PHARMACY ORGANIZATION, STRUCTURE AND SET-UP REGULATORY REQUIREMENTS FOR PHARMACY OPERATION

Question 1

GIVE A SAMPLE ORGANIZATIONAL CHART IN COMMUNITY
PHARMACY

Answer 1

Pharmacy owner
Pharmacist
2 Pharmacy Assistant

Question 2

STANDARDS AND REQUIREMENTS FOR LTO

Give the 7 GENERAL REQUIREMENTS FOR LTO (under APPLICATION)

Answer 2

7 GENERAL requirements for LTO (under APPLICATION)
2.1.1.1 A Standard petition form containing;
- Name
- Age
- Citizenship
- Passport size picture (5x5)

2.1.1.2 Proof of Registration as an establishment
- For single Proprietorship
- For Partnership

2.1.1.3 Certificate of Registration of the Filipino Pharmacist

2.1.1.4 Certificate of attendance to a BFAD seminar

2.1.1.5 An affidavit of undertaking providing that the applicant shall:
- Change the establishment’s name if there is already a
validly registered name similar to it
- Display the duly approved LTO in a conspicuous place
within the establishment
- Notify BFAD in case of an change in the circumstances
described in the application such as: change in location,
change of pharmacist.

2.1.1.6 Tentative of products intended to be sold using generic names with brand names when applicable.

2.1.1.7 Authenticated photocopy of the contract of Lease of the space to be occupied if the applicant does not own it.

Question 3

GIVE THE 8 COMMUNITY PHARMACY STRUCTURE AND SET-UP

Answer 3

• Prescription Counter
• Transaction window
• Storage
• Sink
• Refrigeration
• Equipment
• Computer System
• Prescription Bins or Shelves

Question 4

5 DECLARATION OF PRINCIPLES FOR PHARMACY PROFESSION
Supplement the missing words in the statements:

I. Pharmacy is a _ _ _ _ the primary function of which is to render the public _ _ in _ and _ of prescriptions and the _ of drugs, chemicals, and medicines.

II. As practiced in _ its branches, pharmacy also embraces the _, _, _, _, and _ of drugs and medicine, the _ of medicinal chemicals, and the _ of biological products.

III. In the practice of the profession of pharmacy, _ _, _, and _ are demanded on the part of those engaged in it.

IV. Pharmacists should pursue a _ course of study and should pass a _ _ in order to qualify under the laws of the land.

V. _ laws grant _ pharmacists a _ recognition of their
responsibility for the _ of public health, the _ and _ compliance with their professional ethics, and the maintenance of the _, _ and _ that society requires.

VI. The pharmacist should therefore ever bear in mind that he is more than a _, and that his is a real mission which must be performed with the _, _, and _ _ for the benefit of his fellowmen.

Answer 4

5 DECLARATION OF PRINCIPLES FOR PHARMACY PROFESSION

I. Pharmacy is a HIGHLY SPECIALIZED TECHNICAL-CALLING the primary function of which is to render the public EFFICIENT SERVICE in COMPOUNDING and FILLING of prescriptions and the DISPENSING of drugs, chemicals, and medicines.

II. As practiced in ALL its branches, pharmacy also embraces the COLLECTION, IDENTIFICATION, PRESERVATION, ANALYSIS, and STANDARDIZATION of drugs and medicine, the SYNTHESIS of medicinal chemicals, and the PREPARATION of biological products.

III. In the practice of the profession of pharmacy, SPECIAL KNOWLEDGE, SKILL, and INTEGRITY are demanded on the part of those engaged in it.

IV. Pharmacists should pursue a PRESCRIBED course of study and should pass a PROFESSIONAL EXAMINATION in order to qualify under the laws of the land.

V. SUCH laws grant QUALIFIED pharmacists a FULL recognition of their responsibility for the PRESERVATION of public health, the STRICT and ABSOLUTE compliance with their professional ethics, and the maintenance of the DIGNITY, HONESTY and RESPECT that society requires.

VI. The pharmacist should therefore ever bear in mind that he is more than a MERCHANT, and that his is a real mission which must be performed with the DEVOTION, UNSELFISHNESS, and PERSONAL SACRIFICE for the benefit of his fellowmen.

Question 5

REGULATORY REQUIREMENTS FOR PHARMACY OPERATIONS
Definition of Different Types of Drug Outlets
Supplement the missing words in the statements:

1.1 Drugstores, Pharmacy or Botika, including Hospital
Pharmacy/_ means a drug outlet where registered drugs,
_ _, _ _, _ _ or _ _ and _ _, _ or _ _ are _ and/or _.

