ACTIVITY REGISTRATION REQUIREMENTS OF A PHARMACY

2 WORKSHEET (INDIVIDUAL)

Name: Hirschmann Andro B. Boquila

1. Define or describe the following terms related to the licensing of drugstores:

Terms Definition
General Risk Management Plan must be submitted. This contains
details on how to identify, characterize, prevent or minimize risk
Risk Management Plan relating to the products they engage with. These shall include
pharmacovigilance activities and interventions of the establishment
to manage risks (FDA Circular No. 2014-025, 2014).
A sketch of the location of the establishment must be submitted
which shall be used for inspection purposes. This sketch must
Location Plan
indicate clear directions with identified landmarks to locate the
establishment (FDA Circular No. 2014-025, 2014).
Refer to changes in the drug establishment operations that may
affect significantly and/or directly the aspects of safety. efficacy, and
quality of drug products they are engaged in, and those changes
Major Variation affecting significant particulars of the issued LTO (Administrative
Order No. 2014-0034, 2014). These may be a/an (a) change of
ownership, (b) additional production line, (c) transfer of location, (d)
change of activity (FDA Circular No. 2014-025, 2014).
Refers to changes in administrative documents and/or changes in
the drug establishment operations with minimal impact on the
aspects of safety, efficacy, and quality of drug products they are
Minor Variation engaged in (Administrative Order No. 2014-0034, 2014). These
may be a/an (a) expansion of establishment, (b) change of business
name, (c) zonal change in address (FDA Circular No. 2014-025
2014).
Pharmaceutical establishments/outlets where the direct and
Category A
immediate control and supervision pf a duly registered and licensed
Pharmaceutical
pharmacist is required, per establishment, whether in-store or
Establishments
online (Republic Act 10918, 2016).
Category B Pharmaceutical establishments/outlets where the supervision and
Pharmaceutical oversight of a duly registered and licensed pharmacist is required
Establishment under pertinent provisions of law (Republic Act 10918, 2016).
2. List down the documentary requirements that must be submitted by the drugstore for their Initial LTO
Application.
1. Application Form 5. Location Plan
2. Proof of Business Name Registration 6. Site Master File
3. Credentials of Pharmacist 7. Proof of Payment
4. Risk Management Plan 8. Self-Assessment Toolkit

(FDA Circular No. 2014-025, 2014).

3. Choose two documentary requirements from Q#2. Explain/rationalize the importance of requiring
these documents in applying for an LTO and its importance in the community pharmacy practice.
a. Selected documentary requirement:

Credentials of Pharmacist

(FDA Circular No. 2014-025, 2014).

Explanation (maximum of 4 sentences):

It is important to submit this document because a drug establishment needs to have a registered and
licensed pharmacist to operate. In community pharmacy, the pharmacist is the all-rounder personnel
which manages the administrative, sales, counseling, promotion, and all other aspects in the
pharmacy. The pharmacist is the most knowledgeable and trained personnel when it comes to drugs
and the pharmacy would not function properly without the pharmacist. Requiring this document helps
in the function of the pharmacy and the safety of the customers.

b. Selected documentary requirement:

Risk Management Plan

(FDA Circular No. 2014-025, 2014).

Explanation (maximum of 4 sentences):

It is important to have a risk management plan to mitigate the risks in handling and dispensing drugs.
It is important that before an establishment can operate, the risks are already well-thought and the
management knows already on how to handle different scenarios that could compromise the health
and safety of the patient.
4. List down the documents verified by the Philippine FDA during post-licensing inspection. Then,
explain the relevance of conducting a post-licensing inspection in the community pharmacy practice.
Documents:

In addition to the requirements of the initial application, these are the documents:
1. Agreement between franchisor and franchisee
2. Records/E-files of prescription books, senior citizens and persons with disability record book,
distribution record, etc.
3. Standard Operating Procedures
4. Display of Information, Education, and Communication materials
5. Relevant Reference Materials (e.g. Repuplic Acts, WHO GDP and GSP Guide, Philippine National
Drug Formulary, Standard Practice Guidelines, Pharmacovigilance-related references)

(FDA Circular No. 2014-025, 2014).

Explanation (maximum of 4 sentences):

It is important to have post-licensing inspection in the pharmacy in order to check if the drug
establishments comply to the standards and protocols in the practice which ensures the safety of the
patients. Inspection helps in keeping the pharmacy to be updated and remind the personnel of the
standard practices. Whenever there are breaches to the protocols, inspection will help in reporting
these and keep the people responsible in-check.

5. List down the documentary requirements to be submitted to the Philippine FDA during LTO renewal.
Then rationalize the relevance of renewal of LTOs and setting validity for a certain period only.
Documents:
1. Application Form
2. Copy of Certifications issued as a result of LTO Variation
3. Proof of Payment
4. Self-Assessment Toolkit

(FDA Circular No. 2014-025, 2014).

Explanation (maximum of 4 sentences):
The renewal of LTO helps keep the drug establishment to continue in meeting the regulatory
requirements by government agencies and makes sure that these requirements are updated from
time to time. Having the validity period ensures that drugstores operate within the legal framework
and maintain necessary licenses and the penalties will be resolved. It also helps in the continuous
improvement in the operations and development of the drugstore and the personnel.
 6. Aside from the Philippine FDA, list down other agencies that may be involved in the licensing of
drugstores.
1. Department of Health (DOH) 5. Securities and Exchange Commission (SEC)
2. Professional Regulation Commission (PRC) 6. Bureau of Customs (BOC)
3. Department of Trade and Industry (DTI) 7. Local Government Units (LGU)
4. Board of Pharmacy

(FDA Circular No. 2014-025, 2014; Republic Act No. 10918)

7. Based on your knowledge and lectures, identify at least 3 gaps and issues relevant to licensing
drugstores. Then, briefly explain the impact of each gap and/or issue in the community pharmacy
practice (maximum of 9 sentences).
One gap I have identified in licensing drugstores is that due to the gap in the timeframe of renewal
and inspection, drugstores can operate without a pharmacist similar to the branch of my internship.
The drugstore operated without a pharmacist for almost a month and this can risk the safety of the
patients. Another gap I have found is that the inspection is not particular with the amount of
prescription dispensed and the recorded number in the prescription handbook. The establishment
can dispense without a prescription and they can still renew their license without proper recording of
prescription. Selling of antibiotics without a prescription can cause antimicrobial resistance. The
maintenance medications can also have no beneficial on the patient because it is not updated
anymore. Lastly, although there are risk management plans, there is no provision on the recording of
the problems encountered in the establishment. The risk management plan must be updated for
every renewal as to prevent the escalation of the risks in the practice.

References
Administrative Order No. 2014-0034 (2014). Rules and Regulations on the Licensing of
Establishments Engaged in the Manufacture, Conduct of Clinical Trial, Distribution, Importation,
Exportation, and Retailing of Drug Products, and Issuance of Other Related Authorizations.
Retrieved from https://www.fda.gov.ph/wp-content/uploads/2021/08/Administrative-Order-No.-2014-
0034.pdf

FDA Circular No. 2014-025 (2014). Guidelines on the Implementation of New Rules and Regulations
on the Licensing of Drugstore/Pharmacy/Botica and Similar Outlets following Administrative Order
No. 2014-0034, dated 13 October 2014. Retrieved from https://www.fda.gov.ph/wp-
content/uploads/2021/03/FDA-Circular-No.-2014-025.pdf

Republic Act No. 10918 (2016). Philippine Pharmacy Act. Retrieved from
https://www.officialgazette.gov.ph/downloads/2016/07jul/20160721-RA-10918-BSA.pdf