Title
Exemption from pharmacist requirement for multiple licenses
Law
Bfad Memorandum Circular No. 15
Decision Date
Dec 6, 1990
Tomas P. Maramba Jr.'s memorandum circular allows drug establishments to apply for exemptions from the requirement of employing a pharmacist for each licensed activity, provided they meet specific conditions regarding the scope and volume of their operations.
A

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

  1. All licensed activities must be conducted by one single business entity (establishment).
  2. Pharmacist’s responsibilities are limited to office and warehouse activities only.
  3. All activities must be located under one roof or within the same premises.
  4. 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.
  5. 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.

Analyze Cases Smarter, Faster
Jur helps you analyze cases smarter to comprehend faster, building context before diving into full texts. AI-powered analysis, always verify critical details.