1.2 Retail outlet for non-prescription drugs including
_ outlets such as _ and _, means a drug outlet where registered _ or _ drugs are sold in their _ packages, bottles or containers or in _ quantities _ _their original containers.

Answer 5

REGULATORY REQUIREMENTS FOR PHARMACY OPERATIONS
Definition of Different Types of Drug Outlets

1.1 Drugstores, Pharmacy or Botika, including Hospital Pharmacy/DISPENSARY means a drug outlet where registered drugs, CHEMICAL PRODUCTS, ACTIVE PRINCIPLES, PROPRIETARY MEDICINES or PHARMACEUTICAL SPECIALITIES and DENTAL MEDICINAL, GALENICAL or VETERINARY preparations are COMPOUNDED and/or DISPENSED.

1.2 Retail outlet for non-prescription drugs including NON-TRADITIONAL outlets such as SUPERMARKETS and STORES, means a drug outlet where registered NON-PRESCRIPTION or
OVER-THE-COUNTER drugs are sold in their ORIGINAL
packages, bottles or containers or in SMALLER quantities NOT IN
their original containers.

Question 6

STANDARDS AND REQUIREMENTS FOR LTO
Supplement the missing words in the 6 SPECIFIC requirements for Drugstores, Pharmacy or Botica (PREMISES)

1) A _ in front of the place of business bearing the _
_ of the drug store. For _ pharmacy, the sign “_” is sufficient. For drug outlet selling _ _ or _ _ _ drug product, the signboard should indicate so by putting the symbol _ or its equivalent.

2) A _ area not less than _ sq. m. in floor area with _, _ or _ flooring.

3) A place suitable for _ prescription and for _ and
_ _ (compulsory only for _ pharmacy).

4) A _ and _ place for the _ _ of drugs and _ products as specified on the label.

5) A suitable _ for keeping _ and/or _ drugs.

6) An adequate _ supply.

Answer 6

STANDARDS AND REQUIREMENTS FOR LTO
6 SPECIFIC requirements for Drugstores, Pharmacy or Botica (PREMISES)

1) A SIGNBOARD in front of the place of business bearing the REGISTERED NAME of the drug store. For HOSPITAL pharmacy, the sign “PHARMACY” is sufficient. For drug outlet selling EXCLUSIVELY NON-PRESCRIPTION or OVER THE COUNTER (OTC) drug product, the signboard should indicate so by putting the symbol NON-RX or its equivalent.

2) A WELL-VENTILATED area not less than 15 sq. m. in floor area with CONCRETE, TILE or WOODEN flooring.

3) A place suitable for COMPOUNDING prescription and for WASHING and STERILIZING bottles (compulsory only for HOSPITAL pharmacy).

4) A SUITABLE and PROPER place for the ADEQUATE STORAGE of drugs and BIOLOGICAL products as specified on the label.

5) A suitable CABINET for keeping POISONS and/or DANGEROUS drugs.

6) An adequate WATER

Question 7

Give the 6 SPECIFIC requirements for Drugstores, Pharmacy or Botica (REFERENCE BOOKS and DOCUMENTS)

Answer 7

1. Philippine National Drug Formulary (when available)
   United States Pharmacopeia/National Formulary (USP-NF) (latest
   edition).
2. R.A. 3720, otherwise known as the Foods, Drugs and Devices and Cosmetics Act as amended and relevant implementing rules and regulations.
3. R.A. 6675, Generics Act of 1988 and relevant implementing rules
   and regulations.
4. R.A. 5921 Pharmacy Law, as amended and relevant implementing
   rules and regulations.
5. Remington’s Pharmaceutical Sciences (latest edition).
6. Goodman & Gilman — Pharmacological Basis of Therapeutics (latest
   edition).

Question 8

Give the 6 SPECIFIC requirements for Drugstores, Pharmacy or Botica (PREMISES)

Answer 8

1) A SIGNBOARD in front of the place of business bearing the REGISTERED NAME of the drug store. For HOSPITAL pharmacy, the sign “PHARMACY” is sufficient. For drug outlet selling EXCLUSIVELY NON-PRESCRIPTION or OVER THE COUNTER (OTC) drug product, the signboard should indicate so by putting the symbol NON-RX or its equivalent.

