WORKSHEET NO.

1: The Hospital Pharmacy Environment

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WORKSHEET NO. 1: The Hospital Pharmacy Environment

Introduction:

The Hospital Pharmacy should be properly organized meeting the minimum requirements
prescribed by the Food and Drug Administration (FDA), PDEA and the Department of Health (DOH) and
follows the laws and policies of Pharmacy Practice in the Philippines. The organization of a hospital
pharmacy must satisfy the needs of the pharmacists performing their role as the vital link in the chain of
health providers dedicated to patient care.

The Hospital Pharmacy Service shall be under the general supervision of the administrative officer
or Chief of Hospital (COH); it will directly be administered and supervised by a licensed Pharmacist.

The organization serves to establish the authority relationships between positions and to assign
tasks that achieve the pharmacy’s objectives. An organizational chart showing the flow of administrative
authority is essential to the selection and categorization of employees.

It is imperative to list all the functions of the Pharmacy Service in the planning of personnel
requirements of various work systems; the estimated workload units per function and the time required to
complete each workload unit.
 Plants, facilities, equipment and other materials of the hospital pharmacy must comply with the FDA
minimum standard requirements for the issuance of LTO in the establishment of Hospital Pharmacy.
However, these are further standardized based on the hospital’s capability levels, sizes, and scope of
service.

Adequate spaces, equipment and supplies are provided for the professional and administrative
functions of the Pharmacy Service to assure patient safety through proper storage, preparation and
dispensing of drugs.

Drugs are stored under proper condition of sanitation, temperature, light, ventilation, segregation
and security. There must be a suitable area for compounding, manipulating parenteral medications,
dispensing, adequate storage of drugs and administrative functions.

Objectives:

At the end of this activity the students are expected:

• To familiarize with the organizational chart of a hospital pharmacy based on bed capacities.
• To identify the requirements and responsibilities of the personnel of a hospital pharmacy.
• To identify the requirements for the licensing of a hospital pharmacy (FDA/DOH, PDEA)
• To familiarize with the procedures involved in the application of the LTO in a hospital Pharmacy
• To familiarize with the different laws and regulations governing Pharmacists in a Hospital setting.

Questions:

• Organizational Chart

1. Enumerate the different types of Hospital based on:

• General Classification
A. Clinical Services - family medicine, pediatrics, internal medicine,
obstetrics and gynecology, surgery, emergency services, and outpatient services.
B. Emergency Services
C. Outpatient Services
D. Ancillary and Support Services such as, clinical laboratory, imaging facility
and pharmacy.

• Specialization
1. Treatment of a particular type of illness or for a particular condition
requiring range of treatment. Examples of these hospitals are Philippine Orthopedic Center, National
Center for Mental Health, San Lazaro Hospital, a hospital dedicated to the treatment of cancer.
 2. Treatment of patients suffering from diseases of a particular organ or groups
of organs. Examples of these hospitals are Lung Center of the Philippines, Philippine Heart Center,
National Kidney and Transplant Institute, a hospital dedicated to treatment of eye disorders.

3. Treatment of patients belonging to a particular group such as children,

women, elderly and others. Examples of these hospitals are Philippine Children’s Medical Center,
National Children’s Hospital, and Dr. Jose Fabella Memorial Hospital.

• Capacity

1. General Hospital

A. Level 1

A Level 1 hospital shall have as minimum the services stipulated under Rule V. B. 1. b. 1. of this
Order, including, but not limited to, the following:

1. A staff of qualified medical, allied medical and administrative personnel headed by a physician
duly licensed by PRC;

2. Bed space for its authorized bed capacity in accordance with DOH Guidelines in the Planning
and Design of Hospitals;

3. An operating room with standard equipment and provision for sterilization of equipment
and supplies in accordance with:

a. DOH Reference Plan in the Planning and Design of an Operating Room/Theater (Annex A);

b. DOH Guidelines on Cleaning, Disinfection and Sterilization of Reusable Medical Devices in

Hospital Facilities in the Philippines (Annex B);

4. A post-operative recovery room;

5. Maternity facilities, consisting of ward(s), room(s),a delivery room, exclusively for maternity
patients and newborns;

