellow Prescription (DDB Form 1-72).
The DDB (Dangerous Drugs Board).
They are classified as Regulated Drugs.
They require a Yellow Prescription (DDB Form 1-72).
The DDB.
Codeine is indicated as an Exempt Preparation.
They require an Ordinary Prescription with an S-2 license.
The DDB.
They are classified as Exempt Preparation.
Ordinary Prescription with S-2 license.
The DDB.
It is classified as a Prescription Drug.
They require an Ordinary Prescription, with BFAD exercising jurisdiction.
It is classified as OTC with no prescription required (NONE).
BFAD.
It states that DDB is in charge of compliance regulatory requirements covering registration, record-keeping, production, distribution, retail, import and export of dangerous drugs.
It states that BFAD is in charge of registration and licensing, among others, regarding efficacy, purity and quality of both dangerous drugs and non-dangerous drugs.