2) A WELL-VENTILATED area not less than 15 sq. m. in floor area with CONCRETE, TILE or WOODEN flooring.

3) A place suitable for COMPOUNDING prescription and for WASHING and STERILIZING bottles (compulsory only for HOSPITAL pharmacy).

4) A SUITABLE and PROPER place for the ADEQUATE STORAGE of drugs and BIOLOGICAL products as specified on the label.

5) A suitable CABINET for keeping POISONS and/or DANGEROUS drugs.

6) An adequate WATER

Question 9

Give the 6 SPECIFIC requirements for Drugstores, Pharmacy or Botica (RECORD BOOKS DULY REGISTERED with the FDA)

Answer 9

6 SPECIFIC requirements for Drugstores, Pharmacy or Botica (RECORD BOOKS DULY REGISTERED with the FDA)

1. Prescription Book
2. Dangerous Drug Book
3. Exempt Preparation Book
4. Poisons Book
5. Record Book for Selected Non-Prescription
6. Drugs, subject to abuse as determined by BFAD and/or Dangerous Drugs Board (DDB).

Question 10

Give the 6 SPECIFIC requirements for Drugstores, Pharmacy or Botica (Utensils, Apparatus and Other Equipment)

Answer 10

For all drugstores including hospital pharmacies,
refrigerator for biologicals and other drug products
needing refrigeration.

For hospital pharmacy only:
Prescription balance of one centigram sensitivity and
a set of weights.
Glass volumetric measures a set of not less than six
pieces from 15 ml to 1000 ml capacity.
Mortar and pestle — a set of not less than three in
assorted sizes.

Question 11

Specific Requirement of Drugstores, Pharmacy or Botica

A _ _ _ pharmacist
physically present while the drugstore is open to business.

Answer 11

A full-time validly registered pharmacist
physically present while the drugstore is open to business.

Question 12

Other Additional Requirement of Drugstores, Pharmacy or Botica

Answer 12

Invoices indicating the lot number or batch number of
the manufacturer’s stock pursuant to BFAD Memo.
Circular no. 001 s. 1983.
File of prescription filled, consecutively numbered.
Dry Seal or Rubber Stamp containing the name and
address of the drug outlet.
Red and White labels indicating name and address of
drugstore

Question 13

Specific Requirements for a Retail Outlet for
Non-Prescription Drugs (premises)

Answer 13

A signboard in front of the place of business bearing
the registered name of retail outlet and the symbol
non-Rx or equivalent.
An adequate, well-ventilated area with concrete, tile,
or wooden flooring.
A suitable and proper place for the adequate storage of
non-prescription drugs. When there are products sold
other than drugs, an area exclusively for drug
products shall be allocated within the premises

Question 14

Specific Requirements for a Retail Outlet for
Non-Prescription Drugs (reference books and documents)

Answer 14

Philippine National Drug Formulary (when available);
R.A. 5921, Pharmacy Law and its implementing rules
and regulations;
R.A. 6675, the Generics Act of 1988 and relevant
implementing rules and regulations;
R.A. 3720 as amended or Foods, Drugs and Devices and
Cosmetics Act

Question 15

Specific Requirements for a Retail Outlet for
Non-Prescription Drugs (record books)

Answer 15

selected
non-prescription drugs subject to abuse as determined by BFAD
and/or DDB

Question 16

Other Additional Requirements for Retail Outlet for
Non-Prescription Drugs

Answer 16

Invoices indicating the lot number or batch number of the
manufacturer’s stock pursuant to BFAD Memo. Circular No. 001
s. 1983.
Dry seal or Rubber Stamp containing the name and address of the
drug outlet.

Question 17

Administrative Sanction

Absence of pharmacist on 3 inspection by BFAD inspector

Answer 17

Temporary Closure

Question 18

Failure to produce invoices and receipts together with 1st
number, expiry dates for the drugs in stock.

Failure to properly record and keep a file of all prescriptions
filled in the last two(2)years.

Refusal to allow entry of BFAR inspectors.

Answer 18

Suspension of License to Operate

Question 19

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”.
4.3.2. Failure to properly record dangerous drugs as determined by
DDB.
4.3.3. Lack of pharmacist
4.3.4. Failure to take necessary remedial or corrective measures
within the prescribed periods as directed by BFAD.

