Question & AnswerQ&A (BFAD MEMORANDUM CIRCULAR NO. 7)
Hydrocodone or dihydro-codeinone is classified as a Prohibited Drug requiring a Yellow Prescription (DDB Form 1-72) under the jurisdiction of the Dangerous Drugs Board (DDB).
The Dangerous Drugs Board (DDB) exercises jurisdiction over regulated drugs containing ephedrine and pseudo-ephedrine, which require a Yellow Prescription (DDB Form 1-72).
Cough syrups containing codeine are considered exempt preparations under BR No. 1, s. 1973, but require an ordinary prescription with an S-2 license and are under the jurisdiction of the Dangerous Drugs Board (DDB).
Preparations containing ephedrine and pseudo-ephedrine combined with other ingredients are exempt preparations requiring an ordinary prescription with an S-2 license, regulated by the Dangerous Drugs Board (DDB).
The Bureau of Food and Drugs (BFAD) regulates cough syrups containing dextromethorphan as a single component, which are classified as prescription drugs requiring an ordinary prescription.
Phenylpropanolamine-containing cough syrups are classified as Over-the-Counter (OTC) drugs that require no prescription and fall under BFAD jurisdiction.
No, mucolytic and expectorant cough syrups are classified as Over-the-Counter (OTC) drugs and require no prescription under BFAD jurisdiction.
The Dangerous Drugs Board (DDB) is responsible for monitoring compliance and regulatory requirements involving registration, record-keeping, production, distribution, retail, import, and export of dangerous drugs.
BFAD is responsible for the registration, licensing, and ensuring efficacy, purity, and quality of both dangerous and non-dangerous drugs, including prescription and OTC cough syrups.
Ordinary prescription drugs under BFAD jurisdiction require regular or standard medical prescriptions without the need for special forms like the Yellow Prescription (DDB Form 1-72).