Wianne Mae P.

Balatongle BSPh4C Assignment in Jurisprudence November 21, 2017

Examples of Drug with Limitations

DRUGOXIDE is indicated for the initial treatment of adult women with painful symptoms of endometriosis.

Limitations of Use: The use of DRUGOXIDE over 6 months is not recommended because of the concerns about its adverse
impact on bone mineral density

Months that after the expiry that a drug is still effective

Based on stability data, expiration dates on 88 percent of the lots were extended beyond their original expiration date for an
average of 66 months. Of these 2652 lots, only 18 percent were terminated due to failure. Examples of common drug products
that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. Drug
expiration extension dates on these products ranged from 12 to 184 months.
- https://www.drugs.com/article/drug-expiration-dates.html

How to Put-up a Drugstore Business in the Philippines

1. Location
2. You must have a REGISTERED PHARMACIST
3. Secure Certificate of Business Name Registration (DTI, SEC or CDA), Business Permits and must be registered to
Bureau of Internal Revenue (BIR) for taxes, and Franchise Agreement if franchised.
4. Food and Drug Administration's (FDA) approval granting the License to Operate as a Drugstore.
REQUIREMENTS:

Drugstore's floor plan should not be less than 15 square meters, and must have sink with faucet and comfort room which
is optional. Signage and signboard, containing the name of your drugstore, should be readable up to 20 meters. Floor must be
tiled or concrete but not raw soil.
Pharmacist should photocopy his/her PRC ID, Board Certificate, PTR, 2x2 picture (for application), and including the
certificate of Attendance for Licensing a Drugstore or AO 56 which a seminar conducted by FDA in different places and
schedules. Original copy should be brought for verification when the FDA inspection is being made.
Availability of Reference Materials, which are latest edition, and Law abiding
Other requirements:
1. Record books like Prescription Book, Senior Citizen's book, Disabled book.
2. Menu Card (Generics, MDRP, GMAP)
3. Tablet counter, Graduated Cylinder
4. Generic Dispensing Flow Chart
5. Temperature monitoring facility and Air conditioning appliance (optional, provided that temperature
does not exceed 30 C
6. Rubber stamp of the drugstore

APPLICATION TO FDA

Upon completing the checklist (downloadable in FDA's website) of requirements for drugstore, you are ready to apply your
drugstore for FDA license. The arrangement follows like this with paper bond before each document:

Basic Checklist on How to open a drugstore in Philippines

1. Petition Form (notarized)

2. Joint Affidavit of Undertaking (notarized)
3. Tentative list of Products using Generic and Brand names
Wianne Mae P. Balatongle BSPh4C Assignment in Jurisprudence November 21, 2017

4. Generic White Label and Red Lable

5. Rubber Stamp of Outlets
6. Picture of drugstore with Signboard
7. *Copies of Pharmacist Board Certificate, PRC ID, valid PTR, 1 (2x2) ID Picture, Duties and Responsibilities of the
pharmacist and Certificate of Attendance of Owner/Pharmacist to a FDA sponsored/accredited Seminar on Licensing of
Drug Establishments and Outlets.
8. *DTI Registration (for Single Proprietorship), or SEC (for Corporation or Partnership), or CDA (for Cooperative)
9. *Contract of Lease for the space occupied if not owned, or any proof of ownership if owned or notarized
Certificate of Occupancy
10. Sketch of Location (Should be 15 sq meter at least)
11. Sketch of Floor Plan
* Bring Original Copies for verification

EVALUATION AND INSPECTION PROPER

Differences of 5921 and 10918

Republic Act No. 5921 Republic Act No. 10918

Title Pharmacy Law Philippine Pharmacy Act
Pharmacist Categories A and B were identified
requirement
Penal provisions Fine of 1000 to 4000 pesos; Fine of 250.000.00 to 500.000.00;
Imprisonment of 6 mos and 1 day to 4 years Imprisonment of 1 year and 1 day to 6 years