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REPUBLIC OF THE PHILIPPINES

DEPARTMENT OF HEALTH
FOOD AND DRUG ADMINISTRATION

In re: Report of Violation dated 18


October 2016 submitted by
The Regional Field office V

FDA CASE NO. 2017-0246


DTN20161025080735

For: Violation of Sec. IV (E) and V


( C ) ( 2 ) of AO 2016-0003 in
Relation to Sec. 27 of RA 5921,
As amended

NITA GALVEZ OLIVA,


Owner,
JOVELY B. GALVEZ,
Pharmacist,
CARL JOHN PHARMACY,
Brgy. Poblacion, Balud, Masbate,
Respondent.
x------------------------------------------x

ANSWER
( With sincere apology and prayer for understanding)

We, Jovely B. Galvez, a licensed Pharmacist, of legal age , married,


Filipino and a resident of Brgy. Poblacion ,Balud , Masbate and Nita Galvez
Oliva owner of Carl John Pharmacy also of legal age, Filipino and residing in
Balud, Masbate unto this Honorable office most respectfully avers, that:

1. On June 9, 2017, Carl John Pharmacy received the notice of this Honorable
Office’s Summons ( with cease and Desist Order)dated March 27,2017
anent a violation of RA 5921 in relation to Section 27 to wit;
Pharmacist required and compensation. Every pharmacy, drugstore or hospital pharmacy whether owned by the
government or a private person or firm shall at all times when open for business be under the personal and immediate
supervision of a registered pharmacist: Provided, That no pharmacist shall have personal supervision of more than one
such establishment. In cases where a drug establishment operates in more than one shift, each shift must be under the
supervision and control of a registered pharmacists.

Drug or pharmaceutical laboratories or similar establishments engaged in the repackaging, manufacture or sale of drugs,
biologic products and pharmaceutical products in quantities greatly in excess of the therapeutic doses of each substance;
such processes involving the preparation, quality control or repackaging of said products shall for each respective
operation be under the direct and immediate supervision of a registered pharmacist, or, in the sale of pharmaceuticals,
medicines and drugs at wholesale, such business shall be conducted under the immediate supervision of a registered
pharmacist practicing only in such establishment.

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We were required to submit, within ten (10) days from receipt, or until 19th of
June 2017.

2. With sincerest respect to this Honorable Office, Private Respondent Jovely


B. Galvez together with Nita Galvez Oliva wish to narrate what really
transpired during the inspection on October 18, 2016 and promise to adhere
and to comply to the rules and regulations of operating a pharmacy under the
Food and Drug Administration of the Department of Health;

a. On the morning of October 18,2016, Jovely was at the pharmacy.


However when Edwin E. Castillo, Jr. the Food and Drug Regulation
Officer II came around noontime Jovely was then on her way to
Cawayan, Masbate . She could not wait for the officer Castillo because
travel from Balud to Cawayan is quite extraordinarily long and I admit
but with sincere apology that I was not physically present at the premises
due to some valid and urgent reasons.

b. October 18 was the eve of our( Jovely and Michael) wedding anniversary
since we were legally married on October 19, 2002. Hereto attached is a
copy of our marriage certificate as Annex “A” indicating the date of our
marriage.

c. It is indeed a sacred day for us as married couple and every year we spent
our anniversary by being together at least during the said memorable day.

d. On October 18, 2016 , I ( Jovely) wanted to surprise my husband by


going to Cawayan, Masbate, Philippines to spend our special day. That
is why I temporarily left the pharmacy earlier than usual with a caution to
my associates not to sell any prescription without me having returned
from our anniversary surprise meeting/date.

e. According to the inspection report, a copy of which is hereby attached


as Annex “B”. Everything that had to be displayed at my Pharmacy was
regularly displayed and even the prescription book is updated and all
others were in place and no violative products were noted except that I
was not temporarily present when he came .

3. I humbly submit these cogent reasons along with an apology and with
profound commitment that I ( Jovely) will always be physically present at the
drugstore/pharmacy at all times even including during our anniversary when
open for business, since the said pharmacy is under my personal and
immediate supervision as a registered pharmacist.
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4. Further I would like to appeal to this Honorable office to accept our sincere
and contrite apology and I together with the owner Nita Galvez Oliva will
humbly undertake any recommended action to address our violation or
problem with regard to the proper operation of the Pharmacy with a prayer
and hope for your good office’s kind understanding.

In WITNESS WHEREOF we hereby place our signatures this 16th. day of


June, 2017 at Balud, Masbate, Philippines.

Jovely B. Galvez
PHARMACIST
PRC License no. 0042038
Valid Until May 19, 2019

Nita Galvez Oliva


Owner
Carl John Pharmacy

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