6. Isolation facilities with proper procedures for the care and control of infectious and
communicable diseases as well as for the prevention of cross infections;

7. A separate dental section/clinic;

8. Provision for blood station;

9. A DOH licensed secondary clinical laboratory with the services of a consulting pathologist;

10. A DOH licensed level 1 imaging facility with the services of a consulting radiologist;

11. A DOH licensed pharmacy.

B. Level 2

A Level 2 hospital shall have as minimum, all of Level l capacity, including, but not limited to, the
following:

1. An organized staff of qualified and. competent personnel with Chief of Hospital/Medical Director
and appropriate board certified Clinical Department Heads;

2. Departmentalized and equipped with the service capabilities needed to support board
certified/eligible medical specialists and other licensed physicians rendering services in the
specialties of Medicine, Pediatrics, Obstetrics and Gynecology, Surgery; their subspecialties and
ancillary services;

3. Provision for general ICU for critically ill patients.

4. Provision for NICU (Neonatal Intensive Care Unit)

5. Provision for HRPU (High Risk Pregnancy Unit)

6. Provision for respiratory therapy services;

7. A DOH licensed tertiary clinical laboratory;

8. A DOH licensed level 2 imaging facility with mobile x-ray inside the institution and with capability
for contrast examinations.

C. Level 3

A Level 3 hospital shall have as minimum, all of Level 2 capacity, including, but not limited to, the
following:

1. Teaching and/or training hospital with accredited residency training program for physicians in the
four (4) major specialties namely: Medicine, Pediatrics, Obstetrics and Gynecology, and Surgery;

2. Provision for physical medicine and rehabilitation unit;

3. Provision for ambulatory surgical clinic;

4. Provision for dialysis facility;

5. Provision for blood bank;

6. A DOH licensed tertiary clinical laboratory with standard equipment/reagents/supplies necessary

for the performance of histopathology examinations;

7. A DOH licensed level 3 imaging facility with interventional radiology.

2. Specialty Hospitals (refer to Rule V. B. 1. b. 2. of this Order)

3. Trauma Capability of Hospitals

The trauma capability of hospitals shall be assessed in accordance with the guidelines formulated
by the Philippine College of Surgeons (PCS).

A. Trauma-Capable Facility – a DOH licensed hospital designated as a Trauma Center.

B. Trauma-Receiving Facility – a DOH licensed hospital within the trauma service area which
receives trauma patients for transport to the point of care or a trauma center.