Answer 19

4.3. Revocation of License to Operate

Question 20

Schedule of Fees
“Initial”
_ per drugstore, pharmacy or botica outlet
_ per retail outlet carrying only non-prescription drugs

Answer 20

P500.00 per drugstore, pharmacy or boticaoutlet

P200.00 per retail outlet carrying only non-prescription drugs

Question 21

Schedule of Fees
“Renewal”
_ per drugstore,
pharmacy or botica outlet
_ per retail outlet
carrying only
non-prescription drugs

Answer 21

1k per drugstore,
pharmacy or botica outlet
400 per retail outlet
carrying only
non-prescription drugs

Question 22

Laws that govern the practice of Pharmacy Profession and
relative to drugs in the Philippines

Answer 22

•R.A. No. 10918 - Philippine Pharmacy Act
•R.A. No. 3720 - The Food, Drug, Device and
Cosmetics Act
•R. A. No. 9165 – The Comprehensive
Dangerous Drug Act of 2002
•R.A. No. 6675 – The Generics Law of 1988

Question 23

PHILIPPINE PHARMACY ACT

▪Republic Act _
▪Signed by Pres. _
▪Approved on _

Answer 23

▪Republic Act 10918
▪Signed by Pres. Benigno S. Aquino III
▪Approved on July 21, 2016

Question 24

The Foods, Drugs, Devices and
Cosmetics Act
Republic Act _
■Approved _
■Amended by _
■Amended on _ by President _

Answer 24

The Foods, Drugs, Devices and
Cosmetics Act
Republic Act 3720
■Approved June 22, 1963
■Amended by Executive Order 175
■Amended on May 22, 1987 by President
Corazon C. Aquino

Question 25

Comprehensive Dangerous Drug Act of 2002 Republic Act No. _ Repealing Republic Act No. _, otherwise known as the _

Answer 25

Comprehensive Dangerous Drug Act of 2002 Republic Act No. 9165 Repealing Republic Act No. 6425, otherwise known as the Dangerous Drug Act of 1972

Question 26

Generics Law of 1988 Republic Act No. _ It was signed into law on _

Answer 26

Generics Law of 1988 Republic Act No. 6675 It was signed into law on September 13, 1988

Question 27

Pharmacist Requirement. Establishments/outlets which are required to employ and/or retain and maintain the professional services of duly registered and licensed pharmacists shall be classified as

Answer 27

Category A and Category B

Question 28

Pharmaceutical establishments/outlets where the direct and immediate control and supervision of a duly registered and licensed pharmacist is required, per establishment, whether in-store or online,

Answer 28

Category A

Question 29

Category A or Category B? Pharmaceutical establishments/outlets selling or otherwise making available to the consuming public prescription/ethical medicines, combination products (medical device and drugs) classified as drugs according to the primary intended mode of action, pharmacist-only OTC medicine, whether owned by the government or by a private person or firm, whether sold at wholesale or retail;

Answer 29

Category A

Question 30

Category A or Category B? Establishments involved in the manufacture, importation, exportation, distribution, and sale of combination products (medical device and drugs) classified as drugs according to the primary intended mode of action;

Answer 30

Category A

Question 31

Category A or B? Departments/Divisions/Units of pharmaceutical laboratories, pharmaceutical manufacturing laboratories, or other establishments with processes involving the preparation, manufacture, assay, regulation, product research and development, quality control, repacking, importation, exportation, distribution, sale or transfer of pharmaceutical products in quantities greatly in excess of single therapeutic doses;

Answer 31

Category A

Question 32

Category A or B? Government units, including local government, city, first to third class municipal health units, nongovernment organizations and/or associations involved in the procurement, distribution, dispensing and storage of pharmaceutical products

Answer 32

Category A

Question 33

Pharmaceutical establishments/outlets where the supervision and oversight of a duly registered and licensed pharmacist is required under pertinent provisions of law

Answer 33

Category B

Question 34

Category A or B? Retail outlets selling household remedies and OTC drugs as differentiated from the pharmacist-only OTC medicines

Answer 34

Category B

Question 35

Category A or Category B? Satellite institutional pharmacies providing medicines solely to employees of their respective companies or the employees’ qualified dependents, or both; or members of a duly registered organization or institution

Answer 35

Category B

Question 36

Category A or Category B Fourth, fifth and sixth class municipal health units involved in the procurement, distribution, dispensing, and storage of pharmaceutical products

Answer 36

Category B

Question 37

Category A or Category B? Institutions providing telepharmacy services

Answer 37

Category B

Question 38

Category A or Category B? Nontraditional outlets of pharmaceutical products: Provided, That no prescription medicines and pharmacist-only OTC medicines are sold.

