R.A.

3720 as amended
Respondent was found manufacturing, selling, offering for sale or transfer of
misbranded drug products in violation of Section 11 (a) of Republic Act No.
3720 as amended;

Section 11. The following acts and the causing thereof are
hereby prohibited:

(a) The manufacture, sale, offering for sale or transfer of any

food, drug, device or cosmetic that is adulterated or
misbranded.

Respondent was found to have refused entry for inspection to collect

samples in violation of Section 11 (c) of Republic Act No. 3720 as amended;

(c) The refusal to permit entry or inspection as authorized by

Section twenty-seven hereof or to allow samples to be
collected.

(g) The alteration, mutilation, destruction, obliteration,

or removal of the whole or any part of the labeling of, or
the doing of any other act with respect to, a food, drug,
device, or cosmetic, if such act is done while such
article is held for sale (whether or not the first sale) and
results in such article being adulterated or misbranded.

Respondent was found importing, selling, offering for sale, distributing or

transferring unregistered imported drug products in violation of Section 11 (j)
of Republic Act No. 3720 as amended;

(j) THE MANUFACTURE, IMPORTATION, EXPORTATION,

SALE, OFFERING FOR SALE, DISTRIBUTION, OR
TRANSFER OF ANY DRUG OR DEVICE WHICH IS NOT
REGISTERED WITH THE BUREAU PURSUANT TO THIS
ACT. (As amended by E.O. 175)

Respondent was found operating a drugstore without a valid License to

Operate from the Bureau of Food and Drug (BFAD), now Food and Drug
Administration (FDA), in violation of Section 11 (k) of Republic Act No. 3720
as amended;

(k) THE MANUFACTURE, IMPORTATION,

EXPORTATION, SALE, OFFERING FOR SALE, DISTRIBUTION,
OR TRANSFER OF ANY DRUG OR DEVICE BY ANY PERSON
WITHOUT THE LICENSE FROM THE BUREAU REQUIRED
UNDER THIS ACT. (As amended by E.O. 175)

(l) THE SALE OR OFFERING FOR SALE SALE OF ANY DRUG OR

DEVICE BEYOND ITS EXPIRATION OR EXPIRY DATE.
 RA 5921

Respondent was found selling or offering for sale drug products marked
as Physicians Samples in violation of Section 26 of Republic Act No.
5921;

Section 26. No sample of any drug, biological product, device or

proprietary medicine, given or intended to be given for free to
the physician and other qualified person by any manufacturer or
distributor of its representative or detailman as part of its
program or promotion, may be sold.

The statement "Sample, not for sale" shall appear conspicuously

on the container, package or carton of the drug or device to be
given.

Respondent was found to be operating a drugstore without the immediate

and personal supervision of a registered pharmacist in violation of Section 27
of Republic Act No. 5921;

Section 27. 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 pharmacist.

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.

Every pharmacist employed as such in any of the

establishments mentioned in this section whose capitalization
is not less than ten thousand pesos shall receive,
notwithstanding any provisions of law to the contrary, a
minimum compensation similar to that of government
pharmacists.
 Section 28. Display of certificate required. It shall be the duty
of every pharmacist engaged in the practice of pharmacy
either on his own account or under the employ of another, to
display his certificate of registration in a prominent and
conspicuous place in pharmacy, drugstore, hospital pharmacy
or drug establishment which he operates or in which he is
employed. No pharmacist shall with his knowledge allow his
certificate of registration to be displayed in such
establishments when he is not actually employed or operating
therein in his professional capacity.

R.A. 6675
Respondent was found selling or offering for sale drug product not in
compliance with the generic labeling requirements in violation of Republic
Act 6675;

SECTION 6. Who Shall Use Generic Terminology.

xxx

(c) Any organization or company involved in the manufacture,

importation, repacking, marketing and/or distribution of drugs
and medicines shall indicate prominently the generic name of
the product. In the case of brand name products, the generic
name shall appear prominently and immediately above the
brand name in all product labels as well as in advertising and
other promotional materials.

xxx

SECTION 7. Provision of Quality, Manufacturers Identity and

Responsibility. In order to assure responsibility for drug
quality in all instances, the label of all drugs and medicines
shall have the following: name and country of manufacture,
dates of manufacture and expiration. The quality of such
generically labeled drugs and medicines shall be duly certified
by the Department of Health.

