Classification of Active Ingredients
- Hydrocodone or Dihydro-codeinone: Classified as Prohibited Drugs.
- Ephedrine and Pseudo-ephedrine: Classified as Regulated Drugs.
- Codeine: Classified as Exempt Preparation under Board Regulation No. 1, s. 1973.
- Ephedrine and Pseudo-ephedrine in Combination: Classified also as Exempt Preparation.
- Dextromethorphan (single component): Classified as Prescription Drug.
- Phenylpropanolamine: Classified as Over-The-Counter (OTC) drug.
- Mucolytic and Expectorant: OTC.
- Antihistaminic: OTC.
Prescription and Licensing Requirements
- Prohibited and Regulated Drugs require Yellow Prescription (DDB Form 1-72).
- Exempt Preparations require ordinary prescriptions plus S-2 license.
- Prescription Drugs require ordinary prescription.
- OTC drugs do not require prescription.
Agency Jurisdiction and Regulatory Responsibilities
- Dangerous Drugs Board (DDB) oversees compliance for Prohibited and Regulated Drugs, including registration, record-keeping, production, distribution, retail, import, and export.
- Bureau of Food and Drugs (BFAD) oversees registration, licensing, testing for efficacy, purity, and quality for both dangerous and non-dangerous drugs.
Legal and Compliance Obligations
- Entities involved in manufacture, distribution, or dispensing of cough syrups must adhere to respective classification and prescription requirements.
- Regulatory agencies monitor compliance to ensure public safety and control of dangerous substances.
- Failure to comply with these requirements may lead to legal penalties under applicable laws governing dangerous drugs and pharmaceuticals.