Purpose and regulatory coverage
- The circular provides a general classification of cough formulations by active ingredient category, prescription requirement, and the agency exercising jurisdiction over regulatory requirements.
- The classification links each active ingredient category to the corresponding prescription form and licensing framework, and to the agency responsible for compliance.
- The circular directs concerned entities to apply the classification to cough syrups by their active ingredients.
- The circular requires compliance monitoring based on the attached active ingredient category, prescription, and agency jurisdiction.
General classification framework
- The classification table lists Active Ingredient and assigns each to:
- an Active Ingredient Category,
- a Prescription requirement, and
- the Agency with Requirements Jurisdiction.
- The circular applies to cough formulations and regulates how they are classified and dispensed through the prescribed regulatory and prescription requirements.
- The circular treats dangerous drugs differently from non-dangerous drugs by prescribing different prescription categories and different agency jurisdiction.
Prohibited drugs and yellow prescription
- Hydrocodone or Dihydro-codeinone is categorized as Prohibited Drugs.
- Hydrocodone or Dihydro-codeinone requires a Yellow Prescription (DDB Form 1-72).
- Regulatory jurisdiction for Hydrocodone or Dihydro-codeinone rests with DDB.
- Hydrocodone or Dihydro-codeinone is governed by dangerous-drug compliance coverage including registration, record-keeping, production, distribution, retail, import and export by DDB.
Regulated drugs and yellow prescription
- Ephedrine & Pseudo-ephedrine is categorized as Regulated Drugs.
- Ephedrine & Pseudo-ephedrine requires a Yellow Prescription (DDB Form 1-72).
- Regulatory jurisdiction for Ephedrine & Pseudo-ephedrine rests with DDB.
- DDB is in charge of compliance regulatory requirements covering registration, record-keeping, production, distribution, retail, import and export of dangerous drugs.
Exempt preparations and ordinary prescription with S-2
- Codeine Exempt (BR No. 1, s. 1973) is categorized as Preparation.
- Codeine Exempt (BR No. 1, s. 1973) requires Ordinary Prescription with S-2 license.
- Regulatory jurisdiction for Codeine Exempt (BR No. 1, s. 1973) rests with DDB.
- Ephedrine & Pseudo-ephedrine in combination with other ingredients is categorized as Exempt Preparation.
- Ephedrine & Pseudo-ephedrine in combination with other ingredients requires Ordinary Prescription with S-2 license.
- Regulatory jurisdiction for Ephedrine & Pseudo-ephedrine in combination with other ingredients rests with DDB.
- DDB in charge of compliance regulatory requirements covers registration, record-keeping, production, distribution, retail, import and export for the dangerous-drug aspects identified in the classification.
Prescription and jurisdiction for BFAD-regulated drugs
- Dextrome-torphan (single component) is categorized as Prescription Drug.
- Dextrome-torphan (single component) requires an Ordinary Prescription.
- Regulatory jurisdiction for Dextrome-torphan (single component) rests with BFAD.
OTC categories with no prescription
- PhenyIpro-panotamine is categorized as OTC.
- PhenyIpro-panotamine requires NONE as its prescription requirement.
- Regulatory jurisdiction for PhenyIpro-panotamine rests with BFAD.
- Mucolytic and Expectorant is categorized as OTC.
- Mucolytic and Expectorant requires NONE as its prescription requirement.
- Regulatory jurisdiction for Mucolytic and Expectorant rests with BFAD.
- Antihistaminic is categorized as OTC.
- Antihistaminic requires NONE as its prescription requirement.
- Regulatory jurisdiction for Antihistaminic rests with BFAD.
Agency jurisdiction explained in the circular
- DDB exercises requirements jurisdiction for cough formulations involving dangerous drugs, including registration, record-keeping, production, distribution, retail, import and export.
- BFAD exercises requirements jurisdiction over registration, licensing, etc. focused on efficacy, purity and quality of both dangerous drugs and non-dangerous drugs.
- The classification system assigns the administering compliance function between DDB (dangerous-drug operational/regulatory compliance) and BFAD (registration/licensing and product quality controls) based on the active ingredient category and prescription requirement.
Cross-referenced classification note
- Codeine Exempt is linked to BR No. 1, s. 1973 for exemption treatment within the classification scheme.
- Ephedrine & Pseudo-ephedrine in combination with other ingredients is treated as an Exempt Preparation under the classification scheme when combined with other ingredients.
- The prescribed prescription and jurisdiction outcomes apply to the designated active ingredient entries in the classification table.