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

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

1
Q

GIVE A SAMPLE ORGANIZATIONAL CHART IN COMMUNITY
PHARMACY

A

Pharmacy owner
Pharmacist
2 Pharmacy Assistant

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2
Q

STANDARDS AND REQUIREMENTS FOR LTO

Give the 7 GENERAL REQUIREMENTS FOR LTO (under APPLICATION)

A

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.

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3
Q

GIVE THE 8 COMMUNITY PHARMACY STRUCTURE AND SET-UP

A

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

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4
Q

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.

A

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.

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5
Q

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.

A

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.

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6
Q

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.

A

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

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7
Q

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

A
  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).
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8
Q

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

A

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

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9
Q

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

A

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).
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10
Q

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

A

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.

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11
Q

Specific Requirement of Drugstores, Pharmacy or Botica

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

A

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

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12
Q

Other Additional Requirement of Drugstores, Pharmacy or Botica

A

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

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13
Q

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

A

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

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14
Q

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

A

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

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15
Q

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

A

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

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16
Q

Other Additional Requirements for Retail Outlet for
Non-Prescription Drugs

A

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.

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17
Q

Administrative Sanction

Absence of pharmacist on 3 inspection by BFAD inspector

A

Temporary Closure

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18
Q

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.

A

Suspension of License to Operate

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19
Q

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.

A

4.3. Revocation of License to Operate

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20
Q

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

A

P500.00 per drugstore, pharmacy or boticaoutlet

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

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21
Q

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

A

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

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22
Q

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

A

•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

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23
Q

PHILIPPINE PHARMACY ACT

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

A

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

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24
Q

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

A

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

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25
Q

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

A

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

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26
Q

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

A

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

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27
Q

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

A

Category A and Category B

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28
Q

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,

A

Category A

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29
Q

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;

A

Category A

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30
Q

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;

A

Category A

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31
Q

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;

A

Category A

32
Q

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

A

Category A

33
Q

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

A

Category B

34
Q

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

A

Category B

35
Q

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

A

Category B

36
Q

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

A

Category B

37
Q

Category A or Category B?
Institutions providing telepharmacy services

A

Category B

38
Q

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

A

Category B

39
Q

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.

A

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.

40
Q

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.

A

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.

41
Q

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
A

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.

  1. Owners, managers, or pharmacists in charge of the
    operation of pharmaceutical establishments and outlets
    shall be held jointly responsible for nonconformance
    with these standards
  2. 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.
  3. 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
42
Q

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 _.

A

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.

43
Q

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

A

Physician’s sample

44
Q

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

A

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

45
Q

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

A

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

46
Q

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

A

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

47
Q

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

A

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

48
Q

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.

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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.

49
Q

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.

A

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.

50
Q

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:

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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

51
Q

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

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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.

52
Q

Pharmacy law of 1969

A

RA 5921
June 23 1969

53
Q

Señior Citizen Act of 1992

A

RA 7432
April 23, 1992

54
Q

Expanded Señior Citizen Act of 2003

A

RA 9257
February 26, 2004

55
Q

Expanded Señior Citizen Act of 2010

A

RA 9994
February 15, 2010

56
Q

Comprehensive Dangerous Drug Act of 2002

A

RA 9165
June 7, 2022

57
Q

Dangerous Drug Act of 1972

A

RA 6425
April 4, 1972

58
Q

TAMA Act of 1997

A

RA 8423
December 9, 1997

59
Q

Special Law on Counterfeit Drugs

A

RA 8203
July 22, 1996

60
Q

Consumer’s Act

A

RA 7394
April 13, 1994

61
Q

The Price Act

A

RA 7581
May 7, 1992

62
Q

RA 9502

A

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

63
Q

FDA Act of 2009

A

RA 9711
August 18, 2009

64
Q

Drug Registration of Herbal and/or Traditional

A

AO 172 s. 2004

65
Q

Availing of Compassionate Special Permit (CSP)

A

AO 4 s. 1992

66
Q

Licensing Local Manufacturers of Vaccines and Biologic Products

A

AO 27 s. 2001

67
Q

Requirement for Labelling Materials of Pharml Products

A

AO 55 s. 1988

68
Q

Ammendments of AO 55 s. 1988

A

AO 64 s. 1989

69
Q

Rules and Regulations on Licensing Drug Establishment

A

AO 2014-0034

70
Q

Adopting PNDS as immediate reference of standards

A

EO 302 s. 2004

71
Q

Pharmacist Monitoring Hours

A

MC 17 s. 1989

72
Q

Prescribing requirement

A

AO 62 s. 1989

73
Q

Dispensing requirement

A

AO 63 s. 1989

74
Q

Registration of Pharmaceutical Products

A

AO 67 s. 1987

75
Q

Revised Rules and Regulations on Registration of Pharmaceutical Products

A

AO 2006-0021

CMPI (1 decks)

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