R.A. 7432
Respondent was found to have failed to grant the Mr. Antonio T. Torralba, a
retired government employee and a senior citizen of Tagbilaran City, the
twenty percent (20%) discount when he bought three (3) Norvasc 10mg
Tablets last 5 August 2002 in violation of Section 4 (a) of Republic Act No.
7432;

Sec. 4. Privileges for the Senior Citizens. The senior citizens shall be
entitled to the following:

(a) the grant of twenty percent (20%) discount from all establishments
relative to utilization of transportation services, hotels and similar
lodging establishment, restaurants and recreation centers and
 purchase of medicine anywhere in the country: Provided, That private
establishments may claim the cost as tax credit;

R.A. 8203
Respondent was found selling or offering for sale counterfeit Propan with Iron
Capsules with Lot Numbers 9PIC-5X, 8PIC-4X and Expiration Dates March
2003, March 2002 respectively containing less than eighty percent (80%) of
the active ingredient it purports to possess in violation of Section 3(b)4 in
relation to Section 4 (a) of Republic Act No. 8203;

SECTION 3. Definition of Terms For purposes of this Act,

the terms:
(b) Counterfeit drug/medicine refers to medicinal
products with the correct ingredients but not in the
amounts as provided hereunder, wrong ingredients,
without active ingredients, with sufficient quantity of
active ingredient, which results in the reduction of
the drugs safety, efficacy, quality, strength or purity.
It is a drug which is deliberately and fraudulently
mislabeled with respect to identity and/or source or
with fake packaging, and can apply to both branded
and generic products. It shall also refer to:
4) a drug which contains no amount of or a
different active ingredient or less than eighty
percent (80%) of the active ingredient it
purports to possess as distinguished from an
adulterated drug including reduction or loss or
efficacy due to expiration.

In relation to

SECTION 4 Prohibited Acts. The following acts are

declared unlawful and therefore prohibited;

b) Possession of any such counterfeit drugs.

However, any person found in possession of
counterfeit drugs, in violation of this subsection, shall
be exempted from liability under the provisions of
this Act after:

1) presentation of sales invoices, official

receipts or other legally acceptable documents
evidencing his purchase thereof from a
drugstore, distributor, manufacturer, hospital
pharmacy or dispensary; or any other person
or place duly licensed to sell and/or dispense
drugs or medicines and indicating therein the
batch and lot numbers, as well as the expiry
dates of such drugs; or
 2) presentation of certificates and other
documents evidencing the importation or
exportation of the counterfeit drugs found in
his possession as required by existing laws,
including those documents required in the
preceding paragraph covering the commercial
transactions involving counterfeit drugs.

In both cases, the subject counterfeit drugs

must not on their face appear to be as such, or
do not bear any marking or any patently
unusual characteristic sufficient to arouse the
suspicion of a reasonable and prudent person
that such drugs are counterfeit. Furthermore,
the amount or volume of counterfeit drugs held
is such that it does not negate or is
inconsistent with the averment that the same
are for personal use, notwithstanding the
presentation by the possessor of medical
records and other similar documents
accompanying and justifying the use of such
drugs;

A.O. 55 s. 1988
Respondent was found selling and/or offering for sale drug products not in
compliance with the generic labeling requirements in violation of
Administrative Order No. 55 s. 1988;

Section 3.1.1 In all cases, the generic name shall be

the prominently printed element on the label, defined
as the one with the highest point size among the
various printed elements on the label.

A.O. 56 s. 1989
Respondent failed to display the original License to Operate in a conspicuous
place within the establishment in violation of Section 2.1.1.5 (b) of
Administrative Order No. 56 s. 1989.