Answer 38

Category B

Question 39

Supply the missing words in the statement Pharmacist Requirement. The _, in coordination with the _, and the approval of the _, may add to, delete, reclassify, or modify the above list of establishments, as the need arises, in order to keep pace with the developments in the pharmacy practice.

Answer 39

Pharmacist Requirement. The FDA, in coordination with the Board, and the approval of the PRC, may add to, delete, reclassify, or modify the above list of establishments, as the need arises, in order to keep pace with the developments in the pharmacy practice.

Question 40

Supply the missing word in the statement Pharmacist Requirement. A pharmacist working in a _ establishment may be allowed to simultaneously work or render pharmacy services in Category B establishments, the maximum number of hours of which shall be determined, in accordance with such guidelines as may be established therefor by the Board, in coordination with the FDA, and other agencies, establishments, institutions, and regulatory bodies.

Answer 40

Pharmacist Requirement. A pharmacist working in a Category A establishment may be allowed to simultaneously work or render pharmacy services in Category B establishments, the maximum number of hours of which shall be determined, in accordance with such guidelines as may be established therefor by the Board, in coordination with the FDA, and other agencies, establishments, institutions, and regulatory bodies.

Question 41

Supply the missing words in the statements Responsibility for Quality of Pharmaceutical Products. 1. It shall be the duty of a duly licensed and registered pharmacist of a pharmaceutical establishment and outlet to ensure that all pharmaceutical products _ to standards of _, _ and _, as provided for in this Act and other pertinent rules and regulations and issuances. 2. _, _, or _ in charge of the operation of pharmaceutical establishments and outlets shall be held jointly responsible for _ with these standards 3. It shall be unlawful for any person to manufacture, prepare, sell, or dispense any pharmaceutical product under a _ name, or _ or to _ any pharmaceutical product offered for sale. 4. In cases of pharmaceutical products sold in their _ package, the seal of which has not been broken or tampered with, the liability that may arise because of their quality and purity rests upon the _ or _, the _, _, or _ who is responsible for their distribution or sale

Answer 41

Responsibility for Quality of Pharmaceutical Products. 1. It shall be the duty of a duly licensed and registered pharmacist of a pharmaceutical establishment and outlet to ensure that all pharmaceutical products conform to standards of safety, quality and efficacy, as provided for in this Act and other pertinent rules and regulations and issuances. 2. Owners, managers, or pharmacists in charge of the operation of pharmaceutical establishments and outlets shall be held jointly responsible for nonconformance with these standards 3. It shall be unlawful for any person to manufacture, prepare, sell, or dispense any pharmaceutical product under a fraudulent name, or pretense or to adulterate any pharmaceutical product offered for sale. 4. In cases of pharmaceutical products sold in their original package, the seal of which has not been broken or tampered with, the liability that may arise because of their quality and purity rests upon the manufacturer or importer, the distributor, representative, or dealer who is responsible for their distribution or sale

Question 42

Supply the missing words in the statements Filling and Partial Filling of Prescription. 🡪 All _ and _ medicines shall be filled, compounded and dispensed only by a registered and licensed pharmacist, in accordance with the _, _ and other standards pertaining to _, _ and _. _ filled prescriptions should be surrendered to the _ for recording 🡪 _ filling of prescription less than the total quantity indicated in the prescription shall _ allowed, subject to dispensing guidelines as provided in the immediately preceding paragraph. It is the responsibility of the pharmacist dispensing the last quantity completing the prescription to keep the prescription according to proper prescription recording guidelines 🡪_ medicines may be dispensed only by a duly registered and licensed pharmacist and only with a valid prescription of a _, _, or _.

Answer 42

Filling and Partial Filling of Prescription 🡪 All prescriptions and pharmacist-only OTC medicines shall be filled, compounded and dispensed only by a registered and licensed pharmacist, in accordance with the Philippine Practice Standards for Pharmacists, Dispensing Guidelines and other standards pertaining to purity, safety and quality. Completely filled prescriptions should be surrendered to the pharmacist for recording 🡪 Partial filling of prescription less than the total quantity indicated in the prescription shall be allowed, subject to dispensing guidelines as provided in the immediately preceding paragraph. It is the responsibility of the pharmacist dispensing the last quantity completing the prescription to keep the prescription according to proper prescription recording guidelines. 🡪 Prescription medicines may be dispensed only by a duly registered and licensed pharmacist and only with a valid prescription of a physician, dentist, or veterinarian.