2. Illustrate a Hospital Pharmacy Organizational Chart based on bed capacity:

A. Secondary Level (25 beds)

B. Tertiary Level (200 beds)

3. Illustrate the Functional Chart of the Pharmacy Service.
4. Provide the basic requirements and job descriptions of the following:
POSITION REQUIREMENT
1. B.S. Degree in Pharmacy
Chief Pharmacist 2. Duly licensed by law to
practice pharmacy
3. M.S. in Pharmacy or its
equivalent
4. With 6 years of experience-
3 years supervisory work and
3 years as dispensing
pharmacist, with on- the-job
training/continuing education
5. Physically, mentally,
emotionally and morally fit to
work
1. B.S. Degree in Pharmacy
Supervising Pharmacist 2. Duly licensed by law to
practice pharmacy
3. With 4 years of experience-
with 2 years of supervisory
work in pharmacy and 2 years
as dispensing pharmacist
4. With at least 12 units of
M.A. and on-the-job training/
continuing education
5. Physically, mentally,
emotionally and morally fit to
work
1. B.S. Degree in Pharmacy
Senior Pharmacist 2. Duly licensed by law to
practice pharmacy
3. At least 3 yrs experience, 1
yr on supervisory work and 2
yrs as dispensing pharmacist
with on- the-job
training/continuing education
4. Physically, mentally,
emotionally and morally fit to
work
JOB DESCRIPTION
Provide the overall supervision
of the activities of the
Pharmacy Service of
comparatively large general or
special hospitals and perform
other related functions
Supervise activities of the
Pharmacy Service of smaller
general or special hospitals
and/or supervise the activities
of employees in the Pharmacy
Service of a comparatively
large general or special
hospital, and perform other
related functions
Under general supervision ,the
Senior Pharmacist shall
supervise the activities of a
small group of employees of
the Pharmacy Service of a
general hospital or special
hospital and perform other
related functions
 1. B.S. Degree in Pharmacy
Pharmacist 2. Duly licensed by law to Under general supervision, the
practice pharmacy pharmacist fills and dispenses
3. New graduate/or at least 1 drugs and medical supplies to
year pharmacy practice, in- patients and out-patients
orientation with further on-the- ordered or prescribed by a
job training/continuing licensed physicians
education
4. Physically, mentally,
emotionally and morally fit to
work
1. Completion of at least two 1. Perform work incidental or
Pharmacy Aide years of college studies preparatory to the work of the
2. Two years of experience in pharmacist
a pharmacy 2. Clean empty bottles,
3. Physically, mentally, cylinders, funnels , mortars and
emotionally and morally fit to other pharmacy
work equipment/apparatus
3. Assist the pharmacist on
drug inventory control
4. Prepackage drugs and
pharmaceuticals and arrange
them in shelves
5. Inform the pharmacist of out-
of order equipment
6. Assist in the preparation of
charges for pay/medicare
patients
7. Participate in the QAP of the
Pharmacy Service
8. Attend staff development
programs/seminar-workshops
relevant to his/her work
9. Accomplish the performance
appraisal report
10. Perform other related
functions
1. Completion of two years of 1. Do all the
Clerk college studies typing/filling/safekeeping of
2. One year experience in documents, receiving and
preparation of routine office releasing papers pertinent to
3. Career Service (Sub- the operation of the Pharmacy
professional) Relevant Service
 Eligibility for First
Level 2. Counter-check submitted
Position issue forms of the pharmacy
staff on duty for entry to
4. Physically, mentally, stock/supplies ledger cards
emotionally and morally fit to 3. Record issuances of drugs
work daily in the ledger cards
4. Prepare adjustment sheets
as the basis for the statistical
report on the monthly
consumption and balances of
stocks in the pharmacy
5. Participate in QAP of the
Pharmacy Service
6.Attend staff development
programs and
seminar/workshops relevant to
his/her work
7. Accomplish the performance
appraisal report

8. Perform other related

functions

1. Completion of two years of 1. Receive/check/post drugs on

Storekeeper college studies ledger cards for safekeeping
2. One year experience in and proper storage in the bulk
recording and storing of storage area and record
supplier releases for pharmacy stocks in
3. Career Service (Sub- the active storage area
professional) Relevant 2. Transfer/withdraw drug items
Eligibility for First Level from bulk storeroom to active
Position storeroom of pharmacy for
4. Physically, mentally, distribution assisted by the
emotionally and morally fit to utility worker (UW)
work 3. Conduct regular and weekly
follow-up of physical inventory
of drugs
4. Inspect drugs stored at the
bulk storeroom as the expiry
dates, slow and fast moving
drugs
5. Attend seminar/workshops,
and other staff development
 programs relevant to the work
6. Participate in QAP of the
Pharmacy Service
7. Accomplish performance
appraisal report
8. Perform other related
functions
1. Completion of elementary 1. Maintain housekeeping and
Utility worker school course or must be able sanitation of the pharmacy as
to read, write, count and well as its bulk and active
interpret verbal or written storage areas
instruction of normal 2. Maintain facilities of the
complexity pharmacy
2. Six months of experience in 3. Attend to the administrative
manual work needs in the operation of the
3. Civil Service Eligibility not Pharmacy Service
required 4. Assist the storekeeper in the
transfer or withdrawal of drug
4. Physically, mentally, items from the bulk storage
emotionally and morally fit to area to the active storage area
work of the pharmacy eventual
distribution
5. Participate in the QAP of the
Pharmacy Service
6. Accomplish the performance
appraisal report

7. Perform other related

functions

5. Complete the table for the staffing patterns in a Hospital Pharmacy setting
 10-15 25 50 100 200 300

Chief Pharmacist - - - - - 1

Supervising RPh - - - 1 1 1

Senior RPh - 1 1 1 2 3

Pharmacist(s) 2 3 4 7 8 12

Lab Aide(s) 1 1 1 1 3 3

Clerk(s) - 1 1 2 2 2

Storekeeper - - 1 1 1 1

Utility worker - - - 1 1 1

• Laws and Regulations applied in Hospital Pharmacy

List down the Laws Governing the Practice of Pharmacy in the Philippines

LAWS DESCRIPTION
R.A NO. 5921 An Act Regulating The
Practice Of Pharmacy And
Setting Standards Of
Pharmaceutical Education In
The Philippines And For
Other Purposes.

