Question & AnswerQ&A (BFAD MEMORANDUM CIRCULAR NO. 15)
Section 5.2, Chapter 1 of Administrative Order No. 56, s. 1989 requires applicants applying for licenses for multiple drug establishment activities to secure a License to Operate (LTO) for each category and employ a registered pharmacist for each application.
An exemption may be granted if the activities belong to one establishment, handled by one pharmacist confined to office and warehouse activities, conducted under one roof or premises, with product limits of 30 for traders or 50 for distributors, importers, or exporters, and the transaction volume is manageable by one pharmacist.
'Establishment' refers to a single business entity that may engage in more than one licensed business activity under the same management.
Yes, a regional or provincial branch may employ only one pharmacist provided their activities are limited to distribution and/or wholesaling.
The applicant must submit an affidavit detailing the activities and circumstances under which the exemption is being applied for, to the Regulation Division of the Office concerned.
No, the exemption is conditional and may be withdrawn if the number of products or volume of transactions increases beyond the set limits.
No, this circular explicitly does not cover the requirement for a pharmacist in drug manufacturing due to the nature of such activities.
The applicant must apply for the exemption again and submit the pertinent affidavit and information each time the LTO is renewed.
The requirement ensures that each licensed activity is supervised by a validly registered pharmacist to maintain compliance with regulatory standards and ensure proper handling and safety of drug products.