Question 43

Pharmaceutical products given or intended to be given free to any health professional by a manufacturer or distributor or its professional service representative as part of its program or promotion shall not be sold to any pharmaceutical outlet or the consuming public

Answer 43

Physician's sample

Question 44

Supply the missing words in the statement Prohibition Against the Use of _, _, or Unusual _ in Prescriptions and Prescription _. 🡪 Pharmacists shall _ compound or dispense prescriptions, recipes, or formulas which are written in _, _ or _ or prescriptions of pharmaceutical products with unusual names which differ from those in standard pharmacopeias or formularies

Answer 44

Prohibition Against the Use of Cipher, Codes, or Unusual Terms in Prescriptions and Prescription Substitution. 🡪 Pharmacists shall not compound or dispense prescriptions, recipes, or formulas which are written in ciphers, codes or secret keys or prescriptions of pharmaceutical products with unusual names which differ from those in standard pharmacopeias or formularies

Question 45

Supply the missing words in the statement Label of Dispensed Medicines. > Upon every _, _, or _ of medicines compounded or dispensed by a registered and licensed pharmacist based on prescription, there shall be pasted, affixed, or imprinted a _ or _, among others, the _ and _; _, if any, _, _, _ ; and _, _, the _ and other requirements prescribed in the _ and _, _, otherwise known as the_, its implementing rules and regulations and such other guidelines that may be promulgated by the Board. > _ labels containing special pharmacists" instructions for the patient shall _ required as prescribed for _, _, _ and such other drugs as may be required by law

Answer 45

Label of Dispensed Medicines. > Upon every box, bottle, or package of medicines compounded or dispensed by a registered and licensed pharmacist based on prescription, there shall be pasted, affixed, or imprinted a seal or label bearing, among others, the name of patient and generic name of drug; brand name, if any, strength, expiry date, directions for use; and name and address of pharmacy, name of the doctor, the dispensing pharmacist and other requirements prescribed in the Philippine Practice Standards for Pharmacists and Dispensing Guidelines, Republic Act No. 9502, otherwise known as the "Universally Accessible Cheaper and Quality Medicines Act of 2008", its implementing rules and regulations and such other guidelines that may be promulgated by the Board. > Auxiliary labels containing special pharmacists" instructions for the patient shall be required as prescribed for dangerous drugs, external-use-only drugs, drugs with special storage and administration instructions and such other drugs as may be required by law

Question 46

Supply the missing words in the statements Recording of Patient Medication Profile. > _ prescriptions dispensed in the pharmacy shall be recorded in an appropriate recording system indicating therein, among other things, _, _, _, _ and _ > It shall be open for inspection by the _ of the _ or the _, or both, at any time of the day, when the pharmacy is open, and must be kept for a period of not less than _ after the last entry

Answer 46

Recording of Patient Medication Profile. > All prescriptions dispensed in the pharmacy shall be recorded in an appropriate recording system indicating therein, among other things, the name and address of the patient, name of prescribes generic name and brand, dosage strength, quantity of drug and initials of pharmacist > It shall be open for inspection by the representatives of the Board or the FDA, or both, at any time of the day, when the pharmacy is open, and must be kept for a period of not less than two (2) years after the last entry

Question 47

Requirements for the Opening and Operation of Retail Pharmaceutical Outlet or Establishment. 🡪 The opening of a retail pharmaceutical outlet or establishment shall be subject to requirements provided for in this Act and the rules and regulations prescribed by the FDA. 🡪 The application for the opening and operation of a retail drug outlet or other similar business establishments shall _ approved, unless applied for by a _ registered and licensed pharmacist, either as _ or as _, pursuant to the provisions of this Act

Answer 47

Requirements for the Opening and Operation of Retail Pharmaceutical Outlet or Establishment. 🡪 The opening of a retail pharmaceutical outlet or establishment shall be subject to requirements provided for in this Act and the rules and regulations prescribed by the FDA. 🡪 The application for the opening and operation of a retail drug outlet or other similar business establishments shall not be approved, unless applied for by a Filipino registered and licensed pharmacist, either as owner or as pharmacist-in-charge, pursuant to the provisions of this Act

Question 48

GUIDELINES ON DISPENSING OF MEDICINES * _ drugs can only be dispensed upon a written order of a validly-registered physician, dentist or veterinarian. * _ may be dispensed even without a written order of a validly-registered physician, dentist or veterinarian in duly licensed drug outlets. When dispensing over-the-counter drugs without a doctor’s prescription, the pharmacist shall give the necessary information and direction for use of the drug. * All prescriptions dispensed in the drugstore, botica or hospital pharmacy shall be kept in file for _ years and recorded in a_ book duly registered with the Bureau of Food and Drugs which shall be opened for inspection to_ Inspectors any time _ business hours of the outlet. The prescription book shall be kept for _ years after the last entry.