This Act provides for and shall

govern (a) the standardization
and regulation of
pharmaceutical education; (b)
the examination for
registration of graduates of
schools of pharmacy and (c)
the supervision, control and
regulation of the practice of
pharmacy in the Philippines.

R.A NO. 3720 “Food, Drug, and Cosmetic

Act”

An act to ensure the safety

and purity of foods, drugs,
and cosmetics being made
available to the public by
creating the food and drug
administration which shall
administer and enforce the
laws pertaining thereto.

R.A. NO. 6675 “Generics Act of 1988”

To promote drug safety by

minimizing duplication in
medications and/or use of
drugs with potentially adverse
drug interactions
R.A. NO. 8203 “Special Law on Counterfeit
Drugs”

An Act Prohibiting Counterfeit

Drugs Providing Penalties for
Violations and Appropriating
Funds Therefor. This Act,
consisting of 14 sections, aims
at protecting human and
animal health through
provisions against counterfeit
drugs.

R.A. NO. 7394 “Consumer Act of the

Philippines”

The protection of consumers

from risks to their health and
safety, the prevention of
unfair, deceptive, and
unethical sales practices, the
provision of knowledge and
instruction to aid in informed
decision-making and the
proper exercise of rights by
consumers, the provision of
adequate rights and channels
for redress, and the
participation of consumer
representatives in the
development of social and
economic policies.

AO NO. 56 s. 1989 Revised Regulations for the

Licensing of Drug
Establishments and Outlets

Pursuant to Section 26(a) in

relation to Section 21(a) and
11(k) of Republic Act No.
3720, known as the Foods,
 Drugs and Devices, and
Cosmetics Act as amended by
Executive Order No. 175 s.
1987 and consistent with
Republic Act No. 6675, known
as the Generic Act of 1988,
the following regulations are
hereby promulgated
governing drug
establishments and drug
outlets under the Bureau of
Food and Drugs (BFAD).

R.A. NO. 7581 “Price Act”

An act providing protection to

consumers by stabilizing the
prices of basic necessities and
prime commodities and by
prescribing measures against
undue price increases during
emergency situations and like
occasions.

R.A. NO. 9165 “Comprehensive Dangerous

Drugs Act of 2002”

Provides for importation of

Dangerous Drugs and/or
Controlled Precursors and
Essential Chemicals. It
establishes offences and
penalty according to the
different dangerous drug,
regardless of the quantity and
purity involved

P.D. NO. 881 "Empowering the Secretary

of Health to Regulate
Labeling, Sale and
 Distribution of Hazardous
Substance."

The Department of Health-

Food and Drug Administration
(DOH-FDA) has systems in
place to ensure the safety of
toys, and school supplies like
crayons and pencils
categorized as household
hazardous substances are
likewise being regulated.

E.O. NO. 302 “Providing Policies,

Guidelines, Rules And
Regulations For The
Procurement Of
Goods/Supplies By The
National Government. “

The present policies,

guidelines, rules and
regulations covering contracts
for the procurement of
goods/supplies for project-
related and normal/regular
operations and maintenance
activities of the National
Government appear to be,
generally, fragmented; in the
interest of public service, the
procurement of
goods/supplies by the
National Government must be
based on the public economy;
as a consequence of the
continuous increase in
development projects,
operations and maintenance
requirements of the National
Government, contracts for the
procurement of
goods/supplies have
 substantially increased;

R.A. NO. 9257 “Expanded Senior Citizens Act

of 2003”

RA 9257 grants additional

privileges such as the
provision on employment,
free skills training and
education, among others. The
Administrative Order issued
by the DoH was issued to
guide drug stores, hospitals
and other medical
establishments in providing
health care to senior citizens.

