Transcript Food and Drug Administration CHD-NM Cagayan - rho

Seminar on A.O. # 56 s. 1989
April 29, 2014 – Cagayan de Oro City
April 30, 2014 – Misamis Oriental and Camiguin
CLASSIFICATION OF DRUG ESTABLISHMENTS
Drug Manufacturer shall refer to any establishment
engaged in any and all operations involved in the
production of pharmaceutical products including
preparatory processing, compounding, formulating,
filling, packaging, repackaging, altering, ornamenting,
finishing and labeling with the end in view of its storage,
sale or distribution; provided, that the term shall not
apply to the compounding and filling of prescriptions in
drugstores and hospital pharmacies.
Sub-classification of Drug Manufacturer
Drug Manufacturer-Repacker - – refers to any
establishment that repacks a finished drug product into
smaller quantities in a separate container and/or into
secondary packaging, including but not limited to
relabeling, stickering, & bundling for promo packs with
the end view of storage, distribution, or sale of the
product. Provided, it shall not cover repacking of drugs
at the time of purchase for purposes of dispensing.
Sub-classification of Drug Manufacturer
Drug Manufacturer-Packer - refers to any establishment
that packages a bulk drug product into its immediate
container with the end view of storage, distribution, or sale
of the product
Drug Manufacturer-Trader – refers to any establishment
which is a registered owner of a pharmaceutical product
and the formulation and procures the raw materials and
packing components, and provides the production
monographs, quality control standards and procedures, but
subcontracts the manufacture of such product to a licensed
manufacturer.
In addition, a trader may also engage in the
distribution and or marketing of its products. A trader
shall be categorized as a manufacturer.

Drug Distributor-Exporter refers to any
establishment that exports raw materials, active
ingredients and finished products for distribution to
other drug establishments outside the country.
Drug Distributor-Importer refers to any
establishment that imports raw materials, active
ingredients and/or finished products for wholesale
distribution to other local FDA- licensed drug
establishment.
Drug Distributor-Wholesaler refers to any
establishment that procures raw materials, active
ingredients and/or finished products from a local FDA
licensed drug establishment for local distribution on
wholesale basis.
Drugstore/Pharmacy/Botica, including
hospital pharmacy and institutional pharmacy
shall refer to drug establishment where registered
drugs, chemical products, specialty pharmaceutical
and dental, medicinal and household remedies are
dispensed directly to the general public on a retail
basis.
Botika ng Barangay and its variants that sell
prescription product shall be reclassified and required
to secure LTO as a drugstore.
Retail Outlet for Non-Prescription Drugs shall refer to
drug establishments such as supermarkets, convenient
stores and other similar retail establishments licensed to
sell registered non-prescription or Over-the-Counter
(OTC) drugs which are sold in their individual original and
primary packaging and are dispensed directly to the
general public on a retail basis.
Botika ng Barangay and its variants that sell non-prescription
or OTC product only shall be reclassified and required to
secure LTO as a RONPD.
REQUIREMENTS FOR SECURING A LICENSE TO OPERATE
Any qualified natural or juridical person desiring to
engage or operate in the manufacture, packing,
repacking, importation, exportation, sale, offer for
sale, distribution or transfer of pharmaceutical
products shall comply with the requirements that FDA
is authorized to promulgate through the appropriate
issuance including amendments thereto.
GENERAL REQUIREMENTS ( Opening or Initial)
1.Notarized Petition form
2.Notarized Joint Affidavit of Undertaking
3.Proof of Registration as an Establishment
4.Franchise Agreement ( If applicable)
5.Pharmacist’s credentials
2- (2x2) d picture
Board Certificate
Valid PRC ID
Current PTR
Duties and Responsibilities
Seminar Certificate (AO 56 and FDA
-Updates)
6.Contract of Lease/ Proof of ownership/Certification of
Occupancy
7. Vicinity Map with Landmark/
Location Map
8. Floor Plan with Dimension in meters( not less than 15
sq. meters)
9. Tentative List of products
10. Any one of the following:
United state Pharmacopoeia/ National Drug
Formulary ( USP/NF)
Remington’s Pharmaceutical Science
Goodman and Gilman’s The Pharmacological
Basis of Therapeutics.
11. Reference Materials:
Philippine National Drug Formulary (PNDF)
latest edition
R.A. 3720R.A, 5921
R.A. 6675
R.A. 8203
R.A. 9502
E.O. # 821 MDRP and
ACPR#2009-001 GMAP
12. Prescription Book
13.Senior Citizen’s Record Book
14.Generics Menu Cards
15.MDRP/GMAP posters
16. Drugstore Seal
17. Generics White Label, Partial Filling, Red Label
18. Pictures of Drugstore with permanent Signboard
RENEWAL OF LICENSE TO OPERATE (LTO)
Application for regular renewal of license may be filed
within six months from its expiration. An application
received after expiration of the LTO shall be subject to
a surcharge or penalty equivalent to twice the renewal
licensing fee and an additional ten percent (10%)
per month or a fraction thereof of continuing nonsubmission of such application up to a maximum of
one hundred twenty (120) days.
A. Any application for renewal of license filed beyond
the 120 days after the original expiration shall be
considered expired and shall be subject to a fee
equivalent to the total surcharge or penalty plus the
initial license fee. Such application shall undergo the
initial filing and evaluation procedure.
 For applications for renewal filed within one hundred
twenty (120) days from its original expiry, the LTO shall
be considered valid and existing until a decision or
resolution by the FDA is rendered on the application
for renewal.
B. Automatic renewal shall apply to the following
conditions:
1. The application is filed before the expiration date;
2. The prescribed renewal fee is paid upon filing of the
Application;
3. A sworn statement indicating no change or variation
whatsoever in the establishment is attached to the
application.
C. In considering both renewal application, FDA shall
ascertain the continued compliance by the
establishment with the existing standards and
requirements. In either case above, the instances
provided in Section 4, Article I, Book II of the IRR of RA
9711(Paragraph E, Item VI above) shall be grounds for
non-renewal of application.
Thank You!