2.1.1.5 An Affidavit of undertaking providing that the

applicant shall:

x xx

(b) display the duly approved LTO in a conspicuous place

within the establishment.

Respondent was found to have failed to provide Reference Books and

Documents relative to pharmacy operation in violation of Section 2.2.1.1 of
Administrative Order No. 56 s. 1989;
 2.2.1.1 Guidelines on Current Good Manufacturing Practices
provided for under A.O No. 220 s. 1974, including location,
building and floor plans, and any additional guidelines issued
by BFAD;

2.2.1.1.3 A place suitable for compounding prescription

and for washing and sterilizing bottles (compulsory only
for hospital pharmacy);

2.2.1.3 Record Books Duly Registered with the BFAD

2.2.1.3.1 Prescription Book

Respondent failed to present invoices covering its drug purchases of the

violative drug products in stock in violation of Section 2.2.1.6.1 of
Administrative Order No. 56 s. 1989.

2. Standards and Requirements for License to Operate (LTO)

2.2. Specific Requirements:

Any entity applying for a LTO as a drugstore, pharmacy or

botica or retail outlet shall be required to demonstrate its
capacity to perform adequately its functions to inform its
clientele in accordance with Section 6(d) of RA 6675 and sell
drugs, medicines, which are safe, effective, and of good
quality to the public. It shall be required to conform with
relevant standard and requirements specific for each category,
in addition to the foregoing general requirements.

2.2.1. Drugstore, Pharmacy or Botica

2.2.1.6. Other additional Requirements

2.2.1.6.1. Invoices indicating the lot number or batch

number of the manufacturer's stock pursuant to
BFAD Memo. Circular No. 001 s. 1983.

Respondent was found to have failed to file and record the prescriptions filled
in violation of Section 2.2.1.6.2 of Administrative Order No. 56 s. 1989;

Section 3 Required Information

A Handbook or directory and MENU CARDS or
poster containing the list of drug products using
generic names with their brand names, if any, and
their corresponding current prices for the top 25
selling products, readily accessible by the
patient/buyer shall be considered substantial
compliance with Section 3.1.1.2. of A.O. 63 s. 1989
Menu Cards shall refer to a card of one drug in
generic name with all the brand named products
 available and the corresponding current prices of
each of the products listed.

2.2.1.6 Other Additional Requirements:

2.2.1.6.3 Dry Seal or Rubber Stamp containing the name

and address of the drug outlet;

2.2.1.6.4 Red and White labels indicating name and

address of drugstore are other additional
requirements for a drugstore, pharmacy or botica;

Respondent failed to produce invoices and receipts covering the purchase of

the above-stated violative drug products in violation of Section 4.2.1 of
Administrative Order No. 56 s. 1989;

4.2.1 Minor deficiencies in GMP or material

management that need to be corrected but are not
immediately or likely to result in adulterated, misbranded,
substandard or unsafe products as determined by BFAD.
This includes, among others, poor housekeeping,
inadequate storage facilities, lack of minor equipment or
requirement, and other minor shortcomings.

Respondent was found to have failed to properly record and keep a file of the
prescriptions filled in violation of Section 4.2.2 of Administrative Order No. 56
s. 1989.

4.2.2. Lapses in record keeping of invoices, receipts or

distribution records.

Respondent was found selling or offering for sale drug products marked
Physicians Sample and/or Not for Sale in violation of Section 4.3.1 of
Administrative Order No. 56 s. 1989;

4.3.1 Sale or offer for sale of adulterated, misbranded,

sub-standard, unregistered, expired and/or unsafe drugs or
products marked Not for Sale.

A.O. 149 s. 1971

Respondent was found selling or offering for sale government owned
Logentrol Pills in violation of Administrative Order No. 149 s. 1971; and

Unauthorized Purchase, Possession, Display or Sale of

Government-Owned Drugs, Medicines or Any Other
Medicinal Items:

xxx

It will therefore be unlawful for private drugstores and drug

establishments to possess, display or sell such kinds of
drugs, medicines or medicinal items.