• Requirements of a Hospital Pharmacy (LTO)

• What are the 3 phases of licensing process

Phase Goal Activities

- To coordinate with the health - Fill up application form

Pre-inspection facility to be visited.
Phase - Inspection activity agenda
- To inform the management of
- Copy of administrative order and
the purpose of the inspection and
other related issuance
their participation in the activity.
- Checklist of documents to be
available during inspection.
 To encourage interactive - Leadership interview
Inspection Phase participation of the key staff in the
- Document review session
inspection process.
- Tour of the health facility

- Feedback session

To make a decision on the extent - Regulatory officers collate

Vrv-

Post-inspection to which the health facility is able findings.

Phase to meet the minimum licensing
- The team prepares the report
requirements.
- The team submits the report
together with its
recommendations to the director
of the CHD.

- The CHD director approves or

disapproves the issuance of the
LTO.

• Under Administrative Order No. 2020-0017, Define the following terminologies:

• Authorized Person - refers to the owner, President, Chief Executive Officers (CEO) or its
equivalent, or any organic or full-time employee representing the establishment in an authorized or
official capacity.

• Initial Application - or Original Application refers to the License to Operate (LTO) applied to FDA
prior to engaging in the business or operation involving the manufacture, importation, exportation,
sale, offer for sale, distribution, transfer, and where applicable the use, testing, promotion,
advertisement, and/or sponsorship of health products.

• Packer/ Repacker - refers to any establishment that repacks a finished product into smaller
quantities in a separate container and/or secondary packaging, including but not limited to
relabeling, stickering, and bundling for promo packs with the end view of storage, distribution, or
sale of the product.

• Qualified Person - refers to an organic or full-time employee of the establishment who possess
technical competence related to the establishment's activities and health products by virtue of his
profession, training or experience. A qualified person has the responsibility to comply with the
technical requirements of the FDA or discuss or clarify matters with the FDA when submitting
technical requirements or engage the FDA officials when conducting inspection or post-market
 surveillance activities. The qualified person may also be the duly Authorized Person of the
establishment.

• Refurbished Medical Device - refers to the medical device of which the whole or any part
thereof has been substantially rebuilt, whether or not using parts from one or more used medical
devices of that same kind, so as to create a medical device that can be used for the purpose
originally intended by the product owner of the original medical device, and which may have had
the following work carried out on it: a.) stripping into component parts or subassemblies; b.)
checking their suitability for reuse; c.) replacement of components/sub-assemblies not suitable for
reuse; d.) assembly of the reclaimed and/or replacement components/sub-assemblies; e.) testing
of the assembled device against either original or revised release criteria; or f.) identifying an
assembled medical device as a refurbished medical device. (ASEAN Medical Device Directive,
2015)
• Risk Management Plan - refers to the document that contains the details on how to identify,
characterize, prevent or minimize the risk relating to the products that the establishment is engaged
in. It shall include post-market surveillance activities and interventions to manage identified risks.
• Site Master File - refers to the specific information about the quality assurance the production
and/or quality control of manufacturing operations carried out at the named site and any closely
integrated operations at adjacent and nearby buildings. If only part of an operation is carried out on
the site, a Site Master File need only describe those operations, e.g. analysis, packaging, etc.

• List the Specific requirements of the following:

• Initial LTO
• General Requirements
• Notarized accomplished Application for Authorization Form

• Proof of registration

• Proof of occupancy – office

• Proof of occupancy – warehouse

• Proof of occupancy – manufacturer

• Photocopy of Notarized Fixed Asset & Operating Capital or Financial Statement (new requirement)

• Location Plan

• Floor Plan

• Tentative list of food products to be manufactured or distributed identified on its classification and category

• Facsimile of Proposed Label (for local manufacturer) / sample label of product to be imported or a digital
image of the document in an FDA-approved file type.

• Specific Requirements
 • Application Form (web-based form) Among other information, the applicant shall provide the following
information: Location Plan. Global Positioning System (GPS) coordinates. Name of the Qualified Person.

• Proof of Business Name Registration.

• Premises - shall have the meaning ascribed to it in Recital D of this Agreement.

