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Whereas, Section 5.2, Chapter 1 of A.O. No. 56, s. 1989 provides that:

"If a drug establishment engages in activities belonging to more than one of the (classified) categories, applicant must apply for LTO for each of the category and pay the corresponding fees."

Whereas, the general requirements for the issuance of License to Operate include, among others, "a valid Certificate of Registration of the establishment’s Filipino pharmacist issued by the Professional Regulation Commission (PRC)" necessitating the employment of a validly registered pharmacist for each application for a license to operate;

Whereas, there are applications for exemption from the foregoing requirement and circumstances that may warrant exemptions;

Wherefore, the following guidelines and procedures are issued to govern applications for exemptions from the requirement of one pharmacist for each licensed activity to wit:

1. Exemption may be granted under the following conditions:

   1.1  The activities sought to be licensed belong to one establishment only; (establishment herein shall refer to a single business entity which may engage in more than one licensed business activity)

   1.2  The activities to be handled by the pharmacist are confined only in the office and warehouse;

   1.3  The activities may be accomplished under one roof or within the same premises;

   1.4  The maximum number of drug and non-drug products should not exceed thirty (30) whenever one of the licenses is as a trader; or fifty (50) products if the licensed activities are as a distributor, importer, or exporter; and provided further that the volume of transactions can be adequately handled by one (1) pharmacist.

   1.5  A regional/provincial branch may be allowed to employ only one (1) pharmacist provided its activities are limited to distribution and/or wholesaling.

2. An applicant who intends to avail of this exemption shall apply at the Regulation Division concerned of this Office and shall submit in an affidavit form the activities and the circumstances under which the exemption is being applied for.
3. Such exemption is conditional in that when the number of products or volume of transaction increases, the exemption may be withdrawn.
4. This exemption shall be applied for and pertinent information and affidavit submitted each time the LTO’s concerned are renewed.
5. This circular does not cover the requirement for a pharmacist for a drug manufacturer due to the nature of its activities.

For the information and guidance of all concerned.

Adopted: 6 Dec. 1990

(SGD.) TOMAS P. MARAMBA, JR.

Undersecretary of Health For Standards and Regulation