Purpose of the Circular
- Establishes guidelines and procedures for exemptions from the one-pharmacist-per-licensed-activity requirement.
- Recognizes cases where strict compliance may be impractical and sets conditions under which exemptions may be granted.
Conditions for Granting Exemptions
- All licensed activities must be conducted by one single business entity (establishment).
- Pharmacist’s responsibilities are limited to office and warehouse activities only.
- All activities must be located under one roof or within the same premises.
- Product volume limits:
- Trader license: not more than 30 drug and non-drug products.
- Distributor, importer, or exporter license: not more than 50 products.
- Volume of transactions must be manageable by one pharmacist.
- Regional or provincial branches may employ only one pharmacist if activities are limited to distribution and/or wholesaling.
Application Procedures for Exemption
- Applicants must apply at the appropriate Regulation Division.
- Must submit an affidavit detailing the activities and circumstances warranting the exemption.
- Exemptions are conditional and may be revoked if product number or transaction volume increases.
- Exemptions must be applied for and information re-submitted at each renewal of the respective LTO.
Scope and Limitations
- The circular does not exempt drug manufacturers from the pharmacist requirement, due to the complexity and nature of manufacturing activities.
Legal Effect and Guidance
- The circular serves as a regulatory guideline to balance operational practicality with safety and compliance.
- It is binding for all concerned drug establishments seeking exemption from the one-pharmacist requirement.
Authority and Adoption
- Issued by the Undersecretary of Health for Standards and Regulation on December 6, 1990.