• Reference Books and Documents -
• Your name at the top of the page.

• List your references, including their name, job title, company, and contact information, with a space
in between each reference.

• Include at least three professional references who can attest to your ability to perform the job you
are applying for.

• Record Books Duly Registered with FDA - Prescription Book, Senior Citizen's, Persons with Disability

• Utensils, Apparatus and Other equipments - FDA review teams thoroughly examine all of the
submitted data related to the drug or device and make a decision to approve or not to approve
it.

• Personnel - (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product
shall have education, training, and experience, or any combination thereof, to enable that person to perform
the assigned functions. Training shall be in the particular operations that the employee performs and in
current good manufacturing practice (including the current good manufacturing practice regulations in this
chapter and written procedures required by these regulations) as they relate to the employee's functions.
Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing
basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements
applicable to them. (b) Each person responsible for supervising the manufacture, processing, packing, or
holding of a drug product shall have the education, training, and experience, or any combination thereof, to
perform assigned functions in such a manner as to provide assurance that the drug product has the safety,
identity, strength, quality, and purity that it purports or is represented to possess. (c) There shall be an
adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or
holding of each drug product.

• Other Additional Requirements

• Renewal of LTO

• Validity of LTO - 10 years

 • Schedule of Fees - a list of fees that must be paid for performance of certain
administrative functions.
• Variation
• Minor Variation
• Major Variation

• Complete the requirements of S license in the table below:

License Required

License to prescribe (a) dangerous drug

Prescribing Physician/ Veterinarian/ preparations in any form; and/or (b) drug
Dentist preparations containing controlled chemicals,
except drug preparations containing Norephedrine /
Phenylpropanolamine at doses 25 mg or below
[OTC drugs, per BFAD AO 163, s. 2000] P500.00
or P1,500.00 for three (3) years

License to sell, procure, acquire, deal in or with

Retail Dealer of DDPs specified drug preparations, containing a
controlled chemical for retail, except drug
preparations containing Norephedrine /
Phenylpropanolamine at doses 25 mg or below
[OTC drugs, per BFAD AO 163, s. 2000]. P500

License to sell, procure, acquire, deal in or with

Wholesaler Dealer of DDPs specified (a) dangerous drugs and their
preparations in any form; (b) drug preparations
containing controlled chemicals for wholesale

Manufacturer/ Repacker of DDPs
Importer of DDPs
distribution to license holders, except drug
preparations containing Norephedrine /
Phenylpropanolamine at doses 25 mg or below
[OTC drugs, per BFAD AO 163, s. 2000]; and
(c) controlled chemicals used in the
manufacture of drugs preparations The license
holder need not obtain another license of the
same nature of activity for such controlled
chemicals
License to manufacture specified (a) dangerous
drugs and their preparations in any form; and (b)
drug preparations containing controlled chemicals
provided, that the license shall not apply to the
compounding and filling of prescriptions in
drugstores, clinics and hospitals. The license holder
need not obtain another license of the same nature
of activity for such controlled chemicals; may
engage in wholesale distribution of that substance
or class for which license was issued and may not
distribute any substance or class for which it is not
licensed. May conduct chemical analysis and quality
control analysis with those substances for which
license as a manufacturer was issued; May procure,
acquire scientific apparatus or controlled laboratory
equipment for manufacture of drugs. A controlled
substances trader shall be categorized as a
manufacturer.
License to import specified (a) dangerous drugs and
their preparations in any form; (b) drug preparations
containing controlled chemicals, except drug
preparations containing Norephedrine /
Phenylpropanolamine at doses 25 mg or below
[OTC drugs, per BFAD AO 163, s. 2000]; (c)
controlled chemicals used in the manufacture of
drugs preparations; and, (d) in vitro diagnostic
reagents, buffers and analytical standards, test kits
containing dangerous drugs. The license holder
need not obtain another license of the same nature
of activity for such controlled chemicals; may
 engage in wholesale distribution of that substance
or class for which license was issued and not
distribute any substance or class which is not
licensed]

License to export specified (a) dangerous drugs and

Exporter of DDPs their preparations in any form; and/or (b) drug
preparations containing controlled chemicals : to
foreign license holders.

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