Answer 48

GUIDELINES ON DISPENSING OF MEDICINES * Ethical drugs can only be dispensed upon a written order of a validly-registered physician, dentist or veterinarian. * Non-prescription or over-the-counter drugs may be dispensed even without a written order of a validly-registered physician, dentist or veterinarian in duly licensed drug outlets. When dispensing over-the-counter drugs without a doctor’s prescription, the pharmacist shall give the necessary information and direction for use of the drug. * All prescriptions dispensed in the drugstore, botica or hospital pharmacy shall be kept in file for two years and recorded in a prescription book duly registered with the Bureau of Food and Drugs which shall be opened for inspection to Food and Drugs Inspectors any time during business hours of the outlet. The prescription book shall be kept for two years after the last entry.

Question 49

ADDITIONAL GUIDELINES ON DISPENSING 🡪 All _ are required to practice dispensing of drugs using _ names with some exceptions, modifications or qualifications in certain cases or circumstances prescribed herein. 🡪 To ensure the informed choice and use of drugs by patient/buyer, the drug outlet is required to: * Inform the patient/buyer of all available drug products _ equivalent to the one prescribed with their corresponding prices. In so doing, the drug outlet shall not favor or suggest any particular product so that the patient/buyer may fully and adequately exercise his option to choose. * For this purpose, all drug outlets shall post in a _ place in their respective establishments a list of drug products using generic names with their brand names, if any, and their corresponding current prices. A _ or _ containing the above required information, readily accessible to the patient/buyer shall be considered substantial compliance. Hospital Pharmacies 🡪 The following shall govern generic dispensing in hospital pharmacies, in the case of _-patients only: * To ensure the informed choice and use of drugs by patient/buyer, the drug outlet is required to: * Upon admission, the patient or his/her responsible _ shall indicate in writing whether he/she shall _ to the hospital drug policies or _ the option to buy drugs and medicines outside of the hospital pharmacy. * Hospital pharmacies operating on an acceptable _ system and _ policy as determined by the _, and using _ terminology in procurement, prescribing, dispensing, and recording of drugs shall be exempted from the following: * Recording of prescription filled in the prescription book, provided such prescriptions shall be kept in file for _ years. * Individually informing the _-patient/buyer on available generic equivalents and their corresponding prices. However, a handbook or directory containing the required drug information must be made available in the _ for patients, responsible relatives of patients and professional staff.

Answer 49

ADDITIONAL GUIDELINES ON DISPENSING 🡪 All drug outlets are required to practice dispensing of drugs using generic names with some exceptions, modifications or qualifications in certain cases or circumstances prescribed herein. 🡪 To ensure the informed choice and use of drugs by patient/buyer, the drug outlet is required to: * Inform the patient/buyer of all available drug products generically equivalent to the one prescribed with their corresponding prices. In so doing, the drug outlet shall not favor or suggest any particular product so that the patient/buyer may fully and adequately exercise his option to choose. * For this purpose, all drug outlets shall post in a conspicuous place in their respective establishments a list of drug products using generic names with their brand names, if any, and their corresponding current prices. A handbook or directory containing the above required information, readily accessible to the patient/buyer shall be considered substantial compliance. Hospital Pharmacies 🡪 The following shall govern generic dispensing in hospital pharmacies, in the case of in-patients only: * To ensure the informed choice and use of drugs by patient/buyer, the drug outlet is required to: * Upon admission, the patient or his/her responsible relative shall indicate in writing whether he/she shall submit to the hospital drug policies or reserve the option to buy drugs and medicines outside of the hospital pharmacy. * Hospital pharmacies operating on an acceptable formulary system and pricing policy as determined by the Department of Health, and using generic terminology in procurement, prescribing, dispensing, and recording of drugs shall be exempted from the following: * Recording of prescription filled in the prescription book, provided such prescriptions shall be kept in file for two years. * Individually informing the in-patient/buyer on available generic equivalents and their corresponding prices. However, a handbook or directory containing the required drug information must be made available in the ward for patients, responsible relatives of patients and professional staff.