A.O. 150 s. 1971

Respondent was found selling or offering for sale unregistered cosmetic
products in violation of Section D-4.1 of Administrative Order No. 150 s.
1971;

D-4.1 A cosmetic specialty shall be distributed and sold

only after having been officially registered with the
Food and Drug Administration.

M.C. 8 s. 1990
Respondent was found to have failed to provide generic menu cards in
violation of Section 3 of Memorandum Circular No. 8 s. 1990;

Section 3 Required Information

A Handbook or directory and MENU CARDS or
poster containing the list of drug products using
generic names with their brand names, if any, and
their corresponding current prices for the top 25
selling products, readily accessible by the
patient/buyer shall be considered substantial
compliance with Section 3.1.1.2. of A.O. 63 s. 1989
Menu Cards shall refer to a card of one drug in
generic name with all the brand named products
available and the corresponding current prices of
each of the products listed.

Section 2 Recording in the Prescription Book

Recording of prescription filled in the
drugstores official Prescription Book may be
accomplished not later than the end of each
quarter to comply with Section 2.3 of A.O. 63 s.
1989. A Computerized data base containing
the same information as the Prescription Book
will be considered substantial compliance.

Prescriptions shall be filed consecutively and

systematically as filled for easy retrieval during
inspection and/or when the need arises and
shall be available for inspection to Food and
Drug Regulation Officers or duly authorized
NDP Monitor at any time during business
hours.

M.C. 10 s. 1992
Respondent was found accepting deliveries of drug products from drug
distributors without lot numbers and expiry dates indicated on the sales
invoices covering the sales/transactions in violation of Memorandum Circular
No. 10 s. 92;

The drug outlet, drug distributor/supplier and

manufacturer are therefore liable for the failure to
indicate the lot number and expiry date on a given
 invoice covering the drug products delivered, unless the
drug distributor or manufacturer can prove by
substantial evidence that the invoice subject to
question is spurious and/or was not issued by the same
distributor/manufacturer.

B.C. 8 s. 1990
Respondent, by the documents submitted by Ms. Marilou G. Jucar of MGJucar
Marketing Company, was shown to be importing and distributing
unregistered Mr. Potato Crips products, as evidenced by samples of the
subject products with stickers of the Respondent company as importer/
distributor in violation of Bureau Circular No. 8 s. 1999 2nd Paragraph.
Verification made with the Product Services Division on August 14, 2002
revealed that the Respondents registration of the subject products is still
pending with their division.

x x x all imported products are hereby required to

satisfactorily comply with the requirements for registration
as specified in Bureau Order No. 163, s. 1997 and be
validly registered after passing BFAD criteria of safety and
quality before they are sold or offered for sale in the
market.

B.C. 19 s. 1999
Respondent was found dispensing prescription drug products without
prescription in violation of Bureau Circular No. 19 s. 1999.

Section 20 ((b)(1)(B)) of RA 3720 as amended by

Section 12 of E.O. 175, otherwise known as Food, Drug
and devices and Cosmetic Act states that:

Section 20
(a) xxx
(b) (1) Drugs intended for use by man which:
(A) xxx;
(B) because of their toxicity or other potentially
for harmful effect, or the method of their use is
not safe for use except under the supervisions of
practitioner licensed by law to administer such
drug;
(C) xxx
shall be dispensed only (1) upon a written
prescription of a practitioner licensed by law to
administer such drug, (2) upon an oral prescription of
such practitioner which is reduced promptly to
writing and filled by the pharmacist, or (3) by refilling
any such written or oral prescription if such refilling
is authorized by the prescriber either in the original
prescription or by oral order which is reduced
promptly to writing and filled by the pharmacist. The
act of dispensing a drug contrary to the provisions of
this paragraph shall be deemed to be an act which
results in the drug being misbranded while held for
sale. (underscoring ours)