AMENDMENT TO FDA CIRCULAR NO. 2, S. OF 1992 ON THE IMPORTATION OF SEMI-SYNTHETIC ANTIBIOTICS

Pursuant to Executive Order No. 776, dated February 24, 1982 and by
way of amendment to FDA Circular No. 2 dated April 30, 1982, the
following rules and procedure for the importation of antibiotics are
hereby adopted:

A. Commodities Covered

1.  Semi-synthetic antibiotics produced in the Philippines shall
refer to all forms and salts of ampicillin, amoxycillin and
cloxacillin.

2.  In accordance with Executive Order No. 776, importations of
semi-synthetic antibiotics shall be allowed only for quantities and
types that cannot be produced in the Philippines.

B. Qualification of Importers

1.  The importer should be a drug manufacturer or trader
manufacturing or producing antibiotics for its own account duly
registered as such with the Bureau of Food and Drugs (BFAD);

2.  The importation of semi-synthetic antibiotics shall be used
exclusively by the importer for the manufacture of its own brand of
semi-synthetic antibiotics in dosage/strength forms duly registered with
the BFAD.

C. Authorization to Import

1. All applications for the importation of antibiotics shall be filed with BFAD, and shall contain the following data:

a. The name and address of the Agent Bank

b. The name and address of the Importer

c. The country of origin of the antibiotics

d. The generic, chemical, brand/trade name of the finished
product that will be manufactured or produced using the imported
semi-synthetic antibiotics.

e. The form of the antibiotics

f. The quantity of the antibiotics

g. The pro-forma invoices covering the products to be imported indicating the specifications, prices and delivery dates.

2. The Director, BFAD, by Authority of the Secretary of
Health, shall issue a Certificate of Authority to import Semi-Synthetic
antibiotics and other antibiotics;

3. The Authority to Import shall be valid for ninety (90) days
from date thereof for the purpose of importation and shall be used only
once;

4. Each Authority to Import should refer to one antibiotic either as finished product or raw materials;

5. The original copy of the Certificate of Authority to Import
shall be submitted to Agent Bank, who shall then furnish BFAD, thru
CICCO of the Central Bank, with copies of the Letter of
Credit/Acceptances issued under this specific authority and the
corresponding release certificate issued therefor.

6. The Bureau of Customs will allow the release of such
importation only upon presentation of the Authority to Import together
with all the other requirements in force including the Certificate of
Analysis of every batch of raw material and/or finished products.

D.        Submission of Production Records

1. Each and every importer is required to submit to BFAD
complete records of production and usage report of the imported raw
materials within ninety (90) days from the date of usage of imported
materials. Any diversion or unauthorized use of the imported materials
or failure to submit the production record and usage report as required
shall be a ground to deny application for further authorization to
import without prejudice to the filing of appropriate legal sanctions as
shall be warranted.

Adopted: 08 June 2000

(SGD.) WILLIAM D. TORRES, PH.D.
Director

(SGD.) ALBERTO G. ROMUALDEZ, JR. M.D.
Secretary of Health