Question 50

ADDITIONAL GUIDELINES ON DISPENSING In dispensing to the _, the drug products in the _ dose or products which are not in their original containers but transferred to small bottles, tin cans, boxes, plastic and/or paper envelopes and the like, the pharmacist shall place legibly on the required drug outlet’s label the following information:

Answer 50

In dispensing to the buyer, the drug products in the unit dose or products which are not in their original containers but transferred to small bottles, tin cans, boxes, plastic and/or paper envelopes and the like, the pharmacist shall place legibly on the required drug outlet’s label the following information: Name of patient Dosage strength Generic name of the drug Expiry date Brand name, if any Directions for use Manufacturer Name of Pharmacist

Question 51

ADDITIONAL GUIDELINES ON DISPENSING The _-filled prescription shall be _ to the buyer _ recording the partial filling in the _ book. The drugstore which completes the filling of the prescription shall keep the prescription in file. Dispensing _ and _ Drugs (List) and Drugs Requiring _ Precautions (List _) (Please see attached Lists) * In dispensing _ and _ drugs requiring _ precautions in their use, the following shall be observed: - Dispensing must be done by the pharmacist who shall affix his/her _ on the prescription filled. - The order and instructions of the _ as written on the prescription, must be precisely followed. - Partial filling of prescription for prohibited and regulated drugs (List _) shall not be allowed

Answer 51

ADDITIONAL GUIDELINES ON DISPENSING The partially-filled prescription shall be returned to the buyer after recording the partial filling in the prescription book. The drugstore which completes the filling of the prescription shall keep the prescription in file. Dispensing prohibited and Regulated Drugs (List) and Drugs Requiring Strict Precautions (List B) (Please see attached Lists) * In dispensing prohibited and regulated drugs requiring strict precautions in their use, the following shall be observed: - Dispensing must be done by the pharmacist who shall affix his/her signature on the prescription filled. - The order and instructions of the doctor as written on the prescription, must be precisely followed. - Partial filling of prescription for prohibited and regulated drugs (List A) shall not be allowed.

Question 52

Pharmacy law of 1969

Answer 52

RA 5921 June 23 1969

Question 53

Señior Citizen Act of 1992

Answer 53

RA 7432 April 23, 1992

Question 54

Expanded Señior Citizen Act of 2003

Answer 54

RA 9257 February 26, 2004

Question 55

Expanded Señior Citizen Act of 2010

Answer 55

RA 9994 February 15, 2010

Question 56

Comprehensive Dangerous Drug Act of 2002

Answer 56

RA 9165 June 7, 2022

Question 57

Dangerous Drug Act of 1972

Answer 57

RA 6425 April 4, 1972

Question 58

TAMA Act of 1997

Answer 58

RA 8423 December 9, 1997

Question 59

Special Law on Counterfeit Drugs

Answer 59

RA 8203 July 22, 1996

Question 60

Consumer's Act

Answer 60

RA 7394 April 13, 1994

Question 61

The Price Act

Answer 61

RA 7581 May 7, 1992

Question 62

RA 9502

Answer 62

Universally Accessible Cheaper and Quality Medicines Act of 2008 June 6, 2008

Question 63

FDA Act of 2009

Answer 63

RA 9711 August 18, 2009

Question 64

Drug Registration of Herbal and/or Traditional

Answer 64

AO 172 s. 2004

Question 65

Availing of Compassionate Special Permit (CSP)

Answer 65

AO 4 s. 1992

Question 66

Licensing Local Manufacturers of Vaccines and Biologic Products

Answer 66

AO 27 s. 2001

Question 67

Requirement for Labelling Materials of Pharml Products

Answer 67

AO 55 s. 1988

Question 68

Ammendments of AO 55 s. 1988

Answer 68

AO 64 s. 1989

Question 69

Rules and Regulations on Licensing Drug Establishment

Answer 69

AO 2014-0034

Question 70

Adopting PNDS as immediate reference of standards

Answer 70

EO 302 s. 2004

Question 71

Pharmacist Monitoring Hours

Answer 71

MC 17 s. 1989

Question 72

Prescribing requirement

Answer 72

AO 62 s. 1989

Question 73

Dispensing requirement

Answer 73

AO 63 s. 1989

Question 74

Registration of Pharmaceutical Products

Answer 74

AO 67 s. 1987

Question 75

Revised Rules and Regulations on Registration of Pharmaceutical Products

Answer 75

AO 2006-0021